Rheumatoid Arthritis
Conditions
Keywords
treatment of rheumatoid arthritis, treatment of RA, patients on methotrexate for rheumatoid arthritis, prednisone for rheumatoid arthritis
Brief summary
The purpose of this study is to compare the safety and efficacy of multiple doses of PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo in the treatment of rheumatoid arthritis. All subjects will also be receiving background treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for eight weeks followed by a 4 week period during which the dose of study medication will be gradually reduced. The efficacy of the study medications will be determined by assessing severity of the rheumatoid arthritis during the study and safety will be determined by adverse event reporting, laboratory tests and biomarker analysis.
Interventions
DRUGPF-04171327
1 mg tablet once daily (QD) for 8 weeks
DRUGprednisone
5 mg capsule once daily for 8 weeks
OTHERplacebo
placebo (tablet or capsule) once daily (QD) for 8 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have documented rheumatoid arthritis with a duration of at least 3 months as determined by the investigator using standardly accepted criteria, must have been receiving methotrexate for at least 3 months to treat their rheumatoid arthritis, and must be free of any signs or symptoms of infection.
Exclusion criteria
* Subjects cannot enter the study if they have recently received treatment with certain medications which might interfere with study medications; * subjects cannot enter if they have abnormalities in certain blood tests, history of cancer, recent bone fracture or other significant conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8 | Week 8 | ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). |
| Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg) | Week 8 | Change from baseline in P1NP at week 8 is presented in this outcome measure. |
| Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg) | Week 8 | Change from baseline in uNTx/uCr at week 8 is presented in this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Weeks 2, 4, 6, and 8 | Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen. |
| Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics) | Week 12 | Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen. |
| Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Weeks 2, 4, 6, and 8 | Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen. |
| Change From Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics) | Week 12 | Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen. |
| Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Weeks 2, 4, 6, and 8 | The CRP was collected at each applicable clinic visit and analyzed by a central laboratory. In order to assist with the data clean-up at the end of the study, the CRP results were unblinded to the sponsor at the time of the last subject's last visit. All statistics presented below are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used. |
| Change From Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | Week 12 | The investigator assessed how the participant's overall arthritis appears at the time of the visit. This was an evaluation 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, where 0 mm = no pain and 100 mm = most severe pain. |
| Change From Baseline of CRP at Week 12 (Descriptive Statistics) | Week 12 | The CRP was collected at each applicable clinic visit and analyzed by a central laboratory. In order to assist with the data clean-up at the end of the study, the CRP results were unblinded to the sponsor at the time of the last subject's last visit. |
| Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Weeks 2, 4, 6, and 8 | Participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The subject's response was recorded using a 100 mm Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. |
| Change From Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | Week 12 | Participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The subject's response was recorded using a 100 mm Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain. |
| Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Weeks 2, 4, 6, and 8 | The investigator assessed how the participant's overall arthritis appears at the time of the visit. This was an evaluation 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, where 0 mm = no pain and 100 mm = most severe pain. |
| Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Weeks 2, 4, 6, and 8 | Participants assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain. |
| Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Weeks 2, 4, and 12 (taper period) | ACR20 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. |
| Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Weeks 2, 4, 6, and 8 | Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. |
| Change From Baseline in HAQ-DI at Week 12 (Descriptive Statistics) | Week 12 | Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. |
| Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Weeks 2, 4, 6, and 8 | DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission. |
| Change From Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics) | Week 12 | DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission. |
| Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Weeks 2, 4, 6, and 8 | DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission. All statistics presented below are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used. |
| Change From Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics) | Week 12 | DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission. |
| Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Weeks 4 and 8 | The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness. |
| Change From Baseline in SF-36v2 Mental Component Scores at Week 12 (Descriptive Statistics) | Week 12 | The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness. |
| Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Weeks 4 and 8 | The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness. |
| Change From Baseline in SF-36v2 Physical Component Scores at Week 12 (Descriptive Statistics) | Week 12 | The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness. |
| Change From Baseline in Pain VAS at Week 12 (Descriptive Statistics) | Week 12 | Participants assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain. |
| Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Weeks 2, 4, 6, 8, and 12 (taper period) | ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. |
| Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Weeks 2, 4, 6, 8, and 12 (taper period) | ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. |
Countries
Bulgaria, Colombia, Czechia, Germany, Hungary, India, Malaysia, Mexico, Poland, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Ukraine, United States
Participant flow
Recruitment details
This multi-center, randomized, double-blind, parallel-group, active and placebo-controlled study randomized 323 participants in at 73 centers. An additional 34 centers had no screening activities, but received study medication; and an additional 17 centers had at least 1 participant screened, but did not randomize any participants.
Pre-assignment details
Participants enrolled who had documented rheumatoid arthritis with a duration of at least 3 months as determined by the investigator using standardly accepted criteria, had received methotrexate for at least 3 months to treat their rheumatoid arthritis, and were free of any signs or symptoms of infection.
Participants by arm
| Arm | Count |
|---|---|
| PF-04171327 1 mg Participants received PF-04171327 1 mg Once daily (QD) for 8 weeks. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days. | 45 |
| PF-04171327 5 mg Participants received PF-04171327 5 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days. | 47 |
| PF-04171327 10 mg Participants received PF-04171327 10 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days. | 45 |
| PF-04171327 15 mg Participants received PF-04171327 15 mg QD for 8 weeks. After 8 weeks of study treatment, participants were tapered off study drug. From week 9 through 10, the participants received 1 mg PF-04171327 + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 mg PF-04171327 + 1 placebo tablet every 3 days. | 48 |
| Prednisone 5 mg Participants received prednisone 5 mg QD for 8 weeks. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days. | 45 |
| Prednisone 10 mg Participants received prednisone 10 mg QD for 8 weeks. After 8 weeks of treatment, participants were tapered off prednisone dosage. From week 9 through 10, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every other day. From week 11 through 12, the participants received 1 prednisone 5 mg tablet + 1 placebo tablet every 3 days. | 46 |
| Placebo Participants received placebo QD until week 12. | 47 |
| Total | 323 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 | 1 | 2 | 0 | 2 | 3 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Medication error without associated AE | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Other | 0 | 2 | 0 | 2 | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | PF-04171327 1 mg | PF-04171327 5 mg | PF-04171327 10 mg | PF-04171327 15 mg | Prednisone 5 mg | Prednisone 10 mg | Placebo | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 50.4 Years STANDARD_DEVIATION 14.2 | 55.1 Years STANDARD_DEVIATION 12.1 | 54.7 Years STANDARD_DEVIATION 13.1 | 54.0 Years STANDARD_DEVIATION 11.1 | 52.9 Years STANDARD_DEVIATION 11.2 | 57.3 Years STANDARD_DEVIATION 10.7 | 55.2 Years STANDARD_DEVIATION 13.2 | 54.3 Years STANDARD_DEVIATION 12.3 |
| Sex: Female, Male Female | 33 Participants | 38 Participants | 34 Participants | 37 Participants | 39 Participants | 41 Participants | 37 Participants | 259 Participants |
| Sex: Female, Male Male | 12 Participants | 9 Participants | 11 Participants | 11 Participants | 6 Participants | 5 Participants | 10 Participants | 64 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 45 | 18 / 47 | 22 / 45 | 16 / 48 | 16 / 45 | 19 / 46 | 16 / 47 |
| serious Total, serious adverse events | 0 / 45 | 1 / 47 | 2 / 45 | 2 / 48 | 0 / 45 | 2 / 46 | 2 / 47 |
Outcome results
Primary
Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg)
Change from baseline in P1NP at week 8 is presented in this outcome measure.
Time frame: Week 8
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). N= number of participants with observations.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 1 mg | Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg) | -3.25 Percent change | Standard Error 5.5 |
| PF-04171327 5 mg | Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg) | -11.60 Percent change | Standard Error 5.55 |
| PF-04171327 10 mg | Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg) | -9.96 Percent change | Standard Error 5.49 |
| PF-04171327 15 mg | Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg) | -16.63 Percent change | Standard Error 5.55 |
| Prednisone 5 mg | Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg) | -4.89 Percent change | Standard Error 5.55 |
| Prednisone 10 mg | Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg) | -20.14 Percent change | Standard Error 5.5 |
| Placebo | Mean Percent Change From Baseline in 0 Hour Procollagen Type 1 N Terminal Propeptide (P1NP) at Week 8 (Comparisons to Prednisone 5 mg) | 14.19 Percent change | Standard Error 5.56 |
95% CI: [-13.75, 17.03]
90% CI: [-22.16, 8.75]
90% CI: [-20.45, 10.3]
90% CI: [-27.19, 3.72]
Primary
Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg)
Change from baseline in uNTx/uCr at week 8 is presented in this outcome measure.
