IDentification of Factors Predictive of Tofacitinib's Survival in Patient With Rheumatoid Arthritis

IDentification of Predictive Factors of Continuation of Treatment With Tofacitinib in Patients With Rheumatoid Arthritis in Common Practice and the Impact of the Patient's Behavioural Strategies on Clinical Parameters: The DeFacTo Study.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03981900

Enrollment

314

Registered

2019-06-11

Start date

2019-01-04

Completion date

2023-02-06

Last updated

2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Brief summary

Regarding Tofacitinib, newly introduced on the market, few data on drug retention and no data on the factors predictive of Tofacitinib drug survival in patients with RA are available. Therefore, the primary objective of the DeFacTo study will be to identify the factors predictive of Tofacitinib drug survival in patients with RA. As secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA.

Detailed description

This is an observational, open-label, prospective, multi-centre, national study designed to evaluate the factors predictive of Tofacitinib's survival in patients with rheumatoid arthritis If catastrophisation is described as a distortion of the perception of pain involving a both emotional and cognitive component, pushing the patient to see only the worst, coping involves adaptive strategies by which the patient attempts to find solutions in order to better cope with his/her disease. It has been demonstrated that such behavioural strategies can influence directly or indirectly the intensity of symptoms in patients suffering from chronic disease. Therefore, as secondary objectives, the impact of behavioural strategies on drug survival and other clinical parameters as well as Tofacitinib effectiveness and tolerability will be studied under real-life conditions of use in French patients with RA. The duration of this study will be approximately 48 months including a 24-month recruitment period and a 24-month patient follow-up period. Patients will be followed prospectively and follow-up visits will be conducted after the initial consultations. No visit or additional test is required by the protocol, since the study is observational

Interventions

DRUGTofacitinib

5 mg BID, oral administrtaion

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient 18 years of age or older * Patient in whom the diagnosis of moderate to severe active rheumatoid arthritis has been confirmed by a rheumatologist * Patient for whom the rheumatologist decides to initiate treatment with Tofacitinib * Patient informed of the study

Exclusion criteria

* Patient participating in a randomised clinical trial. * Patient presenting with a contraindication to prescription of Tofacitinib * Patients who are investigational site staff members or patients who are Pfizer employees directly involved in the conduct of the trial.

Design outcomes

Primary

Measure	Time frame	Description
Duration of Tofacitinib Drug Survival	Date of initiation of study drug treatment up to date of permanent drug discontinuation or date of censoring (up to a maximum of 48 months)	The duration of tofacitinib drug survival was calculated as: date of permanent drug discontinuation minus date of first taking the drug + 1. If a participant did not present with the event of interest, that is they did not have a permanent drug discontinuation record during the study, then they were censored at the time of their last visit. Kaplan-Meier method was used for estimation.

