Rheumatoid Arthritis
Conditions
Keywords
extension trial, rheumatoid arthritis, rituximab
Brief summary
This extension study will evaluate the safety (including immunogenicity) of treatment with rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued treatment access to subjects with active rheumatoid arthritis who have participated for at least 16 weeks in other studies in the rituximab Pfizer program.
Interventions
BIOLOGICALRituximab-Pfizer (PF-05280586) x 3 courses
1000 mg intravenous infusion \[IV\] on Days 1 and 15 of each 24 week treatment course for up to 3 treatment courses
BIOLOGICALRituximab-EU+ Rituximab-Pfizer x 2 Courses
Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-EU on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
BIOLOGICALRituximab-US + Rituximab-Pfizer x 2 Courses
Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-US on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * Participated for a minimum of 16 weeks after the initiation of the last course of treatment in a previous rheumatoid arthritis study in the rituximab-Pfizer program within the past 2 months.
Exclusion criteria
* Investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the study. * Initiated treatment with investigational agents or other biologics (including Rituxan and MabThera) since participating in a previous rheumatoid arthritis study in the rituximab-Pfizer program.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall. | Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive (+ve) for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586. |
| Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall. | Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586. |
| Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay | Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3). | Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays - None of the ADA samples tested positive for NAb. |
| Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay | Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3). | Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays. - None of the ADA samples tested positive for NAb. |
| Mean Rituximab Serum Trough Concentrations | Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3), Follow up Months 3, 6, 9, and 12. Course 3/Week 25 is End of Treatment (EOT). | Serum samples for determination of drug concentrations were collected pre-dose concurrent with ADA sample collection. Drug concentrations in the samples were determined using a validated assay. |
| Cluster of Differentiation 19 (CD19+) B Cell Count | Weeks 1, 6, 13, and 25 (Course 1 and Course 2), Weeks 1, 13, 25 (Course 3), and Follow up Months 3, 6, and 9. | Blood samples were assayed for CD19+ B-cell counts using laser scanning cytometry. |
| Circulating Immunoglobulin G (IgG) Concentrations | Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3). | Blood samples for immunoglobulin assessments were obtained to determine IgG levels in serum. |
| Circulating Immunoglobulin M (IgM) Concentrations | Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3). | Blood samples for immunoglobulin assessments were obtained to determine IgM levels in serum. |
| Circulating Rheumatoid Factor (RF) Concentrations | Week 1 and 25 (Course 1, Course 2, and Course 3). | RF is the auto-antibody directed against IgG. Blood samples were obtained to determine RF levels in serum. |
| Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Week 1 and 25 (Course 1, Course 2, and Course 3). | Blood samples were obtained to determine anti-CCP and compliment levels in serum. |
| Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Baseline B3281001, Week 1, 6, 13, and 25 (Course 1). | The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log \[ln\] (CRP \[milligrams per liter, mg/L\] +1) + 0.014 (global assessment of health \[GH\]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. |
| Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2). | The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log \[ln\] (CRP \[milligrams per liter, mg/L\] +1) + 0.014 (global assessment of health \[GH\]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. |
| Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3). | The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log \[ln\] (CRP \[milligrams per liter, mg/L\] +1) + 0.014 (global assessment of health \[GH\]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. |
| Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Week 1, 6, 13, and 25 (Course 1). | The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (\>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline \>0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline \>0.6 with present DAS28 \>3.2 and ≤5.1 or change from baseline \>1.2 with present DAS28 \>5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 \>5.1. |
| Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Week 1, 6, 13, and 25 (Course 1 and Course 2). | The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (\>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline \>0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline \>0.6 with present DAS28 \>3.2 and ≤5.1 or change from baseline \>1.2 with present DAS28 \>5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 \>5.1. |
| Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3). | The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (\>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline \>0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline \>0.6 with present DAS28 \>3.2 and ≤5.1 or change from baseline \>1.2 with present DAS28 \>5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 \>5.1. |
| Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Week 1, 6, 13, and 25 (Course 1). | The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity. |
| Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Week 1, 6, 13, and 25 (Course 1 and Course 2). | The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity. |
| Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3). | The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity. |
| Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Week 1, 6, 13, and 25 (Course 1). | The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP \<2.6 implied remission. |
| Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Week 1, 6, 13, and 25 (Course 1 and Course 2). | The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP \<2.6 implied remission. |
| Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3). | The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP \<2.6 implied remission. |
| Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Week 1, 6, 13, and 25 (Course 1). | ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP. |
| Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Week 1, 6, 13, and 25 (Course 1 and Course 2). | ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP. |
| Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3). | ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP. |
| Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Week 1, 6, 13, and 25 (Course 1). | ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP. |
| Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Week 1, 6, 13, and 25 (Course 1 and Course 2). | ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP. |
| Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3). | ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP. |
| Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Week 1, 6, 13, and 25 (Course 1). | ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP. |
| Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Week 1, 6, 13, and 25 (Course 1 and Course 2). | ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP. |
| Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3). | ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP. |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Screening, Week 1, 6, 13, and 25 (Course 1). | Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed. |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2). | Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed. |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3). | Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed. |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Screening, Week 1, 6, 13, and 25 (Course 1). | Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed. |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2). | Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed. |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3). | Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed. |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Week 1, 6, 13, and 25 (Course 1). | Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain. |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Week 1, 6, 13, and 25 (Course 1 and Course 2). | Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain. |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3). | Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain. |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Week 1, 6, 13, and 25 (Course 1). | Participants were asked the following question, Considering all the ways your arthritis affects you, how are you feeling today? Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor). |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Week 1, 6, 13, and 25 (Course 1 and Course 2). | Participants were asked the following question, Considering all the ways your arthritis affects you, how are you feeling today? Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor). |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3). | Participants were asked the following question, Considering all the ways your arthritis affects you, how are you feeling today? Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor). |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Week 1, 6, 13, and 25 (Course 1). | The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor). |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Week 1, 6, 13, and 25 (Course 1 and Course 2). | The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor). |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3). | The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor). |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Week 1, 6, 13, and 25 (Course 1). | HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible. Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty. Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale. |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Week 1, 6, 13, and 25 (Course 1 and Course 2). | HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible. Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty. Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale. |
| Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3). | HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible. Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty. Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale. |
| Outcome Measure Using HAQ-DI - by the End of Course 1 | Week 1, 6, 13, and 25 (Course 1). | HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible. Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty. Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3. |
| Outcome Measure Using HAQ-DI - by the End of Course 2 | Week 1, 6, 13, and 25 (Course 1 and Course 2). | HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible. Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty. Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3. |
| Outcome Measure Using HAQ-DI - by the End of Course 3 | Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3). | HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible. Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty. Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3. |
Countries
Australia, Canada, Colombia, Germany, Israel, Mexico, Russia, South Africa, United Kingdom, United States
Participant flow
Recruitment details
This was an extension study for participants with active rheumatoid arthritis who had participated for at least 16 weeks in a prior rituximab-Pfizer protocol (B3281001) and had not received intervening treatment with investigational agents or other biologics (including Rituxan and MabThera).
Pre-assignment details
Participants given PF-05280586 in Study B3281001 received PF-05280586. Participants given licensed product in Study B3281001 received the same licensed product or PF-05280586 in Course 1. All participants received PF-05280586 in later courses. 185 participants were randomized to Study B3281004, 183 participants received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| PF-05280586/PF-05280586/PF-05280586 This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study. | 58 |
| Rituximab-EU/PF-05280586/PF-05280586 This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study. | 32 |
| PF-05280586/PF-05280586/PF-05280586 (EU) This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24--week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study. | 33 |
| Rituximab-US/PF-05280586/PF-05280586 This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24--week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study. | 30 |
| PF-05280586/PF-05280586/PF-05280586 (US) This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study. | 30 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 0 | 1 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 | 2 | 0 | 0 |
| Overall Study | Other | 5 | 1 | 1 | 0 | 0 |
| Overall Study | Pregnancy | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | PF-05280586/PF-05280586/PF-05280586 (EU) | PF-05280586/PF-05280586/PF-05280586 | Rituximab-EU/PF-05280586/PF-05280586 | Rituximab-US/PF-05280586/PF-05280586 | PF-05280586/PF-05280586/PF-05280586 (US) | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 56.7 Years STANDARD_DEVIATION 9.35 | 55.3 Years STANDARD_DEVIATION 12.01 | 56.0 Years STANDARD_DEVIATION 11.88 | 52.6 Years STANDARD_DEVIATION 13.73 | 55.8 Years STANDARD_DEVIATION 10.35 | 55.3 Years STANDARD_DEVIATION 11.55 |
| Sex: Female, Male Female | 23 Participants | 50 Participants | 29 Participants | 20 Participants | 25 Participants | 147 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 3 Participants | 10 Participants | 5 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 18 / 58 | 3 / 32 | 8 / 33 | 15 / 30 | 7 / 30 | 26 / 54 | 15 / 30 | 13 / 31 | 18 / 29 | 10 / 29 | 25 / 48 | 18 / 30 | 15 / 30 | 18 / 27 | 17 / 29 |
| serious Total, serious adverse events | 4 / 58 | 2 / 32 | 2 / 33 | 1 / 30 | 2 / 30 | 6 / 54 | 1 / 30 | 4 / 31 | 2 / 29 | 1 / 29 | 4 / 48 | 1 / 30 | 4 / 30 | 1 / 27 | 1 / 29 |
Outcome results
Primary
Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement
Blood samples were obtained to determine anti-CCP and compliment levels in serum.
Time frame: Week 1 and 25 (Course 1, Course 2, and Course 3).
Population: mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 1/Week 1 | 293.7 U/mL | Standard Deviation 206.64 |
| PF-05280586/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 1/Week 25 | 266.9 U/mL | Standard Deviation 222.12 |
| PF-05280586/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 2/Week 1 | 285.7 U/mL | Standard Deviation 211.65 |
| PF-05280586/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 2/Week 25 | 259.0 U/mL | Standard Deviation 224.11 |
| PF-05280586/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 3/Week 1 | 270.0 U/mL | Standard Deviation 213.62 |
| PF-05280586/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 3/Week 25 (EOT) | 249.6 U/mL | Standard Deviation 212.37 |
| Rituximab-EU/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 3/Week 1 | 290.2 U/mL | Standard Deviation 200.75 |
| Rituximab-EU/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 3/Week 25 (EOT) | 250.4 U/mL | Standard Deviation 190.55 |
| Rituximab-EU/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 1/Week 1 | 346.1 U/mL | Standard Deviation 206.78 |
| Rituximab-EU/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 2/Week 1 | 305.2 U/mL | Standard Deviation 208.41 |
| Rituximab-EU/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 2/Week 25 | 332.0 U/mL | Standard Deviation 184.78 |
| Rituximab-EU/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 1/Week 25 | 230.8 U/mL | Standard Deviation 207.06 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 2/Week 25 | 273.3 U/mL | Standard Deviation 188.63 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 3/Week 1 | 308.3 U/mL | Standard Deviation 189.51 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 1/Week 1 | 311.5 U/mL | Standard Deviation 198.13 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 2/Week 1 | 324.6 U/mL | Standard Deviation 196.92 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 1/Week 25 | 300.9 U/mL | Standard Deviation 199.02 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 3/Week 25 (EOT) | 265.7 U/mL | Standard Deviation 207.79 |
| Rituximab-EU Total | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 2/Week 25 | 230.1 U/mL | Standard Deviation 232.38 |
| Rituximab-EU Total | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 1/Week 25 | 258.0 U/mL | Standard Deviation 227.91 |
| Rituximab-EU Total | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 2/Week 1 | 241.5 U/mL | Standard Deviation 229 |
| Rituximab-EU Total | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 3/Week 25 (EOT) | 214.4 U/mL | Standard Deviation 222.43 |
| Rituximab-EU Total | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 3/Week 1 | 214.3 U/mL | Standard Deviation 228.46 |
| Rituximab-EU Total | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 1/Week 1 | 223.9 U/mL | Standard Deviation 224.86 |
| Rituximab-US/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 3/Week 1 | 234.6 U/mL | Standard Deviation 212.97 |
| Rituximab-US/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 2/Week 1 | 262.2 U/mL | Standard Deviation 210.17 |
| Rituximab-US/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 1/Week 25 | 263.6 U/mL | Standard Deviation 190.26 |
| Rituximab-US/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 3/Week 25 (EOT) | 245.1 U/mL | Standard Deviation 207.29 |
| Rituximab-US/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 2/Week 25 | 237.9 U/mL | Standard Deviation 204.7 |
| Rituximab-US/PF-05280586/PF-05280586 | Anti-Cyclic Citrullinated Peptide (Anti-CCP) and Complement | Course 1/Week 1 | 306.1 U/mL | Standard Deviation 210.82 |
Primary
Circulating Immunoglobulin G (IgG) Concentrations
Blood samples for immunoglobulin assessments were obtained to determine IgG levels in serum.
Time frame: Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
Population: mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Screening | 11.7 grams per liter (g/L) | Standard Deviation 3.06 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 1/Week 25 | 10.4 grams per liter (g/L) | Standard Deviation 3.2 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 2/Week 1 | 10.5 grams per liter (g/L) | Standard Deviation 2.73 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 2/Week 25 | 10.6 grams per liter (g/L) | Standard Deviation 2.85 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 3/Week 1 | 10.6 grams per liter (g/L) | Standard Deviation 2.92 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 3/Week 25 (EOT) | 10.4 grams per liter (g/L) | Standard Deviation 2.86 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 3/Week 1 | 10.2 grams per liter (g/L) | Standard Deviation 2.61 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 3/Week 25 (EOT) | 9.8 grams per liter (g/L) | Standard Deviation 3.04 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Screening | 10.9 grams per liter (g/L) | Standard Deviation 2.54 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 2/Week 1 | 10.2 grams per liter (g/L) | Standard Deviation 2.78 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 2/Week 25 | 8.9 grams per liter (g/L) | Standard Deviation 2.4 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 1/Week 25 | 10.7 grams per liter (g/L) | Standard Deviation 3.71 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Immunoglobulin G (IgG) Concentrations | Course 2/Week 25 | 10.4 grams per liter (g/L) | Standard Deviation 2.11 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Immunoglobulin G (IgG) Concentrations | Course 3/Week 1 | 10.6 grams per liter (g/L) | Standard Deviation 2.81 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Immunoglobulin G (IgG) Concentrations | Screening | 11.6 grams per liter (g/L) | Standard Deviation 2.85 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Immunoglobulin G (IgG) Concentrations | Course 2/Week 1 | 10.8 grams per liter (g/L) | Standard Deviation 2.55 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Immunoglobulin G (IgG) Concentrations | Course 1/Week 25 | 11.2 grams per liter (g/L) | Standard Deviation 2.5 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Immunoglobulin G (IgG) Concentrations | Course 3/Week 25 (EOT) | 10.3 grams per liter (g/L) | Standard Deviation 2.34 |
| Rituximab-EU Total | Circulating Immunoglobulin G (IgG) Concentrations | Course 2/Week 25 | 9.2 grams per liter (g/L) | Standard Deviation 2 |
| Rituximab-EU Total | Circulating Immunoglobulin G (IgG) Concentrations | Course 1/Week 25 | 10.3 grams per liter (g/L) | Standard Deviation 3.5 |
| Rituximab-EU Total | Circulating Immunoglobulin G (IgG) Concentrations | Course 2/Week 1 | 10.2 grams per liter (g/L) | Standard Deviation 2.29 |
| Rituximab-EU Total | Circulating Immunoglobulin G (IgG) Concentrations | Course 3/Week 25 (EOT) | 9.7 grams per liter (g/L) | Standard Deviation 2.3 |
| Rituximab-EU Total | Circulating Immunoglobulin G (IgG) Concentrations | Course 3/Week 1 | 9.7 grams per liter (g/L) | Standard Deviation 2.44 |
| Rituximab-EU Total | Circulating Immunoglobulin G (IgG) Concentrations | Screening | 11.3 grams per liter (g/L) | Standard Deviation 3.12 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 3/Week 1 | 10.3 grams per liter (g/L) | Standard Deviation 3.88 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 2/Week 1 | 10.9 grams per liter (g/L) | Standard Deviation 3.59 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 1/Week 25 | 11.4 grams per liter (g/L) | Standard Deviation 3.92 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 3/Week 25 (EOT) | 10.2 grams per liter (g/L) | Standard Deviation 3.25 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Course 2/Week 25 | 11.4 grams per liter (g/L) | Standard Deviation 4.08 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Immunoglobulin G (IgG) Concentrations | Screening | 11.8 grams per liter (g/L) | Standard Deviation 3.52 |
Primary
Circulating Immunoglobulin M (IgM) Concentrations
Blood samples for immunoglobulin assessments were obtained to determine IgM levels in serum.
Time frame: Screening, Week 25 (Course 1), and Weeks 1 and 25 (Course 2 and Course 3).