Time frame: Week 8
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). N= number of participants with observations.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 1 mg | Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg) | 6.08 Percent change | Standard Error 5.83 |
| PF-04171327 5 mg | Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg) | -3.78 Percent change | Standard Error 5.88 |
| PF-04171327 10 mg | Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg) | 6.96 Percent change | Standard Error 5.86 |
| PF-04171327 15 mg | Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg) | 15.57 Percent change | Standard Error 5.83 |
| Prednisone 5 mg | Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg) | 2.74 Percent change | Standard Error 5.87 |
| Prednisone 10 mg | Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg) | -9.14 Percent change | Standard Error 5.83 |
| Placebo | Mean Percent Change From Baseline in 0 Hour Urinary N Telopeptide/Urinary Creatinine (uNTx/uCr) at Week 8 (Comparisons to Prednisone 5 mg) | 3.81 Percent change | Standard Error 5.88 |
95% CI: [-12.92, 19.61]
90% CI: [-22.86, 9.81]
90% CI: [-12.11, 20.55]
90% CI: [-3.49, 29.15]
Primary
Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Time frame: Week 8
Population: Full Analysis Set (FAS) included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). N= number of participants with observations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-04171327 1 mg | Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8 | 47 Percentage of participants |
| PF-04171327 5 mg | Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8 | 61 Percentage of participants |
| PF-04171327 10 mg | Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8 | 69 Percentage of participants |
| PF-04171327 15 mg | Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8 | 73 Percentage of participants |
| Prednisone 5 mg | Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8 | 51 Percentage of participants |
| Prednisone 10 mg | Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8 | 71 Percentage of participants |
| Placebo | Percentage of Participants Achieving a 20% Improvement in American College of Rheumatology (ACR) Criteria at Week 8 | 37 Percentage of participants |
Comparison: Bayesian 4 Parameter Emax Model Based Estimates are provided.60% CI: [5, 15]
Comparison: Bayesian 4 Parameter Emax Model Based Estimates are provided.60% CI: [18, 31]
Comparison: Bayesian 4 Parameter Emax Model Based Estimates are provided.60% CI: [25, 39]
Comparison: Bayesian 4 Parameter Emax Model Based Estimates are provided.60% CI: [29, 43]
Comparison: Bayesian 4 Parameter Emax Model Based Estimates are provided.60% CI: [6, 22]
Comparison: Bayesian 4 Parameter Emax Model Based Estimates are provided.60% CI: [27, 42]
Comparison: Bayesian 4 Parameter Emax Model Based Estimates are provided.60% CI: [-32, -17]
Comparison: Bayesian 4 Parameter Emax Model Based Estimates are provided.60% CI: [-16, -4]
Comparison: Bayesian 4 Parameter Emax Model Based Estimates are provided.60% CI: [-9, 4]
Comparison: Bayesian 4 Parameter Emax Model Based Estimates are provided.60% CI: [-5, 8]
Secondary
Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg)
The CRP was collected at each applicable clinic visit and analyzed by a central laboratory. In order to assist with the data clean-up at the end of the study, the CRP results were unblinded to the sponsor at the time of the last subject's last visit. All statistics presented below are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Time frame: Weeks 2, 4, 6, and 8
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 2 | -7.29 mg/L | Standard Error 2.89 |
| PF-04171327 1 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 4 | -9.77 mg/L | Standard Error 2.77 |
| PF-04171327 1 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 6 | -9.35 mg/L | Standard Error 2.51 |
| PF-04171327 1 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 8 | -7.29 mg/L | Standard Error 2.49 |
| PF-04171327 5 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 8 | -14.28 mg/L | Standard Error 2.52 |
| PF-04171327 5 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 6 | -16.16 mg/L | Standard Error 2.53 |
| PF-04171327 5 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 2 | -12.95 mg/L | Standard Error 2.82 |
| PF-04171327 5 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 4 | -14.33 mg/L | Standard Error 2.78 |
| PF-04171327 10 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 6 | -13.05 mg/L | Standard Error 2.49 |
| PF-04171327 10 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 4 | -11.52 mg/L | Standard Error 2.81 |
| PF-04171327 10 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 2 | -13.73 mg/L | Standard Error 2.87 |
| PF-04171327 10 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 8 | -14.86 mg/L | Standard Error 2.47 |
| PF-04171327 15 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 2 | -18.92 mg/L | Standard Error 2.78 |
| PF-04171327 15 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 4 | -16.57 mg/L | Standard Error 2.75 |
| PF-04171327 15 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 6 | -13.81 mg/L | Standard Error 2.51 |
| PF-04171327 15 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 8 | -11.98 mg/L | Standard Error 2.49 |
| Prednisone 5 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 2 | -8.25 mg/L | Standard Error 2.87 |
| Prednisone 5 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 8 | -7.23 mg/L | Standard Error 2.5 |
| Prednisone 5 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 4 | -3.92 mg/L | Standard Error 2.81 |
| Prednisone 5 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 6 | -6.54 mg/L | Standard Error 2.52 |
| Prednisone 10 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 4 | -17.49 mg/L | Standard Error 2.76 |
| Prednisone 10 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 2 | -16.90 mg/L | Standard Error 2.86 |
| Prednisone 10 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 6 | -16.85 mg/L | Standard Error 2.46 |
| Prednisone 10 mg | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 8 | -17.59 mg/L | Standard Error 2.44 |
| Placebo | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 6 | -3.93 mg/L | Standard Error 2.53 |
| Placebo | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 2 | -2.80 mg/L | Standard Error 2.89 |
| Placebo | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 4 | -6.35 mg/L | Standard Error 2.77 |
| Placebo | Change From Baseline in C Reactive Protein (CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo and Prednisone 10 mg) | Week 8 | -4.19 mg/L | Standard Error 2.49 |
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-15.7, -0.26]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-12.52, 3.55]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-18.1, -2.2]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-18.94, -2.92]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-24.01, -8.24]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-13.45, 2.56]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-22.09, -6.11]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-11.13, 4.29]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-12.93, 2.59]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-17.9, -2.54]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.32, 10.19]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-18.83, -3.45]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-12.44, 1.59]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-19.27, -5.2]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-16.11, -2.14]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-16.89, -2.88]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-9.63, 4.4]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-19.88, -5.98]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-10.03, 3.83]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-17.06, -3.13]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-17.57, -3.77]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-14.72, -0.86]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-9.98, 3.89]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-20.27, -6.54]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [1.62, 17.61]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.96, 11.85]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.8, 11.13]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-9.86, 5.81]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.03, 15.42]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.54, 10.87]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.77, 13.71]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.75, 8.59]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.57, 14.43]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.26, 7.64]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.09, 10.7]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.87, 9.96]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [3.43, 17.18]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.59, 10.22]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.1, 9.57]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.25, 12.48]
Secondary
Change From Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics)
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Time frame: Week 12
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics) | -1.30 Units on a scale | Standard Deviation 1.21 |
| PF-04171327 5 mg | Change From Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics) | -1.37 Units on a scale | Standard Deviation 1.05 |
| PF-04171327 10 mg | Change From Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics) | -1.29 Units on a scale | Standard Deviation 1.14 |
| PF-04171327 15 mg | Change From Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics) | -1.25 Units on a scale | Standard Deviation 1.36 |
| Prednisone 5 mg | Change From Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics) | -1.45 Units on a scale | Standard Deviation 1.05 |
| Prednisone 10 mg | Change From Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics) | -1.62 Units on a scale | Standard Deviation 1 |
| Placebo | Change From Baseline in DAS 28-3 CRP at Week 12 (Descriptive Statistics) | -1.13 Units on a scale | Standard Deviation 1.08 |
Secondary
Change From Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics)
DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Time frame: Week 12
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics) | -1.39 Units on a scale | Standard Deviation 1.31 |
| PF-04171327 5 mg | Change From Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics) | -1.56 Units on a scale | Standard Deviation 1.17 |
| PF-04171327 10 mg | Change From Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics) | -1.42 Units on a scale | Standard Deviation 1.19 |
| PF-04171327 15 mg | Change From Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics) | -1.38 Units on a scale | Standard Deviation 1.47 |
| Prednisone 5 mg | Change From Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics) | -1.59 Units on a scale | Standard Deviation 1.22 |
| Prednisone 10 mg | Change From Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics) | -1.80 Units on a scale | Standard Deviation 1.14 |
| Placebo | Change From Baseline in DAS28-4(CRP) at Week 12 (Descriptive Statistics) | -1.29 Units on a scale | Standard Deviation 1.21 |
Secondary
Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission. All statistics presented below are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.
