Rheumatoid Arthritis
Conditions
Brief summary
This is a 24-month, prospective, non-interventional, multi-center study with primary aim to identify baseline characteristics of patients that predict response at 6 months of treatment. The study also aims to describe the treatment patterns of RA patients prescribed tofacitinib in a real-world setting and assess the effect of treatment on patient quality of life and physical function. Finally the study will assess the use of healthcare resources and costs in patients with RA treated with tofacitinib in Greece. The planned recruitment period is 12 months. The planned observation period of each patient is 12 months. In this time period up to 4 visits will be documented. The study will be reviewed and approved by the Central Regulatory Committee for NIS and IRB Board of each participating site
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult subjects with moderately to severely active rheumatoid arthritis who start treatment with tofacitinib in usual clinical practice conditions in compliance with the label 1. Patients aged ≥ 18 years 2. Confirmed Diagnosis of Rheumatoid Arthritis by rheumatologist 3. Patients with moderate to severe RA diagnosed according to local practice who have already been started on treatment with tofacitinib, for at most seven working days . 4. Patients eligible for tofacitinib treatment according to current approved Summary of Product Characteristics (SmPC). 5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion criteria
* Patients meeting any of the following criteria will not be included in the study: 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Remission and Low Disease Activity (LDA) at Month 6 Assessed Using 28-Joint Disease Activity Score C-Reactive Protein (DAS28-4 CRP) | Month 6 | Remission is defined as DAS28-4 CRP less than (\<) 2.6 and DAS28-4 CRP \< 3.2 corresponds to LDA. DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: tender joint count (TJC) and swollen joint count ((SJC) \[both out of 28 evaluated joints\], CRP milligram per liter (mg/l) and Patient's Global Assessment of Arthritis Disease Activity (PtGA) recorded on 100 millimeter (mm) visual analogue scale (VAS) (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). DAS28-4 CRP is calculated as: 0.56 \* square root (sqrt) (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP) | Baseline, Months 3, 6 and 12 | DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: TJC and SJC both assessed using 28 joints, CRP (mg/l) and PtGA recorded recorded on VAS scores (mm). DAS28-4 CRP is calculated as: 0.56 \* sqrt (TJC28) + 0.28 \* sqrt (SJC28) + 0.36 \* ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm. DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: TJC and SJC both assessed using 28 joints, ESR using mm/ hour and PtGA in recorded on VAS (mm). DAS28-4 ESR is calculated as: 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA where In = natural logarithm. The calculated range of DAS28-4 CRP and DAS 28-4 ESR is 0 (no disease activity) to 10 (maximal disease activity). A decrease from baseline in score indicates improvement of disease activity. |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3, 6 and 12 | Baseline, Months 3, 6 and 12 | HAQ-DI is a participant-reported assessment which assess the degree of difficulty a participant had experienced during the last week in 8 domains/categories of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. 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 indicates least difficulty and 3 indicates extreme difficulty. |
| Number of Participants With Remission According to Simplified Disease Activity Index (SDAI) <=3.3 at Months 3, 6, and 12 | Months 3, 6 and 12 | Remission is defined as SDAI \<=3.3. SDAI is a composite end point, calculated at each time point using the formula: as TJC + SJC both assessed using 28 joints + PtGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity) + Physician's Global Assessment of Health \[PhGA\] (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity)+ CRP (mg/dL). |
| Number of Participants With Remission According to Clinical Disease Activity Index (CDAI) <=2.8 at Months 3, 6, and 12 | Months 3, 6 and 12 | Remission is defined as CDAI \<=2.8. CDAI is a composite end point, calculated based on each time-point using TJC + SJC both assessed using 28 joints + PtGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity) + PhGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). |
| Number of Participants With Remission According to DAS28-4 ESR<2.6 at Months 3, 6, and 12 | Months 3, 6 and 12 | DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC, SJC both assessed using 28 joints, ESR (mm/h) and PtGA (mm) (recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher score indicates high disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \* sqrt (TJC28) + 0.28 \* sqrt (SJC28) + 0.70\* In (ESR) + 0.014\* (PtGA); where ln = natural logarithm. DAS28-4 (ESR) score of \<2.6 indicates remission. |
| Number of Participants With Remission According to DAS28-4 CRP <2.6 at Months 3, 6, and 12 | Months 3, 6 and 12 | DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC, SJC both assessed using 28 joints, CRP (mg/l) and PtGA (mm) (recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher score indicates high disease activity). The calculation of DAS28-4 CRP is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm. DAS28-4 (CRP) score of \<2.6 indicates remission. |
| Number of Participants With LDA According to SDAI <=11 at Months 3, 6, and 12 | Months 3, 6 and 12 | LDA is defined as SDAI \<=11. SDAI is a composite end point, calculated at each time point using the formula: as TJC + SJC (both assessed using 28 joints) + PtGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity) + PhGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity)+ CRP (mg/dL). |
| Number of Participants With LDA According to CDAI <=10 at Months 3, 6, and 12 | Months 3, 6 and 12 | LDA is defined as CDAI \<=10. CDAI is a composite end point, calculated based on each time-point using TJC + SJC (both assessed using 28 joints) + PtGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity) + PhGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity. |
| Number of Participants With LDA According to DAS28-4 ESR (<3.2) at Months 3, 6, and 12 | Months 3, 6 and 12 | DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC, SJC (both assessed using 28 joints), ESR (mm/h) and PtGA (recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher score indicates high disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \* sqrt (TJC28) + 0.28 \* sqrt (SJC28) + 0.70\* In(ESR) + 0.014\* (PtGA); where ln = natural logarithm. DAS28-4 (ESR) score of \<3.2 indicates LDA. |
| Number of Participants With LDA According to DAS28-4 CRP<=3.2 at Months 3, 6, and 12 | Months 3, 6 and 12 | LDA is defined as DAS28-4(CRP) score of \<3.2. DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: TJC, SJC (both assessed using 28 joints), CRP (mg/l) and PtGA (mm) (recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). The calculation of DAS28-4 CRP is as follows: 0.56\*sqrt (TJC) + 0.28\*sqrt (SJC) + 0.36\*ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm. DAS28-4 (CRP) score of \<3.2 indicates LDA. |
| Percentage of Participants Achieving HAQ-DI Response at Months 3,6 and 12 | Months 3, 6 and 12 | HAQ-DI is a participant-reported assessment which assess the degree of difficulty a participant had experienced during the last week in 8 domains/categories of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. 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 indicates least difficulty and 3 indicates extreme difficulty. A HAQ-DI response is defined as a decrease from baseline of at least 0.22. |
