Rhematoid Arthritis
Conditions
Brief summary
To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.
Interventions
DRUGTofacitinib with methotrexate
Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months
DRUGTofacitinib without methotrexate
Tofacitinib 5 mg twice daily, oral for 12 months Placebo for methotrexate (previous stable dose) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months
BIOLOGICALAdalimumab with methotrexate
Placebo for tofacitinib twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Adalimumab 40 mg every other week, subcutaneous for 12 months
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have moderate to severe rheumatoid arthritis * On methotrexate but inadequately controlled * Subjects must not have active tuberculosis or an inadequately treated tuberculosis infection * Subjects must use contraception
Exclusion criteria
* Subjects who have been previously treated with adalimumab or Tofacitinib * Subjects with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ. * Subjects with specific laboratory test abnormalities * Subjects with specific types of infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6 | Month 6 | ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) 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 (CRP) at each visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6 | Month 6 | CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, \>2.8 to 10 indicates low disease activity, \>10 to 22 indicates moderate disease activity, and \>22 indicates high disease activity. |
| Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6 | Month 6 | DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\* PtGA (millimeters \[mm\]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity, \>3.2 to 5.1 indicates moderate to high disease activity, and less than (\<) 2.6 indicates remission. |
| Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6 | Month 6 | DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) ≤3.2 indicates low disease activity, \>3.2 to 5.1 indicates moderate to high disease activity, and \<2.6 indicates remission. |
| Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6 | Month 6 | To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC ≤1 and SJC ≤1 (both based on a 28-joint assessment), CRP ≤1 mg/dL, and PtGA ≤1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). |
| Percentage of Participants Achieving SDAI ≤3.3 at Month 6 | Month 6 | SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission. |
| Percentage of Participants Achieving CDAI ≤2.8 at Month 6 | Month 6 | CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission. |
| Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6 | Month 6 | DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) \<2.6 indicates disease remission. |
| Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6 | Month 6 | DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) \<2.6 indicates remission. |
| Percentage of Participants Achieving SDAI ≤11 at Month 6 | Month 6 | SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission, \>3.4 to 11 indicates low disease activity. |
| Percentage of Participants Achieving CDAI ≤10 at Month 6 | Month 6 | CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, \>2.8 to 10 indicates low disease activity. |
| Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6 | Month 6 | DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) ≤3.2 indicates low disease activity. |
| Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6 | Month 6 | DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity. |
| Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6 | Month 6 | ACR20 response is a ≥20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. |
| Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6 | Month 6 | ACR70 response is a ≥70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. |
| Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6 | Month 6 | SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (≤) 3.3 indicates disease remission, \>3.4 to 11 indicates low disease activity, \>11 to 26 indicates moderate disease activity, and \>26 indicates high disease activity. |
| Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6 | Month 6 | The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. A decrease of 0.22 or more is considered a positive response. |
| Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6 | Month 6 | The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status. |
| Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6 | Month 6 | The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status. |
| Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Month 6 | The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity. |
| Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6 | Month 6 | SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning. |
| Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6 | Month 6 | SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning. |
| Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6 | Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain. |
| Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6 | Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions. |
| Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6 | Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality. |
| Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6 | Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning. |
| Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6 | Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning. |
| Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6 | Month 6 | The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning. |
| Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Month 6 | The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state. |
| Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6 | Month 6 | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). |
| Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6 | Month 6 | The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. |
Countries
Argentina, Australia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, Czechia, Estonia, Israel, Latvia, Lithuania, Mexico, Peru, Philippines, Poland, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Participant flow
Pre-assignment details
Although a total of 1,152 participants were randomized, only 1,146 participants received treatment and are included in the full analysis set summarized below.