Secondary

Measure	Time frame	Description
Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Baseline, Month 1, 3, 6 12, 18 and 24	CSQ evaluates cognitive coping, has 21 items and 5 domains in its French version. For each item, participants rate the frequency of their use of each coping strategy on a 4- point Likert-type scale (0= Never, 1= sometimes, 2= often and 3= very often). Domain scores are derived by summing the individual items scores that make-up the domain. Five domains with score range: distraction (5 items, score range: 0 to 15), catastrophising (4 items, score range: 0 to 12), distancing from pain (4 items, score range: 0 to 12), ignoring pain sensations (5 items, score range: 0 to 15) and praying (3 items, score range: 0 to 9). For each domain, higher scores indicated worse condition. Mean change from baseline in CSQ domain scores are reported in this outcome measure.
Percentage of Participants With Low Disease Activity (LDA) According to Disease Activity Index 28 (DAS28)-4 Erythrocyte Sedimentation Rate (ESR) (<=3.2)	Baseline, Month 1, 3, 6, 12 18, and 24	DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '4' in the name). Components includes: Tender Joint Count (TJC) with 28 joints assessed, Swollen Joint Count (SJC) with 28 joints assessed, ESR (millimeter per hours \[mm/h\]) and Patient Global Assessment (PtGA) 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 ESR is as follows: 0.56 \* square root (sqrt) (TJC) + 0.28 \* sqrt (SJC) + 0.70\* In (ESR) + 0.014\* (PtGA); where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(ESR) score of \<=3.2 indicates LDA. Percentage of participants with DAS28-4 ESR \<=3.2 is presented in this outcome measure.
Percentage of Participants With LDA According to DAS28-4 C Reactive Protein (CRP) (<=3.2)	Baseline, Month 1, 3, 6, 12 18, and 24	DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, 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). The calculation of DAS28-4 CRP is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+l) + 0.014\*PtGA + 0.96; where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(CRP) score of \<=3.2 indicates LDA. Percentage of participants with DAS28-4 CRP \<=3.2 is presented in this outcome measure.
Percentage of Participants With LDA According to Simplified Disease Activity Index (SDAI) <=11	Baseline, Month 1, 3, 6, 12 18, and 24	SDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + Physician Global Assessment (PhGA) (0-10 cm scale, higher score=more disease activity) + CRP (milligrams per deciliter \[mg/dL\]). The SDAI score is classified into four categories: remission (\<=3.3), low (\>3.3-11), moderate (\>11-26), and high (\>26) disease activity. The SDAI score ranges from 0 to 86 where higher scores indicates high disease activity. SDAI score of \<=11 indicates LDA. Percentage of participants with SDAI \<=11 is presented in this outcome measure.
Percentage of Participants With LDA According to Clinical Disease Activity Index (CDAI) <=10	Baseline, Month 1, 3, 6, 12 18, and 24	CDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + PhGA (0-10 cm scale, higher score=more disease activity). The CDAI score is classified into four categories: remission (\<=2.8), low (\>2.8-10), moderate (\>10-22), and high (\>22) disease activity. The CDAI score ranges from 0 to 76, where higher scores indicates high disease activity. CDAI score of \<=10 indicates LDA. Percentage of participants with CDAI \<=10 is presented in this outcome measure.
Percentage of Participants With Remission According to DAS28-4 ESR<2.6	Baseline, Month 1, 3, 6, 12 18, and 24	DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm/h) and PtGA 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 ESR is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.70\* In(ESR) + 0.014\* (PtGA); where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(ESR) score of \<2.6 indicates LDA. Percentage of participants with DAS28-4 ESR \<2.6 is presented in this outcome measure.
Percentage of Participants With Remission According to DAS28-4 CRP <2.6	Baseline, Month 1, 3, 6, 12 18, and 24	DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, 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). The calculation of DAS28-4 CRP is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+l) + 0.014\*PtGA + 0.96; where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. DAS28(CRP) score of \<2.6 indicates LDA. Percentage of participants with DAS28-4 CRP \<2.6 is presented in this outcome measure.
Percentage of Participants in Remission According to SDAI <=3.3	Baseline, Month 1, 3, 6, 12 18, and 24	SDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale, higher score=more disease activity) + PhGA (0-10 cm scale, higher score=more disease activity) + CRP (mg/dL). The SDAI score is classified into four categories: remission (\<=3.3), low (\>3.3-11), moderate (\>11-26), and high (\>26) disease activity. The SDAI score ranges from 0 to 86 where higher scores indicates high disease activity. SDAI score of \<=3.3 indicates LDA. Percentage of participants with SDAI \<=3.3 is presented in this outcome measure.
Percentage of Participants in Remission According to CDAI<=2.8	Baseline, Month 1, 3, 6, 12 18, and 24	CDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale). The CDAI score is classified into four categories: remission (\<=2.8), low (\>2.8-10), moderate (\>10-22), and high (\>22) disease activity. The CDAI score ranges from 0 to 76, where higher scores indicates high disease activity. CDAI score of \<=2.8 indicates LDA. Percentage of participants with CDAI \<=2.8 is presented in this outcome measure.
Percentage of Participants With Remission According to American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) 2011 Boolean Criteria	Baseline, Month 1, 3, 6, 12 18, and 24	ACREULAR 2011 Boolean criteria is derived as: ACR Remission = 1, if SJC (using 28 joints) \<=1, TJC (using 28 joints) \<=1, CRP \<=1 mg/dL, and PtGA (0 to 10 cm scale, higher score=more disease activity) \<=1 centimeter (cm) otherwise ACR remission =0. Higher scores indicated greater affection due to disease activity. Percentage of participants with remission according to ACR-EULAR 2011 Boolean criteria is reported in this outcome measure.
Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24	Baseline, Month 1, 3, 6, 12, 18, and 24	DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm/h) and PtGA 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 ESR is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.70\* In(ESR) + 0.014\* (PtGA); where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. Mean change from baseline in DAS28-4 ESR score at months 3, 6, 12, 18 and 24 is presented in this outcome measure.
Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24	Baseline, Month 1, 3, 6, 12, 18 and 24	PCS is a 13 item questionnaire around thoughts and emotions experienced during pain, with each question scored on a 5-point scale ranging from 0 (not at all) to 4 (all the time), where higher scores indicated worse condition. There are three subscales of PCS: rumination (thinking deeply) \[4 items\], exaggeration \[3 items\] and helplessness \[6 items\]. Total scores and domain scores are derived by summing the scores of the individual items. Overall possible Total PCS score range is 0 to 52, where higher scores signifies worse condition. A total score of greater than or equal to (\>=) 20 indicates a clinically relevant level of catastrophising. Mean change from baseline in total PCS score is reported in this outcome measure.
Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	Month 1, 3, 6, 12, 18, and 24	28 EULAR criteria to evaluate participant's response to treatment is categorised as good responder, moderate responder and non-responder based on participants DAS28-4 CRP score and decrease in DAS28-4 CRP compared to initial pre-treatment visit (Visit 0 \[V0\]). Good response: DAS28 at treatment visit \<= 3.2 and decrease in DAS 28 compared to V0 \>1.2. Moderate responder: DAS28 at treatment visit \> 3.2 to \<= 5.1 or \> 5.1 and decrease in DAS 28 compared to V0 \>1.2 DAS28 at treatment visit \<= 3.2 or \> 3.2 to \<= 5.1 and decrease in DAS 28 compared to V0 \>0.6 and \<=1.2. Non-responder: DAS28 at treatment visit \> 5.1 and decrease in DAS 28 compared to V0 \>0.6 to \<=1.2 DAS28 at treatment visit \<= 3.2 or \> 3.2 to \<= 5.1 or \> 5.1 and decrease in DAS 28 compared to V0 \<=0.6. Number of participants responding to treatment by considering DAS28 (EULAR criterion) is reported in this outcome measure.
Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24	Baseline, Month 1, 3, 6, 12, 18, and 24	TJC (28) is the count of the total number of tender joints out of a possible 28 joints which are checked at the visit. TJC was used to measure the pain and inflammation in the joints. Mean change from baseline in TJC is reported in this outcome measure.
Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24	Baseline, Month 1, 3, 6, 12, 18, and 24	SJC (28) is the count of the total number of swollen joints out of a possible 28 joints which are checked at the visit. SJC was used to measure the pain and inflammation in the joints. Mean change from baseline in TJC is reported in this outcome measure.
Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Baseline, Month 1, 3, 6, 12, 18 and 24	FiRST is used to detect fibromyalgia in participants with diffuse rheumatic pain. It is a questionnaire which contains 6 items: diffuse pain, painful symptoms, fatigue, sleep and cognitive disorders, nonpainful abnormal sensations and functional somatic symptoms. Each of the 6 items contain yes or no response, and a positive answer to 5 out of the 6 answers can detect fibromyalgia. At each specified time points number of participants with Yes or No to fibromyalgia is reported in this outcome measure.
Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24	Baseline, Month 1, 3, 6, 12, 18 and 24	Morning stiffness is a common symptom of rheumatoid arthritis. The duration of morning stiffness is measured in minutes. Mean change from baseline in morning stiffness is reported in this outcome measure.
Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Month 1, 3, 6, 12, 18 and 24	Girerd questionnaire is used to evaluate participant's treatment compliance and is made up of 6 yes or no questions. lf the participant responds no to all questions, it is considered as participant is a good complier. lf the participant responds yes once or twice, it is considered as participant is a minor complier. lf the participant responds yes three times or more, it is considered as participant is a no-complier.
Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24	Baseline, Month 1, 3, 6, 12, 18 and 24	EQ-5D-3L is a standardized, participant administered measure of self-reported instrument used to evaluate health-related quality of life. It consists of two parts: EQ-5D index score (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of function:. 1=no problems, 2=some problems and 3=extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total index score range of 0 to 1.00; higher scores indicating a better health condition. Mean change from baseline in EQ-5D-3L index score is reported in this outcome measure.
Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	Baseline, Month 1, 3, 6, 12, 18 and 24	SF-12 was a participant reported outcome survey that represented overall health status by measuring 8 health-related aspects of an individual: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE) and Mental Health (MH). The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Responses on the SF-12 were also used to calculate 2 summary scores: Physical component score (PCS) and mental component score (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health), where 100 indicated good health condition. Mean change from baseline in PCS and MCS scores are reported in this outcome measure.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24	Baseline, Month 1, 3, 6, 12, 18 and 24	FACIT-Fatigue questionnaire consists of 13 self-evaluated questions. Each question has a response of values 0 (not at all) to 4 (very much). Score for each question is calculated by first reversing negatively stated-items (subtracting the response from '4' except for the 2 positively stated-items) and then summing the raw (0-4) scores. The FACIT-Fatigue total score is derived by summing the response to each question which gives a value between 0 (worse score) and 52 (best score). Higher scores represent better participant's status (less fatigue). Mean change from baseline in FACIT-Fatigue total score is reported in this outcome measure.
Number of Participants With Tofacitinib Tolerance Issue	Month 24	Number of participants who discontinued tofacitinib due to tolerance issue.
Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24	Baseline, Month 1, 3, 6, 12, 18, and 24	DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, 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). The calculation of DAS28-4 CRP is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+l) + 0.014\*PtGA + 0.96; where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. Mean change from baseline in DAS28-4 CRP score at months 3, 6, 12, 18 and 24 is presented in this outcome measure.

