Rheumatoid Arthritis
Conditions
Keywords
Tofacitinib, CP-690,550, Janis kinase, JAK inhibitor, modified release, Xeljanz
Brief summary
This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib modified release tablet taken once a day in patients with rheumatoid arthritis who continue taking methotrexate. Results for the modified release tablets will be compared to the efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in patients with rheumatoid arthritis who continue taking methotrexate.
Interventions
DRUGTofacitinib
tofacitinib modified release 11 mg tablet administered once time a day for 12 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of rheumatoid arthritis * currently taking a stable dose of methotrexate * no evidence of active or latent or inadequately treated tuberculosis
Exclusion criteria
* evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease * clinically significant infections within the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12 | Baseline, Week 12 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, CRP (milligrams per liter \[mg/L\]) and patient global assessment of disease activity on a 100 millimeter (mm) visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) \[less than or equal to\] \<= 3.2 implied low disease activity and greater than (\>) 3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (CRP) less than (\<) 2.6 implied remission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 12 | Baseline, Week 12 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeters per hour \[mm/hr\]) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) \<=3.2 implied low disease activity and \>3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (ESR) \<2.6 implied remission. |
| Number of Participants Achieving an American College of Rheumatology 20 Percent [%] (ACR20) Response at Week 12 | Week 12 | Participants with 20% improvement in 68-tender and 66-swollen joint counts and 20% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP. Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. |
| Number of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12 | Week 12 | Participants with 50% improvement in 68-tender and 66-swollen joint counts and 50% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP. Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. |
| Number of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Week 12 | Week 12 | Participants with 70% improvement in 68-tender and 66-swollen joint counts and 70% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP. Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. |
| Number of Participants With DAS Remission (DAS28-4-CRP <2.6) at Week 12 | Week 12 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) \<=3.2 implied low disease activity and \>3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (CRP) \<2.6 implied remission. Number of participants with DAS remission (DAS28-4-CRP\<2.6) were reported in this outcome measure. |
| Number of Participants With DAS Remission (DAS28-4-ESR <2.6) at Week 12 | Week 12 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (ESR) \<2.6 implied remission. Number of participants with DAS remission (DAS28-4-ESR\<2.6) were reported in this outcome measure. |
| Number of Participants With Low Disease Activity (DAS28-4-CRP <=3.2) at Week 12 | Week 12 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) \<=3.2 implied low disease activity and \>3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (CRP) \<2.6 implied remission. Number of participants with low disease activity (DAS28-4-CRP\<=3.2) were reported in this outcome measure. |
| Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Week 12 | Baseline, Week 12 | The FACIT-Fatigue Scale was a participant completed questionnaire consisted of 13 items that assessed fatigue. Each item was scored on a scale of 0 (not at all) to 4 (very much), Total score ranging from 0 (not at all) to 52 (very much), higher scores represented lower level of fatigue. |
| Change From Baseline in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Week 12 | Baseline, Week 12 | EQ-5D was a participant completed instrument designed to assess impact on quality of life in terms of a single utility score in five domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems). The 5-dimensional systems are converted into a single index utility score between 0 and 1, where higher score indicated a better health state. |
| Number of Participants With Low Disease Activity (DAS28-4-ESR <=3.2) at Week 12 | Week 12 | DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) \<=3.2 implied low disease activity and \>3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (ESR) \<2.6 implied remission. Number of participants with low disease activity (DAS28-4-ESR\<=3.2) were reported in this outcome measure. |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 | Baseline, Week 12 | HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities over past week. Each activity category consisted of 2-3 items. 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 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities. |