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib 5 mg BID One active tofacitinib 5 mg tablet orally BID plus placebo MTX (prior dose) orally every week plus placebo adalimumab 40 mg subcutaneously (SC) every other week for up to 12 months. | 384 |
| Tofacitinib 5 mg BID + MTX One active tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus placebo adalimumab 40 mg SC every other week for up to 12 months. | 376 |
| Adalimumab 40 mg + MTX One placebo tofacitinib 5 mg tablet orally BID plus active MTX (prior dose) orally every week plus active adalimumab 40 mg SC every other week for up to 12 months. | 386 |
| Total | 1,146 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 21 | 26 | 36 |
| Overall Study | Death | 2 | 0 | 0 |
| Overall Study | Lack of Efficacy | 10 | 3 | 7 |
| Overall Study | Lost to Follow-up | 2 | 7 | 3 |
| Overall Study | No longer meets eligibility criteria | 0 | 2 | 0 |
| Overall Study | No longer willing to participate | 6 | 8 | 10 |
| Overall Study | Other | 5 | 6 | 3 |
| Overall Study | Pregnancy | 3 | 1 | 0 |
| Overall Study | Protocol Violation | 9 | 9 | 4 |
| Overall Study | Withdrawal by Subject | 11 | 11 | 11 |
Baseline characteristics
| Characteristic | Tofacitinib 5 mg BID | Tofacitinib 5 mg BID + MTX | Adalimumab 40 mg + MTX | Total |
|---|---|---|---|---|
| Age, Continuous | 49.7 Years STANDARD_DEVIATION 12.2 | 50.0 Years STANDARD_DEVIATION 13.4 | 50.7 Years STANDARD_DEVIATION 13.4 | 50.1 Years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 319 Participants | 311 Participants | 320 Participants | 950 Participants |
| Sex: Female, Male Male | 65 Participants | 65 Participants | 66 Participants | 196 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 51 / 384 | 72 / 376 | 69 / 386 |
| serious Total, serious adverse events | 35 / 384 | 27 / 376 | 24 / 386 |
Outcome results
Primary
Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6
ACR50 is a greater than or equal to (≥) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) 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 (CRP) at each visit.
Time frame: Month 6
Population: Full analysis set (FAS) included all participants who were randomized and received at least one dose of the randomized investigational drug (tofacitinib or adalimumab).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6 | 38.28 Percentage of participants |
| Tofacitinib 5 mg BID + MTX | Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6 | 46.01 Percentage of participants |
| Adalimumab 40 mg + MTX | Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6 | 43.78 Percentage of participants |
p-value: 0.210198.34% CI: [-16.29, 0.83]Normal approximation to proportions
p-value: 0.051298.34% CI: [-13.98, 2.98]Normal approximation to proportions
p-value: <0.000198.34% CI: [-6.4, 10.86]Normal approximation to proportions
Secondary
Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6
CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, \>2.8 to 10 indicates low disease activity, \>10 to 22 indicates moderate disease activity, and \>22 indicates high disease activity.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6 | -22.9 Score on a scale | Standard Error 0.61 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6 | -25.5 Score on a scale | Standard Error 0.61 |
| Adalimumab 40 mg + MTX | Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6 | -24.8 Score on a scale | Standard Error 0.61 |
95% CI: [1.08, 4.18]
95% CI: [0.4, 3.48]
95% CI: [-2.24, 0.86]
Secondary
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6
DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\* PtGA (millimeters \[mm\]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity, \>3.2 to 5.1 indicates moderate to high disease activity, and less than (\<) 2.6 indicates remission.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6 | -2.1 Score on a scale | Standard Error 0.07 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6 | -2.5 Score on a scale | Standard Error 0.07 |
| Adalimumab 40 mg + MTX | Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6 | -2.3 Score on a scale | Standard Error 0.07 |
95% CI: [0.16, 0.5]
95% CI: [0.05, 0.39]
95% CI: [-0.28, 0.06]
Secondary
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6
DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) ≤3.2 indicates low disease activity, \>3.2 to 5.1 indicates moderate to high disease activity, and \<2.6 indicates remission.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6 | -2.1 Score on a scale | Standard Error 0.07 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6 | -2.4 Score on a scale | Standard Error 0.07 |
| Adalimumab 40 mg + MTX | Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6 | -2.4 Score on a scale | Standard Error 0.07 |
95% CI: [0.15, 0.51]
95% CI: [0.1, 0.46]
95% CI: [-0.23, 0.13]
Secondary
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6
The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6 | -0.52 Units on a scale | Standard Error 0.031 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6 | -0.58 Units on a scale | Standard Error 0.031 |
| Adalimumab 40 mg + MTX | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6 | -0.54 Units on a scale | Standard Error 0.031 |
95% CI: [-0.011, 0.148]
95% CI: [-0.054, 0.105]
95% CI: [-0.122, 0.037]
Secondary
Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6
SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (≤) 3.3 indicates disease remission, \>3.4 to 11 indicates low disease activity, \>11 to 26 indicates moderate disease activity, and \>26 indicates high disease activity.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6 | -23.7 Score on a scale | Standard Error 0.62 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6 | -26.6 Score on a scale | Standard Error 0.62 |
| Adalimumab 40 mg + MTX | Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6 | -25.6 Score on a scale | Standard Error 0.62 |
95% CI: [1.23, 4.41]
95% CI: [0.33, 3.49]
95% CI: [-2.51, 0.68]
Secondary
Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6
The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.