| Change From Baseline in European Quality of Life (EuroQol) -5 Dimensions (EQ-5D) Health State Profile at Months 3, 6 and 12 | Baseline, Months 3, 6 and 12 | EQ-5D is a standardized instrument used to measure quality of life. It is based on five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three responses and the participant is asked to select the response that best describes them. The responses are scored 1-3 where 1 indicates no problems, 2 indicates some problems and 3 indicates unable to perform normal activities. The score (1 to 3), for each dimension is weighted based on United Kingdom (UK) data (Dolan et al 1995). An algorithm was applied to calculate the total EQ-5D health state score. Maximum and minimum score value were 1 and -0.6 respectively. Higher score indicates better health state. |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire Score at Months 3, 6 and 12 | Baseline, Months 3, 6 and 12 | FACIT-fatigue questionnaire score consists of 13 self-evaluated questions. Each question is scored from 0 to 4; the sum of all responses resulted in the FACIT-fatigue score of 0 (maximum fatigue) to 52 (no fatigue). A higher score represents better participant status. |
| Percentage of Participants With Remission and LDA at Month 12 Assessed Using DAS28-4 CRP | Month 12 | Remission is defined as DAS28-4 CRP \< 2.6 and DAS28-4 CRP \< 3.2 corresponds to LDA. DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: TJC and SJC assessed using 28 joints, CRP (mg/l) and PtGA recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). DAS28-4 CRP is calculated as: 0.56 \* (sqrt) (TJC28) + 0.28 \* sqrt (SJC28) + 0.36 \* ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm. |
| Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 | Baseline, Months 3, 6 and 12 | WPAI: 6-item questionnaire & scores are derived for four domains:absenteeism, presenteeism,work productivity loss & activity impairment.Question (Q)2 asked participants to indicate number of hours missed due to health problems in past 7 days. Q4 asked participants to indicate number of hours they worked in past 7 days.Q5 asked participants the degree to which their health affected productivity while working in past 7 days,on scale ranging from 0-10, Where 0 = health problems had no effect on their work & 10=health problems completely prevented participant from working. Q6 asked participants to indicate the degree to which their health affected their regular activities in past 7 days.Absenteeism=(Q2/\[Q2 + Q4\])\*100.Presenteeism=(Q5/10)\*100.Work Production Loss={(Q2/\[Q2 + Q4\])+(1-\[Q2/(Q2 + Q4))\*(Q5/10 )\]}\*100.Activity Impairment=(Q6/10)\*100.Each WPAI domain is expressed as impairment percentages ranging from 0 to 100,with higher numbers indicating greater impairment &less productivity. |
| Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 | Baseline, Month 12 | Participant's satisfaction with treatment was assessed on a 5-point scale (where 0 = very dissatisfied and 4 = very satisfied) in response to the question How satisfied are you with the drugs you received for your arthritis during the last year? |
| Patient Global Assessment (PtGA) at Baseline, Months 3, 6 and 12 | Baseline, Months 3, 6 and 12 | PtGA of Arthritis was measured using a VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity in response to the question Considering all the way your arthritis affects you, how are you feeling today?. |
| Physician Global Assessment (PhGA) at Baseline, Months 3, 6 and 12 | Baseline, Months 3, 6 and 12 | PhGA was measured using a VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity in response to how the physician assesses the participant's overall arthritis at the time of the visit. This is an evaluation based on the participant's disease signs, functional capacity and physical examination, and should be independent of the PtGA of arthritis. |
| Number of Participants as Per Treatment Received | Up to 12 months | Number of participants who received tofacitinib as monotherapy,tofacitinib in combination therapy, tofacitinib switched from monotherapy to combination therapy, tofacitinib switched from combination therapy to monotherapy, tofacitinib in combination with disease modifying antirheumatic drugs (DMARD) then switched to tofacitinib monotherapy and tofacitinib in combination with DMARD then discontinued are presented in this outcome measure. |
| Median Number of Visits to Rheumatologist or Other Rheumatoid Arthritis (RA) Specialist Since Last Visit | Months 3, 6 and 12 | The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). The number of visits to a rheumatologist or other RA specialist since the last visit were reported in this outcome measure. |
| Number of Participants With Diagnostic Test Since Last Visit | Months 3, 6 and 12 | The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants who underwent the diagnostic tests since last visit including: whole blood cell (WBC), ESR/CRP, glucose, hepatic enzymes, urea, creatinine, lipid profile (total cholesterol \[TC\], low density lipoprotein \[LDL\], high density lipoprotein \[HDL\], triglycerides \[TG\]), X-rays, others are presented. |
| Number of Participants According to the Type of Diagnostic Test | Months 3, 6 and 12 | The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants who underwent the diagnostic tests including: WBC, ESR/CRP, glucose, hepatic enzymes, urea, creatinine, lipid profile (TC,LDL,HDL,TG), X-rays, others summarized by visit are presented. |
| Number of Diagnostic Tests Since Last Visit | Months 3, 6 and 12 | The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Diagnostic tests performed were as follow: WBC, ESR/CRP, glucose, hepatic enzymes, urea, creatinine, lipid profile (TC, LDL, HDL, TG), X-rays, others summarized by visit are presented. |
| Number of Participants Hospitalized Since Last Visit | Months 3, 6 and 12 | The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants hospitalized since their last visit were reported in this outcome measure. |
| Number of Participants Hospitalized in Daycare and Night Care Since Last Visit | Months 3, 6 and 12 | The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants hospitalized in daycare and nightcare since their last visit were reported in this outcome measure. |
| Mean Number of Days Participants Were Hospitalized Since Last Visit | Baseline, Months 3, 6 and 12 | The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Mean number of days participants were hospitalized since last visit were reported in this outcome measure. |
| Number of Participants According to Reason for Hospitalization Since Last Visit | Months 3, 6 and 12 | The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants according to reason for hospitalization: polyarthritis, RA and pericarditis, RA flare, and right knee arthroplasty due to osteoarthritis since their last visit is presented in this outcome measure. |
| Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12 | Baseline, Day 1 and 2 of Months 3, 6 and 12 | The duration of morning stiffness is determined by asking the following questions: Over the last 2 days, when did you wake in the morning? Over the last 2 days, when were you able to resume your normal activities without stiffness?. Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. |
Countries
Greece
Participant flow
Recruitment details
Participants diagnosed with moderate-to-severe active rheumatoid arthritis who initiated tofacitinib in real-world and in a non-interventional setting in Greece were observed in this study.