Population: mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Screening | 1.0 g/L | Standard Deviation 0.5 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 1/Week 25 | 0.8 g/L | Standard Deviation 0.47 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 2/Week 1 | 0.8 g/L | Standard Deviation 0.48 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 2/Week 25 | 0.8 g/L | Standard Deviation 0.55 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 3/Week 1 | 0.8 g/L | Standard Deviation 0.43 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 3/Week 25 (EOT) | 0.7 g/L | Standard Deviation 0.39 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 3/Week 1 | 0.8 g/L | Standard Deviation 0.46 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 3/Week 25 (EOT) | 0.7 g/L | Standard Deviation 0.44 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Screening | 1.1 g/L | Standard Deviation 0.73 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 2/Week 1 | 0.9 g/L | Standard Deviation 0.56 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 2/Week 25 | 0.8 g/L | Standard Deviation 0.46 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 1/Week 25 | 1.1 g/L | Standard Deviation 0.62 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Immunoglobulin M (IgM) Concentrations | Course 2/Week 25 | 0.9 g/L | Standard Deviation 0.64 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Immunoglobulin M (IgM) Concentrations | Course 3/Week 1 | 0.8 g/L | Standard Deviation 0.57 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Immunoglobulin M (IgM) Concentrations | Screening | 1.1 g/L | Standard Deviation 0.7 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Immunoglobulin M (IgM) Concentrations | Course 2/Week 1 | 0.9 g/L | Standard Deviation 0.64 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Immunoglobulin M (IgM) Concentrations | Course 1/Week 25 | 0.9 g/L | Standard Deviation 0.6 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Immunoglobulin M (IgM) Concentrations | Course 3/Week 25 (EOT) | 0.8 g/L | Standard Deviation 0.54 |
| Rituximab-EU Total | Circulating Immunoglobulin M (IgM) Concentrations | Course 2/Week 25 | 0.9 g/L | Standard Deviation 0.63 |
| Rituximab-EU Total | Circulating Immunoglobulin M (IgM) Concentrations | Course 1/Week 25 | 1.0 g/L | Standard Deviation 0.72 |
| Rituximab-EU Total | Circulating Immunoglobulin M (IgM) Concentrations | Course 2/Week 1 | 0.9 g/L | Standard Deviation 0.61 |
| Rituximab-EU Total | Circulating Immunoglobulin M (IgM) Concentrations | Course 3/Week 25 (EOT) | 0.8 g/L | Standard Deviation 0.52 |
| Rituximab-EU Total | Circulating Immunoglobulin M (IgM) Concentrations | Course 3/Week 1 | 0.8 g/L | Standard Deviation 0.52 |
| Rituximab-EU Total | Circulating Immunoglobulin M (IgM) Concentrations | Screening | 1.1 g/L | Standard Deviation 0.79 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 3/Week 1 | 0.7 g/L | Standard Deviation 0.4 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 2/Week 1 | 0.8 g/L | Standard Deviation 0.47 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 1/Week 25 | 0.9 g/L | Standard Deviation 0.45 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 3/Week 25 (EOT) | 0.7 g/L | Standard Deviation 0.38 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Course 2/Week 25 | 0.8 g/L | Standard Deviation 0.5 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Immunoglobulin M (IgM) Concentrations | Screening | 1.0 g/L | Standard Deviation 0.57 |
Primary
Circulating Rheumatoid Factor (RF) Concentrations
RF is the auto-antibody directed against IgG. Blood samples were obtained to determine RF levels in serum.
Time frame: Week 1 and 25 (Course 1, Course 2, and Course 3).
Population: mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 1/Week 1 | 105.6 international units per milliliter | Standard Deviation 203.88 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 1/Week 25 | 56.1 international units per milliliter | Standard Deviation 104.12 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 2/Week 1 | 92.6 international units per milliliter | Standard Deviation 181.91 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 2/Week 25 | 59.5 international units per milliliter | Standard Deviation 117.79 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 3/Week 1 | 51.7 international units per milliliter | Standard Deviation 89.51 |
| PF-05280586/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 3/Week 25 (EOT) | 46.2 international units per milliliter | Standard Deviation 76.85 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 3/Week 1 | 217.3 international units per milliliter | Standard Deviation 697.3 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 3/Week 25 (EOT) | 181.2 international units per milliliter | Standard Deviation 551.49 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 1/Week 1 | 431.3 international units per milliliter | Standard Deviation 1074.13 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 2/Week 1 | 279.3 international units per milliliter | Standard Deviation 737 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 2/Week 25 | 448.0 international units per milliliter | Standard Deviation 945.12 |
| Rituximab-EU/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 1/Week 25 | 714.8 international units per milliliter | Standard Deviation 1471.95 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Rheumatoid Factor (RF) Concentrations | Course 2/Week 25 | 62.4 international units per milliliter | Standard Deviation 89.14 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Rheumatoid Factor (RF) Concentrations | Course 3/Week 1 | 74.9 international units per milliliter | Standard Deviation 128.83 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Rheumatoid Factor (RF) Concentrations | Course 1/Week 1 | 128.7 international units per milliliter | Standard Deviation 201.11 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Rheumatoid Factor (RF) Concentrations | Course 2/Week 1 | 132.9 international units per milliliter | Standard Deviation 234.84 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Rheumatoid Factor (RF) Concentrations | Course 1/Week 25 | 101.5 international units per milliliter | Standard Deviation 165.85 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Circulating Rheumatoid Factor (RF) Concentrations | Course 3/Week 25 (EOT) | 57.1 international units per milliliter | Standard Deviation 107.47 |
| Rituximab-EU Total | Circulating Rheumatoid Factor (RF) Concentrations | Course 2/Week 25 | 52.0 international units per milliliter | Standard Deviation 54.97 |
| Rituximab-EU Total | Circulating Rheumatoid Factor (RF) Concentrations | Course 1/Week 25 | 53.2 international units per milliliter | Standard Deviation 59.22 |
| Rituximab-EU Total | Circulating Rheumatoid Factor (RF) Concentrations | Course 2/Week 1 | 59.5 international units per milliliter | Standard Deviation 76.56 |
| Rituximab-EU Total | Circulating Rheumatoid Factor (RF) Concentrations | Course 3/Week 25 (EOT) | 45.0 international units per milliliter | Standard Deviation 66.43 |
| Rituximab-EU Total | Circulating Rheumatoid Factor (RF) Concentrations | Course 3/Week 1 | 51.8 international units per milliliter | Standard Deviation 92.06 |
| Rituximab-EU Total | Circulating Rheumatoid Factor (RF) Concentrations | Course 1/Week 1 | 75.2 international units per milliliter | Standard Deviation 102.41 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 3/Week 1 | 40.4 international units per milliliter | Standard Deviation 45.9 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 2/Week 1 | 58.6 international units per milliliter | Standard Deviation 73.13 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 1/Week 25 | 66.5 international units per milliliter | Standard Deviation 69.7 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 3/Week 25 (EOT) | 38.2 international units per milliliter | Standard Deviation 41.46 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 2/Week 25 | 44.2 international units per milliliter | Standard Deviation 44.34 |
| Rituximab-US/PF-05280586/PF-05280586 | Circulating Rheumatoid Factor (RF) Concentrations | Course 1/Week 1 | 109.1 international units per milliliter | Standard Deviation 139.79 |
Primary
Cluster of Differentiation 19 (CD19+) B Cell Count
Blood samples were assayed for CD19+ B-cell counts using laser scanning cytometry.
Time frame: Weeks 1, 6, 13, and 25 (Course 1 and Course 2), Weeks 1, 13, 25 (Course 3), and Follow up Months 3, 6, and 9.
Population: mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 6 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 25 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 1 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 1 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Follow up-Month 6 | 7.5 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 6 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 1 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Follow up-month 3 | 0.2 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 25 (EOT) | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 13 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 13 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Follow up-Month 9 | 39.4 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 25 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 13 | 0.0 cells per microliter |
| Rituximab-EU/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 25 | 0.0 cells per microliter |
| Rituximab-EU/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 1 | 1.1 cells per microliter |
| Rituximab-EU/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 6 | 0.0 cells per microliter |
| Rituximab-EU/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 13 | 0.0 cells per microliter |
| Rituximab-EU/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 1 | 0.0 cells per microliter |
| Rituximab-EU/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 6 | 0.0 cells per microliter |
| Rituximab-EU/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 13 | 0.0 cells per microliter |
| Rituximab-EU/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 25 | 0.0 cells per microliter |
| Rituximab-EU/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 13 | 0.0 cells per microliter |
| Rituximab-EU/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 25 (EOT) | 0.0 cells per microliter |
| Rituximab-EU/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Follow up-month 3 | 0.0 cells per microliter |
| Rituximab-EU/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Follow up-Month 6 | 0.4 cells per microliter |
| Rituximab-EU/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 1 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 6 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 13 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 13 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 25 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 13 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 1 | 0.6 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 25 (EOT) | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 6 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Cluster of Differentiation 19 (CD19+) B Cell Count | Follow up-month 3 | 1.7 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 1 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Cluster of Differentiation 19 (CD19+) B Cell Count | Follow up-Month 6 | 6.8 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 25 | 0.0 cells per microliter |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 1 | 0.0 cells per microliter |
| Rituximab-EU Total | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 25 | 0.0 cells per microliter |
| Rituximab-EU Total | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 6 | 0.0 cells per microliter |
| Rituximab-EU Total | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 25 (EOT) | 0.0 cells per microliter |
| Rituximab-EU Total | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 13 | 0.0 cells per microliter |
| Rituximab-EU Total | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 1 | 0.0 cells per microliter |
| Rituximab-EU Total | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 6 | 0.0 cells per microliter |
| Rituximab-EU Total | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 13 | 0.0 cells per microliter |
| Rituximab-EU Total | Cluster of Differentiation 19 (CD19+) B Cell Count | Follow up-Month 6 | 10.5 cells per microliter |
| Rituximab-EU Total | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 1 | 0.0 cells per microliter |
| Rituximab-EU Total | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 1 | 0.0 cells per microliter |
| Rituximab-EU Total | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 13 | 0.0 cells per microliter |
| Rituximab-EU Total | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 25 | 0.0 cells per microliter |
| Rituximab-EU Total | Cluster of Differentiation 19 (CD19+) B Cell Count | Follow up-month 3 | 0.5 cells per microliter |
| Rituximab-US/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 6 | 0.0 cells per microliter |
| Rituximab-US/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 1 | 0.0 cells per microliter |
| Rituximab-US/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 25 | 0.0 cells per microliter |
| Rituximab-US/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 13 | 0.0 cells per microliter |
| Rituximab-US/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 25 | 0.0 cells per microliter |
| Rituximab-US/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 13 | 0.0 cells per microliter |
| Rituximab-US/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 3/Week 25 (EOT) | 0.0 cells per microliter |
| Rituximab-US/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Follow up-Month 6 | 1.1 cells per microliter |
| Rituximab-US/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Follow up-month 3 | 0.0 cells per microliter |
| Rituximab-US/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 6 | 0.0 cells per microliter |
| Rituximab-US/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 1/Week 1 | 0.6 cells per microliter |
| Rituximab-US/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 13 | 0.0 cells per microliter |
| Rituximab-US/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Follow up-Month 9 | 66.3 cells per microliter |
| Rituximab-US/PF-05280586/PF-05280586 | Cluster of Differentiation 19 (CD19+) B Cell Count | Course 2/Week 1 | 0.0 cells per microliter |
Primary
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1
The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log \[ln\] (CRP \[milligrams per liter, mg/L\] +1) + 0.014 (global assessment of health \[GH\]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
Time frame: Baseline B3281001, Week 1, 6, 13, and 25 (Course 1).
Population: mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 13 | -2.37 Units on a scale | Standard Deviation 1.134 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Baseline B3281001 | 5.59 Units on a scale | Standard Deviation 0.862 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 25 | -2.35 Units on a scale | Standard Deviation 1.31 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 1 | -1.24 Units on a scale | Standard Deviation 1.126 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 6 | -2.03 Units on a scale | Standard Deviation 1.378 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 13 | -2.78 Units on a scale | Standard Deviation 1.355 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 6 | -2.59 Units on a scale | Standard Deviation 1.088 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 1 | -1.86 Units on a scale | Standard Deviation 1.223 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 25 | -2.32 Units on a scale | Standard Deviation 1.166 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Baseline B3281001 | 5.81 Units on a scale | Standard Deviation 0.926 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 6 | -2.54 Units on a scale | Standard Deviation 1.322 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Baseline B3281001 | 5.80 Units on a scale | Standard Deviation 0.988 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 1 | -1.94 Units on a scale | Standard Deviation 1.315 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 13 | -2.66 Units on a scale | Standard Deviation 1.439 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 25 | -2.24 Units on a scale | Standard Deviation 1.182 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 25 | -2.15 Units on a scale | Standard Deviation 1.109 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Baseline B3281001 | 6.16 Units on a scale | Standard Deviation 0.87 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 13 | -2.85 Units on a scale | Standard Deviation 1.368 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 6 | -2.50 Units on a scale | Standard Deviation 1.454 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 1 | -2.02 Units on a scale | Standard Deviation 1.508 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 6 | -2.66 Units on a scale | Standard Deviation 1.226 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 13 | -2.76 Units on a scale | Standard Deviation 1.2 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Baseline B3281001 | 6.12 Units on a scale | Standard Deviation 0.784 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 25 | -2.50 Units on a scale | Standard Deviation 1.179 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 1 | Change at Course 1/Week 1 | -1.95 Units on a scale | Standard Deviation 1.211 |
Primary
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2
The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log \[ln\] (CRP \[milligrams per liter, mg/L\] +1) + 0.014 (global assessment of health \[GH\]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
Time frame: Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Population: mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 25 | -2.35 Units on a scale | Standard Deviation 1.31 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 6 | -2.11 Units on a scale | Standard Deviation 1.353 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Baseline B3281001 | 5.59 Units on a scale | Standard Deviation 0.893 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 13 | -2.41 Units on a scale | Standard Deviation 1.11 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 13 | -2.35 Units on a scale | Standard Deviation 1.319 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 1 | -1.27 Units on a scale | Standard Deviation 1.12 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 25 | -2.30 Units on a scale | Standard Deviation 1.061 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 6 | -2.66 Units on a scale | Standard Deviation 1.177 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 1 | -1.98 Units on a scale | Standard Deviation 1.48 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 13 | -2.56 Units on a scale | Standard Deviation 1.644 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Baseline B3281001 | 5.81 Units on a scale | Standard Deviation 0.956 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 1 | -1.82 Units on a scale | Standard Deviation 1.257 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 6 | -2.56 Units on a scale | Standard Deviation 1.091 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 13 | -2.78 Units on a scale | Standard Deviation 1.355 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 25 | -2.32 Units on a scale | Standard Deviation 1.166 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 1 | -2.05 Units on a scale | Standard Deviation 1.275 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 6 | -2.74 Units on a scale | Standard Deviation 1.552 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 25 | -3.14 Units on a scale | Standard Deviation 1.013 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 6 | -2.53 Units on a scale | Standard Deviation 1.205 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 1 | -1.92 Units on a scale | Standard Deviation 1.147 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 25 | -2.19 Units on a scale | Standard Deviation 1.034 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 6 | -2.75 Units on a scale | Standard Deviation 1.148 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 25 | -2.42 Units on a scale | Standard Deviation 1.125 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Baseline B3281001 | 5.77 Units on a scale | Standard Deviation 1.009 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 13 | -2.65 Units on a scale | Standard Deviation 1.113 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 1 | -1.92 Units on a scale | Standard Deviation 1.132 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 13 | -2.67 Units on a scale | Standard Deviation 1.315 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 13 | -2.76 Units on a scale | Standard Deviation 1.318 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 25 | -2.35 Units on a scale | Standard Deviation 1.01 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 25 | -2.02 Units on a scale | Standard Deviation 1.038 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 1 | -1.93 Units on a scale | Standard Deviation 1.466 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 1 | -2.20 Units on a scale | Standard Deviation 1.295 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 6 | -2.44 Units on a scale | Standard Deviation 1.441 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 6 | -2.92 Units on a scale | Standard Deviation 1.231 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Baseline B3281001 | 6.13 Units on a scale | Standard Deviation 0.865 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 13 | -2.88 Units on a scale | Standard Deviation 1.476 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 13 | -2.76 Units on a scale | Standard Deviation 1.2 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 13 | -3.21 Units on a scale | Standard Deviation 1.135 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 6 | -3.00 Units on a scale | Standard Deviation 1.089 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 25 | -2.50 Units on a scale | Standard Deviation 1.179 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 6 | -2.71 Units on a scale | Standard Deviation 1.211 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 1 | -2.34 Units on a scale | Standard Deviation 1.036 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 2/Week 25 | -2.82 Units on a scale | Standard Deviation 0.901 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Change at Course 1/Week 1 | -1.99 Units on a scale | Standard Deviation 1.218 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 2 | Baseline B3281001 | 6.10 Units on a scale | Standard Deviation 0.792 |
Primary
Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3
The disease activity score (DAS) assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis Visual Analog Scale (VAS). The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP equals (=) 0.56 square root (sqrt) (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 natural log \[ln\] (CRP \[milligrams per liter, mg/L\] +1) + 0.014 (global assessment of health \[GH\]) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity.