| Number of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ Scores) at Week 12 | Week 12 | HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities over past week. Each activity category consisted of 2-3 items. 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 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities. Number of participants with an improvement of at least 0.22 units in HAQ scores from baseline to Week 12 were reported in this outcome measure. |
| Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Baseline, Week 12 | SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of 8 health aspects were aggregated to derive the two component scores (physical component scores \[PCS\], mental component scores \[MCS\]) ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. |
| Change From Baseline in the Short Form 36 (SF-36) Health Survey Component Scores at Week 12 | Baseline, Week 12 | SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of 8 health aspects were aggregated to derive the two component scores PCS and MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline up to 12 weeks | An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to 12 weeks that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non- serious adverse events. |
| Number of Participants With Clinically Significant Laboratory Test Abnormalities | Baseline up to 12 weeks | Criteria: lipids(cholesterol\[CH\] milligrams/deciliter\[mg/dL\] \>1.3\*upper limit normal(ULN), high-density lipoprotein CH mg/dL \<0.8\*lower limit normal(LLN), Low-density lipoprotein CH mg/dL \>1.2\* ULN, triglycerides mg/dL \>1.3\*ULN); neutrophil count(NC) \<1000 cells/cubic milliliters(mm\^3), platelet counts(PC) \<100,000 P/mm\^3, lymphocyte counts(LC) \<500 L/mm\^3, any single (aspartate transaminase elevation(ASTE)/alanine transaminase elevation(ALTE) \>=3\*ULN, hemoglobin(Hb) value \<8.0 grams(g)/dL or \>=2 g/dL below baseline, any serum creatinine(SC) increase(inc) \>50% or inc \>0.5 mg/dL over the average of screening(OAS) and baseline values(BV), 2 sequential ASTE/ALTE\>=3\*ULN with total bilirubin value(TBV) \>=2\*ULN, ASTE/ALTE \>=3\*ULN, ASTE/ALTE \>=5\*ULN, Hb \<8.0 g/dL or decrease of \>30% from BV, PC \<75,000 P/mm\^3, NC \<1000 cells/mm\^3, LC \<500 L/mm\^3, confirmed inc in SC \>50% OAS and BV and detection of hepatitis B virus-deoxyribonucleic acid(HBV-DNA) by the two sequential quantitative tests. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib Modified Release (MR) Participants orally received 11 mg of tofacitinib MR tablets once daily and matching placebo of tofacitinib IR tablets twice daily for 12 weeks. | 104 |
| Tofacitinib Immediate Release (IR) Participants orally received 5 mg of tofacitinib IR tablets twice daily and matching placebo of tofacitinib MR tablets once daily for 12 weeks. | 105 |
| Total | 209 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 9 |
| Overall Study | Insufficient clinical response | 0 | 1 |
| Overall Study | Medication error | 1 | 0 |
Baseline characteristics
| Characteristic | Tofacitinib Modified Release (MR) | Tofacitinib Immediate Release (IR) | Total |
|---|---|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 11.4 | 58.9 years STANDARD_DEVIATION 10.2 | 58 years STANDARD_DEVIATION 10.8 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 104 Participants | 105 Participants | 209 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 86 Participants | 75 Participants | 161 Participants |
| Sex: Female, Male Male | 18 Participants | 30 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 104 | 0 / 105 |
| other Total, other adverse events | 10 / 104 | 13 / 105 |
| serious Total, serious adverse events | 5 / 104 | 4 / 105 |
Outcome results
Primary
Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, CRP (milligrams per liter \[mg/L\]) and patient global assessment of disease activity on a 100 millimeter (mm) visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) \[less than or equal to\] \<= 3.2 implied low disease activity and greater than (\>) 3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (CRP) less than (\<) 2.6 implied remission.
Time frame: Baseline, Week 12
Population: Full analysis set (FAS) included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib Modified Release (MR) | Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12 | -2.43 units on a scale | Standard Error 0.09 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12 | -2.85 units on a scale | Standard Error 0.09 |
Comparison: Analysis was conducted using a linear mixed effect model with repeated measures (MMRM), which included treatment (tofacitinib MR 11 mg QD and IR 5 mg BID), visit, and treatment by visit interaction as fixed effects and participants as a random effect.95% CI: [0.17, 0.69]
Secondary
Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 12
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeters per hour \[mm/hr\]) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) \<=3.2 implied low disease activity and \>3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (ESR) \<2.6 implied remission.