Time frame: Weeks 2, 4, 6, and 8
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -0.88 Units on a scale | Standard Error 0.14 |
| PF-04171327 1 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -1.29 Units on a scale | Standard Error 0.16 |
| PF-04171327 1 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -1.51 Units on a scale | Standard Error 0.18 |
| PF-04171327 1 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -1.55 Units on a scale | Standard Error 0.19 |
| PF-04171327 5 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -2.07 Units on a scale | Standard Error 0.19 |
| PF-04171327 5 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -2.06 Units on a scale | Standard Error 0.18 |
| PF-04171327 5 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -1.29 Units on a scale | Standard Error 0.14 |
| PF-04171327 5 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -1.68 Units on a scale | Standard Error 0.16 |
| PF-04171327 10 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -2.32 Units on a scale | Standard Error 0.18 |
| PF-04171327 10 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -1.97 Units on a scale | Standard Error 0.16 |
| PF-04171327 10 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -1.45 Units on a scale | Standard Error 0.14 |
| PF-04171327 10 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -2.53 Units on a scale | Standard Error 0.19 |
| PF-04171327 15 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -1.69 Units on a scale | Standard Error 0.14 |
| PF-04171327 15 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -1.90 Units on a scale | Standard Error 0.16 |
| PF-04171327 15 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -2.21 Units on a scale | Standard Error 0.18 |
| PF-04171327 15 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -2.38 Units on a scale | Standard Error 0.19 |
| Prednisone 5 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -0.82 Units on a scale | Standard Error 0.14 |
| Prednisone 5 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -1.65 Units on a scale | Standard Error 0.19 |
| Prednisone 5 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -1.15 Units on a scale | Standard Error 0.16 |
| Prednisone 5 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -1.56 Units on a scale | Standard Error 0.18 |
| Prednisone 10 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -1.92 Units on a scale | Standard Error 0.16 |
| Prednisone 10 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -1.46 Units on a scale | Standard Error 0.14 |
| Prednisone 10 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -2.27 Units on a scale | Standard Error 0.18 |
| Prednisone 10 mg | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -2.44 Units on a scale | Standard Error 0.19 |
| Placebo | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -1.12 Units on a scale | Standard Error 0.18 |
| Placebo | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -0.52 Units on a scale | Standard Error 0.14 |
| Placebo | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -0.90 Units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline in DAS28-4(CRP) at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -1.11 Units on a scale | Standard Error 0.19 |
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.76, 0.03]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.17, -0.39]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.32, -0.54]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.56, -0.78]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.7, 0.09]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.34, -0.55]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.84, 0.07]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.23, -0.32]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.52, -0.61]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.45, -0.54]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.71, 0.21]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.48, -0.57]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.89, 0.11]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.44, -0.45]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.71, -0.71]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.59, -0.59]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.95, 0.05]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.65, -0.66]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.96, 0.08]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.48, -0.44]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.94, -0.91]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.8, -0.76]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.06, -0.03]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.85, -0.81]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.19, 0.98]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.22, 0.56]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.38, 0.41]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.62, 0.16]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.18, 1.09]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.21, 0.7]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.5, 0.42]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.43, 0.48]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.26, 1.26]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.29, 0.7]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.55, 0.44]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.43, 0.56]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.37, 1.41]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.15, 0.89]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.61, 0.42]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.46, 0.57]
Secondary
Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Time frame: Weeks 2, 4, 6, and 8
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -0.81 Units on a scale | Standard Error 0.13 |
| PF-04171327 1 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -1.19 Units on a scale | Standard Error 0.15 |
| PF-04171327 1 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -1.38 Units on a scale | Standard Error 0.16 |
| PF-04171327 1 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -1.44 Units on a scale | Standard Error 0.17 |
| PF-04171327 5 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -1.84 Units on a scale | Standard Error 0.17 |
| PF-04171327 5 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -1.81 Units on a scale | Standard Error 0.16 |
| PF-04171327 5 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -1.15 Units on a scale | Standard Error 0.13 |
| PF-04171327 5 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -1.49 Units on a scale | Standard Error 0.15 |
| PF-04171327 10 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -2.01 Units on a scale | Standard Error 0.16 |
| PF-04171327 10 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -1.71 Units on a scale | Standard Error 0.15 |
| PF-04171327 10 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -1.21 Units on a scale | Standard Error 0.13 |
| PF-04171327 10 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -2.22 Units on a scale | Standard Error 0.17 |
| PF-04171327 15 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -1.51 Units on a scale | Standard Error 0.13 |
| PF-04171327 15 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -1.73 Units on a scale | Standard Error 0.15 |
| PF-04171327 15 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -1.99 Units on a scale | Standard Error 0.16 |
| PF-04171327 15 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -2.13 Units on a scale | Standard Error 0.17 |
| Prednisone 5 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -0.75 Units on a scale | Standard Error 0.13 |
| Prednisone 5 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -1.42 Units on a scale | Standard Error 0.17 |
| Prednisone 5 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -1.01 Units on a scale | Standard Error 0.15 |
| Prednisone 5 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -1.37 Units on a scale | Standard Error 0.16 |
| Prednisone 10 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -1.67 Units on a scale | Standard Error 0.15 |
| Prednisone 10 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -1.23 Units on a scale | Standard Error 0.13 |
| Prednisone 10 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -1.98 Units on a scale | Standard Error 0.16 |
| Prednisone 10 mg | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -2.14 Units on a scale | Standard Error 0.17 |
| Placebo | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -0.94 Units on a scale | Standard Error 0.16 |
| Placebo | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -0.40 Units on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -0.76 Units on a scale | Standard Error 0.15 |
| Placebo | Change From Baseline in Disease Activity Score (DAS) 28-3 CRP at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -0.93 Units on a scale | Standard Error 0.17 |
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.78, -0.04]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.12, -0.39]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.18, -0.44]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.48, -0.74]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.72, 0.02]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.19, -0.46]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.85, 0]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.15, -0.31]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.37, -0.52]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.39, -0.54]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.67, 0.18]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.33, -0.49]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.9, 0.02]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.32, -0.41]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.53, -0.62]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.51, -0.6]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.89, 0.03]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.5, -0.59]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1, -0.03]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.4, -0.43]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.77, -0.8]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.69, -0.72]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.98, -0.01]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.69, -0.73]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.04, 0.78]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.29, 0.44]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.35, 0.38]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.65, 0.08]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.06, 0.91]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.24, 0.6]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.46, 0.38]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.48, 0.37]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.15, 1.06]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.28, 0.63]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.49, 0.42]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.47, 0.44]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.22, 1.18]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.18, 0.78]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.55, 0.4]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.47, 0.49]
Secondary
Change From Baseline in HAQ-DI at Week 12 (Descriptive Statistics)
Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Week 12
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in HAQ-DI at Week 12 (Descriptive Statistics) | -0.28 Units on a scale | Standard Deviation 0.63 |
| PF-04171327 5 mg | Change From Baseline in HAQ-DI at Week 12 (Descriptive Statistics) | -0.57 Units on a scale | Standard Deviation 0.65 |
| PF-04171327 10 mg | Change From Baseline in HAQ-DI at Week 12 (Descriptive Statistics) | -0.37 Units on a scale | Standard Deviation 0.5 |
| PF-04171327 15 mg | Change From Baseline in HAQ-DI at Week 12 (Descriptive Statistics) | -0.38 Units on a scale | Standard Deviation 0.5 |
| Prednisone 5 mg | Change From Baseline in HAQ-DI at Week 12 (Descriptive Statistics) | -0.52 Units on a scale | Standard Deviation 0.63 |
| Prednisone 10 mg | Change From Baseline in HAQ-DI at Week 12 (Descriptive Statistics) | -0.56 Units on a scale | Standard Deviation 0.59 |
| Placebo | Change From Baseline in HAQ-DI at Week 12 (Descriptive Statistics) | -0.26 Units on a scale | Standard Deviation 0.56 |
Secondary
Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Weeks 2, 4, 6, and 8
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -0.25 Units on a scale | Standard Error 0.06 |
| PF-04171327 1 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -0.26 Units on a scale | Standard Error 0.07 |
| PF-04171327 1 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -0.35 Units on a scale | Standard Error 0.07 |
| PF-04171327 1 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -0.26 Units on a scale | Standard Error 0.08 |
| PF-04171327 5 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -0.59 Units on a scale | Standard Error 0.08 |
| PF-04171327 5 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -0.60 Units on a scale | Standard Error 0.07 |
| PF-04171327 5 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -0.34 Units on a scale | Standard Error 0.06 |
| PF-04171327 5 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -0.50 Units on a scale | Standard Error 0.07 |
| PF-04171327 10 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -0.52 Units on a scale | Standard Error 0.07 |
| PF-04171327 10 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -0.43 Units on a scale | Standard Error 0.07 |
| PF-04171327 10 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -0.33 Units on a scale | Standard Error 0.06 |
| PF-04171327 10 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -0.60 Units on a scale | Standard Error 0.08 |
| PF-04171327 15 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -0.41 Units on a scale | Standard Error 0.06 |
| PF-04171327 15 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -0.51 Units on a scale | Standard Error 0.07 |
| PF-04171327 15 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -0.56 Units on a scale | Standard Error 0.07 |
| PF-04171327 15 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -0.55 Units on a scale | Standard Error 0.08 |
| Prednisone 5 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -0.23 Units on a scale | Standard Error 0.06 |
| Prednisone 5 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -0.50 Units on a scale | Standard Error 0.08 |
| Prednisone 5 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -0.34 Units on a scale | Standard Error 0.07 |
| Prednisone 5 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -0.39 Units on a scale | Standard Error 0.07 |
| Prednisone 10 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -0.58 Units on a scale | Standard Error 0.07 |
| Prednisone 10 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -0.41 Units on a scale | Standard Error 0.06 |
| Prednisone 10 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -0.68 Units on a scale | Standard Error 0.07 |
| Prednisone 10 mg | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -0.77 Units on a scale | Standard Error 0.08 |
| Placebo | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -0.21 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -0.05 Units on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -0.14 Units on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline in HAQ-DI at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -0.19 Units on a scale | Standard Error 0.08 |
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.37, -0.02]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.46, -0.11]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.45, -0.1]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.52, -0.18]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.35, 0]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.53, -0.18]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.31, 0.07]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.54, -0.17]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.47, -0.09]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.56, -0.18]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.39, -0.01]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.63, -0.25]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.34, 0.05]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.59, -0.2]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.51, -0.12]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.55, -0.16]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.38, 0.01]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.67, -0.27]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.3, 0.15]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.63, -0.18]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.64, -0.18]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.59, -0.14]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.54, -0.09]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.81, -0.35]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.01, 0.34]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.1, 0.24]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.1, 0.25]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.17, 0.18]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.13, 0.51]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.11, 0.27]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.04, 0.34]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.13, 0.25]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.13, 0.52]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.12, 0.27]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.05, 0.35]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.08, 0.31]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.28, 0.73]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.05, 0.4]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.06, 0.4]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.01, 0.44]
Secondary
Change From Baseline in Pain VAS at Week 12 (Descriptive Statistics)
Participants assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain.