Time frame: Baseline B3281001, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Population: mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 13 | -2.34 Units on a scale | Standard Deviation 1.369 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 13 | -2.46 Units on a scale | Standard Deviation 1.428 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Baseline B3281001 | 5.54 Units on a scale | Standard Deviation 0.896 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 13 | -2.47 Units on a scale | Standard Deviation 1.101 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 1 | -1.93 Units on a scale | Standard Deviation 1.5 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 25 | -2.30 Units on a scale | Standard Deviation 1.245 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 1 | -1.98 Units on a scale | Standard Deviation 1.477 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 6 | -2.10 Units on a scale | Standard Deviation 1.38 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 25 | -2.25 Units on a scale | Standard Deviation 1.293 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 6 | -2.62 Units on a scale | Standard Deviation 1.172 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 1 | -1.25 Units on a scale | Standard Deviation 1.158 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 25 | -2.34 Units on a scale | Standard Deviation 1.114 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 25 | -2.53 Units on a scale | Standard Deviation 1.641 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 1 | -2.05 Units on a scale | Standard Deviation 1.275 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 1 | -1.82 Units on a scale | Standard Deviation 1.257 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 6 | -2.74 Units on a scale | Standard Deviation 1.552 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Baseline B3281001 | 5.81 Units on a scale | Standard Deviation 0.956 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 13 | -2.78 Units on a scale | Standard Deviation 1.519 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 6 | -2.56 Units on a scale | Standard Deviation 1.091 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 13 | -2.56 Units on a scale | Standard Deviation 1.644 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 1 | -2.34 Units on a scale | Standard Deviation 1.525 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 13 | -2.78 Units on a scale | Standard Deviation 1.355 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 25 | -3.14 Units on a scale | Standard Deviation 1.013 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 25 | -2.32 Units on a scale | Standard Deviation 1.166 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 13 | -2.74 Units on a scale | Standard Deviation 1.103 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Baseline B3281001 | 5.79 Units on a scale | Standard Deviation 1.019 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 1 | -1.86 Units on a scale | Standard Deviation 1.121 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 6 | -2.51 Units on a scale | Standard Deviation 1.221 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 13 | -2.64 Units on a scale | Standard Deviation 1.322 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 25 | -2.12 Units on a scale | Standard Deviation 1.023 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 1 | -1.87 Units on a scale | Standard Deviation 1.118 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 6 | -2.75 Units on a scale | Standard Deviation 1.148 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 13 | -2.65 Units on a scale | Standard Deviation 1.113 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 25 | -2.42 Units on a scale | Standard Deviation 1.125 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 1 | -2.33 Units on a scale | Standard Deviation 1.106 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 25 | -2.59 Units on a scale | Standard Deviation 1.314 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 1 | -2.27 Units on a scale | Standard Deviation 1.314 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Baseline B3281001 | 6.14 Units on a scale | Standard Deviation 0.886 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 13 | -2.96 Units on a scale | Standard Deviation 1.507 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 25 | -2.21 Units on a scale | Standard Deviation 0.848 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 25 | -2.41 Units on a scale | Standard Deviation 1.02 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 13 | -2.82 Units on a scale | Standard Deviation 1.284 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 25 | -2.88 Units on a scale | Standard Deviation 1.127 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 1 | -2.43 Units on a scale | Standard Deviation 1.6 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 6 | -2.53 Units on a scale | Standard Deviation 1.438 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 1 | -2.01 Units on a scale | Standard Deviation 1.438 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 13 | -3.09 Units on a scale | Standard Deviation 1.489 |
| Rituximab-EU Total | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 6 | -2.97 Units on a scale | Standard Deviation 1.241 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 1 | -2.34 Units on a scale | Standard Deviation 1.036 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 1 | -2.51 Units on a scale | Standard Deviation 1.238 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Baseline B3281001 | 6.10 Units on a scale | Standard Deviation 0.792 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 13 | -3.21 Units on a scale | Standard Deviation 1.135 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 1 | -1.99 Units on a scale | Standard Deviation 1.218 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 13 | -2.76 Units on a scale | Standard Deviation 1.2 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 25 | -2.86 Units on a scale | Standard Deviation 1.392 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 25 | -2.50 Units on a scale | Standard Deviation 1.179 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 25 | -2.82 Units on a scale | Standard Deviation 0.901 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 2/Week 6 | -3.00 Units on a scale | Standard Deviation 1.089 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 1/Week 6 | -2.71 Units on a scale | Standard Deviation 1.211 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Change From Initial Study Baseline in Disease Activity Score (DAS28)-C-Reactive Protein (CRP) - by the End of Course 3 | Change at Course 3/Week 13 | -3.03 Units on a scale | Standard Deviation 1.145 |
Primary
Mean Rituximab Serum Trough Concentrations
Serum samples for determination of drug concentrations were collected pre-dose concurrent with ADA sample collection. Drug concentrations in the samples were determined using a validated assay.
Time frame: Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3), Follow up Months 3, 6, 9, and 12. Course 3/Week 25 is End of Treatment (EOT).
Population: mITT Population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 1/Week 25 | 2844.2 nanograms per milliliter | Standard Deviation 4271.65 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 2/Week 25 | 3431.9 nanograms per milliliter | Standard Deviation 4155.8 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 3/Week 3 | 101043.8 nanograms per milliliter | Standard Deviation 27832.21 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 1/Week 1 | 636.5 nanograms per milliliter | Standard Deviation 816.33 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Follow up-Month 6 | 44.2 nanograms per milliliter | Standard Deviation 140.06 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 2/Week 1 | 1628.2 nanograms per milliliter | Standard Deviation 2712.3 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 3/Week 1 | 3347.7 nanograms per milliliter | Standard Deviation 6919.26 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 3/Week 25 (EOT) | 5908.1 nanograms per milliliter | Standard Deviation 22274.41 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Follow up-Month 9 | 0.0 nanograms per milliliter | Standard Deviation 0 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 3/Week 13 | 26795.2 nanograms per milliliter | Standard Deviation 18635.09 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 2/Week 3 | 108064.2 nanograms per milliliter | Standard Deviation 37043.94 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 2/Week 13 | 26527.9 nanograms per milliliter | Standard Deviation 17903 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 1/Week 13 | 22613.1 nanograms per milliliter | Standard Deviation 16526.33 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 1/Week 3 | 103019.3 nanograms per milliliter | Standard Deviation 29250.13 |
| PF-05280586/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Follow up-Month 3 | 2448.3 nanograms per milliliter | Standard Deviation 13132.59 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Follow up-Month 6 | 99.3 nanograms per milliliter | Standard Deviation 253.66 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 2/Week 13 | 31829.7 nanograms per milliliter | Standard Deviation 17954.12 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 3/Week 3 | 118256.7 nanograms per milliliter | Standard Deviation 30549.75 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 1/Week 3 | 114341.9 nanograms per milliliter | Standard Deviation 39023.45 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 2/Week 25 | 4074.2 nanograms per milliliter | Standard Deviation 5043.55 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 1/Week 13 | 27542.3 nanograms per milliliter | Standard Deviation 18879.35 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 3/Week 25 (EOT) | 6485.6 nanograms per milliliter | Standard Deviation 12462.24 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 3/Week 1 | 4276.1 nanograms per milliliter | Standard Deviation 4959.22 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 1/Week 1 | 855.5 nanograms per milliliter | Standard Deviation 1594.51 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Follow up-Month 3 | 9061.5 nanograms per milliliter | Standard Deviation 30261.67 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 1/Week 25 | 3573.3 nanograms per milliliter | Standard Deviation 3569.9 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 2/Week 1 | 2493.2 nanograms per milliliter | Standard Deviation 3631.38 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 2/Week 3 | 114266.7 nanograms per milliliter | Standard Deviation 29897.86 |
| Rituximab-EU/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 3/Week 13 | 31180.0 nanograms per milliliter | Standard Deviation 20926.62 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Rituximab Serum Trough Concentrations | Course 3/Week 1 | 1569.5 nanograms per milliliter | Standard Deviation 2592.13 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Rituximab Serum Trough Concentrations | Course 3/Week 3 | 96213.3 nanograms per milliliter | Standard Deviation 22232.76 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Rituximab Serum Trough Concentrations | Follow up-Month 6 | 17.4 nanograms per milliliter | Standard Deviation 46.39 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Rituximab Serum Trough Concentrations | Course 3/Week 13 | 21268.6 nanograms per milliliter | Standard Deviation 11639.25 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Rituximab Serum Trough Concentrations | Course 1/Week 13 | 16973.6 nanograms per milliliter | Standard Deviation 10736.22 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Rituximab Serum Trough Concentrations | Course 1/Week 25 | 1719.3 nanograms per milliliter | Standard Deviation 3383.03 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Rituximab Serum Trough Concentrations | Course 2/Week 1 | 924.1 nanograms per milliliter | Standard Deviation 1546.2 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Rituximab Serum Trough Concentrations | Follow up-Month 3 | 208.3 nanograms per milliliter | Standard Deviation 255.87 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Rituximab Serum Trough Concentrations | Course 2/Week 3 | 91006.7 nanograms per milliliter | Standard Deviation 23725.24 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Rituximab Serum Trough Concentrations | Course 2/Week 13 | 21467.0 nanograms per milliliter | Standard Deviation 11390.72 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Rituximab Serum Trough Concentrations | Course 2/Week 25 | 1375.8 nanograms per milliliter | Standard Deviation 1507.1 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Rituximab Serum Trough Concentrations | Course 1/Week 3 | 89790.9 nanograms per milliliter | Standard Deviation 23247.03 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Rituximab Serum Trough Concentrations | Course 3/Week 25 (EOT) | 6539.7 nanograms per milliliter | Standard Deviation 23577.35 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Mean Rituximab Serum Trough Concentrations | Course 1/Week 1 | 416.6 nanograms per milliliter | Standard Deviation 615.86 |
| Rituximab-EU Total | Mean Rituximab Serum Trough Concentrations | Course 1/Week 25 | 8205.1 nanograms per milliliter | Standard Deviation 9923.43 |
| Rituximab-EU Total | Mean Rituximab Serum Trough Concentrations | Course 1/Week 1 | 1525.8 nanograms per milliliter | Standard Deviation 3709.9 |
| Rituximab-EU Total | Mean Rituximab Serum Trough Concentrations | Course 1/Week 3 | 96323.3 nanograms per milliliter | Standard Deviation 33396.81 |
| Rituximab-EU Total | Mean Rituximab Serum Trough Concentrations | Course 1/Week 13 | 26359.8 nanograms per milliliter | Standard Deviation 27063.7 |
| Rituximab-EU Total | Mean Rituximab Serum Trough Concentrations | Course 2/Week 1 | 3463.6 nanograms per milliliter | Standard Deviation 5311.01 |
| Rituximab-EU Total | Mean Rituximab Serum Trough Concentrations | Course 2/Week 3 | 102937.9 nanograms per milliliter | Standard Deviation 29824.58 |
| Rituximab-EU Total | Mean Rituximab Serum Trough Concentrations | Course 2/Week 13 | 27730.7 nanograms per milliliter | Standard Deviation 21932 |
| Rituximab-EU Total | Mean Rituximab Serum Trough Concentrations | Course 2/Week 25 | 5103.3 nanograms per milliliter | Standard Deviation 5344.88 |
| Rituximab-EU Total | Mean Rituximab Serum Trough Concentrations | Course 3/Week 1 | 3239.2 nanograms per milliliter | Standard Deviation 4330.47 |
| Rituximab-EU Total | Mean Rituximab Serum Trough Concentrations | Course 3/Week 3 | 107677.8 nanograms per milliliter | Standard Deviation 38759.97 |
| Rituximab-EU Total | Mean Rituximab Serum Trough Concentrations | Course 3/Week 13 | 28801.2 nanograms per milliliter | Standard Deviation 21593.73 |
| Rituximab-EU Total | Mean Rituximab Serum Trough Concentrations | Course 3/Week 25 (EOT) | 8603.7 nanograms per milliliter | Standard Deviation 13217.69 |
| Rituximab-EU Total | Mean Rituximab Serum Trough Concentrations | Follow up-Month 3 | 2477.5 nanograms per milliliter | Standard Deviation 5571.32 |
| Rituximab-EU Total | Mean Rituximab Serum Trough Concentrations | Follow up-Month 6 | 140.8 nanograms per milliliter | Standard Deviation 297.54 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 2/Week 25 | 5228.6 nanograms per milliliter | Standard Deviation 7171.47 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 1/Week 1 | 980.0 nanograms per milliliter | Standard Deviation 2091.41 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 3/Week 25 (EOT) | 4887.2 nanograms per milliliter | Standard Deviation 5543.05 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 2/Week 13 | 36007.9 nanograms per milliliter | Standard Deviation 23651.2 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 2/Week 3 | 114992.6 nanograms per milliliter | Standard Deviation 31832.89 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 2/Week 1 | 3596.1 nanograms per milliliter | Standard Deviation 5514.43 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Follow up-Month 9 | 0.0 nanograms per milliliter | Standard Deviation 0 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Follow up-Month 3 | 4199.1 nanograms per milliliter | Standard Deviation 15777.12 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 1/Week 25 | 3005.6 nanograms per milliliter | Standard Deviation 5227.33 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 1/Week 13 | 31006.6 nanograms per milliliter | Standard Deviation 23055.79 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 1/Week 3 | 107790.0 nanograms per milliliter | Standard Deviation 26168.99 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Follow up-Month 12 | 0.0 nanograms per milliliter | — |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Follow up-Month 6 | 4631.8 nanograms per milliliter | Standard Deviation 19826.17 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 3/Week 13 | 33489.7 nanograms per milliliter | Standard Deviation 21522.53 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 3/Week 3 | 116134.5 nanograms per milliliter | Standard Deviation 29028.01 |
| Rituximab-US/PF-05280586/PF-05280586 | Mean Rituximab Serum Trough Concentrations | Course 3/Week 1 | 4372.0 nanograms per milliliter | Standard Deviation 5836.09 |
Primary
Outcome Measure Using HAQ-DI - by the End of Course 1
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible. Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty. Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
Time frame: Week 1, 6, 13, and 25 (Course 1).