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib Modified Release (MR) | Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 12 | -2.50 units on a scale | Standard Error 0.09 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 12 | -2.86 units on a scale | Standard Error 0.09 |
Secondary
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities over past week. Each activity category consisted of 2-3 items. 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 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib Modified Release (MR) | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 | -0.44 units on a scale | Standard Error 0.04 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 | -0.46 units on a scale | Standard Error 0.04 |
Secondary
Change From Baseline in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Week 12
EQ-5D was a participant completed instrument designed to assess impact on quality of life in terms of a single utility score in five domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems). The 5-dimensional systems are converted into a single index utility score between 0 and 1, where higher score indicated a better health state.
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib Modified Release (MR) | Change From Baseline in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Week 12 | 0.20 units on a scale | Standard Error 0.02 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Week 12 | 0.25 units on a scale | Standard Error 0.02 |
Secondary
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Week 12
The FACIT-Fatigue Scale was a participant completed questionnaire consisted of 13 items that assessed fatigue. Each item was scored on a scale of 0 (not at all) to 4 (very much), Total score ranging from 0 (not at all) to 52 (very much), higher scores represented lower level of fatigue.
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib Modified Release (MR) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Week 12 | 5.28 units on a scale | Standard Error 0.66 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Week 12 | 6.12 units on a scale | Standard Error 0.67 |
Secondary
Change From Baseline in the Short Form 36 (SF-36) Health Survey Component Scores at Week 12
SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of 8 health aspects were aggregated to derive the two component scores PCS and MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Modified Release (MR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Component Scores at Week 12 | PCS | 6.59 units on a scale | Standard Error 0.58 |
| Tofacitinib Modified Release (MR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Component Scores at Week 12 | MCS | 5.29 units on a scale | Standard Error 0.76 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Component Scores at Week 12 | PCS | 7.85 units on a scale | Standard Error 0.59 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Component Scores at Week 12 | MCS | 5.08 units on a scale | Standard Error 0.77 |
Secondary
Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12
SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of 8 health aspects were aggregated to derive the two component scores (physical component scores \[PCS\], mental component scores \[MCS\]) ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.
Time frame: Baseline, Week 12
Population: FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib Modified Release (MR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Physical Functioning | 5.54 units on a scale | Standard Error 0.67 |
| Tofacitinib Modified Release (MR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Bodily Pain | 9.41 units on a scale | Standard Error 0.77 |
| Tofacitinib Modified Release (MR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | General Health | 4.53 units on a scale | Standard Error 0.52 |
| Tofacitinib Modified Release (MR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Social Function | 4.26 units on a scale | Standard Error 0.63 |
| Tofacitinib Modified Release (MR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Role Emotional | 7.23 units on a scale | Standard Error 0.86 |
| Tofacitinib Modified Release (MR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Mental Health | 4.46 units on a scale | Standard Error 0.8 |
| Tofacitinib Modified Release (MR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Role Physical | 6.51 units on a scale | Standard Error 0.81 |
| Tofacitinib Modified Release (MR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Vitality | 8.07 units on a scale | Standard Error 0.75 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Social Function | 5.06 units on a scale | Standard Error 0.64 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Physical Functioning | 6.29 units on a scale | Standard Error 0.68 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Role Emotional | 6.56 units on a scale | Standard Error 0.87 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Bodily Pain | 11.92 units on a scale | Standard Error 0.78 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Role Physical | 6.97 units on a scale | Standard Error 0.83 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | General Health | 4.72 units on a scale | Standard Error 0.53 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Vitality | 8.20 units on a scale | Standard Error 0.76 |
| Tofacitinib Immediate Release (IR) | Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 | Mental Health | 5.26 units on a scale | Standard Error 0.81 |
Secondary
Number of Participants Achieving an American College of Rheumatology 20 Percent [%] (ACR20) Response at Week 12
Participants with 20% improvement in 68-tender and 66-swollen joint counts and 20% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP. Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Time frame: Week 12
Population: FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using non-responder imputation (NRI) method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | Number of Participants Achieving an American College of Rheumatology 20 Percent [%] (ACR20) Response at Week 12 | 87 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants Achieving an American College of Rheumatology 20 Percent [%] (ACR20) Response at Week 12 | 83 participants |
Secondary
Number of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12
Participants with 50% improvement in 68-tender and 66-swollen joint counts and 50% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP. Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Time frame: Week 12
Population: FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | Number of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12 | 70 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12 | 71 participants |
Secondary
Number of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Week 12
Participants with 70% improvement in 68-tender and 66-swollen joint counts and 70% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP. Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis. Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
Time frame: Week 12
Population: FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | Number of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Week 12 | 32 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Week 12 | 48 participants |
Secondary
Number of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ Scores) at Week 12
HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities over past week. Each activity category consisted of 2-3 items. 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 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities. Number of participants with an improvement of at least 0.22 units in HAQ scores from baseline to Week 12 were reported in this outcome measure.