Time frame: Week 12
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in Pain VAS at Week 12 (Descriptive Statistics) | -17.86 mm | Standard Deviation 26.7 |
| PF-04171327 5 mg | Change From Baseline in Pain VAS at Week 12 (Descriptive Statistics) | -19.40 mm | Standard Deviation 29.04 |
| PF-04171327 10 mg | Change From Baseline in Pain VAS at Week 12 (Descriptive Statistics) | -18.23 mm | Standard Deviation 27.75 |
| PF-04171327 15 mg | Change From Baseline in Pain VAS at Week 12 (Descriptive Statistics) | -16.60 mm | Standard Deviation 30.5 |
| Prednisone 5 mg | Change From Baseline in Pain VAS at Week 12 (Descriptive Statistics) | -21.52 mm | Standard Deviation 24.69 |
| Prednisone 10 mg | Change From Baseline in Pain VAS at Week 12 (Descriptive Statistics) | -25.17 mm | Standard Deviation 29.6 |
| Placebo | Change From Baseline in Pain VAS at Week 12 (Descriptive Statistics) | -16.30 mm | Standard Deviation 22.41 |
Secondary
Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
Participants assessed the severity of their arthritis pain using a 100 mm VAS placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponds to the magnitude of their pain.
Time frame: Weeks 2, 4, 6, and 8
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -13.41 mm | Standard Error 2.88 |
| PF-04171327 1 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -18.95 mm | Standard Error 3.45 |
| PF-04171327 1 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -19.03 mm | Standard Error 3.33 |
| PF-04171327 1 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -15.55 mm | Standard Error 3.08 |
| PF-04171327 5 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -29.16 mm | Standard Error 3.35 |
| PF-04171327 5 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -17.40 mm | Standard Error 2.83 |
| PF-04171327 5 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -28.53 mm | Standard Error 3.5 |
| PF-04171327 5 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -24.38 mm | Standard Error 3.09 |
| PF-04171327 10 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -24.90 mm | Standard Error 2.86 |
| PF-04171327 10 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -34.37 mm | Standard Error 3.33 |
| PF-04171327 10 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -29.70 mm | Standard Error 3.1 |
| PF-04171327 10 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -37.96 mm | Standard Error 3.46 |
| PF-04171327 15 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -26.08 mm | Standard Error 3.05 |
| PF-04171327 15 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -22.86 mm | Standard Error 2.8 |
| PF-04171327 15 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -30.15 mm | Standard Error 3.3 |
| PF-04171327 15 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -30.91 mm | Standard Error 3.43 |
| Prednisone 5 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -20.26 mm | Standard Error 3.1 |
| Prednisone 5 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -25.86 mm | Standard Error 3.46 |
| Prednisone 5 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -24.16 mm | Standard Error 3.33 |
| Prednisone 5 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -12.68 mm | Standard Error 2.86 |
| Prednisone 10 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -29.65 mm | Standard Error 3.11 |
| Prednisone 10 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -37.60 mm | Standard Error 3.47 |
| Prednisone 10 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -34.69 mm | Standard Error 3.34 |
| Prednisone 10 mg | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -24.59 mm | Standard Error 2.87 |
| Placebo | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -18.26 mm | Standard Error 3.47 |
| Placebo | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -10.54 mm | Standard Error 2.88 |
| Placebo | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -14.28 mm | Standard Error 3.08 |
| Placebo | Change From Baseline in Pain VAS at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -18.80 mm | Standard Error 3.32 |
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-10.89, 5.14]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-14.8, 1.08]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-22.34, -6.38]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-20.22, -4.41]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-10.12, 5.85]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-22.05, -6.04]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-9.83, 7.3]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-18.67, -1.53]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-24.01, -6.82]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-20.33, -3.26]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-14.57, 2.62]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-23.98, -6.76]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-9.49, 9.03]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-19.64, -1.08]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-24.83, -6.32]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-20.56, -2.13]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-14.61, 3.89]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-25.15, -6.61]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-10.32, 8.94]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-19.95, -0.59]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-29.34, -10.06]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-22.25, -3.04]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-17.24, 2.04]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-28.99, -9.68]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [3.18, 19.16]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.78, 15.15]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-8.28, 7.65]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.14, 9.61]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [5.51, 22.71]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.38, 13.92]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-8.68, 8.59]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.99, 12.15]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [6.38, 24.93]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.81, 14.86]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-8.97, 9.59]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.69, 13.77]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [9.03, 28.27]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.64, 18.78]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-10, 9.28]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-2.91, 16.29]
Secondary
Change From Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics)
Participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The subject's response was recorded using a 100 mm Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time frame: Week 12
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | -14.54 mm | Standard Deviation 27.33 |
| PF-04171327 5 mg | Change From Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | -22.26 mm | Standard Deviation 26.11 |
| PF-04171327 10 mg | Change From Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | -18.10 mm | Standard Deviation 25.35 |
| PF-04171327 15 mg | Change From Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | -16.74 mm | Standard Deviation 31.57 |
| Prednisone 5 mg | Change From Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | -19.24 mm | Standard Deviation 29.32 |
| Prednisone 10 mg | Change From Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | -25.29 mm | Standard Deviation 29.2 |
| Placebo | Change From Baseline in Patient Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | -17.90 mm | Standard Deviation 23.14 |
Secondary
Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
Participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The subject's response was recorded using a 100 mm Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
Time frame: Weeks 2, 4, 6, and 8
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -10.24 mm | Standard Error 2.85 |
| PF-04171327 1 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -14.93 mm | Standard Error 3.21 |
| PF-04171327 1 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -18.77 mm | Standard Error 3.28 |
| PF-04171327 1 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -16.51 mm | Standard Error 3.49 |
| PF-04171327 5 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -29.08 mm | Standard Error 3.52 |
| PF-04171327 5 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -30.84 mm | Standard Error 3.28 |
| PF-04171327 5 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -18.77 mm | Standard Error 2.79 |
| PF-04171327 5 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -24.04 mm | Standard Error 3.22 |
| PF-04171327 10 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -35.00 mm | Standard Error 3.27 |
| PF-04171327 10 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -27.98 mm | Standard Error 3.24 |
| PF-04171327 10 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -24.72 mm | Standard Error 2.83 |
| PF-04171327 10 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -36.88 mm | Standard Error 3.5 |
| PF-04171327 15 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -22.50 mm | Standard Error 2.77 |
| PF-04171327 15 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -23.14 mm | Standard Error 3.19 |
| PF-04171327 15 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -27.93 mm | Standard Error 3.24 |
| PF-04171327 15 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -31.32 mm | Standard Error 3.47 |
| Prednisone 5 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -10.04 mm | Standard Error 2.83 |
| Prednisone 5 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -25.82 mm | Standard Error 3.5 |
| Prednisone 5 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -17.16 mm | Standard Error 3.24 |
| Prednisone 5 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -23.07 mm | Standard Error 3.27 |
| Prednisone 10 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -28.31 mm | Standard Error 3.24 |
| Prednisone 10 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -23.51 mm | Standard Error 2.84 |
| Prednisone 10 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -32.34 mm | Standard Error 3.27 |
| Prednisone 10 mg | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -34.60 mm | Standard Error 3.51 |
| Placebo | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -18.55 mm | Standard Error 3.26 |
| Placebo | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -10.61 mm | Standard Error 2.85 |
| Placebo | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -14.56 mm | Standard Error 3.21 |
| Placebo | Change From Baseline in Patient Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -18.36 mm | Standard Error 3.51 |
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-7.56, 8.31]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-16.01, -0.3]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-22.01, -6.2]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-19.7, -4.06]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-7.33, 8.48]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-20.8, -4.98]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-9.31, 8.58]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-18.43, -0.53]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-22.39, -4.44]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-17.48, 0.33]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-11.57, 6.38]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-22.73, -4.78]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-9.32, 8.88]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-21.39, -3.17]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-25.53, -7.36]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-18.42, -0.34]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-13.61, 4.57]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-22.87, -4.69]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-7.9, 11.6]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-20.51, -0.93]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-28.28, -8.77]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-22.67, -3.25]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-17.21, 2.3]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-26, -6.48]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [5.34, 21.2]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.12, 12.59]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-9.1, 6.68]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.79, 8.81]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [4.39, 22.38]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.73, 13.27]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-8.68, 9.35]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.77, 14.12]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [4.44, 22.68]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-7.64, 10.64]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-11.76, 6.44]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.65, 13.46]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [8.34, 27.84]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.27, 15.32]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-12.03, 7.46]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.42, 12.98]
Secondary
Change From Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics)
The investigator assessed how the participant's overall arthritis appears at the time of the visit. This was an evaluation 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, where 0 mm = no pain and 100 mm = most severe pain.