Population: mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 1 | 1.4 Score on a scale | Standard Deviation 0.66 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 6 | 1.3 Score on a scale | Standard Deviation 0.7 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 13 | 1.3 Score on a scale | Standard Deviation 0.63 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 25 | 1.2 Score on a scale | Standard Deviation 0.6 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 1 | 1.1 Score on a scale | Standard Deviation 0.73 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 25 | 1.3 Score on a scale | Standard Deviation 0.67 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 6 | 1.0 Score on a scale | Standard Deviation 0.68 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 13 | 1.0 Score on a scale | Standard Deviation 0.74 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 25 | 0.9 Score on a scale | Standard Deviation 0.65 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 6 | 0.9 Score on a scale | Standard Deviation 0.62 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 13 | 0.8 Score on a scale | Standard Deviation 0.59 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 1 | 1.0 Score on a scale | Standard Deviation 0.63 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 1 | 1.2 Score on a scale | Standard Deviation 0.71 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 6 | 1.1 Score on a scale | Standard Deviation 0.66 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 25 | 1.1 Score on a scale | Standard Deviation 0.75 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 13 | 1.2 Score on a scale | Standard Deviation 0.65 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 25 | 1.1 Score on a scale | Standard Deviation 0.66 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 13 | 1.1 Score on a scale | Standard Deviation 0.7 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 6 | 1.2 Score on a scale | Standard Deviation 0.75 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 1 | Course 1/Week 1 | 1.3 Score on a scale | Standard Deviation 0.78 |
Primary
Outcome Measure Using HAQ-DI - by the End of Course 2
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible. Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty. Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
Population: mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 1 | 1.4 Score on a scale | Standard Deviation 0.68 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 6 | 1.3 Score on a scale | Standard Deviation 0.71 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 13 | 1.3 Score on a scale | Standard Deviation 0.64 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 25 | 1.2 Score on a scale | Standard Deviation 0.6 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 1 | 1.3 Score on a scale | Standard Deviation 0.66 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 6 | 1.2 Score on a scale | Standard Deviation 0.67 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 13 | 1.2 Score on a scale | Standard Deviation 0.69 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 25 | 1.1 Score on a scale | Standard Deviation 0.71 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 13 | 1.0 Score on a scale | Standard Deviation 0.73 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 6 | 1.0 Score on a scale | Standard Deviation 0.69 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 1 | 1.2 Score on a scale | Standard Deviation 0.72 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 25 | 1.3 Score on a scale | Standard Deviation 0.67 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 6 | 1.0 Score on a scale | Standard Deviation 0.66 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 25 | 1.2 Score on a scale | Standard Deviation 0.75 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 1 | 1.0 Score on a scale | Standard Deviation 0.75 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 13 | 1.0 Score on a scale | Standard Deviation 0.69 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 13 | 0.9 Score on a scale | Standard Deviation 0.6 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 25 | 0.9 Score on a scale | Standard Deviation 0.69 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 25 | 0.9 Score on a scale | Standard Deviation 0.63 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 6 | 0.9 Score on a scale | Standard Deviation 0.6 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 13 | 0.8 Score on a scale | Standard Deviation 0.58 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 6 | 0.9 Score on a scale | Standard Deviation 0.6 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 1 | 1.0 Score on a scale | Standard Deviation 0.6 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 1 | 0.9 Score on a scale | Standard Deviation 0.64 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 6 | 1.1 Score on a scale | Standard Deviation 0.66 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 13 | 1.2 Score on a scale | Standard Deviation 0.64 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 25 | 1.1 Score on a scale | Standard Deviation 0.78 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 1 | 1.3 Score on a scale | Standard Deviation 0.69 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 6 | 1.2 Score on a scale | Standard Deviation 0.61 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 25 | 1.4 Score on a scale | Standard Deviation 0.75 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 1 | 1.3 Score on a scale | Standard Deviation 0.7 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 13 | 1.2 Score on a scale | Standard Deviation 0.65 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 25 | 1.1 Score on a scale | Standard Deviation 0.66 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 25 | 0.8 Score on a scale | Standard Deviation 0.6 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 13 | 1.1 Score on a scale | Standard Deviation 0.7 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 13 | 1.0 Score on a scale | Standard Deviation 0.67 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 1 | 1.2 Score on a scale | Standard Deviation 0.77 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 6 | 1.0 Score on a scale | Standard Deviation 0.65 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 1/Week 6 | 1.1 Score on a scale | Standard Deviation 0.73 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 2 | Course 2/Week 1 | 1.2 Score on a scale | Standard Deviation 0.75 |
Primary
Outcome Measure Using HAQ-DI - by the End of Course 3
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible. Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty. Primary outcome reported in the table is mean HAQ-DI score at each time point, and it is on the scale of HAQ-DI score with the range from 0 to 3.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Population: mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 6 | 1.2 Score on a scale | Standard Deviation 0.66 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 13 | 1.2 Score on a scale | Standard Deviation 0.69 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 1 | 1.4 Score on a scale | Standard Deviation 0.67 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 1 | 1.3 Score on a scale | Standard Deviation 0.67 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 25 | 1.1 Score on a scale | Standard Deviation 0.59 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 13 | 1.2 Score on a scale | Standard Deviation 0.67 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 25 (EOT) | 1.2 Score on a scale | Standard Deviation 0.68 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 13 | 1.2 Score on a scale | Standard Deviation 0.62 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 25 | 1.1 Score on a scale | Standard Deviation 0.66 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 1 | 1.3 Score on a scale | Standard Deviation 0.64 |
| PF-05280586/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 6 | 1.2 Score on a scale | Standard Deviation 0.69 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 1 | 1.0 Score on a scale | Standard Deviation 0.75 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 13 | 1.0 Score on a scale | Standard Deviation 0.69 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 6 | 1.0 Score on a scale | Standard Deviation 0.69 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 6 | 1.0 Score on a scale | Standard Deviation 0.66 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 1 | 1.2 Score on a scale | Standard Deviation 0.72 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 13 | 1.1 Score on a scale | Standard Deviation 0.74 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 13 | 1.0 Score on a scale | Standard Deviation 0.73 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 25 (EOT) | 1.0 Score on a scale | Standard Deviation 0.77 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 1 | 1.0 Score on a scale | Standard Deviation 0.71 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 25 | 1.3 Score on a scale | Standard Deviation 0.67 |
| Rituximab-EU/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 25 | 1.2 Score on a scale | Standard Deviation 0.75 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 6 | 0.9 Score on a scale | Standard Deviation 0.6 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 1 | 1.0 Score on a scale | Standard Deviation 0.6 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 6 | 0.9 Score on a scale | Standard Deviation 0.6 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 13 | 0.9 Score on a scale | Standard Deviation 0.57 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 25 | 1.0 Score on a scale | Standard Deviation 0.62 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 1 | 0.9 Score on a scale | Standard Deviation 0.64 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 13 | 0.9 Score on a scale | Standard Deviation 0.6 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 25 | 0.9 Score on a scale | Standard Deviation 0.69 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 1 | 0.9 Score on a scale | Standard Deviation 0.64 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 13 | 0.9 Score on a scale | Standard Deviation 0.54 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 25 (EOT) | 0.9 Score on a scale | Standard Deviation 0.6 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 25 | 1.1 Score on a scale | Standard Deviation 0.8 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 1 | 1.3 Score on a scale | Standard Deviation 0.7 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 6 | 1.2 Score on a scale | Standard Deviation 0.67 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 25 (EOT) | 1.2 Score on a scale | Standard Deviation 0.68 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 13 | 1.2 Score on a scale | Standard Deviation 0.67 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 13 | 1.2 Score on a scale | Standard Deviation 0.65 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 6 | 1.2 Score on a scale | Standard Deviation 0.63 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 25 | 1.3 Score on a scale | Standard Deviation 0.77 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 1 | 1.3 Score on a scale | Standard Deviation 0.72 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 1 | 1.3 Score on a scale | Standard Deviation 0.71 |
| Rituximab-EU Total | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 13 | 1.2 Score on a scale | Standard Deviation 0.66 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 1 | 1.2 Score on a scale | Standard Deviation 0.77 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 13 | 1.0 Score on a scale | Standard Deviation 0.67 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 25 | 1.1 Score on a scale | Standard Deviation 0.66 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 25 | 0.8 Score on a scale | Standard Deviation 0.6 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 13 | 1.1 Score on a scale | Standard Deviation 0.7 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 25 (EOT) | 1.0 Score on a scale | Standard Deviation 0.71 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 1 | 1.1 Score on a scale | Standard Deviation 0.71 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 1/Week 6 | 1.1 Score on a scale | Standard Deviation 0.73 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 3/Week 13 | 0.9 Score on a scale | Standard Deviation 0.66 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 6 | 1.0 Score on a scale | Standard Deviation 0.65 |
| Rituximab-US/PF-05280586/PF-05280586 | Outcome Measure Using HAQ-DI - by the End of Course 3 | Course 2/Week 1 | 1.2 Score on a scale | Standard Deviation 0.75 |
Primary
Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay
Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.
Time frame: Course 1 Overall, Course 2 Overall, Course 3 Overall, and All Courses Overall.
Population: mITT population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively. Only participants with a positive ADA status were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C1) +ve | 3.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C2) +ve | 5.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C3) +ve | 2.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | C1 to C3 +ve | 8.6 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | C1 to C3 +ve | 6.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C3) +ve | 0.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C1) +ve | 3.2 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C2) +ve | 6.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C3) +ve | 3.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C2) +ve | 3.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C1) +ve | 15.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | C1 to C3 +ve | 18.2 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C1) +ve | 9.4 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C2) +ve | 4.9 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C3) +ve | 1.7 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | C1 to C3 +ve | 12.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C1) +ve | 10.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | C1 to C3 +ve | 13.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C2) +ve | 3.4 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C3) +ve | 0.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (US) | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C2) +ve | 13.8 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (US) | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C1) +ve | 10.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (US) | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C3) +ve | 3.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (US) | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | C1 to C3 +ve | 13.3 Percentage of Participants |
| Rituximab-US Total | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C3) +ve | 1.8 Percentage of Participants |
| Rituximab-US Total | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C1) +ve | 10.0 Percentage of Participants |
| Rituximab-US Total | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | Total (C2) +ve | 8.6 Percentage of Participants |
| Rituximab-US Total | Percentage of Participants by ADA Status Using Anti-Rituximab Antibody Assay | C1 to C3 +ve | 13.3 Percentage of Participants |
Primary
Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay
Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive (+ve) for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reactivity of the ADA. For participants assigned to the licensed products in Study B3281001, blood samples were screened for ADA using both assays in order to assess any product-specific ADA and/or cross-reactivity for the transition from the licensed products to PF-05280586.
Time frame: Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall.
Population: Modified intent-to-treat (mITT) population - mITT populations for Courses 1, 2 and 3 were defined as all participants who received the first course, first 2 courses and all 3 courses of treatment respectively. Only participants with a positive ADA status were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C1) +ve | 3.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C2) +ve | 5.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C3) +ve | 2.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | C1 to C3 +ve | 8.6 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | C1 to C3 +ve | 3.1 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C3) +ve | 0.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C1) +ve | 0.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C2) +ve | 3.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C3) +ve | 0.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C2) +ve | 0.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C1) +ve | 15.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | C1 to C3 +ve | 15.2 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C1) +ve | 7.8 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C2) +ve | 1.6 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C3) +ve | 0.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | C1 to C3 +ve | 9.2 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C1) +ve | 13.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | C1 to C3 +ve | 13.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C2) +ve | 0.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C3) +ve | 0.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (US) | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C2) +ve | 6.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (US) | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C1) +ve | 6.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (US) | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C3) +ve | 0.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (US) | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | C1 to C3 +ve | 6.7 Percentage of Participants |
| Rituximab-US Total | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C3) +ve | 0.0 Percentage of Participants |
| Rituximab-US Total | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C1) +ve | 10.0 Percentage of Participants |
| Rituximab-US Total | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | Total (C2) +ve | 3.4 Percentage of Participants |
| Rituximab-US Total | Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay | C1 to C3 +ve | 10.0 Percentage of Participants |
Primary
Percentage of Participants by Nab Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay Using Anti-Rituximab NAb Assay
Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays. - None of the ADA samples tested positive for NAb.
Time frame: Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
Population: mITT Population. Only participants with a positive ADA status were included in the analysis.
Primary
Percentage of Participants by Neutralizing Antibody (Nab) Status in Participants With a Positive ADA Using Anti-PF-05280586 NAb Assay
Blood samples that were confirmed as positive for ADA were further evaluated for Nab using validated assays - None of the ADA samples tested positive for NAb.
Time frame: Weeks 1, 3, 13, and 25 (Course 1, Course 2, and Course 3).
Population: mITT Population. Only participants with a positive ADA status were included in the analysis.
Primary
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1
ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP.
Time frame: Week 1, 6, 13, and 25 (Course 1).
Population: mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 1 | 50.0 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 6 | 66.7 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 13 | 69.6 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 25 | 77.1 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 1 | 59.4 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 25 | 90.0 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 6 | 71.0 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 13 | 77.4 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 25 | 81.8 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 6 | 84.8 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 13 | 84.8 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 1 | 63.6 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 1 | 66.7 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 6 | 73.3 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 25 | 76.9 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 13 | 83.3 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 25 | 73.7 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 13 | 82.8 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 6 | 76.7 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 1 | Course 1/Week 1 | 60.0 Percentage of participants |
Primary
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2
ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
Population: mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 1 | 51.9 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 6 | 70.4 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 13 | 70.4 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 25 | 77.1 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 1 | 66.7 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 6 | 79.2 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 13 | 66.0 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 25 | 79.3 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 13 | 76.7 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 6 | 70.0 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 1 | 60.0 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 25 | 90.0 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 6 | 70.0 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 25 | 88.9 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 1 | 63.3 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 13 | 60.0 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 13 | 86.7 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 25 | 85.0 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 25 | 80.0 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 6 | 93.1 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 13 | 87.1 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 6 | 87.1 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 1 | 64.5 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 1 | 71.0 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 6 | 72.4 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 13 | 82.8 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 25 | 75.0 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 1 | 72.4 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 6 | 79.3 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 25 | 80.0 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 1 | 65.5 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 13 | 78.6 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 25 | 73.7 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 25 | 93.8 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 13 | 82.8 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 13 | 89.7 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 1 | 62.1 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 6 | 86.2 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 1/Week 6 | 75.9 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 2 | Course 2/Week 1 | 69.0 Percentage of participants |
Primary
Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3
ACR20 response: ≥ 20 percent (%) improvement in tender/painful joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Population: mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 6 | 77.1 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 13 | 64.6 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 1 | 50.0 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 1 | 60.4 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 25 | 75.0 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 13 | 67.4 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 59.6 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 13 | 70.8 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 25 | 80.8 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 1 | 68.8 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 6 | 70.8 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 1 | 63.3 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 13 | 60.0 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 6 | 70.0 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 6 | 70.0 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 1 | 60.0 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 13 | 73.3 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 13 | 76.7 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 66.7 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 1 | 56.7 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 25 | 90.0 Percentage of participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 25 | 88.9 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 6 | 93.1 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 1 | 63.3 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 6 | 86.7 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 13 | 86.7 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 25 | 78.9 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 1 | 70.0 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 13 | 86.7 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 25 | 85.0 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 1 | 70.0 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 13 | 82.8 Percentage of participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 89.7 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 25 | 81.8 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 1 | 70.4 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 6 | 74.1 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 74.1 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 13 | 69.2 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 13 | 85.2 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 6 | 81.5 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 25 | 85.7 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 1 | 59.3 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 1 | 74.1 Percentage of participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 13 | 76.9 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 1 | 62.1 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 13 | 89.7 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 25 | 73.7 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 25 | 93.8 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 13 | 82.8 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 86.2 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 1 | 69.0 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 1/Week 6 | 75.9 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 3/Week 13 | 82.8 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 6 | 86.2 Percentage of participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 20% Improvement (ACR20) Response - by the End of Course 3 | Course 2/Week 1 | 69.0 Percentage of participants |
Primary
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1
ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Week 1, 6, 13, and 25 (Course 1).
Population: mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 1 | 17.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 6 | 33.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 13 | 37.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 25 | 51.4 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 1 | 28.1 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 25 | 30.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 6 | 51.6 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 13 | 41.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 25 | 63.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 6 | 51.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 13 | 66.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 1 | 48.5 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 1 | 30.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 6 | 50.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 25 | 46.2 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 13 | 66.7 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 25 | 36.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 13 | 58.6 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 6 | 53.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 1 | Course 1/Week 1 | 30.0 Percentage of Participants |
Primary
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2
ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
Population: mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 1 | 18.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 6 | 35.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 13 | 38.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 25 | 51.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 1 | 40.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 6 | 50.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 13 | 47.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 25 | 58.6 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 13 | 40.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 6 | 53.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 1 | 26.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 25 | 30.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 6 | 50.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 25 | 55.6 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 1 | 33.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 13 | 46.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 13 | 56.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 25 | 50.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 25 | 65.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 6 | 58.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 13 | 67.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 6 | 51.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 1 | 48.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 1 | 41.9 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 6 | 48.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 13 | 65.5 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 25 | 41.7 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 1 | 34.5 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 6 | 55.2 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 25 | 40.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 1 | 27.6 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 13 | 53.6 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 25 | 36.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 25 | 50.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 13 | 58.6 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 13 | 55.2 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 1 | 31.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 6 | 55.2 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 1/Week 6 | 55.2 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 2 | Course 2/Week 1 | 24.1 Percentage of Participants |
Primary
Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3
ACR50 response: ≥50% improvement in tender/painful joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Population: mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 6 | 50.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 13 | 45.8 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 1 | 18.8 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 1 | 31.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 25 | 46.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 13 | 58.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 42.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 13 | 43.8 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 25 | 65.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 1 | 41.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 6 | 33.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 1 | 33.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 13 | 46.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 6 | 53.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 6 | 50.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 1 | 26.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 13 | 56.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 1 | 43.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 13 | 40.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 43.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 25 | 30.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 25 | 55.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 6 | 58.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 1 | 46.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 6 | 50.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 13 | 66.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 25 | 63.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 1 | 40.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 13 | 56.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 25 | 50.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 1 | 33.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 13 | 58.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 62.1 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 25 | 45.5 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 13 | 66.7 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 6 | 51.9 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 59.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 13 | 53.8 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 1 | 29.6 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 6 | 55.6 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 25 | 42.9 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 1 | 44.4 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 1 | 37.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 13 | 57.7 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 1 | 31.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 13 | 55.2 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 25 | 36.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 25 | 50.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 13 | 58.6 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 62.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 1 | 37.9 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 1/Week 6 | 55.2 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 3/Week 13 | 62.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 6 | 55.2 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 50% Improvement (ACR50) Response - by the End of Course 3 | Course 2/Week 1 | 24.1 Percentage of Participants |
Primary
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1
ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Week 1, 6, 13, and 25 (Course 1).