Time frame: Week 12
Population: FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | Number of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ Scores) at Week 12 | 65 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ Scores) at Week 12 | 60 participants |
Secondary
Number of Participants With DAS Remission (DAS28-4-CRP <2.6) at Week 12
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) \<=3.2 implied low disease activity and \>3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (CRP) \<2.6 implied remission. Number of participants with DAS remission (DAS28-4-CRP\<2.6) were reported in this outcome measure.
Time frame: Week 12
Population: FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | Number of Participants With DAS Remission (DAS28-4-CRP <2.6) at Week 12 | 52 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With DAS Remission (DAS28-4-CRP <2.6) at Week 12 | 72 participants |
Secondary
Number of Participants With DAS Remission (DAS28-4-ESR <2.6) at Week 12
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (ESR) \<2.6 implied remission. Number of participants with DAS remission (DAS28-4-ESR\<2.6) were reported in this outcome measure.
Time frame: Week 12
Population: FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | Number of Participants With DAS Remission (DAS28-4-ESR <2.6) at Week 12 | 18 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With DAS Remission (DAS28-4-ESR <2.6) at Week 12 | 36 participants |
Secondary
Number of Participants With Low Disease Activity (DAS28-4-CRP <=3.2) at Week 12
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) \<=3.2 implied low disease activity and \>3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (CRP) \<2.6 implied remission. Number of participants with low disease activity (DAS28-4-CRP\<=3.2) were reported in this outcome measure.
Time frame: Week 12
Population: FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | Number of Participants With Low Disease Activity (DAS28-4-CRP <=3.2) at Week 12 | 76 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Low Disease Activity (DAS28-4-CRP <=3.2) at Week 12 | 82 participants |
Secondary
Number of Participants With Low Disease Activity (DAS28-4-ESR <=3.2) at Week 12
DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and patient global assessment of disease activity on a 100 mm visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) \<=3.2 implied low disease activity and \>3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (ESR) \<2.6 implied remission. Number of participants with low disease activity (DAS28-4-ESR\<=3.2) were reported in this outcome measure.