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib Participants with rheumatoid arthritis who were treated with tofacitinib in usual clinical practice conditions (outpatient clinics of hospitals) in compliance with the current approved SmPC were observed in this study. The recommended dosage was tofacitinib 5 mg tablet twice daily. | 198 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse event, not related to study drug | 2 |
| Overall Study | Adverse event related to study drug | 10 |
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 22 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | Tofacitinib | — |
|---|---|---|
| Age, Continuous | 58.9 Years STANDARD_DEVIATION 11.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 157 Participants | — |
| Sex: Female, Male Male | 41 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 198 |
| other Total, other adverse events | 52 / 198 |
| serious Total, serious adverse events | 24 / 198 |
Outcome results
Primary
Percentage of Participants With Remission and Low Disease Activity (LDA) at Month 6 Assessed Using 28-Joint Disease Activity Score C-Reactive Protein (DAS28-4 CRP)
Remission is defined as DAS28-4 CRP less than (\<) 2.6 and DAS28-4 CRP \< 3.2 corresponds to LDA. DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: tender joint count (TJC) and swollen joint count ((SJC) \[both out of 28 evaluated joints\], CRP milligram per liter (mg/l) and Patient's Global Assessment of Arthritis Disease Activity (PtGA) recorded on 100 millimeter (mm) visual analogue scale (VAS) (scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). DAS28-4 CRP is calculated as: 0.56 \* square root (sqrt) (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm.
Time frame: Month 6
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, Number of Participants Analyzed signifies number of participants evaluable and who contributed to data for this outcome measure. Missing components were imputed by carrying forward the last non-missing post-baseline value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib | Percentage of Participants With Remission and Low Disease Activity (LDA) at Month 6 Assessed Using 28-Joint Disease Activity Score C-Reactive Protein (DAS28-4 CRP) | Remission | 29.6 Percentage of participants |
| Tofacitinib | Percentage of Participants With Remission and Low Disease Activity (LDA) at Month 6 Assessed Using 28-Joint Disease Activity Score C-Reactive Protein (DAS28-4 CRP) | LDA | 41.4 Percentage of participants |
Secondary
Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP)
DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: TJC and SJC both assessed using 28 joints, CRP (mg/l) and PtGA recorded recorded on VAS scores (mm). DAS28-4 CRP is calculated as: 0.56 \* sqrt (TJC28) + 0.28 \* sqrt (SJC28) + 0.36 \* ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm. DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: TJC and SJC both assessed using 28 joints, ESR using mm/ hour and PtGA in recorded on VAS (mm). DAS28-4 ESR is calculated as: 0.56\*sqrt (TJC28) + 0.28\*sqrt (SJC28) + 0.70\*In (ESR) + 0.014\*PtGA where In = natural logarithm. The calculated range of DAS28-4 CRP and DAS 28-4 ESR is 0 (no disease activity) to 10 (maximal disease activity). A decrease from baseline in score indicates improvement of disease activity.
Time frame: Baseline, Months 3, 6 and 12
Population: FAS population was analyzed. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable at specified time points. Missing components were imputed by carrying forward the last non-missing post-baseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib | Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP) | Change at Month 3: DAS28-4(CRP) | -1.25 Units on a scale | Standard Deviation 1.38 |
| Tofacitinib | Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP) | Change at Month 6: DAS28-4(CRP) | -1.47 Units on a scale | Standard Deviation 1.4 |
| Tofacitinib | Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP) | Change at Month 12: DAS28-4(CRP) | -1.73 Units on a scale | Standard Deviation 1.46 |
| Tofacitinib | Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP) | Change at Month 3: DAS 28-4 (ESR) | -1.15 Units on a scale | Standard Deviation 1.47 |
| Tofacitinib | Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP) | Change at Month 6:DAS 28-4 (ESR) | -1.42 Units on a scale | Standard Deviation 1.58 |
| Tofacitinib | Change From Baseline in DAS28-4 (ESR) and DAS28-4 (CRP) | Change at Month 12: DAS 28-4 (ESR) | -1.58 Units on a scale | Standard Deviation 1.61 |
Secondary
Change From Baseline in European Quality of Life (EuroQol) -5 Dimensions (EQ-5D) Health State Profile at Months 3, 6 and 12
EQ-5D is a standardized instrument used to measure quality of life. It is based on five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three responses and the participant is asked to select the response that best describes them. The responses are scored 1-3 where 1 indicates no problems, 2 indicates some problems and 3 indicates unable to perform normal activities. The score (1 to 3), for each dimension is weighted based on United Kingdom (UK) data (Dolan et al 1995). An algorithm was applied to calculate the total EQ-5D health state score. Maximum and minimum score value were 1 and -0.6 respectively. Higher score indicates better health state.