Time frame: Month 6
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Mobility score | -0.29 Units on a scale | Standard Error 0.027 |
| Tofacitinib 5 mg BID | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Utility score | 0.20 Units on a scale | Standard Error 0.013 |
| Tofacitinib 5 mg BID | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Self-care score | -0.27 Units on a scale | Standard Error 0.028 |
| Tofacitinib 5 mg BID | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Usual activities score | -0.24 Units on a scale | Standard Error 0.029 |
| Tofacitinib 5 mg BID | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Pain/discomfort score | -0.32 Units on a scale | Standard Error 0.026 |
| Tofacitinib 5 mg BID | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Anxiety/depression score | -0.21 Units on a scale | Standard Error 0.029 |
| Tofacitinib 5 mg BID | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | VAS score | 20.84 Units on a scale | Standard Error 1.1 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | VAS score | 20.98 Units on a scale | Standard Error 1.1 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Self-care score | -0.33 Units on a scale | Standard Error 0.028 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Anxiety/depression score | -0.24 Units on a scale | Standard Error 0.029 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Usual activities score | -0.26 Units on a scale | Standard Error 0.029 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Pain/discomfort score | -0.34 Units on a scale | Standard Error 0.026 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Utility score | 0.22 Units on a scale | Standard Error 0.013 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Mobility score | -0.26 Units on a scale | Standard Error 0.027 |
| Adalimumab 40 mg + MTX | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Utility score | 0.22 Units on a scale | Standard Error 0.013 |
| Adalimumab 40 mg + MTX | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | VAS score | 19.61 Units on a scale | Standard Error 1.1 |
| Adalimumab 40 mg + MTX | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Self-care score | -0.32 Units on a scale | Standard Error 0.028 |
| Adalimumab 40 mg + MTX | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Pain/discomfort score | -0.37 Units on a scale | Standard Error 0.026 |
| Adalimumab 40 mg + MTX | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Mobility score | -0.28 Units on a scale | Standard Error 0.027 |
| Adalimumab 40 mg + MTX | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Usual activities score | -0.30 Units on a scale | Standard Error 0.029 |
| Adalimumab 40 mg + MTX | Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 | Anxiety/depression score | -0.22 Units on a scale | Standard Error 0.029 |
Comparison: Utility score95% CI: [-0.057, 0.011]
Comparison: Utility score95% CI: [-0.054, 0.013]
Comparison: Utility score95% CI: [-0.031, 0.036]
Comparison: Mobility score95% CI: [-0.098, 0.042]
Comparison: Mobility score95% CI: [-0.079, 0.06]
Comparison: Mobility score95% CI: [-0.051, 0.089]
Comparison: Self-care score95% CI: [-0.014, 0.127]
Comparison: Self-care score95% CI: [-0.027, 0.114]
Comparison: Self-care score95% CI: [-0.083, 0.058]
Comparison: Usual activities score95% CI: [-0.062, 0.084]
Comparison: Usual activities score95% CI: [-0.018, 0.129]
Comparison: Usual activities score95% CI: [-0.029, 0.118]
Comparison: Pain/discomfort score95% CI: [-0.041, 0.091]
Comparison: Pain/discomfort score95% CI: [-0.015, 0.116]
Comparison: Pain/discomfort score95% CI: [-0.041, 0.091]
Comparison: Anxiety/depression score95% CI: [-0.046, 0.103]
Comparison: Anxiety/depression score95% CI: [-0.066, 0.083]
Comparison: Anxiety/depression score95% CI: [-0.094, 0.055]
Comparison: VAS score95% CI: [-2.934, 2.648]
Comparison: VAS score95% CI: [-1.556, 4.016]
Comparison: VAS score95% CI: [-1.425, 4.171]
Secondary
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6 | 7.14 Units on a scale | Standard Error 0.5 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6 | 7.59 Units on a scale | Standard Error 0.498 |
| Adalimumab 40 mg + MTX | Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6 | 6.07 Units on a scale | Standard Error 0.499 |
95% CI: [-1.706, 0.808]
95% CI: [-0.178, 2.325]
95% CI: [0.266, 2.779]
Secondary
Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6 | 8.2 Score on a scale | Standard Error 0.48 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6 | 10.3 Score on a scale | Standard Error 0.48 |
| Adalimumab 40 mg + MTX | Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6 | 9.9 Score on a scale | Standard Error 0.48 |
95% CI: [-3.25, -0.8]
95% CI: [-2.91, -0.47]
95% CI: [-0.89, 1.55]
Secondary
Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6 | 5.1 Score on a scale | Standard Error 0.44 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6 | 6.3 Score on a scale | Standard Error 0.44 |
| Adalimumab 40 mg + MTX | Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6 | 5.4 Score on a scale | Standard Error 0.44 |
95% CI: [-2.27, -0.05]
95% CI: [-1.4, 0.82]
95% CI: [-0.25, 1.98]
Secondary
Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6
The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6 | 5.2 Score on a scale | Standard Error 0.52 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6 | 5.7 Score on a scale | Standard Error 0.51 |
| Adalimumab 40 mg + MTX | Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6 | 4.4 Score on a scale | Standard Error 0.51 |
95% CI: [-1.74, 0.85]
95% CI: [-0.48, 2.11]
95% CI: [-0.04, 2.56]
Secondary
Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6 | 5.3 Score on a scale | Standard Error 0.52 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6 | 5.5 Score on a scale | Standard Error 0.52 |
| Adalimumab 40 mg + MTX | Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6 | 5.0 Score on a scale | Standard Error 0.52 |
95% CI: [-1.55, 1.08]
95% CI: [-1.01, 1.62]
95% CI: [-0.78, 1.86]
Secondary
Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6
SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6 | 6.4 Score on a scale | Standard Error 0.52 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6 | 7.3 Score on a scale | Standard Error 0.52 |
| Adalimumab 40 mg + MTX | Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6 | 7.3 Score on a scale | Standard Error 0.52 |
95% CI: [-2.22, 0.39]
95% CI: [-2.19, 0.42]
95% CI: [-1.27, 1.34]
Secondary
Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6 | 6.7 Score on a scale | Standard Error 0.58 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6 | 7.7 Score on a scale | Standard Error 0.58 |
| Adalimumab 40 mg + MTX | Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6 | 6.0 Score on a scale | Standard Error 0.58 |
95% CI: [-2.54, 0.39]
95% CI: [-0.76, 2.16]
95% CI: [0.3, 3.24]
Secondary
Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6
SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6 | 6.7 Score on a scale | Standard Error 0.47 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6 | 7.0 Score on a scale | Standard Error 0.47 |
| Adalimumab 40 mg + MTX | Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6 | 6.3 Score on a scale | Standard Error 0.47 |
95% CI: [-1.52, 0.87]
95% CI: [-0.8, 1.58]
95% CI: [-0.47, 1.91]
Secondary
Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6 | 6.3 Score on a scale | Standard Error 0.52 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6 | 7.2 Score on a scale | Standard Error 0.52 |
| Adalimumab 40 mg + MTX | Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6 | 6.2 Score on a scale | Standard Error 0.52 |
95% CI: [-2.2, 0.45]
95% CI: [-1.13, 1.51]
95% CI: [-0.26, 2.39]
Secondary
Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6
The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6 | 5.6 Score on a scale | Standard Error 0.48 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6 | 6.1 Score on a scale | Standard Error 0.47 |
| Adalimumab 40 mg + MTX | Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6 | 5.7 Score on a scale | Standard Error 0.47 |
95% CI: [-1.71, 0.68]
95% CI: [-1.33, 1.05]
95% CI: [-0.83, 1.57]
Secondary
Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6
The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6 | 6.7 Score on a scale | Standard Error 0.44 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6 | 7.9 Score on a scale | Standard Error 0.43 |
| Adalimumab 40 mg + MTX | Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6 | 7.8 Score on a scale | Standard Error 0.43 |
95% CI: [-2.28, -0.11]
95% CI: [-2.16, 0.01]
95% CI: [-0.97, 1.2]
Secondary
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6
The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity.