Population: mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 1 | 5.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 6 | 21.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 13 | 23.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 25 | 22.9 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 1 | 12.5 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 25 | 10.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 6 | 22.6 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 13 | 32.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 25 | 36.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 6 | 33.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 13 | 36.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 1 | 21.2 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 1 | 16.7 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 6 | 26.7 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 25 | 0.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 13 | 33.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 25 | 15.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 13 | 34.5 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 6 | 30.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 1 | Course 1/Week 1 | 10.0 Percentage of Participants |
Primary
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2
ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
Population: mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 1 | 5.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 6 | 22.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 13 | 24.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 25 | 22.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 1 | 13.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 6 | 26.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 13 | 30.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 25 | 24.1 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 1 | 10.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 6 | 30.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 6 | 20.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 13 | 30.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 25 | 22.2 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 25 | 10.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 13 | 30.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 1 | 16.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 13 | 35.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 6 | 32.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 25 | 35.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 6 | 37.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 1 | 19.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 13 | 33.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 1 | 19.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 25 | 30.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 6 | 24.1 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 13 | 32.1 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 13 | 31.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 25 | 0.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 1 | 17.2 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 25 | 20.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 6 | 24.1 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 1 | 13.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 6 | 24.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 1 | 10.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 25 | 15.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 6 | 31.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 1 | 10.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 13 | 24.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 1/Week 13 | 34.5 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 2 | Course 2/Week 25 | 31.3 Percentage of Participants |
Primary
Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3
ACR70 response: ≥70% improvement in tender/painful joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of arthritis pain; participant global assessment of arthritis; physician global assessment of arthritis; self-assessed disability (disability index of the HAQ); and CRP.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Population: mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 25 | 26.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 6 | 27.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 13 | 27.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 13 | 29.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 6 | 22.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 1 | 6.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 25.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 1 | 12.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 25 | 21.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 13 | 30.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 1 | 12.5 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 6 | 20.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 25 | 10.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 1 | 16.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 6 | 30.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 13 | 30.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 25 | 22.2 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 1 | 23.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 13 | 33.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 20.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 1 | 10.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 13 | 30.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 1 | 16.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 25 | 31.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 25 | 30.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 6 | 37.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 13 | 33.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 1 | 16.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 13 | 37.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 6 | 30.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 34.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 1 | 20.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 13 | 33.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 25 | 21.4 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 1 | 14.8 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 1 | 33.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 25 | 0.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 6 | 25.9 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 13 | 42.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 37.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 13 | 33.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 1 | 18.5 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 13 | 34.6 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 6 | 25.9 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 13 | 24.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 25 | 31.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 1 | 20.7 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 6 | 31.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 13 | 34.5 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 25 | 15.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 13 | 34.5 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 3/Week 25 (EOT) | 24.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 1/Week 1 | 10.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 6 | 24.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With American College of Rheumatology (ACR) 70% Improvement (ACR70) Response - by the End of Course 3 | Course 2/Week 1 | 10.3 Percentage of Participants |
Primary
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP \<2.6 implied remission.
Time frame: Week 1, 6, 13, and 25 (Course 1).
Population: mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 1 | 3.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 6 | 32.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 13 | 33.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 25 | 45.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 1 | 10.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 25 | 20.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 6 | 38.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 13 | 46.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 25 | 27.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 6 | 34.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 13 | 45.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 1 | 19.4 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 1 | 12.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 6 | 30.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 25 | 15.4 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 13 | 27.6 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 25 | 21.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 13 | 37.9 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 6 | 32.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 1 | Course 1/Week 1 | 7.1 Percentage of Participants |
Primary
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP \<2.6 implied remission.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
Population: mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 25 | 45.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 13 | 35.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 25 | 27.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 13 | 30.8 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 6 | 42.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 6 | 34.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 1 | 4.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 1 | 22.2 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 1 | 11.5 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 6 | 36.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 13 | 46.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 25 | 20.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 1 | 13.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 6 | 41.4 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 13 | 37.9 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 25 | 33.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 13 | 33.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 6 | 24.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 25 | 35.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 1 | 17.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 6 | 33.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 13 | 45.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 1 | 19.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 25 | 25.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 6 | 31.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 25 | 16.7 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 1 | 17.2 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 6 | 37.9 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 1 | 12.5 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 25 | 20.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 13 | 33.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 13 | 25.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 1 | 10.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 13 | 37.9 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 6 | 33.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 1 | 7.4 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 13 | 44.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 6 | 31.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 2/Week 25 | 25.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 2 | Course 1/Week 25 | 21.1 Percentage of Participants |
Primary
Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP \<2.6 implied remission.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Population: mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 13 | 29.8 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 1 | 4.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 6 | 44.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 1 | 22.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 25 | 43.8 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 13 | 41.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 25 (EOT) | 34.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 13 | 39.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 25 | 30.8 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 1 | 22.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 6 | 36.2 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 1 | 13.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 13 | 37.9 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 6 | 41.4 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 6 | 36.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 1 | 11.5 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 13 | 46.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 13 | 46.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 25 (EOT) | 37.9 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 1 | 30.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 25 | 20.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 25 | 33.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 13 | 33.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 1 | 14.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 6 | 31.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 13 | 43.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 25 | 21.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 1 | 16.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 6 | 24.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 25 | 35.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 1 | 26.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 13 | 44.8 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 25 (EOT) | 41.4 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 1 | 18.5 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 25 | 18.2 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 1 | 13.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 25 | 21.4 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 13 | 26.9 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 1 | 22.2 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 6 | 33.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 25 (EOT) | 33.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 13 | 44.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 6 | 40.7 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 13 | 36.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 1 | 24.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 13 | 44.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 25 | 21.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 6 | 33.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 1 | 7.4 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 6 | 31.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 25 | 25.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 1/Week 13 | 37.9 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 2/Week 1 | 10.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 25 (EOT) | 37.9 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With DAS Remission (DAS28-CRP Less Than [<] 2.6) - by the End of Course 3 | Course 3/Week 13 | 34.5 Percentage of Participants |
Primary
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (\>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline \>0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline \>0.6 with present DAS28 \>3.2 and ≤5.1 or change from baseline \>1.2 with present DAS28 \>5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 \>5.1.
Time frame: Week 1, 6, 13, and 25 (Course 1).
Population: mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 1 | 13.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 6 | 35.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 13 | 51.8 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 25 | 57.1 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 1 | 25.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 25 | 20.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 6 | 54.8 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 13 | 66.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 25 | 36.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 6 | 46.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 13 | 51.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 1 | 32.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 1 | 32.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 6 | 43.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 25 | 23.1 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 13 | 44.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 25 | 36.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 13 | 44.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 6 | 46.4 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 1 | Course 1/Week 1 | 21.4 Percentage of Participants |
Primary
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (\>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline \>0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline \>0.6 with present DAS28 \>3.2 and ≤5.1 or change from baseline \>1.2 with present DAS28 \>5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 \>5.1.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
Population: mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 1 | 14.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 6 | 37.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 25 | 57.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 1 | 44.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 6 | 61.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 25 | 55.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 13 | 51.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 13 | 51.9 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 13 | 51.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 6 | 55.2 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 1 | 33.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 6 | 53.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 25 | 66.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 1 | 26.9 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 13 | 66.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 25 | 20.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 6 | 46.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 13 | 51.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 25 | 50.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 1 | 29.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 6 | 51.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 13 | 53.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 25 | 35.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 1 | 31.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 25 | 25.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 13 | 42.9 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 6 | 41.4 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 25 | 46.7 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 1 | 29.2 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 1 | 27.6 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 13 | 55.6 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 6 | 37.9 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 25 | 43.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 1 | 22.2 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 6 | 48.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 13 | 65.5 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 6 | 48.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 13 | 44.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 2/Week 1 | 24.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 2 | Course 1/Week 25 | 36.8 Percentage of Participants |
Primary
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (\>) 1.2 with present DAS28 less than or equal to (≤) 3.2; moderate responders had a change from baseline \>0.6 and ≤1.2 with present DAS28 ≤3.2 or change from baseline \>0.6 with present DAS28 \>3.2 and ≤5.1 or change from baseline \>1.2 with present DAS28 \>5.1; non-responders had a change from baseline ≤0.6 with present DAS28 ≤5.1 or change from baseline ≤1.2 with present DAS28 \>5.1.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2) and Week 1, 13, and 25 (Course 3).
Population: mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 25 (EOT) | 48.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 1 | 43.8 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 13 | 51.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 13 | 56.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 25 | 57.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 1 | 47.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 25 | 53.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 13 | 56.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 6 | 59.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 6 | 40.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 1 | 15.9 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 6 | 53.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 13 | 51.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 25 | 66.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 1 | 43.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 13 | 53.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 25 (EOT) | 48.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 1 | 26.9 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 13 | 66.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 25 | 20.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 1 | 33.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 6 | 55.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 1 | 28.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 13 | 53.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 25 (EOT) | 55.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 1 | 36.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 13 | 58.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 25 | 50.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 6 | 51.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 6 | 44.8 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 1 | 26.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 13 | 50.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 25 | 31.6 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 13 | 60.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 25 | 27.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 1 | 30.4 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 13 | 42.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 1 | 37.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 6 | 44.4 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 25 (EOT) | 48.1 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 6 | 40.7 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 1 | 29.6 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 13 | 60.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 25 | 50.0 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 13 | 58.6 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 25 (EOT) | 51.7 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 1 | 22.2 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 6 | 48.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 13 | 65.5 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 1 | 24.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 13 | 44.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 6 | 48.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 1/Week 25 | 36.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 3/Week 1 | 34.5 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Good European League Against Rheumatism (EULAR) Response Based on DAS28 - by the End of Course 3 | Course 2/Week 25 | 43.8 Percentage of Participants |
Primary
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.
Time frame: Week 1, 6, 13, and 25 (Course 1).
Population: mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 25 | 57.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 1 | 13.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 6 | 35.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 13 | 51.8 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 1 | 25.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 13 | 66.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 6 | 54.8 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 25 | 20.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 13 | 57.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 1 | 32.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 6 | 50.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 25 | 45.5 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 13 | 44.8 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 1 | 32.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 6 | 43.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 25 | 23.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 13 | 44.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 6 | 46.4 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 25 | 36.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 1 | Course 1/Week 1 | 21.4 Percentage of Participants |
Primary
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
Population: mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 1 | 14.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 6 | 37.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 13 | 51.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 25 | 57.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 1 | 44.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 6 | 61.5 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 13 | 51.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 25 | 55.2 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 13 | 66.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 6 | 55.2 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 1 | 26.9 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 25 | 20.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 6 | 53.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 25 | 66.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 1 | 33.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 13 | 51.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 13 | 56.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 25 | 50.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 25 | 45.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 6 | 55.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 13 | 58.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 6 | 50.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 1 | 31.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 1 | 29.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 6 | 41.4 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 13 | 42.9 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 25 | 25.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 1 | 27.6 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 6 | 37.9 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 25 | 46.7 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 1 | 29.2 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 13 | 55.6 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 25 | 36.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 25 | 43.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 13 | 44.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 13 | 65.5 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 1 | 22.2 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 6 | 48.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 1/Week 6 | 48.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 2 | Course 2/Week 1 | 24.1 Percentage of Participants |
Primary
Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3
The DAS assessment is a continuous composite measure derived using differential weighting given to the following 4 components: tender/painful joint count (28 joints), swollen joint count (28 joints), CRP and patient's global assessment of arthritis VAS. The formula for calculation of DAS28-CRP from these 4 components is DAS28-CRP = 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 (ln CRP \[mg/L\] +1) + 0.014 (GH) + 0.96. Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-CRP ≤3.2 implied low disease activity.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Population: mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 13 | 51.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 25 (EOT) | 48.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 6 | 59.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 1 | 15.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 25 | 53.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 13 | 58.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 1 | 43.8 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 25 | 57.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 6 | 40.4 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 1 | 47.9 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 13 | 56.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 25 | 20.0 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 25 | 66.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 1 | 43.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 13 | 66.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 1 | 26.9 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 25 (EOT) | 48.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 1 | 33.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 6 | 55.2 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 6 | 53.3 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 13 | 56.7 Percentage of Participants |
| Rituximab-EU/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 13 | 51.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 1 | 40.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 13 | 58.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 1 | 28.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 25 | 50.0 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 6 | 55.2 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 6 | 48.3 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 25 (EOT) | 58.6 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 13 | 56.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 25 | 42.1 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 13 | 56.7 Percentage of Participants |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 1 | 26.7 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 1 | 37.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 1 | 30.4 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 6 | 44.4 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 13 | 42.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 25 | 27.3 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 1 | 29.6 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 6 | 40.7 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 13 | 60.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 25 | 50.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 13 | 60.0 Percentage of Participants |
| Rituximab-EU Total | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 25 (EOT) | 48.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 13 | 65.5 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 6 | 48.3 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 1 | 24.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 6 | 48.1 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 13 | 58.6 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 25 | 36.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 13 | 44.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 1/Week 1 | 22.2 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 25 (EOT) | 51.7 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 2/Week 25 | 43.8 Percentage of Participants |
| Rituximab-US/PF-05280586/PF-05280586 | Percentage of Participants With Low Disease Activity State (LDAS) (≤3.2) - by the End of Course 3 | Course 3/Week 1 | 34.5 Percentage of Participants |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible. Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty. Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
Time frame: Week 1, 6, 13, and 25 (Course 1).
Population: mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 1 | -12.2 Percent change in score | Standard Deviation 54.91 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 6 | -20.0 Percent change in score | Standard Deviation 48.09 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 13 | -17.7 Percent change in score | Standard Deviation 41.95 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 25 | -26.3 Percent change in score | Standard Deviation 42.52 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 1 | -31.0 Percent change in score | Standard Deviation 38.52 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 25 | -24.1 Percent change in score | Standard Deviation 32.5 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 6 | -39.1 Percent change in score | Standard Deviation 38.66 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 13 | -40.0 Percent change in score | Standard Deviation 43.21 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 25 | -43.6 Percent change in score | Standard Deviation 38.36 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 6 | -45.8 Percent change in score | Standard Deviation 35.63 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 13 | -47.5 Percent change in score | Standard Deviation 34.34 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 1 | -39.1 Percent change in score | Standard Deviation 45.85 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 1 | -28.8 Percent change in score | Standard Deviation 33.42 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 6 | -35.9 Percent change in score | Standard Deviation 30.65 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 25 | -33.9 Percent change in score | Standard Deviation 39.17 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 13 | -30.0 Percent change in score | Standard Deviation 37.25 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 25 | -27.2 Percent change in score | Standard Deviation 41.12 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 13 | -35.8 Percent change in score | Standard Deviation 33.09 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 6 | -31.7 Percent change in score | Standard Deviation 36.38 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 1 | Change at Course 1/Week 1 | -27.7 Percent change in score | Standard Deviation 36.15 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible. Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty. Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
Population: mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 1 | -15.6 Percent change in score | Standard Deviation 45.37 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 6 | -23.4 Percent change in score | Standard Deviation 41.6 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 13 | -21.6 Percent change in score | Standard Deviation 34.03 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 25 | -26.3 Percent change in score | Standard Deviation 42.52 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 1 | -19.4 Percent change in score | Standard Deviation 44.16 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 6 | -27.3 Percent change in score | Standard Deviation 42.86 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 13 | -24.9 Percent change in score | Standard Deviation 44.4 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 25 | -23.4 Percent change in score | Standard Deviation 79.52 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 13 | -38.0 Percent change in score | Standard Deviation 42.46 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 6 | -38.2 Percent change in score | Standard Deviation 41.14 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 1 | -29.3 Percent change in score | Standard Deviation 37.54 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 25 | -24.1 Percent change in score | Standard Deviation 32.5 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 6 | -37.1 Percent change in score | Standard Deviation 37.61 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 25 | -30.7 Percent change in score | Standard Deviation 37 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 1 | -36.6 Percent change in score | Standard Deviation 41.08 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 13 | -38.5 Percent change in score | Standard Deviation 40.36 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 13 | -45.3 Percent change in score | Standard Deviation 41.12 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 25 | -43.2 Percent change in score | Standard Deviation 38.79 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 25 | -44.0 Percent change in score | Standard Deviation 35.3 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 6 | -44.1 Percent change in score | Standard Deviation 38.55 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 13 | -48.4 Percent change in score | Standard Deviation 31.07 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 6 | -46.8 Percent change in score | Standard Deviation 31.78 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 1 | -40.0 Percent change in score | Standard Deviation 43.05 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 1 | -44.9 Percent change in score | Standard Deviation 34.41 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 6 | -34.1 Percent change in score | Standard Deviation 29.58 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 13 | -28.0 Percent change in score | Standard Deviation 36.26 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 25 | -31.5 Percent change in score | Standard Deviation 39.92 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 1 | -24.2 Percent change in score | Standard Deviation 35.47 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 6 | -27.2 Percent change in score | Standard Deviation 40.71 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 25 | -22.3 Percent change in score | Standard Deviation 29.32 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 1 | -26.7 Percent change in score | Standard Deviation 32.08 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 13 | -28.4 Percent change in score | Standard Deviation 38.05 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 25 | -27.2 Percent change in score | Standard Deviation 41.12 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 25 | -48.7 Percent change in score | Standard Deviation 27.77 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 13 | -35.8 Percent change in score | Standard Deviation 33.09 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 13 | -32.3 Percent change in score | Standard Deviation 64.88 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 1 | -28.4 Percent change in score | Standard Deviation 36.53 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 6 | -35.4 Percent change in score | Standard Deviation 44.1 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 1/Week 6 | -32.6 Percent change in score | Standard Deviation 36.66 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 2 | Change at Course 2/Week 1 | -27.6 Percent change in score | Standard Deviation 32.91 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3
HAQ-DI assessed the degree of difficulty participants experienced in 8 daily living activity domains during a week: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consisted of 2-3 items. Each question's difficulty was scored from 0-3 (0=no difficulty, 1=some difficulty, 2=much difficulty, 3=unable to do). Activities requiring assistance (from people or assistive devices) were adjusted to ≥2 to denote more limited functional status. The questionnaire was to be completed by the participant prior to any procedures during the visit, if possible. Overall HAQ-DI score was computed as the sum of domain scores divided by the number of domains answered, providing a score from 0-3. Low scores denoted improvement of disability/lower degree of domain difficulty. Primary outcomes reported post baseline mean percent (%) changes in HAQ-DI score. Post baseline values are reported on the % change from initial study Baseline scale.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Population: mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 6 | -26.6 Percent change in score | Standard Deviation 43.6 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 13 | -22.9 Percent change in score | Standard Deviation 44.48 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 1 | -13.9 Percent change in score | Standard Deviation 46.19 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 1 | -18.7 Percent change in score | Standard Deviation 54.57 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 25 | -26.7 Percent change in score | Standard Deviation 44.36 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 13 | -25.3 Percent change in score | Standard Deviation 43.76 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 25 | -23.7 Percent change in score | Standard Deviation 42.05 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 13 | -23.2 Percent change in score | Standard Deviation 35.62 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 25 | -21.0 Percent change in score | Standard Deviation 82.68 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 1 | -18.8 Percent change in score | Standard Deviation 45.07 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 6 | -23.1 Percent change in score | Standard Deviation 42.48 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 1 | -36.6 Percent change in score | Standard Deviation 41.08 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 13 | -38.5 Percent change in score | Standard Deviation 40.36 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 6 | -38.2 Percent change in score | Standard Deviation 41.14 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 6 | -37.1 Percent change in score | Standard Deviation 37.61 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 1 | -29.3 Percent change in score | Standard Deviation 37.54 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 13 | -32.6 Percent change in score | Standard Deviation 42.25 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 13 | -38.0 Percent change in score | Standard Deviation 42.46 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 25 | -37.7 Percent change in score | Standard Deviation 42.58 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 1 | -37.2 Percent change in score | Standard Deviation 41.42 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 25 | -24.1 Percent change in score | Standard Deviation 32.5 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 25 | -30.7 Percent change in score | Standard Deviation 37 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 6 | -44.1 Percent change in score | Standard Deviation 38.55 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 1 | -38.6 Percent change in score | Standard Deviation 42.99 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 6 | -45.2 Percent change in score | Standard Deviation 31.03 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 13 | -46.8 Percent change in score | Standard Deviation 30.36 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 25 | -41.3 Percent change in score | Standard Deviation 34.12 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 1 | -43.2 Percent change in score | Standard Deviation 33.71 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 13 | -45.3 Percent change in score | Standard Deviation 41.12 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 25 | -43.2 Percent change in score | Standard Deviation 38.79 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 1 | -41.5 Percent change in score | Standard Deviation 47.06 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 13 | -40.8 Percent change in score | Standard Deviation 50.01 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 25 | -48.7 Percent change in score | Standard Deviation 29.85 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 25 | -30.2 Percent change in score | Standard Deviation 41.61 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 1 | -26.7 Percent change in score | Standard Deviation 31.76 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 6 | -33.4 Percent change in score | Standard Deviation 30.08 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 25 | -31.1 Percent change in score | Standard Deviation 32.38 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 13 | -24.8 Percent change in score | Standard Deviation 36.5 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 13 | -27.7 Percent change in score | Standard Deviation 37.07 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 6 | -26.6 Percent change in score | Standard Deviation 42.19 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 25 | -25.0 Percent change in score | Standard Deviation 28.3 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 1 | -20.4 Percent change in score | Standard Deviation 43.26 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 1 | -24.3 Percent change in score | Standard Deviation 36.6 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 13 | -27.2 Percent change in score | Standard Deviation 39.12 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 1 | -28.4 Percent change in score | Standard Deviation 36.53 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 13 | -32.3 Percent change in score | Standard Deviation 64.88 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 25 | -27.2 Percent change in score | Standard Deviation 41.12 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 25 | -48.7 Percent change in score | Standard Deviation 27.77 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 13 | -35.8 Percent change in score | Standard Deviation 33.09 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 25 | -34.5 Percent change in score | Standard Deviation 46.2 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 1 | -22.5 Percent change in score | Standard Deviation 60.13 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 1/Week 6 | -32.6 Percent change in score | Standard Deviation 36.66 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 3/Week 13 | -40.7 Percent change in score | Standard Deviation 44.12 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 6 | -35.4 Percent change in score | Standard Deviation 44.1 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Health Assessment Questionnaire - Disability Index (HAQ-DI) - by the End of Course 3 | Change at Course 2/Week 1 | -27.6 Percent change in score | Standard Deviation 32.91 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Time frame: Week 1, 6, 13, and 25 (Course 1).