Time frame: Baseline, Months 3, 6 and 12
Population: FAS population was analyzed. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants with EQ-5D score at specified time points. Missing weighted dimension scores were replaced by the mean of non-missing ones.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib | Change From Baseline in European Quality of Life (EuroQol) -5 Dimensions (EQ-5D) Health State Profile at Months 3, 6 and 12 | Change at Month 3 | 0.18 Units on a scale | Standard Error 0.02 |
| Tofacitinib | Change From Baseline in European Quality of Life (EuroQol) -5 Dimensions (EQ-5D) Health State Profile at Months 3, 6 and 12 | Change at Month 6 | 0.23 Units on a scale | Standard Error 0.02 |
| Tofacitinib | Change From Baseline in European Quality of Life (EuroQol) -5 Dimensions (EQ-5D) Health State Profile at Months 3, 6 and 12 | Change at Month 12 | 0.23 Units on a scale | Standard Error 0.02 |
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire Score at Months 3, 6 and 12
FACIT-fatigue questionnaire score consists of 13 self-evaluated questions. Each question is scored from 0 to 4; the sum of all responses resulted in the FACIT-fatigue score of 0 (maximum fatigue) to 52 (no fatigue). A higher score represents better participant status.
Time frame: Baseline, Months 3, 6 and 12
Population: FAS population was analyzed. All participants reported under Number of Participants analyzed =number of participant evaluable and contributed data to table; however, may not have evaluable data for every row. Number Analyzed=number of participants evaluable at specified time points. If more than 50% of the items were non-missing, then score was prorated by multiplying the sum of the subscale by the number of items in the subscale, then dividing by the number of items actually answered.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire Score at Months 3, 6 and 12 | Change at Month 3 | 6.8 Units on a scale | Standard Error 0.66 |
| Tofacitinib | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire Score at Months 3, 6 and 12 | Change at Month 6 | 7.21 Units on a scale | Standard Error 0.65 |
| Tofacitinib | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire Score at Months 3, 6 and 12 | Change at Month 12 | 8.71 Units on a scale | Standard Error 0.66 |
Secondary
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3, 6 and 12
HAQ-DI is a participant-reported assessment which assess the degree of difficulty a participant had experienced during the last week in 8 domains/categories of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. 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 indicates least difficulty and 3 indicates extreme difficulty.
Time frame: Baseline, Months 3, 6 and 12
Population: FAS population was analyzed. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. All participants reported under Number of Participants Analyzed contributed data to table; however, may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable at specified time points. If one or two domains had missing data, score was calculated as: sum of non-missing domain scores/number of non-missing domains.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3, 6 and 12 | Change at Month 3 | -0.25 Units on a scale | Standard Deviation 0.56 |
| Tofacitinib | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3, 6 and 12 | Change at Month 6 | -0.40 Units on a scale | Standard Deviation 0.6 |
| Tofacitinib | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3, 6 and 12 | Change at Month 12 | -0.40 Units on a scale | Standard Deviation 0.6 |
Secondary
Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12
The duration of morning stiffness is determined by asking the following questions: Over the last 2 days, when did you wake in the morning? Over the last 2 days, when were you able to resume your normal activities without stiffness?. Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes.
Time frame: Baseline, Day 1 and 2 of Months 3, 6 and 12
Population: FAS population was analyzed. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants with morning stiffness evaluable at specified time points. No imputation was applied for missing values in any visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib | Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12 | Change at Month 3: Day 1 | -25.7 Minutes | Standard Deviation 43.02 |
| Tofacitinib | Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12 | Change at Month 6: Day 1 | -29.9 Minutes | Standard Deviation 42.68 |
| Tofacitinib | Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12 | Change at Month 12: Day 1 | -34.2 Minutes | Standard Deviation 44.27 |
| Tofacitinib | Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12 | Change at Month 3: Day 2 | -30.42 Minutes | Standard Deviation 46.9 |
| Tofacitinib | Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12 | Change at Month 6: Day 2 | -33.8 Minutes | Standard Deviation 43.5 |
| Tofacitinib | Change From Baseline in Mean Duration of Morning Stiffness at Day 1 and 2 of Months 3, 6 and 12 | Change at Month 12: Day 2 | -37.04 Minutes | Standard Deviation 41.89 |
Secondary
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12
WPAI: 6-item questionnaire & scores are derived for four domains:absenteeism, presenteeism,work productivity loss & activity impairment.Question (Q)2 asked participants to indicate number of hours missed due to health problems in past 7 days. Q4 asked participants to indicate number of hours they worked in past 7 days.Q5 asked participants the degree to which their health affected productivity while working in past 7 days,on scale ranging from 0-10, Where 0 = health problems had no effect on their work & 10=health problems completely prevented participant from working. Q6 asked participants to indicate the degree to which their health affected their regular activities in past 7 days.Absenteeism=(Q2/\[Q2 + Q4\])\*100.Presenteeism=(Q5/10)\*100.Work Production Loss={(Q2/\[Q2 + Q4\])+(1-\[Q2/(Q2 + Q4))\*(Q5/10 )\]}\*100.Activity Impairment=(Q6/10)\*100.Each WPAI domain is expressed as impairment percentages ranging from 0 to 100,with higher numbers indicating greater impairment &less productivity.
Time frame: Baseline, Months 3, 6 and 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. All participants reported under Number of Participants Analyzed contributed data to table; however, may not have evaluable data for every row. Here, Number Analyzed= number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 | Change in Absenteeism: Month 3 | 3.9 Percentage of impairment | Standard Error 1.4 |
| Tofacitinib | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 | Change in Absenteeism: Month 6 | 1.7 Percentage of impairment | Standard Error 1.6 |
| Tofacitinib | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 | Change in Absenteeism: Month 12 | -0.08 Percentage of impairment | Standard Error 1.5 |
| Tofacitinib | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 | Change in Presenteeism: Month 3 | 4.0 Percentage of impairment | Standard Error 2.8 |
| Tofacitinib | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 | Change in Presenteeism: Month 6 | 4.2 Percentage of impairment | Standard Error 3.6 |
| Tofacitinib | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 | Change in Presenteeism: Month 12 | 2.8 Percentage of impairment | Standard Error 3.8 |
| Tofacitinib | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 | Change in Work Production Loss: Month 3 | 0.2 Percentage of impairment | Standard Error 3.1 |
| Tofacitinib | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 | Change in Work Production Loss: Month 6 | -1.9 Percentage of impairment | Standard Error 3.7 |
| Tofacitinib | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 | Change in Work Production Loss: Month 12 | -1.9 Percentage of impairment | Standard Error 3.6 |
| Tofacitinib | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 | Change in Activity Impairment: Month 3 | 5.1 Percentage of impairment | Standard Error 1.8 |
| Tofacitinib | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 | Change in Activity Impairment: Month 6 | 7.6 Percentage of impairment | Standard Error 2.2 |
| Tofacitinib | Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Months 3, 6 and 12 | Change in Activity Impairment: Month 12 | 10.3 Percentage of impairment | Standard Error 2.3 |
Secondary
Mean Number of Days Participants Were Hospitalized Since Last Visit
The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Mean number of days participants were hospitalized since last visit were reported in this outcome measure.