Countries

France

Participant flow

Recruitment details

Participants diagnosed with moderate-to-severe active rheumatoid arthritis who initiated Tofacitinib in the real-world setting were observed in this study.

Participants by arm

Arm	Count
Tofacitinib Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).	309
Total	309

Arm

Count

Tofacitinib

Participants with rheumatoid arthritis who received tofacitinib were included in this observational study. The recommended dosage is one Tofacitinib 5 milligram (mg) tablet (immediate release tablets) twice daily or Tofacitinib 11 mg (extended-release tablets) once a day, the transition from one formulation to another is possible according to the recommendations mentioned in the summary of product characteristics (SmPC).

309

Total

309

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	5
Overall Study	Death	3
Overall Study	Decision of the researcher	3
Overall Study	Lost to Follow-up	46
Overall Study	Other	5
Overall Study	Participant decision - Without withdrawal of consent	17
Overall Study	Protocol Violation	1
Overall Study	Withdrawal by Subject	7

Baseline characteristics

Characteristic	Tofacitinib	—
Age, Customized < 65 years	194 Participants	—
Age, Customized >= 65 Years	112 Participants	—
Age, Customized Missing	3 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Sex/Gender, Customized Female	241 Participants	—
Sex/Gender, Customized Male	65 Participants	—
Sex/Gender, Customized Missing	3 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	3 / 309
other Total, other adverse events	197 / 309
serious Total, serious adverse events	64 / 309

Outcome results

Primary

Duration of Tofacitinib Drug Survival

The duration of tofacitinib drug survival was calculated as: date of permanent drug discontinuation minus date of first taking the drug + 1. If a participant did not present with the event of interest, that is they did not have a permanent drug discontinuation record during the study, then they were censored at the time of their last visit. Kaplan-Meier method was used for estimation.

Time frame: Date of initiation of study drug treatment up to date of permanent drug discontinuation or date of censoring (up to a maximum of 48 months)

Population: Full analysis set 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	Value (MEDIAN)
Tofacitinib	Duration of Tofacitinib Drug Survival	26.4 Months

Secondary

Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24

CSQ evaluates cognitive coping, has 21 items and 5 domains in its French version. For each item, participants rate the frequency of their use of each coping strategy on a 4- point Likert-type scale (0= Never, 1= sometimes, 2= often and 3= very often). Domain scores are derived by summing the individual items scores that make-up the domain. Five domains with score range: distraction (5 items, score range: 0 to 15), catastrophising (4 items, score range: 0 to 12), distancing from pain (4 items, score range: 0 to 12), ignoring pain sensations (5 items, score range: 0 to 15) and praying (3 items, score range: 0 to 9). For each domain, higher scores indicated worse condition. Mean change from baseline in CSQ domain scores are reported in this outcome measure.

Time frame: Baseline, Month 1, 3, 6 12, 18 and 24

Population: Full analysis set 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 at specified time points. No imputation used for missing values.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Distraction at baseline	13.2 Units on a scale	Standard Deviation 3.8
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Catastrophising at baseline	8.4 Units on a scale	Standard Deviation 3
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Distancing from Pain at baseline	7.3 Units on a scale	Standard Deviation 3.2
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Ignoring Pain Sensations at baseline	11.3 Units on a scale	Standard Deviation 3.6
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Praying at baseline	5.6 Units on a scale	Standard Deviation 2.9
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Distraction, Change at month 1	-0.4 Units on a scale	Standard Deviation 3.3
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Catastrophising, Change at month 1	-0.6 Units on a scale	Standard Deviation 2.8
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Distancing from Pain, Change at month 1	-0.0 Units on a scale	Standard Deviation 2.9
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Ignoring Pain Sensations, Change at month 1	-0.7 Units on a scale	Standard Deviation 3.7
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Praying, Change at month 1	-0.1 Units on a scale	Standard Deviation 2.2
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Distraction, Change at month 3	-0.9 Units on a scale	Standard Deviation 4.5
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Catastrophising, Change at month 3	-1.0 Units on a scale	Standard Deviation 3.3
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Distancing from Pain, Change at month 3	-0.2 Units on a scale	Standard Deviation 3.9
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Ignoring Pain Sensations, Change at month 3	-0.2 Units on a scale	Standard Deviation 4.1
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Praying, Change at month 3	-0.5 Units on a scale	Standard Deviation 2
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Distraction, Change at month 6	-1.5 Units on a scale	Standard Deviation 4.2
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Catastrophising, Change at month 6	-1.5 Units on a scale	Standard Deviation 2.6
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Distancing from Pain, Change at month 6	-0.5 Units on a scale	Standard Deviation 4.1
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Ignoring Pain Sensations, Change at month 6	-0.3 Units on a scale	Standard Deviation 4.4
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Praying, Change at month 6	-0.7 Units on a scale	Standard Deviation 2.1
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Distraction, Change at month 12	-1.5 Units on a scale	Standard Deviation 4.3
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Catastrophising, Change at month 12	-1.8 Units on a scale	Standard Deviation 2.4
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Distancing from Pain, Change at month 12	-0.6 Units on a scale	Standard Deviation 3.9
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Ignoring Pain Sensations, Change at month 12	-0.9 Units on a scale	Standard Deviation 4.5
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Praying, Change at month 12	-0.7 Units on a scale	Standard Deviation 2.2
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Distraction, Change at month 18	-1.5 Units on a scale	Standard Deviation 4.5
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Catastrophising, Change at month 18	-1.6 Units on a scale	Standard Deviation 2.7
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Distancing from Pain, Change at month 18	-0.5 Units on a scale	Standard Deviation 3.3
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Ignoring Pain Sensations, Change at month 18	-0.8 Units on a scale	Standard Deviation 4.4
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Praying, Change at month 18	-0.6 Units on a scale	Standard Deviation 2.2
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Distraction, Change at month 24	-1.6 Units on a scale	Standard Deviation 5.4
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Catastrophising, Change at month 24	-1.6 Units on a scale	Standard Deviation 2.6
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Distancing from Pain, Change at month 24	-0.7 Units on a scale	Standard Deviation 2.8
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Ignoring Pain Sensations, Change at month 24	-0.5 Units on a scale	Standard Deviation 4.4
Tofacitinib	Change From Baseline in Coping Strategies Questionnaire (CSQ) Score at Month 1, 3, 6, 12, 18 and 24	Praying, Change at month 24	-0.7 Units on a scale	Standard Deviation 2.2