Time frame: Week 12
Population: FAS included all participants who were randomized and received at least one dose of the randomized investigational drug. Here, N (number of participants analyzed) signifies those participants who were evaluable for this specified outcome measure. Missing values due to withdrawal were imputed using NRI method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib Modified Release (MR) | Number of Participants With Low Disease Activity (DAS28-4-ESR <=3.2) at Week 12 | 44 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Low Disease Activity (DAS28-4-ESR <=3.2) at Week 12 | 63 participants |
Other Pre-specified
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Criteria: lipids(cholesterol\[CH\] milligrams/deciliter\[mg/dL\] \>1.3\*upper limit normal(ULN), high-density lipoprotein CH mg/dL \<0.8\*lower limit normal(LLN), Low-density lipoprotein CH mg/dL \>1.2\* ULN, triglycerides mg/dL \>1.3\*ULN); neutrophil count(NC) \<1000 cells/cubic milliliters(mm\^3), platelet counts(PC) \<100,000 P/mm\^3, lymphocyte counts(LC) \<500 L/mm\^3, any single (aspartate transaminase elevation(ASTE)/alanine transaminase elevation(ALTE) \>=3\*ULN, hemoglobin(Hb) value \<8.0 grams(g)/dL or \>=2 g/dL below baseline, any serum creatinine(SC) increase(inc) \>50% or inc \>0.5 mg/dL over the average of screening(OAS) and baseline values(BV), 2 sequential ASTE/ALTE\>=3\*ULN with total bilirubin value(TBV) \>=2\*ULN, ASTE/ALTE \>=3\*ULN, ASTE/ALTE \>=5\*ULN, Hb \<8.0 g/dL or decrease of \>30% from BV, PC \<75,000 P/mm\^3, NC \<1000 cells/mm\^3, LC \<500 L/mm\^3, confirmed inc in SC \>50% OAS and BV and detection of hepatitis B virus-deoxyribonucleic acid(HBV-DNA) by the two sequential quantitative tests.
Time frame: Baseline up to 12 weeks
Population: Safety analysis set included all participants who were randomized and received at least one dose of the randomized investigational drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Cholesterol | 11 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Low-density lipoprotein Cholesterol | 22 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Neutrophil counts <1000 cells/mm3 | 0 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Platelet counts <100,000 platelets/mm3 | 0 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Lymphocyte counts <500 lymphocytes/mm3 | 1 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Any single AST and/or ALT elevation >=3xULN | 1 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Any single Hb value <8.0 g/dL or >=2 gm/dL | 0 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 2 sequential AST or ALT elevations >=3xULN | 1 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 2 sequential AST or ALT elevations >=5xULN | 0 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 2 sequential platelet counts <75,000 platelets/mm3 | 0 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Confirmed increases in serum creatinine >50% | 0 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Detection of HBV-DNA | 0 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | High-density lipoprotein Cholesterol | 1 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Triglycerides | 6 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Any serum creatinine increase >50% | 0 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 2sequential AST/ALT elevations>=3xULN, TBV>=2xULN | 0 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 2sequential Hb<8.0 g/dL or decrease of >30%from BV | 0 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 2 sequential neutrophil counts <1000 cells/mm3 | 0 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 2 sequential lymphocyte count <500 lymphocytes/mm3 | 0 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 2 sequential lymphocyte count <500 lymphocytes/mm3 | 0 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | High-density lipoprotein Cholesterol | 1 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Platelet counts <100,000 platelets/mm3 | 0 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Triglycerides | 10 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Confirmed increases in serum creatinine >50% | 0 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 2sequential AST/ALT elevations>=3xULN, TBV>=2xULN | 0 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Detection of HBV-DNA | 0 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Lymphocyte counts <500 lymphocytes/mm3 | 0 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Cholesterol | 8 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Any single AST and/or ALT elevation >=3xULN | 0 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Any serum creatinine increase >50% | 0 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Any single Hb value <8.0 g/dL or >=2 gm/dL | 2 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Low-density lipoprotein Cholesterol | 21 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 2 sequential AST or ALT elevations >=3xULN | 0 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 2sequential Hb<8.0 g/dL or decrease of >30%from BV | 1 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 2 sequential AST or ALT elevations >=5xULN | 0 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Neutrophil counts <1000 cells/mm3 | 0 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 2 sequential platelet counts <75,000 platelets/mm3 | 0 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Clinically Significant Laboratory Test Abnormalities | 2 sequential neutrophil counts <1000 cells/mm3 | 0 participants |
Other Pre-specified
Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to 12 weeks that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non- serious adverse events.
Time frame: Baseline up to 12 weeks
Population: Safety analysis set included all participants who were randomized and received at least one dose of the randomized investigational drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib Modified Release (MR) | Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | AEs | 55 participants |
| Tofacitinib Modified Release (MR) | Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 5 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | AEs | 54 participants |
| Tofacitinib Immediate Release (IR) | Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 4 participants |