Time frame: Week 12
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | -25.00 mm | Standard Deviation 21.57 |
| PF-04171327 5 mg | Change From Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | -28.56 mm | Standard Deviation 26.41 |
| PF-04171327 10 mg | Change From Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | -23.04 mm | Standard Deviation 22 |
| PF-04171327 15 mg | Change From Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | -24.30 mm | Standard Deviation 28.15 |
| Prednisone 5 mg | Change From Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | -27.25 mm | Standard Deviation 23.71 |
| Prednisone 10 mg | Change From Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | -27.25 mm | Standard Deviation 20.42 |
| Placebo | Change From Baseline in Physician Global Assessment of Arthritis at Week 12 (Descriptive Statistics) | -19.34 mm | Standard Deviation 27.21 |
Secondary
Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
The investigator assessed how the participant's overall arthritis appears at the time of the visit. This was an evaluation 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, where 0 mm = no pain and 100 mm = most severe pain.
Time frame: Weeks 2, 4, 6, and 8
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -16.35 mm | Standard Error 2.53 |
| PF-04171327 1 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -22.25 mm | Standard Error 2.68 |
| PF-04171327 1 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -25.58 mm | Standard Error 2.68 |
| PF-04171327 1 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -26.24 mm | Standard Error 2.81 |
| PF-04171327 5 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -33.92 mm | Standard Error 2.82 |
| PF-04171327 5 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -32.54 mm | Standard Error 2.67 |
| PF-04171327 5 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -21.74 mm | Standard Error 2.45 |
| PF-04171327 5 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -27.03 mm | Standard Error 2.64 |
| PF-04171327 10 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -34.79 mm | Standard Error 2.66 |
| PF-04171327 10 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -30.72 mm | Standard Error 2.66 |
| PF-04171327 10 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -22.14 mm | Standard Error 2.48 |
| PF-04171327 10 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -38.00 mm | Standard Error 2.79 |
| PF-04171327 15 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -25.21 mm | Standard Error 2.43 |
| PF-04171327 15 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -28.95 mm | Standard Error 2.62 |
| PF-04171327 15 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -32.79 mm | Standard Error 2.63 |
| PF-04171327 15 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -33.71 mm | Standard Error 2.77 |
| Prednisone 5 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -13.24 mm | Standard Error 2.48 |
| Prednisone 5 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -29.25 mm | Standard Error 2.79 |
| Prednisone 5 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -20.94 mm | Standard Error 2.66 |
| Prednisone 5 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -28.54 mm | Standard Error 2.66 |
| Prednisone 10 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -31.16 mm | Standard Error 2.66 |
| Prednisone 10 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -22.80 mm | Standard Error 2.48 |
| Prednisone 10 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -33.92 mm | Standard Error 2.66 |
| Prednisone 10 mg | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -35.50 mm | Standard Error 2.79 |
| Placebo | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -19.48 mm | Standard Error 2.65 |
| Placebo | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -9.29 mm | Standard Error 2.5 |
| Placebo | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -15.00 mm | Standard Error 2.64 |
| Placebo | Change From Baseline in Physician Global Assessment of Arthritis at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -21.52 mm | Standard Error 2.79 |
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-14.07, -0.06]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-19.34, -5.56]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-19.79, -5.91]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-22.79, -9.06]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-10.89, 2.99]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-20.44, -6.57]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-14.65, 0.16]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-19.38, -4.68]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-23.1, -8.35]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-21.27, -6.63]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-13.31, 1.43]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-23.54, -8.79]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-13.5, 1.32]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-20.46, -5.65]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-22.69, -7.93]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-20.66, -5.96]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-16.44, -1.68]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-21.82, -7.06]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-12.53, 3.09]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-20.21, -4.59]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-24.25, -8.71]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-19.94, -4.44]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-15.5, 0.04]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-21.75, -6.21]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.53, 13.42]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.81, 7.92]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.25, 7.57]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-9.26, 4.42]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [1.48, 16.35]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.24, 11.51]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.96, 7.84]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.14, 9.56]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.92, 15.77]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.03, 8.8]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-8.26, 6.52]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.23, 8.49]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [1.46, 17.06]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.23, 9.38]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-10.27, 5.27]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.95, 9.53]
Secondary
Change From Baseline in SF-36v2 Mental Component Scores at Week 12 (Descriptive Statistics)
The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
Time frame: Week 12
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in SF-36v2 Mental Component Scores at Week 12 (Descriptive Statistics) | 3.35 Units on a scale | Standard Deviation 11.99 |
| PF-04171327 5 mg | Change From Baseline in SF-36v2 Mental Component Scores at Week 12 (Descriptive Statistics) | 4.19 Units on a scale | Standard Deviation 9.19 |
| PF-04171327 10 mg | Change From Baseline in SF-36v2 Mental Component Scores at Week 12 (Descriptive Statistics) | 0.48 Units on a scale | Standard Deviation 8.97 |
| PF-04171327 15 mg | Change From Baseline in SF-36v2 Mental Component Scores at Week 12 (Descriptive Statistics) | 2.72 Units on a scale | Standard Deviation 10.67 |
| Prednisone 5 mg | Change From Baseline in SF-36v2 Mental Component Scores at Week 12 (Descriptive Statistics) | 3.08 Units on a scale | Standard Deviation 12.91 |
| Prednisone 10 mg | Change From Baseline in SF-36v2 Mental Component Scores at Week 12 (Descriptive Statistics) | 6.11 Units on a scale | Standard Deviation 12.9 |
| Placebo | Change From Baseline in SF-36v2 Mental Component Scores at Week 12 (Descriptive Statistics) | 4.69 Units on a scale | Standard Deviation 10.72 |
Secondary
Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg)
The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
Time frame: Weeks 4 and 8
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 3.59 Units on a scale | Standard Error 1.28 |
| PF-04171327 1 mg | Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 2.57 Units on a scale | Standard Error 1.39 |
| PF-04171327 5 mg | Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 4.53 Units on a scale | Standard Error 1.26 |
| PF-04171327 5 mg | Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 6.07 Units on a scale | Standard Error 1.41 |
| PF-04171327 10 mg | Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 5.22 Units on a scale | Standard Error 1.3 |
| PF-04171327 10 mg | Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 6.03 Units on a scale | Standard Error 1.4 |
| PF-04171327 15 mg | Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 5.74 Units on a scale | Standard Error 1.25 |
| PF-04171327 15 mg | Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 6.47 Units on a scale | Standard Error 1.39 |
| Prednisone 5 mg | Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 3.67 Units on a scale | Standard Error 1.29 |
| Prednisone 5 mg | Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 5.30 Units on a scale | Standard Error 1.4 |
| Prednisone 10 mg | Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 7.23 Units on a scale | Standard Error 1.29 |
| Prednisone 10 mg | Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 8.76 Units on a scale | Standard Error 1.4 |
| Placebo | Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 4.98 Units on a scale | Standard Error 1.28 |
| Placebo | Change From Baseline in SF-36v2 Mental Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 4.58 Units on a scale | Standard Error 1.39 |
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.94, 2.17]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.98, 3.08]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.34, 3.82]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-2.75, 4.28]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.88, 2.27]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.32, 5.82]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.89, 1.87]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-2.41, 5.4]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-2.44, 5.34]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.98, 5.76]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.16, 4.61]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.29, 8.06]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-7.21, -0.06]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.25, 0.85]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.63, 1.6]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.02, 2.05]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-10.07, -2.31]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.6, 1.23]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.64, 1.18]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.16, 1.58]
Secondary
Change From Baseline in SF-36v2 Physical Component Scores at Week 12 (Descriptive Statistics)
The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
Time frame: Week 12
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in SF-36v2 Physical Component Scores at Week 12 (Descriptive Statistics) | 4.64 Units on a scale | Standard Deviation 8.21 |
| PF-04171327 5 mg | Change From Baseline in SF-36v2 Physical Component Scores at Week 12 (Descriptive Statistics) | 5.39 Units on a scale | Standard Deviation 7.05 |
| PF-04171327 10 mg | Change From Baseline in SF-36v2 Physical Component Scores at Week 12 (Descriptive Statistics) | 7.42 Units on a scale | Standard Deviation 8.56 |
| PF-04171327 15 mg | Change From Baseline in SF-36v2 Physical Component Scores at Week 12 (Descriptive Statistics) | 3.91 Units on a scale | Standard Deviation 7.16 |
| Prednisone 5 mg | Change From Baseline in SF-36v2 Physical Component Scores at Week 12 (Descriptive Statistics) | 7.63 Units on a scale | Standard Deviation 7.95 |
| Prednisone 10 mg | Change From Baseline in SF-36v2 Physical Component Scores at Week 12 (Descriptive Statistics) | 5.85 Units on a scale | Standard Deviation 7.32 |
| Placebo | Change From Baseline in SF-36v2 Physical Component Scores at Week 12 (Descriptive Statistics) | 3.23 Units on a scale | Standard Deviation 4.8 |
Secondary
Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg)
The 36 item Short Form Health Survey (SF-36) (Versions 2, acute version) is a 36 item generic health status measure. It measures 8 general health concepts: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These concepts can also be summarized as physical component score (PCS) and mental component score (MCS). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). This questionnaire was completed by the participant prior to any procedures being performed at the visit, if possible. The form was then checked by site staff for completeness.