Secondary

Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24

DAS28-4 CRP is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, 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). The calculation of DAS28-4 CRP is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.36 \* ln (CRP+l) + 0.014\*PtGA + 0.96; where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. Mean change from baseline in DAS28-4 CRP score at months 3, 6, 12, 18 and 24 is presented in this outcome measure.

Time frame: Baseline, Month 1, 3, 6, 12, 18, and 24

Population: Full analysis set 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 contributed to data for this outcome measure. Here, Number Analyzed signifies number of participants evaluable at specified time points. No imputation used for missing values.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tofacitinib	Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24	Baseline	4.526 Units on a scale	Standard Deviation 1.088
Tofacitinib	Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 1	-1.295 Units on a scale	Standard Deviation 1.135
Tofacitinib	Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 3	-1.498 Units on a scale	Standard Deviation 1.363
Tofacitinib	Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 6	-1.902 Units on a scale	Standard Deviation 1.198
Tofacitinib	Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 12	-1.909 Units on a scale	Standard Deviation 1.269
Tofacitinib	Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 18	-1.971 Units on a scale	Standard Deviation 1.275
Tofacitinib	Change From Baseline in DAS28-4 CRP Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 24	-2.077 Units on a scale	Standard Deviation 1.215

Secondary

Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24

DAS28-4 ESR is a composite endpoint, calculated using 4 variables (represented by '-4' in the name). Components includes: TJC with 28 joints assessed, SJC with 28 joints assessed, ESR (mm/h) and PtGA 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 ESR is as follows: 0.56 \* sqrt (TJC) + 0.28 \* sqrt (SJC) + 0.70\* In(ESR) + 0.014\* (PtGA); where ln = natural logarithm. Total DAS28-4 score range: 0 to 9.4, higher score=more disease activity. Mean change from baseline in DAS28-4 ESR score at months 3, 6, 12, 18 and 24 is presented in this outcome measure.

Time frame: Baseline, Month 1, 3, 6, 12, 18, and 24

Population: Full analysis set 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 contributed to data for this outcome measure. Here, Number Analyzed signifies number of participants evaluable at specified time points. No imputation used for missing values.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tofacitinib	Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24	Baseline	4.850 Units on a scale	Standard Deviation 1.18
Tofacitinib	Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 1	-1.129 Units on a scale	Standard Deviation 1.187
Tofacitinib	Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 3	-1.419 Units on a scale	Standard Deviation 1.487
Tofacitinib	Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 6	-1.941 Units on a scale	Standard Deviation 1.367
Tofacitinib	Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 12	-1.764 Units on a scale	Standard Deviation 1.347
Tofacitinib	Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 18	-1.954 Units on a scale	Standard Deviation 1.487
Tofacitinib	Change From Baseline in DAS28-4 ESR Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 24	-2.008 Units on a scale	Standard Deviation 1.363

Secondary

Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24

Morning stiffness is a common symptom of rheumatoid arthritis. The duration of morning stiffness is measured in minutes. Mean change from baseline in morning stiffness is reported in this outcome measure.

Time frame: Baseline, Month 1, 3, 6, 12, 18 and 24

Population: Full analysis set 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 contributed to data for this outcome measure. Here, Number Analyzed signifies number of participants evaluable at specified time points. No imputation used for missing values.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tofacitinib	Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24	Change at Month 6	-31.5 Minutes	Standard Deviation 49.1
Tofacitinib	Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24	Baseline	51.5 Minutes	Standard Deviation 53.3
Tofacitinib	Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24	Change at Month 1	-24.3 Minutes	Standard Deviation 43
Tofacitinib	Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24	Change at Month 3	-31.3 Minutes	Standard Deviation 48.8
Tofacitinib	Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24	Change at Month 12	-36.6 Minutes	Standard Deviation 50.8
Tofacitinib	Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24	Change at Month 18	-32.2 Minutes	Standard Deviation 47.9
Tofacitinib	Change From Baseline in Duration of Morning Stiffness at Month 1, 3, 6, 12, 18 and 24	Change at Month 24	-40.0 Minutes	Standard Deviation 49.3

Secondary

Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24

EQ-5D-3L is a standardized, participant administered measure of self-reported instrument used to evaluate health-related quality of life. It consists of two parts: EQ-5D index score (Part I) and the EQ-VAS (Part II). For Part I, i.e. EQ-5D-3L index score, participants rated their current health state on 5 single-item dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with each dimension having three levels of function:. 1=no problems, 2=some problems and 3=extreme problems. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total index score range of 0 to 1.00; higher scores indicating a better health condition. Mean change from baseline in EQ-5D-3L index score is reported in this outcome measure.