Time frame: Month 6
Population: FAS
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib 5 mg BID | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Problems affecting productivity | -1.94 Percentage of impairment | Standard Error 0.228 |
| Tofacitinib 5 mg BID | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | % activity impairment due to health | -22.36 Percentage of impairment | Standard Error 1.375 |
| Tofacitinib 5 mg BID | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | % work time missed due to health | -4.51 Percentage of impairment | Standard Error 1.79 |
| Tofacitinib 5 mg BID | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Problem affecting daily activities | -2.24 Percentage of impairment | Standard Error 0.137 |
| Tofacitinib 5 mg BID | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Work hours missed due to problems | -2.62 Percentage of impairment | Standard Error 0.717 |
| Tofacitinib 5 mg BID | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | % overall work impairment due to health | -20.16 Percentage of impairment | Standard Error 2.663 |
| Tofacitinib 5 mg BID | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Hours worked in past 7 days | 4.13 Percentage of impairment | Standard Error 1.729 |
| Tofacitinib 5 mg BID | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Work hours missed other reason | 0.14 Percentage of impairment | Standard Error 1.019 |
| Tofacitinib 5 mg BID | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | % impairment while working due to health | -19.38 Percentage of impairment | Standard Error 2.276 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Problem affecting daily activities | -2.47 Percentage of impairment | Standard Error 0.138 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Work hours missed due to problems | -2.19 Percentage of impairment | Standard Error 0.7 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Work hours missed other reason | 0.43 Percentage of impairment | Standard Error 0.991 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Hours worked in past 7 days | -0.82 Percentage of impairment | Standard Error 1.672 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Problems affecting productivity | -2.14 Percentage of impairment | Standard Error 0.224 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | % work time missed due to health | -3.41 Percentage of impairment | Standard Error 1.794 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | % impairment while working due to health | -21.44 Percentage of impairment | Standard Error 2.235 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | % overall work impairment due to health | -22.27 Percentage of impairment | Standard Error 2.638 |
| Tofacitinib 5 mg BID + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | % activity impairment due to health | -24.74 Percentage of impairment | Standard Error 1.383 |
| Adalimumab 40 mg + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Hours worked in past 7 days | 1.28 Percentage of impairment | Standard Error 1.788 |
| Adalimumab 40 mg + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Work hours missed due to problems | -1.75 Percentage of impairment | Standard Error 0.741 |
| Adalimumab 40 mg + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | % impairment while working due to health | -19.52 Percentage of impairment | Standard Error 2.32 |
| Adalimumab 40 mg + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Work hours missed other reason | -0.77 Percentage of impairment | Standard Error 1.059 |
| Adalimumab 40 mg + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | % activity impairment due to health | -22.45 Percentage of impairment | Standard Error 1.394 |
| Adalimumab 40 mg + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Problem affecting daily activities | -2.24 Percentage of impairment | Standard Error 0.139 |
| Adalimumab 40 mg + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | Problems affecting productivity | -1.95 Percentage of impairment | Standard Error 0.232 |
| Adalimumab 40 mg + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | % overall work impairment due to health | -21.87 Percentage of impairment | Standard Error 2.71 |
| Adalimumab 40 mg + MTX | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 | % work time missed due to health | -1.87 Percentage of impairment | Standard Error 1.831 |