Time frame: Baseline, Months 3, 6 and 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib | Mean Number of Days Participants Were Hospitalized Since Last Visit | Month 3 | 6.7 Days | Standard Deviation 2.1 |
Secondary
Median Number of Visits to Rheumatologist or Other Rheumatoid Arthritis (RA) Specialist Since Last Visit
The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). The number of visits to a rheumatologist or other RA specialist since the last visit were reported in this outcome measure.
Time frame: Months 3, 6 and 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tofacitinib | Median Number of Visits to Rheumatologist or Other Rheumatoid Arthritis (RA) Specialist Since Last Visit | Month 3 | 0.0 Visits |
| Tofacitinib | Median Number of Visits to Rheumatologist or Other Rheumatoid Arthritis (RA) Specialist Since Last Visit | Month 6 | 0.0 Visits |
| Tofacitinib | Median Number of Visits to Rheumatologist or Other Rheumatoid Arthritis (RA) Specialist Since Last Visit | Month 12 | 1.0 Visits |
Secondary
Number of Diagnostic Tests Since Last Visit
The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Diagnostic tests performed were as follow: WBC, ESR/CRP, glucose, hepatic enzymes, urea, creatinine, lipid profile (TC, LDL, HDL, TG), X-rays, others summarized by visit are presented.
Time frame: Months 3, 6 and 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib | Number of Diagnostic Tests Since Last Visit | Month 3 | 488 Diagnostic tests |
| Tofacitinib | Number of Diagnostic Tests Since Last Visit | Month 6 | 292 Diagnostic tests |
| Tofacitinib | Number of Diagnostic Tests Since Last Visit | Month 12 | 323 Diagnostic tests |
Secondary
Number of Participants According to Reason for Hospitalization Since Last Visit
The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants according to reason for hospitalization: polyarthritis, RA and pericarditis, RA flare, and right knee arthroplasty due to osteoarthritis since their last visit is presented in this outcome measure.
Time frame: Months 3, 6 and 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib | Number of Participants According to Reason for Hospitalization Since Last Visit | Polyarthritis: Month 3 | 1 Participants |
| Tofacitinib | Number of Participants According to Reason for Hospitalization Since Last Visit | Polyarthritis: Month 12 | 0 Participants |
| Tofacitinib | Number of Participants According to Reason for Hospitalization Since Last Visit | RA and Pericarditis: Month 3 | 1 Participants |
| Tofacitinib | Number of Participants According to Reason for Hospitalization Since Last Visit | RA and Pericarditis: Month 12 | 0 Participants |
| Tofacitinib | Number of Participants According to Reason for Hospitalization Since Last Visit | RA flare: Month 3 | 1 Participants |
| Tofacitinib | Number of Participants According to Reason for Hospitalization Since Last Visit | RA flare: Month 12 | 0 Participants |
| Tofacitinib | Number of Participants According to Reason for Hospitalization Since Last Visit | Right knee arthroplasty due to Osteoarthritis: Month 3 | 0 Participants |
| Tofacitinib | Number of Participants According to Reason for Hospitalization Since Last Visit | Right knee arthroplasty due to Osteoarthritis: Month 12 | 1 Participants |
Secondary
Number of Participants According to the Type of Diagnostic Test
The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants who underwent the diagnostic tests including: WBC, ESR/CRP, glucose, hepatic enzymes, urea, creatinine, lipid profile (TC,LDL,HDL,TG), X-rays, others summarized by visit are presented.
Time frame: Months 3, 6 and 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | WBC- Month 3 | 69 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | WBC- Month 6 | 50 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | WBC- Month 12 | 42 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | ESR- Month 3 | 69 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | ESR- Month 6 | 55 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | ESR- Month 12 | 48 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | CRP- Month 3 | 67 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | CRP- Month 6 | 55 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | CRP- Month 12 | 47 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Glucose- Month 3 | 56 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Glucose- Month 6 | 44 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Glucose- Month 12 | 39 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Hepatic enzymes- Month 3 | 66 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Hepatic enzymes- Month 6 | 49 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Hepatic enzymes- Month 12 | 44 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Urea- Month 3 | 62 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Urea- Month 6 | 48 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Urea- Month 12 | 44 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Creatinine- Month 3 | 63 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Creatinine- Month 6 | 50 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Creatinine- Month 12 | 44 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Lipid profile (TC, LDL, HDL, TG)- Month 3 | 29 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Lipid profile (TC, LDL, HDL, TG)- Month 6 | 37 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Lipid profile (TC, LDL, HDL, TG)- Month 12 | 29 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | X-rays- Month 3 | 1 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | X-rays- Month 6 | 4 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | X-rays- Month 12 | 3 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Others- Month 3 | 13 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Others- Month 6 | 8 Participants |
| Tofacitinib | Number of Participants According to the Type of Diagnostic Test | Others- Month 12 | 4 Participants |
Secondary
Number of Participants as Per Treatment Received
Number of participants who received tofacitinib as monotherapy,tofacitinib in combination therapy, tofacitinib switched from monotherapy to combination therapy, tofacitinib switched from combination therapy to monotherapy, tofacitinib in combination with disease modifying antirheumatic drugs (DMARD) then switched to tofacitinib monotherapy and tofacitinib in combination with DMARD then discontinued are presented in this outcome measure.