Time frame: Baseline, Month 1, 3, 6, 12, 18 and 24

Population: Full analysis set 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 contributed to data for this outcome measure. Here, Number Analyzed signifies number of participants evaluable at specified time points. No imputation used for missing values.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tofacitinib	Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24	Baseline	0.3987 Units on a scale	Standard Deviation 0.3731
Tofacitinib	Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 1	0.1314 Units on a scale	Standard Deviation 0.3185
Tofacitinib	Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 3	0.1767 Units on a scale	Standard Deviation 0.4054
Tofacitinib	Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 6	0.1886 Units on a scale	Standard Deviation 0.3638
Tofacitinib	Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 12	0.2362 Units on a scale	Standard Deviation 0.4058
Tofacitinib	Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 18	0.2190 Units on a scale	Standard Deviation 0.402
Tofacitinib	Change From Baseline in European Quality of Life (EuroQoL) 5-Dimension 3 Levels of Severity (EQ-5D-3L) Index Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 24	0.2123 Units on a scale	Standard Deviation 0.3911

Secondary

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24

FACIT-Fatigue questionnaire consists of 13 self-evaluated questions. Each question has a response of values 0 (not at all) to 4 (very much). Score for each question is calculated by first reversing negatively stated-items (subtracting the response from '4' except for the 2 positively stated-items) and then summing the raw (0-4) scores. The FACIT-Fatigue total score is derived by summing the response to each question which gives a value between 0 (worse score) and 52 (best score). Higher scores represent better participant's status (less fatigue). Mean change from baseline in FACIT-Fatigue total score is reported in this outcome measure.

Time frame: Baseline, Month 1, 3, 6, 12, 18 and 24

Population: Full analysis set 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 contributed to data for this outcome measure. Here, Number Analyzed signifies number of participants evaluable at specified time points.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Tofacitinib	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24	Baseline	26.9 Units on a scale	Standard Error 11.7
Tofacitinib	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 1	3.9 Units on a scale	Standard Error 9.3
Tofacitinib	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 3	6.2 Units on a scale	Standard Error 10.9
Tofacitinib	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 6	6.2 Units on a scale	Standard Error 10.1
Tofacitinib	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 12	6.9 Units on a scale	Standard Error 12.1
Tofacitinib	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 18	6.8 Units on a scale	Standard Error 11.6
Tofacitinib	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 24	8.4 Units on a scale	Standard Error 11.4

Secondary

Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24

SF-12 was a participant reported outcome survey that represented overall health status by measuring 8 health-related aspects of an individual: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE) and Mental Health (MH). The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Responses on the SF-12 were also used to calculate 2 summary scores: Physical component score (PCS) and mental component score (MCS). The score range for each of these 2 summary scores was from 0 (poor health) to 100 (better health), where 100 indicated good health condition. Mean change from baseline in PCS and MCS scores are reported in this outcome measure.

Time frame: Baseline, Month 1, 3, 6, 12, 18 and 24

Arm	Measure	Group	Value (MEAN)	Dispersion
Tofacitinib	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	MCS at Baseline	40.2 Units on a scale	Standard Deviation 10.4
Tofacitinib	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	PCS at Baseline	35.0 Units on a scale	Standard Deviation 8.7
Tofacitinib	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	PCS at Change at Month 1	3.5 Units on a scale	Standard Deviation 7.6
Tofacitinib	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	PCS at Change at Month 3	5.8 Units on a scale	Standard Deviation 8.9
Tofacitinib	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	PCS at Change at Month 6	5.9 Units on a scale	Standard Deviation 8.7
Tofacitinib	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	PCS at Change at Month 12	6.9 Units on a scale	Standard Deviation 9.2
Tofacitinib	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	PCS at Change at Month 18	6.9 Units on a scale	Standard Deviation 9.1
Tofacitinib	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	PCS at Change at Month 24	7.3 Units on a scale	Standard Deviation 9.8
Tofacitinib	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	MCS at Change at Month 1	1.7 Units on a scale	Standard Deviation 9.1
Tofacitinib	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	MCS at Change at Month 3	3.7 Units on a scale	Standard Deviation 10.6
Tofacitinib	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	MCS at Change at Month 6	3.9 Units on a scale	Standard Deviation 9.5
Tofacitinib	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	MCS at Change at Month 12	3.9 Units on a scale	Standard Deviation 11.1
Tofacitinib	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	MCS at Change at Month 18	4.0 Units on a scale	Standard Deviation 10.2
Tofacitinib	Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Month 1, 3, 6, 12, 18 and 24	MCS at Change at Month 24	4.9 Units on a scale	Standard Deviation 10.7

Secondary

Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24

SJC (28) is the count of the total number of swollen joints out of a possible 28 joints which are checked at the visit. SJC was used to measure the pain and inflammation in the joints. Mean change from baseline in TJC is reported in this outcome measure.