Population: mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 1 | -18.2 Percent change in score | Standard Deviation 67.42 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 6 | -31.9 Percent change in score | Standard Deviation 79.38 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 13 | -34.6 Percent change in score | Standard Deviation 52.28 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 25 | -49.7 Percent change in score | Standard Deviation 35.41 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 1 | -36.3 Percent change in score | Standard Deviation 44.85 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 25 | -19.6 Percent change in score | Standard Deviation 75.23 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 6 | -51.5 Percent change in score | Standard Deviation 44.45 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 13 | -42.4 Percent change in score | Standard Deviation 57.97 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 25 | -52.5 Percent change in score | Standard Deviation 42.73 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 6 | -59.7 Percent change in score | Standard Deviation 33.09 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 13 | -65.3 Percent change in score | Standard Deviation 28.79 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 1 | -44.0 Percent change in score | Standard Deviation 58.9 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 1 | -38.8 Percent change in score | Standard Deviation 39.7 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 6 | -42.5 Percent change in score | Standard Deviation 46.78 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 25 | -32.7 Percent change in score | Standard Deviation 67.3 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 13 | -54.8 Percent change in score | Standard Deviation 41.14 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 25 | -45.4 Percent change in score | Standard Deviation 32.5 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 13 | -50.1 Percent change in score | Standard Deviation 30.48 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 6 | -55.2 Percent change in score | Standard Deviation 28.28 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 1 | Change at Course 1/Week 1 | -39.8 Percent change in score | Standard Deviation 27.6 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
Population: mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 1 | -19.4 Percent change in score | Standard Deviation 68.24 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 6 | -33.2 Percent change in score | Standard Deviation 80.43 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 13 | -36.1 Percent change in score | Standard Deviation 51.66 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 25 | -49.7 Percent change in score | Standard Deviation 35.41 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 1 | -26.1 Percent change in score | Standard Deviation 77.23 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 6 | -42.8 Percent change in score | Standard Deviation 69.12 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 13 | -33.1 Percent change in score | Standard Deviation 61.98 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 25 | -50.7 Percent change in score | Standard Deviation 41.77 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 13 | -40.5 Percent change in score | Standard Deviation 58.05 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 6 | -50.5 Percent change in score | Standard Deviation 48.6 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 1 | -34.9 Percent change in score | Standard Deviation 44.82 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 25 | -19.6 Percent change in score | Standard Deviation 75.23 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 6 | -50.1 Percent change in score | Standard Deviation 44.48 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 25 | -59.4 Percent change in score | Standard Deviation 29.28 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 1 | -36.4 Percent change in score | Standard Deviation 57.62 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 13 | -40.6 Percent change in score | Standard Deviation 65.18 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 13 | -53.0 Percent change in score | Standard Deviation 42.09 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 25 | -55.8 Percent change in score | Standard Deviation 31.08 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 25 | -50.5 Percent change in score | Standard Deviation 43.76 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 6 | -55.3 Percent change in score | Standard Deviation 30.66 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 13 | -64.8 Percent change in score | Standard Deviation 29.18 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 6 | -59.1 Percent change in score | Standard Deviation 33.46 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 1 | -43.2 Percent change in score | Standard Deviation 59.94 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 1 | -43.9 Percent change in score | Standard Deviation 46.93 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 6 | -40.9 Percent change in score | Standard Deviation 46.73 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 13 | -53.4 Percent change in score | Standard Deviation 41.2 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 25 | -31.0 Percent change in score | Standard Deviation 70.03 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 1 | -40.6 Percent change in score | Standard Deviation 47.26 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 6 | -60.1 Percent change in score | Standard Deviation 33.26 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 25 | -44.8 Percent change in score | Standard Deviation 25.66 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 1 | -37.1 Percent change in score | Standard Deviation 39.36 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 13 | -36.0 Percent change in score | Standard Deviation 94.22 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 25 | -45.4 Percent change in score | Standard Deviation 32.5 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 25 | -61.3 Percent change in score | Standard Deviation 24.95 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 13 | -50.1 Percent change in score | Standard Deviation 30.48 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 13 | -55.9 Percent change in score | Standard Deviation 28.76 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 1 | -40.1 Percent change in score | Standard Deviation 28.05 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 6 | -58.1 Percent change in score | Standard Deviation 26.39 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 1/Week 6 | -56.1 Percent change in score | Standard Deviation 28.28 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 2 | Change at Course 2/Week 1 | -41.6 Percent change in score | Standard Deviation 30.62 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3
Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Population: mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 25 | -49.0 Percent change in score | Standard Deviation 36.46 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 6 | -31.8 Percent change in score | Standard Deviation 84.65 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 6 | -41.1 Percent change in score | Standard Deviation 71.99 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 1 | -19.1 Percent change in score | Standard Deviation 70.91 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 13 | -33.9 Percent change in score | Standard Deviation 62.57 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 25 | -28.5 Percent change in score | Standard Deviation 69.63 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 13 | -37.9 Percent change in score | Standard Deviation 63.45 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 1 | -24.0 Percent change in score | Standard Deviation 74.65 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 1 | -26.4 Percent change in score | Standard Deviation 80.49 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 13 | -39.2 Percent change in score | Standard Deviation 51.83 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 25 | -56.7 Percent change in score | Standard Deviation 33.85 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 1 | -34.9 Percent change in score | Standard Deviation 44.82 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 13 | -45.7 Percent change in score | Standard Deviation 52.35 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 25 | -44.1 Percent change in score | Standard Deviation 45.48 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 1 | -36.4 Percent change in score | Standard Deviation 57.62 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 6 | -50.5 Percent change in score | Standard Deviation 48.6 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 25 | -19.6 Percent change in score | Standard Deviation 75.23 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 6 | -50.1 Percent change in score | Standard Deviation 44.48 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 13 | -40.6 Percent change in score | Standard Deviation 65.18 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 25 | -59.4 Percent change in score | Standard Deviation 29.28 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 1 | -39.4 Percent change in score | Standard Deviation 50.56 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 13 | -40.5 Percent change in score | Standard Deviation 58.05 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 6 | -58.0 Percent change in score | Standard Deviation 33.47 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 1 | -42.5 Percent change in score | Standard Deviation 47.03 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 1 | -37.2 Percent change in score | Standard Deviation 62.77 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 25 | -55.8 Percent change in score | Standard Deviation 31.08 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 25 | -48.4 Percent change in score | Standard Deviation 43.85 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 1 | -41.6 Percent change in score | Standard Deviation 60.23 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 25 | -53.9 Percent change in score | Standard Deviation 36.8 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 6 | -55.3 Percent change in score | Standard Deviation 30.66 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 13 | -57.9 Percent change in score | Standard Deviation 33.8 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 13 | -53.0 Percent change in score | Standard Deviation 42.09 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 13 | -63.8 Percent change in score | Standard Deviation 29.15 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 13 | -35.8 Percent change in score | Standard Deviation 97.72 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 13 | -52.5 Percent change in score | Standard Deviation 42.6 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 25 | -31.7 Percent change in score | Standard Deviation 73.41 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 1 | -40.0 Percent change in score | Standard Deviation 48.91 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 6 | -60.3 Percent change in score | Standard Deviation 34.45 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 25 | -47.8 Percent change in score | Standard Deviation 23.72 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 1 | -39.3 Percent change in score | Standard Deviation 44.07 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 13 | -43.3 Percent change in score | Standard Deviation 50.22 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 25 | -43.4 Percent change in score | Standard Deviation 62.71 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 1 | -38.2 Percent change in score | Standard Deviation 40.64 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 6 | -40.7 Percent change in score | Standard Deviation 48.45 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 1 | -45.3 Percent change in score | Standard Deviation 34.84 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 25 | -61.3 Percent change in score | Standard Deviation 24.95 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 25 | -45.4 Percent change in score | Standard Deviation 32.5 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 1 | -40.1 Percent change in score | Standard Deviation 28.05 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 13 | -55.9 Percent change in score | Standard Deviation 28.76 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 6 | -58.1 Percent change in score | Standard Deviation 26.39 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 2/Week 1 | -41.6 Percent change in score | Standard Deviation 30.62 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 13 | -50.1 Percent change in score | Standard Deviation 30.48 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 1/Week 6 | -56.1 Percent change in score | Standard Deviation 28.28 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 25 | -53.9 Percent change in score | Standard Deviation 35.77 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Assessment of Arthritis Pain - by the End of Course 3 | Change at Course 3/Week 13 | -55.7 Percent change in score | Standard Deviation 31.01 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1
Participants were asked the following question, Considering all the ways your arthritis affects you, how are you feeling today? Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
Time frame: Week 1, 6, 13, and 25 (Course 1).
Population: mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 1 | -18.9 Percent change in score | Standard Deviation 62.81 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 6 | -34.6 Percent change in score | Standard Deviation 65.37 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 13 | -39.1 Percent change in score | Standard Deviation 48.65 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 25 | -52.6 Percent change in score | Standard Deviation 33.84 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 1 | -43.8 Percent change in score | Standard Deviation 41.27 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 25 | -42.3 Percent change in score | Standard Deviation 52.55 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 6 | -56.2 Percent change in score | Standard Deviation 34.62 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 13 | -55.9 Percent change in score | Standard Deviation 46.04 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 25 | -48.4 Percent change in score | Standard Deviation 42.71 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 6 | -56.8 Percent change in score | Standard Deviation 34.01 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 13 | -62.0 Percent change in score | Standard Deviation 29.52 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 1 | -40.3 Percent change in score | Standard Deviation 55.42 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 1 | -45.1 Percent change in score | Standard Deviation 32.92 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 6 | -51.0 Percent change in score | Standard Deviation 33.61 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 25 | -47.7 Percent change in score | Standard Deviation 22.7 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 13 | -61.3 Percent change in score | Standard Deviation 29.78 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 25 | -46.5 Percent change in score | Standard Deviation 31.47 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 13 | -56.2 Percent change in score | Standard Deviation 27.35 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 6 | -58.3 Percent change in score | Standard Deviation 24.77 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 1 | -39.2 Percent change in score | Standard Deviation 23.89 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2
Participants were asked the following question, Considering all the ways your arthritis affects you, how are you feeling today? Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
Population: mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 1 | -21.5 Percent change in score | Standard Deviation 62.57 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 6 | -37.4 Percent change in score | Standard Deviation 64.66 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 13 | -41.2 Percent change in score | Standard Deviation 47.09 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 25 | -52.6 Percent change in score | Standard Deviation 33.84 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 1 | -32.1 Percent change in score | Standard Deviation 62.08 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 6 | -46.8 Percent change in score | Standard Deviation 46.61 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 13 | -43.7 Percent change in score | Standard Deviation 40.69 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 25 | -55.6 Percent change in score | Standard Deviation 33.12 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 13 | -54.6 Percent change in score | Standard Deviation 46.26 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 6 | -51.5 Percent change in score | Standard Deviation 49.96 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 1 | -41.7 Percent change in score | Standard Deviation 41.5 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 25 | -42.3 Percent change in score | Standard Deviation 52.55 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 6 | -55.0 Percent change in score | Standard Deviation 34.56 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 25 | -59.1 Percent change in score | Standard Deviation 29.99 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 1 | -41.9 Percent change in score | Standard Deviation 54.71 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 13 | -45.1 Percent change in score | Standard Deviation 55.55 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 13 | -29.8 Percent change in score | Standard Deviation 142.51 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 25 | -51.0 Percent change in score | Standard Deviation 33.35 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 25 | -47.1 Percent change in score | Standard Deviation 43.42 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 6 | -46.2 Percent change in score | Standard Deviation 49.97 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 13 | -62.2 Percent change in score | Standard Deviation 29.35 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 6 | -56.4 Percent change in score | Standard Deviation 34.31 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 1 | -40.5 Percent change in score | Standard Deviation 55.52 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 1 | -39.1 Percent change in score | Standard Deviation 45.93 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 6 | -49.7 Percent change in score | Standard Deviation 33.52 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 13 | -60.3 Percent change in score | Standard Deviation 29.79 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 25 | -46.3 Percent change in score | Standard Deviation 23.14 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 1 | -50.6 Percent change in score | Standard Deviation 31.39 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 6 | -62.0 Percent change in score | Standard Deviation 29.11 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 25 | -47.3 Percent change in score | Standard Deviation 28.57 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 1 | -43.8 Percent change in score | Standard Deviation 32.81 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 13 | -53.3 Percent change in score | Standard Deviation 41.09 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 25 | -46.5 Percent change in score | Standard Deviation 31.47 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 25 | -60.9 Percent change in score | Standard Deviation 21.76 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 13 | -56.2 Percent change in score | Standard Deviation 27.35 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 13 | -57.2 Percent change in score | Standard Deviation 23.56 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 1 | -39.9 Percent change in score | Standard Deviation 24.05 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 6 | -59.0 Percent change in score | Standard Deviation 25.26 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 6 | -59.5 Percent change in score | Standard Deviation 24.29 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 1 | -43.3 Percent change in score | Standard Deviation 27.34 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3
Participants were asked the following question, Considering all the ways your arthritis affects you, how are you feeling today? Their response was recorded using a 100 mm VAS between 0 (very well) and 100 (very poor).