Time frame: Weeks 4 and 8
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 3.84 Units on a scale | Standard Error 0.92 |
| PF-04171327 1 mg | Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 5.24 Units on a scale | Standard Error 1.03 |
| PF-04171327 5 mg | Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 5.00 Units on a scale | Standard Error 0.91 |
| PF-04171327 5 mg | Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 7.85 Units on a scale | Standard Error 1.04 |
| PF-04171327 10 mg | Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 8.22 Units on a scale | Standard Error 0.93 |
| PF-04171327 10 mg | Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 9.65 Units on a scale | Standard Error 1.03 |
| PF-04171327 15 mg | Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 6.83 Units on a scale | Standard Error 0.9 |
| PF-04171327 15 mg | Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 7.15 Units on a scale | Standard Error 1.02 |
| Prednisone 5 mg | Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 4.28 Units on a scale | Standard Error 0.93 |
| Prednisone 5 mg | Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 7.06 Units on a scale | Standard Error 1.03 |
| Prednisone 10 mg | Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 7.51 Units on a scale | Standard Error 0.93 |
| Prednisone 10 mg | Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 9.62 Units on a scale | Standard Error 1.03 |
| Placebo | Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 2.10 Units on a scale | Standard Error 0.92 |
| Placebo | Change From Baseline in SF-36v2 Physical Component Scores at Weeks 4 and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 3.45 Units on a scale | Standard Error 1.03 |
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.83, 4.3]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.35, 5.45]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [3.54, 8.7]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [2.19, 7.26]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.39, 4.76]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [2.83, 7.99]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.08, 4.65]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [1.52, 7.28]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [3.33, 9.07]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.85, 6.55]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [0.74, 6.47]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [3.29, 9.04]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.27, -1.09]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.07, 0.05]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.88, 3.3]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.23, 1.87]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-7.26, -1.5]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.65, 1.12]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-2.84, 2.91]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.33, 0.39]
Secondary
Change From Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics)
Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.
Time frame: Week 12
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics) | -6.20 Joints | Standard Deviation 6.21 |
| PF-04171327 5 mg | Change From Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics) | -5.98 Joints | Standard Deviation 4.81 |
| PF-04171327 10 mg | Change From Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics) | -5.86 Joints | Standard Deviation 6.17 |
| PF-04171327 15 mg | Change From Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics) | -5.58 Joints | Standard Deviation 6.24 |
| Prednisone 5 mg | Change From Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics) | -7.43 Joints | Standard Deviation 5.82 |
| Prednisone 10 mg | Change From Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics) | -7.07 Joints | Standard Deviation 5.02 |
| Placebo | Change From Baseline in Swollen-Joint Counts at Week 12 (Descriptive Statistics) | -6.17 Joints | Standard Deviation 5.48 |
Secondary
Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg)
Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.
Time frame: Weeks 2, 4, 6, and 8
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -3.42 Joints | Standard Error 0.62 |
| PF-04171327 1 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -5.54 Joints | Standard Error 0.7 |
| PF-04171327 1 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -6.26 Joints | Standard Error 0.69 |
| PF-04171327 1 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -6.50 Joints | Standard Error 0.79 |
| PF-04171327 5 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -7.45 Joints | Standard Error 0.8 |
| PF-04171327 5 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -6.90 Joints | Standard Error 0.7 |
| PF-04171327 5 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -4.70 Joints | Standard Error 0.61 |
| PF-04171327 5 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -5.85 Joints | Standard Error 0.71 |
| PF-04171327 10 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -7.36 Joints | Standard Error 0.69 |
| PF-04171327 10 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -5.94 Joints | Standard Error 0.7 |
| PF-04171327 10 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -4.27 Joints | Standard Error 0.62 |
| PF-04171327 10 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -7.95 Joints | Standard Error 0.79 |
| PF-04171327 15 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -5.36 Joints | Standard Error 0.61 |
| PF-04171327 15 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -7.00 Joints | Standard Error 0.7 |
| PF-04171327 15 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -7.68 Joints | Standard Error 0.69 |
| PF-04171327 15 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -7.83 Joints | Standard Error 0.79 |
| Prednisone 5 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -3.65 Joints | Standard Error 0.62 |
| Prednisone 5 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -6.90 Joints | Standard Error 0.79 |
| Prednisone 5 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -5.75 Joints | Standard Error 0.71 |
| Prednisone 5 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -6.89 Joints | Standard Error 0.69 |
| Prednisone 10 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -6.71 Joints | Standard Error 0.7 |
| Prednisone 10 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -5.04 Joints | Standard Error 0.61 |
| Prednisone 10 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -8.02 Joints | Standard Error 0.69 |
| Prednisone 10 mg | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -8.38 Joints | Standard Error 0.78 |
| Placebo | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -4.94 Joints | Standard Error 0.69 |
| Placebo | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -2.25 Joints | Standard Error 0.62 |
| Placebo | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -3.87 Joints | Standard Error 0.7 |
| Placebo | Change From Baseline in Swollen-Joint Counts at Weeks 2, 4, 6, and 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -4.51 Joints | Standard Error 0.8 |
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-2.91, 0.56]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.17, -0.73]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.76, -0.29]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.82, -1.4]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.13, 0.33]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.52, -1.07]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.63, 0.29]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.94, -0.01]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.03, -0.11]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.09, -1.17]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.85, 0.09]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.79, -0.88]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.25, 0.6]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.9, -0.04]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.35, -0.5]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.66, -0.83]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.88, -0.03]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5, -1.17]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.2, 0.21]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.17, -0.72]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.65, -1.23]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.52, -1.12]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.6, -0.18]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.07, -1.68]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.1, 3.34]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.36, 2.05]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.94, 2.48]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-2.01, 1.38]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.79, 3.12]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.1, 2.82]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.19, 2.72]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-2.24, 1.66]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.16, 3.67]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.81, 3.04]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.26, 2.57]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.57, 2.25]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.31, 4.07]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.28, 3.13]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.76, 2.62]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.63, 2.74]
Secondary
Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics)
Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.
Time frame: Week 12
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics) | -6.25 Joints | Standard Deviation 6.77 |
| PF-04171327 5 mg | Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics) | -7.24 Joints | Standard Deviation 6.13 |
| PF-04171327 10 mg | Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics) | -6.16 Joints | Standard Deviation 6.4 |
| PF-04171327 15 mg | Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics) | -6.47 Joints | Standard Deviation 7.54 |
| Prednisone 5 mg | Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics) | -7.07 Joints | Standard Deviation 5.89 |
| Prednisone 10 mg | Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics) | -8.16 Joints | Standard Deviation 4.66 |
| Placebo | Change From Baseline in Tender-Joint Counts at Week 12 (Descriptive Statistics) | -5.59 Joints | Standard Deviation 6.67 |
Secondary
Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg)
Twenty-eight tender/painful joint count included the following joints: shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints, and knees. Artificial joints were not assessed. These joints were assessed by a joint assessor, who was blinded to the participant's safety data, previous efficacy data and treatment randomization, to determine the number of joints that were considered tender or painful, and swollen.