Time frame: Up to 12 months
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib | Number of Participants as Per Treatment Received | Tofacitinib as Monotherapy | 59 Participants |
| Tofacitinib | Number of Participants as Per Treatment Received | Tofacitinib in Combination Therapy | 113 Participants |
| Tofacitinib | Number of Participants as Per Treatment Received | Tofacitinib Switched From Monotherapy to Combination Therapy | 1 Participants |
| Tofacitinib | Number of Participants as Per Treatment Received | Tofacitinib Switched From Combination Therapy to Monotherapy | 5 Participants |
| Tofacitinib | Number of Participants as Per Treatment Received | Tofacitinib in Combination with DMARD Then Switched to Tofacitinib Monotherapy | 2 Participants |
| Tofacitinib | Number of Participants as Per Treatment Received | Tofacitinib in Combination with DMARD Then Discontinued | 18 Participants |
Secondary
Number of Participants Hospitalized in Daycare and Night Care Since Last Visit
The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants hospitalized in daycare and nightcare since their last visit were reported in this outcome measure.
Time frame: Months 3, 6 and 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. Here, Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib | Number of Participants Hospitalized in Daycare and Night Care Since Last Visit | Participants Hospitalized With Daycare: Month 3 | 0 Participants |
| Tofacitinib | Number of Participants Hospitalized in Daycare and Night Care Since Last Visit | Participants Hospitalized With Daycare: Month 12 | 0 Participants |
| Tofacitinib | Number of Participants Hospitalized in Daycare and Night Care Since Last Visit | Participants Hospitalized With Overnight Stay: Month 3 | 3 Participants |
| Tofacitinib | Number of Participants Hospitalized in Daycare and Night Care Since Last Visit | Participants Hospitalized With Overnight Stay: Month 12 | 1 Participants |
Secondary
Number of Participants Hospitalized Since Last Visit
The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants hospitalized since their last visit were reported in this outcome measure.
Time frame: Months 3, 6 and 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib | Number of Participants Hospitalized Since Last Visit | Month 3 | 3 Participants |
| Tofacitinib | Number of Participants Hospitalized Since Last Visit | Month 6 | 0 Participants |
| Tofacitinib | Number of Participants Hospitalized Since Last Visit | Month 12 | 1 Participants |
Secondary
Number of Participants With Diagnostic Test Since Last Visit
The study consisted of 4 visits. Baseline (visit 1), Month 3 (visit 2), Month 6 (visit 3), Month 12 (final or close out visit). Number of participants who underwent the diagnostic tests since last visit including: whole blood cell (WBC), ESR/CRP, glucose, hepatic enzymes, urea, creatinine, lipid profile (total cholesterol \[TC\], low density lipoprotein \[LDL\], high density lipoprotein \[HDL\], triglycerides \[TG\]), X-rays, others are presented.
Time frame: Months 3, 6 and 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib | Number of Participants With Diagnostic Test Since Last Visit | Month 3 | 76 Participants |
| Tofacitinib | Number of Participants With Diagnostic Test Since Last Visit | Month 6 | 59 Participants |
| Tofacitinib | Number of Participants With Diagnostic Test Since Last Visit | Month 12 | 50 Participants |
Secondary
Number of Participants With LDA According to CDAI <=10 at Months 3, 6, and 12
LDA is defined as CDAI \<=10. CDAI is a composite end point, calculated based on each time-point using TJC + SJC (both assessed using 28 joints) + PtGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity) + PhGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity.
Time frame: Months 3, 6 and 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants with CDAI at specified time points. No imputation was applied for missing values in any visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib | Number of Participants With LDA According to CDAI <=10 at Months 3, 6, and 12 | Month 3 | 56 Participants |
| Tofacitinib | Number of Participants With LDA According to CDAI <=10 at Months 3, 6, and 12 | Month 6 | 61 Participants |
| Tofacitinib | Number of Participants With LDA According to CDAI <=10 at Months 3, 6, and 12 | Month 12 | 73 Participants |
Secondary
Number of Participants With LDA According to DAS28-4 CRP<=3.2 at Months 3, 6, and 12
LDA is defined as DAS28-4(CRP) score of \<3.2. DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: TJC, SJC (both assessed using 28 joints), CRP (mg/l) and PtGA (mm) (recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). The calculation of DAS28-4 CRP is as follows: 0.56\*sqrt (TJC) + 0.28\*sqrt (SJC) + 0.36\*ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm. DAS28-4 (CRP) score of \<3.2 indicates LDA.
Time frame: Months 3, 6 and 12
Population: FAS population was analyzed. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants with DAS 28-4 (CRP) at specified time points. No imputation was applied for missing values in any visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib | Number of Participants With LDA According to DAS28-4 CRP<=3.2 at Months 3, 6, and 12 | Month 6 | 63 Participants |
| Tofacitinib | Number of Participants With LDA According to DAS28-4 CRP<=3.2 at Months 3, 6, and 12 | Month 3 | 59 Participants |
| Tofacitinib | Number of Participants With LDA According to DAS28-4 CRP<=3.2 at Months 3, 6, and 12 | Month 12 | 82 Participants |
Secondary
Number of Participants With LDA According to DAS28-4 ESR (<3.2) at Months 3, 6, and 12
DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC, SJC (both assessed using 28 joints), ESR (mm/h) and PtGA (recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher score indicates high disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \* sqrt (TJC28) + 0.28 \* sqrt (SJC28) + 0.70\* In(ESR) + 0.014\* (PtGA); where ln = natural logarithm. DAS28-4 (ESR) score of \<3.2 indicates LDA.