Comparison: Work hours missed due to problems95% CI: [-2.279, 1.427]
Comparison: Work hours missed due to problems95% CI: [-2.783, 1.044]
Comparison: Work hours missed due to problems95% CI: [-2.349, 1.462]
Comparison: Work hours missed other reason95% CI: [-2.928, 2.346]
Comparison: Work hours missed other reason95% CI: [-1.832, 3.64]
Comparison: Work hours missed other reason95% CI: [-1.52, 3.911]
Comparison: Hours worked in past 7 days95% CI: [0.52, 9.37]
Comparison: Hours worked in past 7 days90% CI: [-1.736, 7.43]
Comparison: Hours worked in past 7 days95% CI: [-6.65, 2.454]
Comparison: Problems affecting productivity95% CI: [-0.373, 0.786]
Comparison: Problems affecting productivity95% CI: [-0.578, 0.607]
Comparison: Problems affecting productivity95% CI: [-0.784, 0.4]
Comparison: Problem affecting daily activities95% CI: [-0.112, 0.587]
Comparison: Problem affecting daily activities95% CI: [-0.341, 0.357]
Comparison: Problem affecting daily activities95% CI: [-0.582, 0.122]
Comparison: % work time missed due to health95% CI: [-5.748, 3.553]
Comparison: % work time missed due to health95% CI: [-7.339, 2.067]
Comparison: % work time missed due to health95% CI: [-6.283, 3.207]
Comparison: % impairment while working due to health95% CI: [-3.726, 7.858]
Comparison: % impairment while working due to health95% CI: [-5.777, 6.068]
Comparison: % impairment while working due to health95% CI: [-7.839, 3.998]
Comparison: % overall work impairment due to health95% CI: [-4.664, 8.877]
Comparison: % overall work impairment due to health95% CI: [-5.164, 8.58]
Comparison: % overall work impairment due to health95% CI: [-7.307, 6.51]
Comparison: % activity impairment due to health95% CI: [-1.118, 5.873]
Comparison: % activity impairment due to health95% CI: [-3.411, 3.573]
Comparison: % activity impairment due to health95% CI: [-5.818, 1.225]
Secondary
Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6
ACR20 response is a ≥20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6 | 70.06 Percentage of participants |
| Tofacitinib 5 mg BID + MTX | Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6 | 79.13 Percentage of participants |
| Adalimumab 40 mg + MTX | Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6 | 77.65 Percentage of participants |
95% CI: [-14.84, -1.75]
95% CI: [-12.72, 0.44]
95% CI: [-4.22, 8.52]
Secondary
Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6
ACR70 response is a ≥70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6 | 19.66 Percentage of participants |
| Tofacitinib 5 mg BID + MTX | Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6 | 27.11 Percentage of participants |
| Adalimumab 40 mg + MTX | Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6 | 22.64 Percentage of participants |
95% CI: [-12.61, -0.93]
95% CI: [-8.09, 3.1]
95% CI: [-1.68, 10.23]
Secondary
Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6
The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. A decrease of 0.22 or more is considered a positive response.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6 | 71.07 Percentage of participants |
| Tofacitinib 5 mg BID + MTX | Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6 | 75.57 Percentage of participants |
| Adalimumab 40 mg + MTX | Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6 | 72.86 Percentage of participants |
95% CI: [-10.68, 2.55]
95% CI: [-7.87, 5.44]
95% CI: [-3.72, 9.43]
Secondary
Percentage of Participants Achieving CDAI ≤10 at Month 6
CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission, \>2.8 to 10 indicates low disease activity.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants Achieving CDAI ≤10 at Month 6 | 45.53 Percentage of participants |
| Tofacitinib 5 mg BID + MTX | Percentage of Participants Achieving CDAI ≤10 at Month 6 | 52.45 Percentage of participants |
| Adalimumab 40 mg + MTX | Percentage of Participants Achieving CDAI ≤10 at Month 6 | 50.00 Percentage of participants |
95% CI: [-13.29, 0.85]
95% CI: [-10.94, 3.09]
95% CI: [-4.79, 9.39]
Secondary
Percentage of Participants Achieving CDAI ≤2.8 at Month 6
CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI ≤2.8 indicates disease remission.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants Achieving CDAI ≤2.8 at Month 6 | 10.89 Percentage of participants |
| Tofacitinib 5 mg BID + MTX | Percentage of Participants Achieving CDAI ≤2.8 at Month 6 | 14.70 Percentage of participants |