Time frame: Weeks 2, 4, 6, and 8
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -4.08 Joints | Standard Error 0.74 |
| PF-04171327 1 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -5.97 Joints | Standard Error 0.8 |
| PF-04171327 1 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -6.87 Joints | Standard Error 0.87 |
| PF-04171327 1 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -7.06 Joints | Standard Error 0.91 |
| PF-04171327 5 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -8.65 Joints | Standard Error 0.92 |
| PF-04171327 5 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -8.83 Joints | Standard Error 0.87 |
| PF-04171327 5 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -5.55 Joints | Standard Error 0.72 |
| PF-04171327 5 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -6.99 Joints | Standard Error 0.79 |
| PF-04171327 10 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -8.37 Joints | Standard Error 0.87 |
| PF-04171327 10 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -7.01 Joints | Standard Error 0.8 |
| PF-04171327 10 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -4.97 Joints | Standard Error 0.73 |
| PF-04171327 10 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -9.46 Joints | Standard Error 0.91 |
| PF-04171327 15 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -5.65 Joints | Standard Error 0.72 |
| PF-04171327 15 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -6.93 Joints | Standard Error 0.79 |
| PF-04171327 15 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -8.31 Joints | Standard Error 0.86 |
| PF-04171327 15 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -9.17 Joints | Standard Error 0.91 |
| Prednisone 5 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -3.88 Joints | Standard Error 0.73 |
| Prednisone 5 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -7.00 Joints | Standard Error 0.91 |
| Prednisone 5 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -5.79 Joints | Standard Error 0.8 |
| Prednisone 5 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -6.91 Joints | Standard Error 0.87 |
| Prednisone 10 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -7.44 Joints | Standard Error 0.79 |
| Prednisone 10 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -5.38 Joints | Standard Error 0.72 |
| Prednisone 10 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -8.75 Joints | Standard Error 0.86 |
| Prednisone 10 mg | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -8.84 Joints | Standard Error 0.9 |
| Placebo | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | -4.64 Joints | Standard Error 0.87 |
| Placebo | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | -1.95 Joints | Standard Error 0.74 |
| Placebo | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | -4.16 Joints | Standard Error 0.8 |
| Placebo | Change From Baseline in Tender-Joint Counts at Weeks 2, 4, 6, 8 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | -4.27 Joints | Standard Error 0.92 |
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.19, -0.07]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.63, -1.57]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.06, -0.97]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.73, -1.68]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.97, 0.12]
Comparison: Week 2 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.46, -1.39]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.03, 0.42]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.04, -0.62]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.07, -0.64]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.98, -0.56]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.85, 0.59]
Comparison: Week 4 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.48, -1.06]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.66, 0.2]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.62, -1.77]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.15, -1.31]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.09, -1.26]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-4.69, 0.16]
Comparison: Week 6 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.52, -1.7]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.34, -0.25]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-6.93, -1.83]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-7.74, -2.66]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-7.43, -2.36]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-5.28, -0.2]
Comparison: Week 8 analysis presented in this section for comparison to placebo. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-7.1, -2.05]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.73, 3.33]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-2.18, 1.84]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.61, 2.44]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-2.27, 1.73]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.74, 3.68]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.76, 2.65]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.79, 2.63]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.69, 2.7]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.53, 4.29]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-2.5, 2.33]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-2.03, 2.79]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-1.97, 2.84]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-0.75, 4.3]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-2.34, 2.73]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-3.14, 1.89]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg. Statistical analyses presented are derived from mixed model with fixed effects for treatment, visit, treatment-by-visit interaction and baseline value; unstructured covariance matrix was used.95% CI: [-2.84, 2.19]
Secondary
Change From Baseline of CRP at Week 12 (Descriptive Statistics)
The CRP was collected at each applicable clinic visit and analyzed by a central laboratory. In order to assist with the data clean-up at the end of the study, the CRP results were unblinded to the sponsor at the time of the last subject's last visit.
Time frame: Week 12
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants with observations in the below table.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04171327 1 mg | Change From Baseline of CRP at Week 12 (Descriptive Statistics) | 0.72 mg/L | Standard Deviation 27.4 |
| PF-04171327 5 mg | Change From Baseline of CRP at Week 12 (Descriptive Statistics) | -6.24 mg/L | Standard Deviation 23.06 |
| PF-04171327 10 mg | Change From Baseline of CRP at Week 12 (Descriptive Statistics) | -4.52 mg/L | Standard Deviation 20.35 |
| PF-04171327 15 mg | Change From Baseline of CRP at Week 12 (Descriptive Statistics) | -0.64 mg/L | Standard Deviation 29.08 |
| Prednisone 5 mg | Change From Baseline of CRP at Week 12 (Descriptive Statistics) | -2.90 mg/L | Standard Deviation 16.1 |
| Prednisone 10 mg | Change From Baseline of CRP at Week 12 (Descriptive Statistics) | -9.39 mg/L | Standard Deviation 36.1 |
| Placebo | Change From Baseline of CRP at Week 12 (Descriptive Statistics) | -4.07 mg/L | Standard Deviation 22.1 |
Secondary
Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg)
ACR20 response: greater than or equal to (≥) 90 percent (%) improvement in tender or swollen joint counts and 90% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time frame: Weeks 2, 4, and 12 (taper period)
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| PF-04171327 1 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 35.56 Percentage of Participants | 7.13 |
| PF-04171327 1 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 31.11 Percentage of Participants | 6.9 |
| PF-04171327 1 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 31.82 Percentage of Participants | 7.02 |
| PF-04171327 5 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 55.32 Percentage of Participants | 7.25 |
| PF-04171327 5 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 32.61 Percentage of Participants | 6.91 |
| PF-04171327 5 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 48.94 Percentage of Participants | 7.29 |
| PF-04171327 10 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 55.56 Percentage of Participants | 7.4 |
| PF-04171327 10 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 40.00 Percentage of Participants | 7.3 |
| PF-04171327 10 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 66.67 Percentage of Participants | 7.02 |
| PF-04171327 15 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 53.19 Percentage of Participants | 7.27 |
| PF-04171327 15 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 42.55 Percentage of Participants | 7.21 |
| PF-04171327 15 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 38.30 Percentage of Participants | 7.09 |
| Prednisone 5 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 48.89 Percentage of Participants | 7.45 |
| Prednisone 5 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 28.89 Percentage of Participants | 6.75 |
| Prednisone 5 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 48.89 Percentage of Participants | 7.45 |
| Prednisone 10 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 36.96 Percentage of Participants | 7.11 |
| Prednisone 10 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 56.52 Percentage of Participants | 7.3 |
| Prednisone 10 mg | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 65.22 Percentage of Participants | 7.02 |
| Placebo | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 33.33 Percentage of Participants | 7.02 |
| Placebo | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 40.00 Percentage of Participants | 7.3 |
| Placebo | Percentage of Participants Achieving ACR20 Response at Weeks 2, 4, and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 20.45 Percentage of Participants | 6.08 |
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [-6.84, 29.56]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [-5.88, 30.19]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [0.91, 38.17]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [3.6, 40.58]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [-9.38, 26.25]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [-1.84, 34.84]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [-28.58, 10.8]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [-4.85, 35.49]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [6.8, 46.53]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [-7.01, 33.4]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [-11.56, 29.33]
Comparison: Week 4 comparisons presented in this section for comparison to placebo.95% CI: [5.35, 45.07]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-17.4, 21.85]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-4.24, 35.45]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [2.2, 42.23]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-14.6, 24.53]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-4.51, 35.63]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [3.31, 43.06]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-24.73, 14.45]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-23.79, 15.09]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-16.94, 23.02]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-14.26, 25.45]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-53.4, -14.8]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-29.68, 9.88]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-18.02, 20.92]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-31.84, 7.79]
Comparison: Week 12 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-40.98, -0.94]
Comparison: Week 12 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-27.82, 12.65]
Comparison: Week 12 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-21.36, 19.43]
Comparison: Week 12 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-38.18, 1.73]
Secondary
Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg)
ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time frame: Weeks 2, 4, 6, 8, and 12 (taper period)
Population: FAS included all participants who were randomized to the study and received at least one dose of the randomized study drug (PF 04171327, prednisone, or placebo). Note, N = number of participants in FAS and n = number of participants with observations in the below table.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| PF-04171327 1 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | 11.11 Percentage of Participants | 4.68 |
| PF-04171327 1 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 4.55 Percentage of Participants | 3.14 |
| PF-04171327 1 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 17.78 Percentage of Participants | 5.69 |
| PF-04171327 1 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 8.89 Percentage of Participants | 4.24 |
| PF-04171327 1 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 22.22 Percentage of Participants | 6.19 |
| PF-04171327 5 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | 27.66 Percentage of Participants | 6.52 |
| PF-04171327 5 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 23.40 Percentage of Participants | 6.17 |
| PF-04171327 5 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 31.91 Percentage of Participants | 6.79 |
| PF-04171327 5 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 8.70 Percentage of Participants | 4.15 |
| PF-04171327 5 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 21.28 Percentage of Participants | 5.96 |
| PF-04171327 10 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 24.44 Percentage of Participants | 6.4 |
| PF-04171327 10 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 35.56 Percentage of Participants | 7.13 |
| PF-04171327 10 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 8.89 Percentage of Participants | 4.24 |
| PF-04171327 10 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | 40.00 Percentage of Participants | 7.3 |