Time frame: Months 3, 6 and 12
Population: FAS population was analyzed. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants with DAS 28-4 (ESR) at specified time points. No imputation was applied for missing values in any visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib | Number of Participants With LDA According to DAS28-4 ESR (<3.2) at Months 3, 6, and 12 | Month 3 | 46 Participants |
| Tofacitinib | Number of Participants With LDA According to DAS28-4 ESR (<3.2) at Months 3, 6, and 12 | Month 6 | 62 Participants |
| Tofacitinib | Number of Participants With LDA According to DAS28-4 ESR (<3.2) at Months 3, 6, and 12 | Month 12 | 65 Participants |
Secondary
Number of Participants With LDA According to SDAI <=11 at Months 3, 6, and 12
LDA is defined as SDAI \<=11. SDAI is a composite end point, calculated at each time point using the formula: as TJC + SJC (both assessed using 28 joints) + PtGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity) + PhGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity)+ CRP (mg/dL).
Time frame: Months 3, 6 and 12
Population: FAS population was analyzed. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants with SDAI at specified time points. No imputation was applied for missing values in any visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib | Number of Participants With LDA According to SDAI <=11 at Months 3, 6, and 12 | Month 3 | 54 Participants |
| Tofacitinib | Number of Participants With LDA According to SDAI <=11 at Months 3, 6, and 12 | Month 6 | 63 Participants |
| Tofacitinib | Number of Participants With LDA According to SDAI <=11 at Months 3, 6, and 12 | Month 12 | 74 Participants |
Secondary
Number of Participants With Remission According to Clinical Disease Activity Index (CDAI) <=2.8 at Months 3, 6, and 12
Remission is defined as CDAI \<=2.8. CDAI is a composite end point, calculated based on each time-point using TJC + SJC both assessed using 28 joints + PtGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity) + PhGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity).
Time frame: Months 3, 6 and 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants with CDAI at specified time points. No imputation was applied for missing values in any visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib | Number of Participants With Remission According to Clinical Disease Activity Index (CDAI) <=2.8 at Months 3, 6, and 12 | Month 3 | 11 Participants |
| Tofacitinib | Number of Participants With Remission According to Clinical Disease Activity Index (CDAI) <=2.8 at Months 3, 6, and 12 | Month 6 | 16 Participants |
| Tofacitinib | Number of Participants With Remission According to Clinical Disease Activity Index (CDAI) <=2.8 at Months 3, 6, and 12 | Month 12 | 24 Participants |
Secondary
Number of Participants With Remission According to DAS28-4 CRP <2.6 at Months 3, 6, and 12
DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC, SJC both assessed using 28 joints, CRP (mg/l) and PtGA (mm) (recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher score indicates high disease activity). The calculation of DAS28-4 CRP is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm. DAS28-4 (CRP) score of \<2.6 indicates remission.
Time frame: Months 3, 6 and 12
Population: FAS population was analyzed. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants with DAS28-4 (CRP) at specified time points. No imputation was applied for missing values in any visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib | Number of Participants With Remission According to DAS28-4 CRP <2.6 at Months 3, 6, and 12 | Month 3 | 31 Participants |
| Tofacitinib | Number of Participants With Remission According to DAS28-4 CRP <2.6 at Months 3, 6, and 12 | Month 6 | 45 Participants |
| Tofacitinib | Number of Participants With Remission According to DAS28-4 CRP <2.6 at Months 3, 6, and 12 | Month 12 | 49 Participants |
Secondary
Number of Participants With Remission According to DAS28-4 ESR<2.6 at Months 3, 6, and 12
DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC, SJC both assessed using 28 joints, ESR (mm/h) and PtGA (mm) (recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher score indicates high disease activity). The calculation of DAS28-4 ESR is as follows: 0.56 \* sqrt (TJC28) + 0.28 \* sqrt (SJC28) + 0.70\* In (ESR) + 0.014\* (PtGA); where ln = natural logarithm. DAS28-4 (ESR) score of \<2.6 indicates remission.
Time frame: Months 3, 6 and 12
Population: FAS population was analyzed. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants with DAS 28-4 (ESR) at specified time points. No imputation was applied for missing values in any visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib | Number of Participants With Remission According to DAS28-4 ESR<2.6 at Months 3, 6, and 12 | Month 3 | 25 Participants |
| Tofacitinib | Number of Participants With Remission According to DAS28-4 ESR<2.6 at Months 3, 6, and 12 | Month 6 | 30 Participants |
| Tofacitinib | Number of Participants With Remission According to DAS28-4 ESR<2.6 at Months 3, 6, and 12 | Month 12 | 40 Participants |
Secondary
Number of Participants With Remission According to Simplified Disease Activity Index (SDAI) <=3.3 at Months 3, 6, and 12
Remission is defined as SDAI \<=3.3. SDAI is a composite end point, calculated at each time point using the formula: as TJC + SJC both assessed using 28 joints + PtGA (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity) + Physician's Global Assessment of Health \[PhGA\] (assessed on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity)+ CRP (mg/dL).
Time frame: Months 3, 6 and 12
Population: FAS population was analyzed. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. All participants reported under Number of Participants Analyzed contributed data to the table; however, may not have evaluable data for every row. Here, Number Analyzed signifies number of participants with SDAI at specified time points. No imputation was applied for missing values in any visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tofacitinib | Number of Participants With Remission According to Simplified Disease Activity Index (SDAI) <=3.3 at Months 3, 6, and 12 | Month 3 | 12 Participants |
| Tofacitinib | Number of Participants With Remission According to Simplified Disease Activity Index (SDAI) <=3.3 at Months 3, 6, and 12 | Month 6 | 14 Participants |
| Tofacitinib | Number of Participants With Remission According to Simplified Disease Activity Index (SDAI) <=3.3 at Months 3, 6, and 12 | Month 12 | 22 Participants |
Secondary
Patient Global Assessment (PtGA) at Baseline, Months 3, 6 and 12
PtGA of Arthritis was measured using a VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity in response to the question Considering all the way your arthritis affects you, how are you feeling today?.