Time frame: Baseline, Month 1, 3, 6, 12, 18, and 24

Population: Full analysis set 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 contributed to data for this outcome measure. Here, Number Analyzed signifies number of participants evaluable at specified time points. No imputation used for missing values.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tofacitinib	Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24	Baseline	5.3 Swollen Joints	Standard Deviation 5.1
Tofacitinib	Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24	Change at Month 1	-3.0 Swollen Joints	Standard Deviation 4.5
Tofacitinib	Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24	Change at Month 3	-3.5 Swollen Joints	Standard Deviation 4.9
Tofacitinib	Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24	Change at Month 6	-3.9 Swollen Joints	Standard Deviation 5.1
Tofacitinib	Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24	Change at Month 12	-4.3 Swollen Joints	Standard Deviation 5.1
Tofacitinib	Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24	Change at Month 18	-4.4 Swollen Joints	Standard Deviation 5.2
Tofacitinib	Change From Baseline in SJC at Month 1, 3, 6, 12, 18 and 24	Change at Month 24	-4.3 Swollen Joints	Standard Deviation 5.1

Secondary

Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24

TJC (28) is the count of the total number of tender joints out of a possible 28 joints which are checked at the visit. TJC was used to measure the pain and inflammation in the joints. Mean change from baseline in TJC is reported in this outcome measure.

Time frame: Baseline, Month 1, 3, 6, 12, 18, and 24

Population: Full analysis set 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 contributed to data for this outcome measure. Here, Number Analyzed signifies number of participants evaluable at specified time points. No imputation used for missing values.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tofacitinib	Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24	Baseline	7.4 Tender Joints	Standard Deviation 6
Tofacitinib	Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24	Change at Month 1	-4.2 Tender Joints	Standard Deviation 5.8
Tofacitinib	Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24	Change at Month 3	-4.3 Tender Joints	Standard Deviation 6.5
Tofacitinib	Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24	Change at Month 6	-4.9 Tender Joints	Standard Deviation 6.3
Tofacitinib	Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24	Change at Month 12	-5.0 Tender Joints	Standard Deviation 7
Tofacitinib	Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24	Change at Month 18	-5.1 Tender Joints	Standard Deviation 5.9
Tofacitinib	Change From Baseline in TJC at Month 1, 3, 6, 12, 18 and 24	Change at Month 24	-5.1 Tender Joints	Standard Deviation 6.7

Secondary

Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24

PCS is a 13 item questionnaire around thoughts and emotions experienced during pain, with each question scored on a 5-point scale ranging from 0 (not at all) to 4 (all the time), where higher scores indicated worse condition. There are three subscales of PCS: rumination (thinking deeply) \[4 items\], exaggeration \[3 items\] and helplessness \[6 items\]. Total scores and domain scores are derived by summing the scores of the individual items. Overall possible Total PCS score range is 0 to 52, where higher scores signifies worse condition. A total score of greater than or equal to (\>=) 20 indicates a clinically relevant level of catastrophising. Mean change from baseline in total PCS score is reported in this outcome measure.

Time frame: Baseline, Month 1, 3, 6, 12, 18 and 24

Population: Full analysis set 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 contributed to data for this outcome measure. Here, Number Analyzed signifies number of participants evaluable at specified time points. No imputation used for missing values.

Arm	Measure	Group	Value (MEAN)	Dispersion
Tofacitinib	Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24	Baseline	20.4 Units on a scale	Standard Deviation 14
Tofacitinib	Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 1	-5.2 Units on a scale	Standard Deviation 10.4
Tofacitinib	Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 3	-6.6 Units on a scale	Standard Deviation 11.1
Tofacitinib	Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 6	-8.4 Units on a scale	Standard Deviation 11.4
Tofacitinib	Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 12	-8.2 Units on a scale	Standard Deviation 11.6
Tofacitinib	Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 18	-8.8 Units on a scale	Standard Deviation 11.2
Tofacitinib	Change From Baseline in Total Pain Catastrophising Scale (PCS) Score at Month 1, 3, 6, 12, 18 and 24	Change at Month 24	-8.7 Units on a scale	Standard Deviation 10.8

Secondary

Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24

Girerd questionnaire is used to evaluate participant's treatment compliance and is made up of 6 yes or no questions. lf the participant responds no to all questions, it is considered as participant is a good complier. lf the participant responds yes once or twice, it is considered as participant is a minor complier. lf the participant responds yes three times or more, it is considered as participant is a no-complier.