| PF-04171327 10 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 48.89 Percentage of Participants | 7.45 |
| PF-04171327 15 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | 42.55 Percentage of Participants | 7.21 |
| PF-04171327 15 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 25.53 Percentage of Participants | 6.36 |
| PF-04171327 15 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 27.66 Percentage of Participants | 6.52 |
| PF-04171327 15 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 42.55 Percentage of Participants | 7.21 |
| PF-04171327 15 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 17.02 Percentage of Participants | 5.48 |
| Prednisone 5 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 2.22 Percentage of Participants | 2.19 |
| Prednisone 5 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 26.67 Percentage of Participants | 6.59 |
| Prednisone 5 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | 24.44 Percentage of Participants | 6.4 |
| Prednisone 5 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 26.67 Percentage of Participants | 6.59 |
| Prednisone 5 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 11.11 Percentage of Participants | 4.68 |
| Prednisone 10 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 19.57 Percentage of Participants | 5.84 |
| Prednisone 10 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 23.91 Percentage of Participants | 6.28 |
| Prednisone 10 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 45.65 Percentage of Participants | 7.34 |
| Prednisone 10 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 30.43 Percentage of Participants | 6.78 |
| Prednisone 10 mg | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | 36.96 Percentage of Participants | 7.11 |
| Placebo | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 13.33 Percentage of Participants | 5.16 |
| Placebo | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 11.11 Percentage of Participants | 4.68 |
| Placebo | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | 15.56 Percentage of Participants | 5.4 |
| Placebo | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 6.82 Percentage of Participants | 3.79 |
| Placebo | Percentage of Participants Achieving ACR50 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 17.78 Percentage of Participants | 5.69 |
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [-11.93, 7.38]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [-9.15, 12.91]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [-9.09, 13.23]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [4.19, 33.23]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [-13.19, 4]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [-0.92, 26.41]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [-14.6, 10.16]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [-2.9, 27.48]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [7.71, 41.17]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [0.8, 32.29]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [-12.98, 12.98]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [3.16, 35.48]
Comparison: Week 6 analysis presented in this section for comparison to placebo.95% CI: [-18.46, 9.57]
Comparison: Week 6 analysis presented in this section for comparison to placebo.95% CI: [-4.49, 28.7]
Comparison: Week 6 analysis presented in this section for comparison to placebo.95% CI: [6.63, 42.24]
Comparison: Week 6 analysis presented in this section for comparison to placebo.95% CI: [9.33, 44.65]
Comparison: Week 6 analysis presented in this section for comparison to placebo.95% CI: [-7.53, 25.31]
Comparison: Week 6 analysis presented in this section for comparison to placebo.95% CI: [3.88, 38.91]
Comparison: Week 8 analysis presented in this section for comparison to placebo.95% CI: [-6.8, 24.57]
Comparison: Week 8 analysis presented in this section for comparison to placebo.95% CI: [1.96, 35.2]
Comparison: Week 8 analysis presented in this section for comparison to placebo.95% CI: [17.89, 53.21]
Comparison: Week 8 analysis presented in this section for comparison to placebo.95% CI: [11.94, 46.49]
Comparison: Week 8 analysis presented in this section for comparison to placebo.95% CI: [-2.96, 29.63]
Comparison: Week 8 analysis presented in this section for comparison to placebo.95% CI: [14.83, 49.8]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-15.79, 15.79]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-12.67, 19.67]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-10.13, 23.47]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-16.25, 14.74]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-8.19, 25.96]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-10.5, 22.77]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-28.03, -2]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-24.93, 3.19]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-24.83, 3.48]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-10.96, 22.9]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-37.22, -5.86]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-25.01, 10.95]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-14.17, 24.41]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-21.22, 15.67]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-42.54, -9.14]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-28.22, 9.62]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-16.94, 23.02]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-14.26, 25.45]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-42.26, -4.59]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-33.35, 5.87]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-17.26, 23.74]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-23.27, 17.07]
Comparison: Week 12 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-22.77, 10.5]
Comparison: Week 12 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-19.63, 14.35]
Comparison: Week 12 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-17.06, 18.12]
Comparison: Week 12 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-23.24, 9.46]
Secondary
Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg)
ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Time frame: Weeks 2, 4, 6, 8, and 12 (taper period)
Population: Full analysis set was used. Note, N = number of participants in FAS and n = number of participants with observations in the below table.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04171327 1 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | 2.22 Percentage of Participants |
| PF-04171327 1 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 0.0 Percentage of Participants |
| PF-04171327 1 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 6.67 Percentage of Participants |
| PF-04171327 1 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 0.0 Percentage of Participants |
| PF-04171327 1 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 8.89 Percentage of Participants |
| PF-04171327 5 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | 12.77 Percentage of Participants |
| PF-04171327 5 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 8.51 Percentage of Participants |
| PF-04171327 5 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 17.02 Percentage of Participants |
| PF-04171327 5 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 4.35 Percentage of Participants |
| PF-04171327 5 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 12.77 Percentage of Participants |
| PF-04171327 10 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 6.67 Percentage of Participants |
| PF-04171327 10 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 15.56 Percentage of Participants |
| PF-04171327 10 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 2.22 Percentage of Participants |
| PF-04171327 10 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | 13.33 Percentage of Participants |
| PF-04171327 10 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 26.67 Percentage of Participants |
| PF-04171327 15 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | 17.02 Percentage of Participants |
| PF-04171327 15 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 6.38 Percentage of Participants |
| PF-04171327 15 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 17.02 Percentage of Participants |
| PF-04171327 15 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 21.28 Percentage of Participants |
| PF-04171327 15 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 8.51 Percentage of Participants |
| Prednisone 5 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 2.22 Percentage of Participants |
| Prednisone 5 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 11.11 Percentage of Participants |
| Prednisone 5 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | 6.67 Percentage of Participants |
| Prednisone 5 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 6.67 Percentage of Participants |
| Prednisone 5 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 4.44 Percentage of Participants |
| Prednisone 10 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 8.70 Percentage of Participants |
| Prednisone 10 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 10.87 Percentage of Participants |
| Prednisone 10 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 26.09 Percentage of Participants |
| Prednisone 10 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 15.22 Percentage of Participants |
| Prednisone 10 mg | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | 21.74 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 8 | 11.11 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 4 | 0.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 6 | 4.44 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 2 | 0.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving ACR70 Response at Weeks 2, 4, 6, 8 and 12 (Comparisons to Placebo, and Prednisone 10 mg) | Week 12 | 6.67 Percentage of Participants |
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [0, 0]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [-1.54, 10.24]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [-2.08, 6.52]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [-0.6, 13.37]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [-2.08, 6.52]
Comparison: Week 2 analysis presented in this section for comparison to placebo.95% CI: [0.55, 16.83]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [0, 0]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [0.53, 16.48]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [4.96, 26.14]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [6.27, 27.76]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [-1.57, 10.46]
Comparison: Week 4 analysis presented in this section for comparison to placebo.95% CI: [4.83, 25.59]
Comparison: Week 6 analysis presented in this section for comparison to placebo.95% CI: [-9.62, 5.18]
Comparison: Week 6 analysis presented in this section for comparison to placebo.95% CI: [-2.96, 19.6]
Comparison: Week 6 analysis presented in this section for comparison to placebo.95% CI: [-2.72, 20.5]
Comparison: Week 6 analysis presented in this section for comparison to placebo.95% CI: [0.26, 24.89]
Comparison: Week 6 analysis presented in this section for comparison to placebo.95% CI: [-7.23, 11.67]
Comparison: Week 6 analysis presented in this section for comparison to placebo.95% CI: [3.94, 30.64]
Comparison: Week 8 analysis presented in this section for comparison to placebo.95% CI: [-14.6, 10.16]
Comparison: Week 8 analysis presented in this section for comparison to placebo.95% CI: [-8.22, 20.04]
Comparison: Week 8 analysis presented in this section for comparison to placebo.95% CI: [-0.29, 31.4]
Comparison: Week 8 analysis presented in this section for comparison to placebo.95% CI: [-4.7, 25.03]
Comparison: Week 8 analysis presented in this section for comparison to placebo.95% CI: [-16.16, 7.27]
Comparison: Week 8 analysis presented in this section for comparison to placebo.95% CI: [-0.68, 30.63]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-10.3, 10.3]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-5.9, 18.1]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-10.3, 10.3]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-8.96, 12.64]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-7.27, 16.16]
Comparison: Week 12 analysis presented in this section for comparison to placebo.95% CI: [-7.37, 15.77]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-16.83, -0.55]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-14.39, 5.7]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-15.68, 2.73]
Comparison: Week 2 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-13.04, 8.41]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-25.59, -4.83]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-19.79, 6.38]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-14.49, 15.16]
Comparison: Week 4 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-13.13, 16.74]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-32.19, -6.84]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-24.24, 6.29]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-23.92, 7.1]
Comparison: Week 6 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-20.76, 11.32]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-32.36, -2.02]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-25.69, 7.56]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-17.53, 18.68]
Comparison: Week 8 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-22.07, 12.45]
Comparison: Week 12 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-15.77, 7.37]
Comparison: Week 12 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-11.21, 15]
Comparison: Week 12 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-15.77, 7.37]
Comparison: Week 12 analysis presented in this section for comparison to prednisone 10 mg.95% CI: [-14.38, 9.66]