Time frame: Baseline, Months 3, 6 and 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, Number Analyzed signifies number of participants evaluable with PtGA score at specified time points. No imputation was applied for missing values in any visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib | Patient Global Assessment (PtGA) at Baseline, Months 3, 6 and 12 | Baseline | 59.0 mm | Standard Deviation 23.43 |
| Tofacitinib | Patient Global Assessment (PtGA) at Baseline, Months 3, 6 and 12 | Month 3 | 39.2 mm | Standard Deviation 23.6 |
| Tofacitinib | Patient Global Assessment (PtGA) at Baseline, Months 3, 6 and 12 | Month 6 | 35.8 mm | Standard Deviation 23.65 |
| Tofacitinib | Patient Global Assessment (PtGA) at Baseline, Months 3, 6 and 12 | Month 12 | 31.0 mm | Standard Deviation 21.56 |
Secondary
Percentage of Participants Achieving HAQ-DI Response at Months 3,6 and 12
HAQ-DI is a participant-reported assessment which assess the degree of difficulty a participant had experienced during the last week in 8 domains/categories of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. 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 indicates least difficulty and 3 indicates extreme difficulty. A HAQ-DI response is defined as a decrease from baseline of at least 0.22.
Time frame: Months 3, 6 and 12
Population: FAS population was analyzed. Number of Participants analyzed signifies number of participant evaluable for this outcome measure. All participants reported under Number of Participants Analyzed contributed data to table; however, may not have evaluable data for every row. Number Analyzed signifies number of participants evaluable at specified time points. If one or two domains had missing data, score was calculated as: sum of non-missing domain scores/number of non-missing domains.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib | Percentage of Participants Achieving HAQ-DI Response at Months 3,6 and 12 | Month 3 | 56.6 Percentage of participants |
| Tofacitinib | Percentage of Participants Achieving HAQ-DI Response at Months 3,6 and 12 | Month 6 | 65.9 Percentage of participants |
| Tofacitinib | Percentage of Participants Achieving HAQ-DI Response at Months 3,6 and 12 | Month 12 | 71.3 Percentage of participants |
Secondary
Percentage of Participants With Remission and LDA at Month 12 Assessed Using DAS28-4 CRP
Remission is defined as DAS28-4 CRP \< 2.6 and DAS28-4 CRP \< 3.2 corresponds to LDA. DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). It includes components: TJC and SJC assessed using 28 joints, CRP (mg/l) and PtGA recorded on 100 mm VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity). DAS28-4 CRP is calculated as: 0.56 \* (sqrt) (TJC28) + 0.28 \* sqrt (SJC28) + 0.36 \* ln (CRP+1) + 0.014\*PtGA + 0.96; where ln = natural logarithm.
Time frame: Month 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, Number of Participants Analyzed signifies number of participants evaluable and who contributed to data for this outcome measure. Missing components were imputed by carrying forward the last non-missing post-baseline value.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib | Percentage of Participants With Remission and LDA at Month 12 Assessed Using DAS28-4 CRP | Remission | 33.3 Percentage of participants |
| Tofacitinib | Percentage of Participants With Remission and LDA at Month 12 Assessed Using DAS28-4 CRP | LDA | 55.3 Percentage of participants |
Secondary
Percentage of Participants With Treatment Satisfaction at Baseline and Month 12
Participant's satisfaction with treatment was assessed on a 5-point scale (where 0 = very dissatisfied and 4 = very satisfied) in response to the question How satisfied are you with the drugs you received for your arthritis during the last year?
Time frame: Baseline, Month 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. No imputation was applied for missing values in any visit. Here, Number Analyzed signifies number of participants evaluable at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tofacitinib | Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 | Month 12: Somewhat satisfied | 46.0 Percentage of participants |
| Tofacitinib | Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 | Month 12: Very satisfied | 30.7 Percentage of participants |
| Tofacitinib | Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 | Baseline: Very dissatisfied | 13.6 Percentage of participants |
| Tofacitinib | Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 | Baseline: Somewhat dissatisfied | 34.3 Percentage of participants |
| Tofacitinib | Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 | Baseline: Neither satisfied nor dissatisfied | 31.8 Percentage of participants |
| Tofacitinib | Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 | Baseline: Somewhat satisfied | 17.7 Percentage of participants |
| Tofacitinib | Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 | Baseline: Very satisfied | 2.5 Percentage of participants |
| Tofacitinib | Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 | Month 12: Very dissatisfied | 2.0 Percentage of participants |
| Tofacitinib | Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 | Month 12: Somewhat dissatisfied | 4.7 Percentage of participants |
| Tofacitinib | Percentage of Participants With Treatment Satisfaction at Baseline and Month 12 | Month 12: Neither satisfied nor dissatisfied | 16.7 Percentage of participants |
Secondary
Physician Global Assessment (PhGA) at Baseline, Months 3, 6 and 12
PhGA was measured using a VAS scores ranging 0 \[no disease activity\] to 100 mm \[maximum disease activity\], higher scores=more disease activity in response to how the physician assesses the participant's overall arthritis at the time of the visit. This is an evaluation based on the participant's disease signs, functional capacity and physical examination, and should be independent of the PtGA of arthritis.
Time frame: Baseline, Months 3, 6 and 12
Population: FAS population included participants who met the eligibility criteria, received at least one dose of tofacitinib and had at least one set of post-baseline measurements. Here, Number Analyzed signifies number of participants evaluable with PhGA score at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tofacitinib | Physician Global Assessment (PhGA) at Baseline, Months 3, 6 and 12 | Baseline | 59.6 mm | Standard Deviation 19.8 |
| Tofacitinib | Physician Global Assessment (PhGA) at Baseline, Months 3, 6 and 12 | Month 3 | 35.9 mm | Standard Deviation 21.93 |
| Tofacitinib | Physician Global Assessment (PhGA) at Baseline, Months 3, 6 and 12 | Month 6 | 30.0 mm | Standard Deviation 20.73 |
| Tofacitinib | Physician Global Assessment (PhGA) at Baseline, Months 3, 6 and 12 | Month 12 | 27.1 mm | Standard Deviation 21.26 |