| Adalimumab 40 mg + MTX | Percentage of Participants Achieving CDAI ≤2.8 at Month 6 | 14.57 Percentage of participants |
95% CI: [-8.29, 0.94]
95% CI: [-7.59, 1.48]
95% CI: [-4.24, 5.47]
Secondary
Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6
DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) \<2.6 indicates remission.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6 | 22.69 Percentage of participants |
| Tofacitinib 5 mg BID + MTX | Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6 | 32.75 Percentage of participants |
| Adalimumab 40 mg + MTX | Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6 | 30.17 Percentage of participants |
95% CI: [-15.68, -3.3]
95% CI: [-12.94, -0.83]
95% CI: [-3.86, 9.07]
Secondary
Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6
DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) ≤3.2 indicates low disease activity.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6 | 44.54 Percentage of participants |
| Tofacitinib 5 mg BID + MTX | Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6 | 49.57 Percentage of participants |
| Adalimumab 40 mg + MTX | Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6 | 50.86 Percentage of participants |
95% CI: [-11.92, 2.18]
95% CI: [-12.49, 1.52]
95% CI: [-7.7, 6.47]
Secondary
Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6
DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) \<2.6 indicates disease remission.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6 | 11.33 Percentage of participants |
| Tofacitinib 5 mg BID + MTX | Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6 | 12.79 Percentage of participants |
| Adalimumab 40 mg + MTX | Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6 | 13.58 Percentage of participants |
95% CI: [-6.03, 2.93]
95% CI: [-6.51, 2.47]
95% CI: [-5.11, 4.18]
Secondary
Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6
DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) ≤3.2 indicates low disease activity.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6 | 22.10 Percentage of participants |
| Tofacitinib 5 mg BID + MTX | Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6 | 28.49 Percentage of participants |
| Adalimumab 40 mg + MTX | Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6 | 29.77 Percentage of participants |
95% CI: [-12.05, 0]
95% CI: [-12.9, -0.87]
95% CI: [-7.17, 5.44]
Secondary
Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6
To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC ≤1 and SJC ≤1 (both based on a 28-joint assessment), CRP ≤1 mg/dL, and PtGA ≤1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity).
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6 | 7.54 Percentage of participants |
| Tofacitinib 5 mg BID + MTX | Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6 | 8.67 Percentage of participants |
| Adalimumab 40 mg + MTX | Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6 | 9.58 Percentage of participants |
95% CI: [-4.99, 2.56]
95% CI: [-5.59, 2.04]
95% CI: [-4.53, 3.4]
Secondary
Percentage of Participants Achieving SDAI ≤11 at Month 6
SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission, \>3.4 to 11 indicates low disease activity.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants Achieving SDAI ≤11 at Month 6 | 46.78 Percentage of participants | 0.62 |
| Tofacitinib 5 mg BID + MTX | Percentage of Participants Achieving SDAI ≤11 at Month 6 | 53.33 Percentage of participants | 0.62 |
| Adalimumab 40 mg + MTX | Percentage of Participants Achieving SDAI ≤11 at Month 6 | 51.15 Percentage of participants | 0.62 |
95% CI: [-13.32, 0.84]
95% CI: [-10.69, 3.37]
95% CI: [-4.51, 9.68]
Secondary
Percentage of Participants Achieving SDAI ≤3.3 at Month 6
SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI ≤3.3 indicates disease remission.
Time frame: Month 6
Population: FAS
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Tofacitinib 5 mg BID | Percentage of Participants Achieving SDAI ≤3.3 at Month 6 | 10.64 Percentage of participants | 0.62 |
| Tofacitinib 5 mg BID + MTX | Percentage of Participants Achieving SDAI ≤3.3 at Month 6 | 13.91 Percentage of participants | 0.62 |
| Adalimumab 40 mg + MTX | Percentage of Participants Achieving SDAI ≤3.3 at Month 6 | 14.37 Percentage of participants | 0.62 |
95% CI: [-7.95, 1.15]
95% CI: [-7.55, 1.43]
95% CI: [-4.45, 5.14]