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Population: mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 6 | -45.1 Percent change in score | Standard Deviation 48.34 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 13 | -43.3 Percent change in score | Standard Deviation 41.5 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 1 | -21.7 Percent change in score | Standard Deviation 65.6 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 1 | -26.9 Percent change in score | Standard Deviation 63.81 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 25 | -51.5 Percent change in score | Standard Deviation 35.06 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 13 | -40.5 Percent change in score | Standard Deviation 48.27 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 25 | -34.7 Percent change in score | Standard Deviation 50.49 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 13 | -44.1 Percent change in score | Standard Deviation 48.95 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 25 | -59.1 Percent change in score | Standard Deviation 31.65 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 1 | -31.0 Percent change in score | Standard Deviation 65.11 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 6 | -36.9 Percent change in score | Standard Deviation 67.42 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 1 | -41.9 Percent change in score | Standard Deviation 54.71 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 13 | -45.1 Percent change in score | Standard Deviation 55.55 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 6 | -51.5 Percent change in score | Standard Deviation 49.96 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 6 | -55.0 Percent change in score | Standard Deviation 34.56 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 1 | -41.7 Percent change in score | Standard Deviation 41.5 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 13 | -52.6 Percent change in score | Standard Deviation 45.33 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 13 | -54.6 Percent change in score | Standard Deviation 46.26 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 25 | -43.3 Percent change in score | Standard Deviation 44.82 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 1 | -45.4 Percent change in score | Standard Deviation 41.98 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 25 | -42.3 Percent change in score | Standard Deviation 52.55 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 25 | -59.1 Percent change in score | Standard Deviation 29.99 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 6 | -46.2 Percent change in score | Standard Deviation 49.97 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 1 | -38.8 Percent change in score | Standard Deviation 55.71 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 6 | -55.5 Percent change in score | Standard Deviation 34.55 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 13 | -61.3 Percent change in score | Standard Deviation 29.42 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 25 | -44.8 Percent change in score | Standard Deviation 43.28 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 1 | -37.5 Percent change in score | Standard Deviation 45.85 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 13 | -29.8 Percent change in score | Standard Deviation 142.51 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 25 | -51.0 Percent change in score | Standard Deviation 33.35 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 1 | -39.1 Percent change in score | Standard Deviation 46.9 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 13 | -53.2 Percent change in score | Standard Deviation 34.27 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 25 | -50.6 Percent change in score | Standard Deviation 39.52 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 25 | -47.4 Percent change in score | Standard Deviation 23.93 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 1 | -44.4 Percent change in score | Standard Deviation 33.89 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 6 | -50.2 Percent change in score | Standard Deviation 34.42 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 25 | -53.9 Percent change in score | Standard Deviation 42.61 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 13 | -52.3 Percent change in score | Standard Deviation 35.92 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 13 | -60.1 Percent change in score | Standard Deviation 30.8 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 6 | -63.5 Percent change in score | Standard Deviation 29.54 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 25 | -49.9 Percent change in score | Standard Deviation 27.77 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 1 | -42.9 Percent change in score | Standard Deviation 43.85 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 1 | -50.2 Percent change in score | Standard Deviation 32.39 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 13 | -54.7 Percent change in score | Standard Deviation 42.05 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 1 | -39.9 Percent change in score | Standard Deviation 24.05 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 13 | -57.2 Percent change in score | Standard Deviation 23.56 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 25 | -46.5 Percent change in score | Standard Deviation 31.47 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 25 | -60.9 Percent change in score | Standard Deviation 21.76 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 13 | -56.2 Percent change in score | Standard Deviation 27.35 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 25 | -50.3 Percent change in score | Standard Deviation 44.57 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 1 | -48.6 Percent change in score | Standard Deviation 34.18 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 6 | -59.5 Percent change in score | Standard Deviation 24.29 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 13 | -55.2 Percent change in score | Standard Deviation 28.16 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 6 | -59.0 Percent change in score | Standard Deviation 25.26 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Patient's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 1 | -43.3 Percent change in score | Standard Deviation 27.34 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Time frame: Week 1, 6, 13, and 25 (Course 1).
Population: mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 1 | -40.3 Percent change in score | Standard Deviation 42.01 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 6 | -60.4 Percent change in score | Standard Deviation 45.47 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 13 | -69.3 Percent change in score | Standard Deviation 30.36 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 25 | -67.0 Percent change in score | Standard Deviation 29.61 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 1 | -46.1 Percent change in score | Standard Deviation 42.81 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 25 | -73.2 Percent change in score | Standard Deviation 25 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 6 | -66.1 Percent change in score | Standard Deviation 40.4 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 13 | -68.1 Percent change in score | Standard Deviation 37.74 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 25 | -71.4 Percent change in score | Standard Deviation 23.32 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 6 | -71.3 Percent change in score | Standard Deviation 24.62 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 13 | -76.1 Percent change in score | Standard Deviation 14.01 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 1 | -54.2 Percent change in score | Standard Deviation 34.06 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 1 | -55.0 Percent change in score | Standard Deviation 26.03 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 6 | -59.5 Percent change in score | Standard Deviation 39.66 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 25 | -55.1 Percent change in score | Standard Deviation 28.56 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 13 | -71.0 Percent change in score | Standard Deviation 27.86 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 25 | -59.9 Percent change in score | Standard Deviation 25.95 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 13 | -69.9 Percent change in score | Standard Deviation 21.09 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 6 | -73.0 Percent change in score | Standard Deviation 22.41 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 1 | Change at Course 1/Week 1 | -52.4 Percent change in score | Standard Deviation 26.51 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2).
Population: mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 1 | -41.3 Percent change in score | Standard Deviation 42.2 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 6 | -62.1 Percent change in score | Standard Deviation 44.83 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 13 | -70.3 Percent change in score | Standard Deviation 28.43 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 25 | -67.0 Percent change in score | Standard Deviation 29.61 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 1 | -56.9 Percent change in score | Standard Deviation 50.62 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 6 | -76.4 Percent change in score | Standard Deviation 26.53 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 13 | -74.0 Percent change in score | Standard Deviation 24.66 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 25 | -68.5 Percent change in score | Standard Deviation 26.4 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 13 | -67.2 Percent change in score | Standard Deviation 38.04 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 6 | -66.9 Percent change in score | Standard Deviation 36.14 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 1 | -45.4 Percent change in score | Standard Deviation 43.77 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 25 | -73.2 Percent change in score | Standard Deviation 25 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 6 | -65.1 Percent change in score | Standard Deviation 40.66 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 25 | -73.7 Percent change in score | Standard Deviation 21.26 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 1 | -49.5 Percent change in score | Standard Deviation 43.91 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 13 | -64.6 Percent change in score | Standard Deviation 44.61 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 13 | -72.1 Percent change in score | Standard Deviation 22.92 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 25 | -71.9 Percent change in score | Standard Deviation 27.15 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 25 | -71.5 Percent change in score | Standard Deviation 22.98 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 6 | -74.0 Percent change in score | Standard Deviation 24.77 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 13 | -76.5 Percent change in score | Standard Deviation 13.39 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 6 | -72.3 Percent change in score | Standard Deviation 23.31 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 1 | -54.4 Percent change in score | Standard Deviation 33.27 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 1 | -59.3 Percent change in score | Standard Deviation 28.59 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 6 | -58.5 Percent change in score | Standard Deviation 40.01 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 13 | -70.3 Percent change in score | Standard Deviation 28.11 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 25 | -54.7 Percent change in score | Standard Deviation 29.79 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 1 | -56.6 Percent change in score | Standard Deviation 31.54 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 6 | -69.4 Percent change in score | Standard Deviation 25.81 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 25 | -58.9 Percent change in score | Standard Deviation 34.65 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 1 | -54.0 Percent change in score | Standard Deviation 25.84 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 13 | -69.0 Percent change in score | Standard Deviation 35.02 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 25 | -59.9 Percent change in score | Standard Deviation 25.95 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 25 | -68.7 Percent change in score | Standard Deviation 32.49 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 13 | -69.9 Percent change in score | Standard Deviation 21.09 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 13 | -72.9 Percent change in score | Standard Deviation 30.55 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 1 | -53.9 Percent change in score | Standard Deviation 25.58 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 6 | -74.6 Percent change in score | Standard Deviation 21.81 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 1/Week 6 | -74.4 Percent change in score | Standard Deviation 21.44 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 2 | Change at Course 2/Week 1 | -60.7 Percent change in score | Standard Deviation 23.54 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3
The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).
Time frame: Week 1, 6, 13, and 25 (Course 1 and Course 2), and Week 1, 13, and 25 (Course 3).
Population: mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 6 | -75.3 Percent change in score | Standard Deviation 27.47 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 13 | -73.4 Percent change in score | Standard Deviation 25.64 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 1 | -39.7 Percent change in score | Standard Deviation 43.82 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 1 | -52.6 Percent change in score | Standard Deviation 55.21 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 25 | -65.9 Percent change in score | Standard Deviation 30.76 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 13 | -74.6 Percent change in score | Standard Deviation 33.44 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 25 | -74.0 Percent change in score | Standard Deviation 25.59 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 13 | -72.5 Percent change in score | Standard Deviation 29.26 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 25 | -70.6 Percent change in score | Standard Deviation 24.17 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 1 | -57.2 Percent change in score | Standard Deviation 53.03 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 6 | -62.8 Percent change in score | Standard Deviation 45.89 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 1 | -49.5 Percent change in score | Standard Deviation 43.91 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 13 | -64.6 Percent change in score | Standard Deviation 44.61 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 6 | -66.9 Percent change in score | Standard Deviation 36.14 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 6 | -65.1 Percent change in score | Standard Deviation 40.66 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 1 | -45.4 Percent change in score | Standard Deviation 43.77 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 13 | -62.3 Percent change in score | Standard Deviation 54.14 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 13 | -67.2 Percent change in score | Standard Deviation 38.04 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 25 | -59.9 Percent change in score | Standard Deviation 42.55 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 1 | -54.6 Percent change in score | Standard Deviation 43.47 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 25 | -73.2 Percent change in score | Standard Deviation 25 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 25 | -73.7 Percent change in score | Standard Deviation 21.26 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 6 | -74.0 Percent change in score | Standard Deviation 24.77 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 1 | -53.1 Percent change in score | Standard Deviation 32.94 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 6 | -71.6 Percent change in score | Standard Deviation 23.44 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 13 | -76.0 Percent change in score | Standard Deviation 13.34 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 25 | -70.4 Percent change in score | Standard Deviation 22.98 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 1 | -58.2 Percent change in score | Standard Deviation 28.45 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 13 | -72.1 Percent change in score | Standard Deviation 22.92 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 25 | -71.9 Percent change in score | Standard Deviation 27.15 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 1 | -59.6 Percent change in score | Standard Deviation 29.85 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 13 | -73.3 Percent change in score | Standard Deviation 19.12 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 25 | -74.3 Percent change in score | Standard Deviation 20.48 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 25 | -60.1 Percent change in score | Standard Deviation 24.56 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 1 | -55.6 Percent change in score | Standard Deviation 25.07 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 6 | -61.0 Percent change in score | Standard Deviation 40.38 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 25 | -72.7 Percent change in score | Standard Deviation 23.3 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 13 | -71.5 Percent change in score | Standard Deviation 22.57 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 13 | -70.5 Percent change in score | Standard Deviation 29.13 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 6 | -70.2 Percent change in score | Standard Deviation 26.55 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 25 | -63.8 Percent change in score | Standard Deviation 30.1 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 1 | -52.8 Percent change in score | Standard Deviation 44.2 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 1 | -56.2 Percent change in score | Standard Deviation 31.66 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 13 | -69.7 Percent change in score | Standard Deviation 36.19 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 1 | -53.9 Percent change in score | Standard Deviation 25.58 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 13 | -72.9 Percent change in score | Standard Deviation 30.55 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 25 | -59.9 Percent change in score | Standard Deviation 25.95 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 25 | -68.7 Percent change in score | Standard Deviation 32.49 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 13 | -69.9 Percent change in score | Standard Deviation 21.09 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 25 | -70.9 Percent change in score | Standard Deviation 26.63 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 1 | -62.9 Percent change in score | Standard Deviation 28.65 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 1/Week 6 | -74.4 Percent change in score | Standard Deviation 21.44 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 3/Week 13 | -73.0 Percent change in score | Standard Deviation 23.11 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 6 | -74.6 Percent change in score | Standard Deviation 21.81 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Physician's Global Assessment of Arthritis - by the End of Course 3 | Change at Course 2/Week 1 | -60.7 Percent change in score | Standard Deviation 23.54 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Time frame: Screening, Week 1, 6, 13, and 25 (Course 1).
Population: mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 13 | -78.0 Percent change in joint count | Standard Deviation 29.2 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Screening | -58.1 Percent change in joint count | Standard Deviation 33.22 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 25 | -75.0 Percent change in joint count | Standard Deviation 27.92 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 1 | -51.7 Percent change in joint count | Standard Deviation 40.21 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 6 | -60.2 Percent change in joint count | Standard Deviation 116.58 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 13 | -47.2 Percent change in joint count | Standard Deviation 133.31 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 6 | -55.1 Percent change in joint count | Standard Deviation 94.22 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 1 | -49.9 Percent change in joint count | Standard Deviation 46.14 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 25 | -74.1 Percent change in joint count | Standard Deviation 16.33 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Screening | -54.2 Percent change in joint count | Standard Deviation 39.43 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 6 | -70.6 Percent change in joint count | Standard Deviation 35.2 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Screening | -62.9 Percent change in joint count | Standard Deviation 32.45 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 1 | -53.4 Percent change in joint count | Standard Deviation 48.36 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 13 | -75.6 Percent change in joint count | Standard Deviation 34.36 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 25 | -74.7 Percent change in joint count | Standard Deviation 27.15 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 25 | -58.6 Percent change in joint count | Standard Deviation 50.63 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Screening | -54.9 Percent change in joint count | Standard Deviation 41.05 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 13 | -79.5 Percent change in joint count | Standard Deviation 22.58 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 6 | -68.2 Percent change in joint count | Standard Deviation 45.65 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 1 | -47.9 Percent change in joint count | Standard Deviation 55.08 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 6 | -76.9 Percent change in joint count | Standard Deviation 26.79 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 13 | -70.0 Percent change in joint count | Standard Deviation 44.41 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Screening | -59.1 Percent change in joint count | Standard Deviation 29.43 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 25 | -67.2 Percent change in joint count | Standard Deviation 28.49 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 1 | Change at Course 1/Week 1 | -58.4 Percent change in joint count | Standard Deviation 32.65 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Time frame: Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Population: mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 25 | -75.0 Percent change in joint count | Standard Deviation 26.74 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 25 | -75.0 Percent change in joint count | Standard Deviation 27.92 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 1 | -55.1 Percent change in joint count | Standard Deviation 35.01 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 1 | -58.0 Percent change in joint count | Standard Deviation 76.91 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 13 | -77.3 Percent change in joint count | Standard Deviation 30.1 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 6 | -62.7 Percent change in joint count | Standard Deviation 117.28 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 6 | -81.3 Percent change in joint count | Standard Deviation 25.98 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 13 | -78.3 Percent change in joint count | Standard Deviation 29.13 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Screening | -60.4 Percent change in joint count | Standard Deviation 29.31 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 6 | -64.6 Percent change in joint count | Standard Deviation 51.49 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 1 | -51.0 Percent change in joint count | Standard Deviation 54.16 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 13 | -45.4 Percent change in joint count | Standard Deviation 135.23 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 25 | -74.1 Percent change in joint count | Standard Deviation 16.33 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 6 | -53.8 Percent change in joint count | Standard Deviation 95.58 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 25 | -84.4 Percent change in joint count | Standard Deviation 16.09 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 1 | -47.7 Percent change in joint count | Standard Deviation 46.81 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Screening | -52.5 Percent change in joint count | Standard Deviation 40.15 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 13 | -54.7 Percent change in joint count | Standard Deviation 91.62 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 1 | -53.1 Percent change in joint count | Standard Deviation 46.17 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Screening | -64.0 Percent change in joint count | Standard Deviation 30.26 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 1 | -53.8 Percent change in joint count | Standard Deviation 48.02 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 6 | -72.5 Percent change in joint count | Standard Deviation 32.18 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 13 | -77.8 Percent change in joint count | Standard Deviation 30.83 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 25 | -76.0 Percent change in joint count | Standard Deviation 25.18 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 6 | -82.3 Percent change in joint count | Standard Deviation 21.43 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 13 | -75.0 Percent change in joint count | Standard Deviation 34.02 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 25 | -77.9 Percent change in joint count | Standard Deviation 21.66 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 13 | -78.7 Percent change in joint count | Standard Deviation 22.64 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 1 | -59.2 Percent change in joint count | Standard Deviation 39.14 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 6 | -67.2 Percent change in joint count | Standard Deviation 46.15 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 6 | -74.3 Percent change in joint count | Standard Deviation 32.1 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 1 | -46.4 Percent change in joint count | Standard Deviation 55.43 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 25 | -77.1 Percent change in joint count | Standard Deviation 28.22 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 13 | -76.7 Percent change in joint count | Standard Deviation 29.58 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Screening | -53.3 Percent change in joint count | Standard Deviation 40.86 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 25 | -55.9 Percent change in joint count | Standard Deviation 51.86 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Screening | -60.2 Percent change in joint count | Standard Deviation 29.3 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 13 | -70.0 Percent change in joint count | Standard Deviation 44.41 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 1 | -56.2 Percent change in joint count | Standard Deviation 45.29 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 6 | -78.2 Percent change in joint count | Standard Deviation 26.25 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 25 | -67.2 Percent change in joint count | Standard Deviation 28.49 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 25 | -80.0 Percent change in joint count | Standard Deviation 21.86 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 13 | -81.3 Percent change in joint count | Standard Deviation 26.43 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 2/Week 6 | -82.0 Percent change in joint count | Standard Deviation 20.56 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 2 | Change at Course 1/Week 1 | -59.2 Percent change in joint count | Standard Deviation 32.91 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3
Sixty-six joints were assessed by a blinded joint assessor for swelling. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Time frame: Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
Population: mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 1 | -66.3 Percent change in joint count | Standard Deviation 55.96 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 25 | -73.5 Percent change in joint count | Standard Deviation 28.74 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 1 | -55.6 Percent change in joint count | Standard Deviation 36.38 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 25 | -78.1 Percent change in joint count | Standard Deviation 24.72 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 25 | -72.2 Percent change in joint count | Standard Deviation 46.88 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 13 | -79.3 Percent change in joint count | Standard Deviation 27.17 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 1 | -57.8 Percent change in joint count | Standard Deviation 80.94 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 13 | -76.4 Percent change in joint count | Standard Deviation 31.23 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 6 | -62.1 Percent change in joint count | Standard Deviation 124.1 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 13 | -78.6 Percent change in joint count | Standard Deviation 36.94 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Screening | -60.5 Percent change in joint count | Standard Deviation 30.41 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 6 | -81.5 Percent change in joint count | Standard Deviation 26.08 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 25 | -51.5 Percent change in joint count | Standard Deviation 94.79 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 25 | -84.4 Percent change in joint count | Standard Deviation 16.09 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 13 | -54.7 Percent change in joint count | Standard Deviation 91.62 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Screening | -52.5 Percent change in joint count | Standard Deviation 40.15 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 13 | -45.4 Percent change in joint count | Standard Deviation 135.23 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 6 | -64.6 Percent change in joint count | Standard Deviation 51.49 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 25 | -74.1 Percent change in joint count | Standard Deviation 16.33 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 6 | -53.8 Percent change in joint count | Standard Deviation 95.58 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 13 | -70.4 Percent change in joint count | Standard Deviation 37.09 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 1 | -51.0 Percent change in joint count | Standard Deviation 54.16 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 1 | -47.7 Percent change in joint count | Standard Deviation 46.81 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 1 | -59.9 Percent change in joint count | Standard Deviation 45.11 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 13 | -76.7 Percent change in joint count | Standard Deviation 29.14 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 1 | -52.2 Percent change in joint count | Standard Deviation 48.06 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 6 | -71.5 Percent change in joint count | Standard Deviation 32.31 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 13 | -77.0 Percent change in joint count | Standard Deviation 31.08 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 25 | -74.8 Percent change in joint count | Standard Deviation 25.21 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 1 | -51.5 Percent change in joint count | Standard Deviation 46.11 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 6 | -82.3 Percent change in joint count | Standard Deviation 21.43 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 13 | -75.0 Percent change in joint count | Standard Deviation 34.02 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 25 | -77.9 Percent change in joint count | Standard Deviation 21.66 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 1 | -63.9 Percent change in joint count | Standard Deviation 39.07 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 25 | -75.7 Percent change in joint count | Standard Deviation 29.79 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Screening | -62.7 Percent change in joint count | Standard Deviation 30.01 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Screening | -53.9 Percent change in joint count | Standard Deviation 42.34 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 6 | -73.2 Percent change in joint count | Standard Deviation 32.9 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 1 | -74.3 Percent change in joint count | Standard Deviation 29.11 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 1 | -60.8 Percent change in joint count | Standard Deviation 38.8 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 1 | -49.0 Percent change in joint count | Standard Deviation 55.86 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 13 | -84.0 Percent change in joint count | Standard Deviation 24.36 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 25 | -59.9 Percent change in joint count | Standard Deviation 52.34 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 6 | -68.2 Percent change in joint count | Standard Deviation 47.4 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 25 | -79.1 Percent change in joint count | Standard Deviation 27.77 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 13 | -79.2 Percent change in joint count | Standard Deviation 22.12 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 13 | -76.8 Percent change in joint count | Standard Deviation 30.73 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 25 | -76.1 Percent change in joint count | Standard Deviation 29.01 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 6 | -78.2 Percent change in joint count | Standard Deviation 26.25 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 25 | -80.0 Percent change in joint count | Standard Deviation 21.86 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 13 | -70.0 Percent change in joint count | Standard Deviation 44.41 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 1 | -56.2 Percent change in joint count | Standard Deviation 45.29 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Screening | -60.2 Percent change in joint count | Standard Deviation 29.3 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 1 | -59.2 Percent change in joint count | Standard Deviation 32.91 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 1 | -66.2 Percent change in joint count | Standard Deviation 31.33 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 13 | -81.3 Percent change in joint count | Standard Deviation 26.43 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 1/Week 25 | -67.2 Percent change in joint count | Standard Deviation 28.49 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 25 | -76.6 Percent change in joint count | Standard Deviation 37.5 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 2/Week 6 | -82.0 Percent change in joint count | Standard Deviation 20.56 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Swollen Joint Count - by the End of Course 3 | Change at Course 3/Week 13 | -83.2 Percent change in joint count | Standard Deviation 26.99 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Time frame: Screening, Week 1, 6, 13, and 25 (Course 1).
Population: mITT Population - The mITT population for Course 1 was defined as all participants who received the treatment of the first course of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 13 | -70.2 Percent change in joint count | Standard Deviation 41.21 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Screening | -52.2 Percent change in joint count | Standard Deviation 31.46 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 25 | -52.2 Percent change in joint count | Standard Deviation 31.46 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 1 | -41.4 Percent change in joint count | Standard Deviation 46.1 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 6 | -52.2 Percent change in joint count | Standard Deviation 117.76 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 13 | -76.6 Percent change in joint count | Standard Deviation 32.37 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 6 | -72.1 Percent change in joint count | Standard Deviation 29.69 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 1 | -51.1 Percent change in joint count | Standard Deviation 44.62 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 25 | -57.1 Percent change in joint count | Standard Deviation 37.14 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Screening | -57.1 Percent change in joint count | Standard Deviation 37.14 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 6 | -72.5 Percent change in joint count | Standard Deviation 31.75 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Screening | -64.2 Percent change in joint count | Standard Deviation 29.79 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 1 | -57.8 Percent change in joint count | Standard Deviation 40.25 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 13 | -72.9 Percent change in joint count | Standard Deviation 28.99 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 25 | -64.2 Percent change in joint count | Standard Deviation 29.79 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 25 | -57.0 Percent change in joint count | Standard Deviation 39.55 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Screening | -57.0 Percent change in joint count | Standard Deviation 39.55 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 13 | -70.6 Percent change in joint count | Standard Deviation 37.69 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 6 | -68.7 Percent change in joint count | Standard Deviation 36.39 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 1 | -50.5 Percent change in joint count | Standard Deviation 44.08 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 6 | -69.5 Percent change in joint count | Standard Deviation 37.71 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 13 | -68.7 Percent change in joint count | Standard Deviation 33.16 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Screening | -55.2 Percent change in joint count | Standard Deviation 31.97 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 25 | -55.2 Percent change in joint count | Standard Deviation 31.97 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 1 | Change at Course 1/Week 1 | -51.6 Percent change in joint count | Standard Deviation 33 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Time frame: Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2).
Population: mITT Population - The mITT population for Course 2 was defined as all participants who received the treatments of the first 2 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 25 | -76.5 Percent change in joint count | Standard Deviation 19.3 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 25 | -70.7 Percent change in joint count | Standard Deviation 34.48 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 1 | -42.7 Percent change in joint count | Standard Deviation 46.01 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 1 | -54.6 Percent change in joint count | Standard Deviation 68.22 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 13 | -70.7 Percent change in joint count | Standard Deviation 35.12 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 6 | -53.4 Percent change in joint count | Standard Deviation 120.45 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 6 | -81.5 Percent change in joint count | Standard Deviation 24.73 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 13 | -70.9 Percent change in joint count | Standard Deviation 40.98 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Screening | -54.1 Percent change in joint count | Standard Deviation 31 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 6 | -73.7 Percent change in joint count | Standard Deviation 31.95 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 1 | -61.5 Percent change in joint count | Standard Deviation 30.9 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 13 | -75.8 Percent change in joint count | Standard Deviation 32.62 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 25 | -74.0 Percent change in joint count | Standard Deviation 19.08 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 6 | -71.5 Percent change in joint count | Standard Deviation 29.97 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 25 | -84.9 Percent change in joint count | Standard Deviation 19.6 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 1 | -48.9 Percent change in joint count | Standard Deviation 45.19 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Screening | -56.0 Percent change in joint count | Standard Deviation 38.11 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 13 | -69.3 Percent change in joint count | Standard Deviation 39.85 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 1 | -60.0 Percent change in joint count | Standard Deviation 39.43 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Screening | -64.7 Percent change in joint count | Standard Deviation 28.61 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 1 | -57.8 Percent change in joint count | Standard Deviation 40.07 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 6 | -74.1 Percent change in joint count | Standard Deviation 29.12 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 13 | -74.5 Percent change in joint count | Standard Deviation 25.85 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 25 | -70.3 Percent change in joint count | Standard Deviation 26.87 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 6 | -79.5 Percent change in joint count | Standard Deviation 25.12 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 13 | -77.5 Percent change in joint count | Standard Deviation 22.83 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 25 | -72.4 Percent change in joint count | Standard Deviation 25.01 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 13 | -69.6 Percent change in joint count | Standard Deviation 37.93 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 1 | -55.4 Percent change in joint count | Standard Deviation 38.38 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 6 | -67.8 Percent change in joint count | Standard Deviation 36.66 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 6 | -70.1 Percent change in joint count | Standard Deviation 32.79 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 1 | -49.1 Percent change in joint count | Standard Deviation 44.15 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 25 | -69.7 Percent change in joint count | Standard Deviation 27.1 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 13 | -74.4 Percent change in joint count | Standard Deviation 34.04 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Screening | -55.5 Percent change in joint count | Standard Deviation 39.39 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 25 | -49.8 Percent change in joint count | Standard Deviation 44.9 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Screening | -55.9 Percent change in joint count | Standard Deviation 32.29 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 13 | -68.7 Percent change in joint count | Standard Deviation 33.16 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 1 | -60.0 Percent change in joint count | Standard Deviation 30.18 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 6 | -70.5 Percent change in joint count | Standard Deviation 37.95 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 25 | -69.9 Percent change in joint count | Standard Deviation 20.36 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 25 | -75.5 Percent change in joint count | Standard Deviation 14.06 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 13 | -82.5 Percent change in joint count | Standard Deviation 21.63 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 2/Week 6 | -77.3 Percent change in joint count | Standard Deviation 27.37 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 2 | Change at Course 1/Week 1 | -51.9 Percent change in joint count | Standard Deviation 33.54 |
Primary
Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3
Sixty-eight joints were assessed by a blinded joint assessor to determine the number of joints that were considered tender or painful. For consistency, a single assessor was preferred to perform all evaluations across the study for an individual participant. The response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Artificial joints were not be assessed.
Time frame: Screening, Week 1, 6, 13, and 25 (Course 1 and Course 2), and Screening, Week 1, 13, and 25 (Course 3).
Population: mITT Population - The mITT population for Course 3 was defined as all participants who received the treatments of all 3 courses of study B3281004.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 13 | -69.4 Percent change in joint count | Standard Deviation 36.44 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 13 | -69.1 Percent change in joint count | Standard Deviation 54.91 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Screening | -53.4 Percent change in joint count | Standard Deviation 31.93 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 13 | -75.1 Percent change in joint count | Standard Deviation 30.47 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 1 | -54.9 Percent change in joint count | Standard Deviation 69.76 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 25 | -71.8 Percent change in joint count | Standard Deviation 31.2 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 1 | -57.3 Percent change in joint count | Standard Deviation 63.73 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 6 | -53.6 Percent change in joint count | Standard Deviation 127.05 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 25 | -69.0 Percent change in joint count | Standard Deviation 35.57 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 6 | -81.5 Percent change in joint count | Standard Deviation 25.65 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 1 | -41.5 Percent change in joint count | Standard Deviation 47.81 |
| PF-05280586/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 25 | -75.7 Percent change in joint count | Standard Deviation 19.82 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 25 | -59.2 Percent change in joint count | Standard Deviation 80.64 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 1 | -61.5 Percent change in joint count | Standard Deviation 30.9 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 1 | -48.9 Percent change in joint count | Standard Deviation 45.19 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 6 | -73.7 Percent change in joint count | Standard Deviation 31.95 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Screening | -56.0 Percent change in joint count | Standard Deviation 38.11 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 13 | -69.2 Percent change in joint count | Standard Deviation 52.97 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 6 | -71.5 Percent change in joint count | Standard Deviation 29.97 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 13 | -69.3 Percent change in joint count | Standard Deviation 39.85 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 1 | -65.6 Percent change in joint count | Standard Deviation 32.53 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 13 | -75.8 Percent change in joint count | Standard Deviation 32.62 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 25 | -84.9 Percent change in joint count | Standard Deviation 19.6 |
| Rituximab-EU/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 25 | -74.0 Percent change in joint count | Standard Deviation 19.08 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 13 | -79.6 Percent change in joint count | Standard Deviation 22.21 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Screening | -63.5 Percent change in joint count | Standard Deviation 28.31 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 1 | -56.4 Percent change in joint count | Standard Deviation 39.97 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 6 | -73.3 Percent change in joint count | Standard Deviation 29.22 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 13 | -73.7 Percent change in joint count | Standard Deviation 25.85 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 25 | -68.8 Percent change in joint count | Standard Deviation 26.66 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 1 | -58.7 Percent change in joint count | Standard Deviation 39.38 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 6 | -79.5 Percent change in joint count | Standard Deviation 25.12 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 13 | -77.5 Percent change in joint count | Standard Deviation 22.83 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 25 | -72.4 Percent change in joint count | Standard Deviation 25.01 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 1 | -66.5 Percent change in joint count | Standard Deviation 30.69 |
| PF-05280586/PF-05280586/PF-05280586 (EU) | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 25 | -75.6 Percent change in joint count | Standard Deviation 29.79 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 1 | -59.2 Percent change in joint count | Standard Deviation 36.67 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Screening | -59.6 Percent change in joint count | Standard Deviation 37.63 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 13 | -76.0 Percent change in joint count | Standard Deviation 34.73 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 25 | -58.9 Percent change in joint count | Standard Deviation 33.62 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 25 | -72.8 Percent change in joint count | Standard Deviation 25.18 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 13 | -74.4 Percent change in joint count | Standard Deviation 28.15 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 25 | -79.0 Percent change in joint count | Standard Deviation 17.65 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 1 | -59.5 Percent change in joint count | Standard Deviation 41.25 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 6 | -72.4 Percent change in joint count | Standard Deviation 33.42 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 1 | -53.7 Percent change in joint count | Standard Deviation 41.95 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 13 | -80.8 Percent change in joint count | Standard Deviation 21.63 |
| Rituximab-EU Total | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 6 | -73.2 Percent change in joint count | Standard Deviation 30.5 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 1 | -60.0 Percent change in joint count | Standard Deviation 30.18 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 1 | -67.8 Percent change in joint count | Standard Deviation 26.58 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Screening | -55.9 Percent change in joint count | Standard Deviation 32.29 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 13 | -82.5 Percent change in joint count | Standard Deviation 21.63 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 1 | -51.9 Percent change in joint count | Standard Deviation 33.54 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 13 | -68.7 Percent change in joint count | Standard Deviation 33.16 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 25 | -78.6 Percent change in joint count | Standard Deviation 24.11 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 25 | -69.9 Percent change in joint count | Standard Deviation 20.36 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 25 | -75.5 Percent change in joint count | Standard Deviation 14.06 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 2/Week 6 | -77.3 Percent change in joint count | Standard Deviation 27.37 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 1/Week 6 | -70.5 Percent change in joint count | Standard Deviation 37.95 |
| Rituximab-US/PF-05280586/PF-05280586 | Percent Change From Initial Study Baseline in Individual Components of the ACR Response: Tender/Painful Joint Count - by the End of Course 3 | Change at Course 3/Week 13 | -79.6 Percent change in joint count | Standard Deviation 22.11 |