Time frame: Month 1, 3, 6, 12, 18 and 24

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Good complier at month 24	42 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Good complier at baseline	100 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Minor complier at baseline	139 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	No-complier at baseline	17 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Good complier at month 1	89 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Minor complier at month 1	91 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	No-complier at month 1	7 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Good complier at month 3	87 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Minor complier at month 3	110 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	No-complier at month 3	14 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Good complier at month 6	58 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Minor complier at month 6	106 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	No-complier at month 6	18 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Good complier at month 12	58 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Minor complier at month 12	85 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	No-complier at month 12	6 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Good complier at month 18	49 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Minor complier at month 18	63 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	No-complier at month 18	9 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	Minor complier at month 24	62 Participants
Tofacitinib	Number of Participants Based on Response to Girerd Questionnaire at Month 1, 3, 6, 12, 18 and 24	No-complier at month 24	5 Participants

Secondary

Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)

28 EULAR criteria to evaluate participant's response to treatment is categorised as good responder, moderate responder and non-responder based on participants DAS28-4 CRP score and decrease in DAS28-4 CRP compared to initial pre-treatment visit (Visit 0 \[V0\]). Good response: DAS28 at treatment visit \<= 3.2 and decrease in DAS 28 compared to V0 \>1.2. Moderate responder: DAS28 at treatment visit \> 3.2 to \<= 5.1 or \> 5.1 and decrease in DAS 28 compared to V0 \>1.2 DAS28 at treatment visit \<= 3.2 or \> 3.2 to \<= 5.1 and decrease in DAS 28 compared to V0 \>0.6 and \<=1.2. Non-responder: DAS28 at treatment visit \> 5.1 and decrease in DAS 28 compared to V0 \>0.6 to \<=1.2 DAS28 at treatment visit \<= 3.2 or \> 3.2 to \<= 5.1 or \> 5.1 and decrease in DAS 28 compared to V0 \<=0.6. Number of participants responding to treatment by considering DAS28 (EULAR criterion) is reported in this outcome measure.

Time frame: Month 1, 3, 6, 12, 18, and 24

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, good responder, month 1	67 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, moderate responder, month 1	61 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, non-responder, month 1	49 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, good responder, month 3	97 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, moderate responder, month 3	63 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, non-responder, month 3	51 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, good responder, month 6	111 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, moderate responder, month 6	47 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, non-responder, month 6	27 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, good responder, month 12	84 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, moderate responder, month 12	41 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, non-responder, month 12	23 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, good responder, month 18	78 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, moderate responder, month 18	24 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, non-responder, month 18	23 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, good responder, month 24	70 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, moderate responder, month 24	28 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	CRP, non-responder, month 24	13 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, good responder, month 1	37 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, moderate responder, month 1	50 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, non-responder, month 1	48 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, good responder, month 3	59 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, moderate responder, month 3	56 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, non-responder, month 3	55 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, good responder, month 6	65 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, moderate responder, month 6	62 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, non-responder, month 6	23 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, good responder, month 12	55 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, moderate responder, month 12	40 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, non-responder, month 12	24 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, good responder, month 18	51 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, moderate responder, month 18	30 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, non-responder, month 18	18 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, good responder, month 24	43 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, moderate responder, month 24	28 Participants
Tofacitinib	Number of Participants Responding To Treatment by Considering DAS28 (EULAR Criterion)	ESR, non-responder, month 24	14 Participants

Secondary

Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response

FiRST is used to detect fibromyalgia in participants with diffuse rheumatic pain. It is a questionnaire which contains 6 items: diffuse pain, painful symptoms, fatigue, sleep and cognitive disorders, nonpainful abnormal sensations and functional somatic symptoms. Each of the 6 items contain yes or no response, and a positive answer to 5 out of the 6 answers can detect fibromyalgia. At each specified time points number of participants with Yes or No to fibromyalgia is reported in this outcome measure.

Time frame: Baseline, Month 1, 3, 6, 12, 18 and 24

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib	Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Baseline, Fibromyalgia: No	156 Participants
Tofacitinib	Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Baseline, Fibromyalgia: Yes	91 Participants
Tofacitinib	Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Month 1, Fibromyalgia: No	124 Participants
Tofacitinib	Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Month 1, Fibromyalgia: Yes	60 Participants
Tofacitinib	Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Month 3, Fibromyalgia: No	149 Participants
Tofacitinib	Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Month 3, Fibromyalgia: Yes	56 Participants
Tofacitinib	Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Month 6, Fibromyalgia: No	135 Participants
Tofacitinib	Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Month 6, Fibromyalgia: Yes	41 Participants
Tofacitinib	Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Month 12, Fibromyalgia: No	111 Participants
Tofacitinib	Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Month 12, Fibromyalgia: Yes	32 Participants
Tofacitinib	Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Month 18, Fibromyalgia: No	89 Participants
Tofacitinib	Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Month 18, Fibromyalgia: Yes	25 Participants
Tofacitinib	Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Month 24, Fibromyalgia: No	80 Participants
Tofacitinib	Number of Participants With Fibromyalgia Rapid Screening Tool (FiRST) Questionnaire Response	Month 24, Fibromyalgia: Yes	25 Participants

Secondary

Number of Participants With Tofacitinib Tolerance Issue

Number of participants who discontinued tofacitinib due to tolerance issue.

Time frame: Month 24

Population: Full analysis set 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	Value (COUNT_OF_PARTICIPANTS)
Tofacitinib	Number of Participants With Tofacitinib Tolerance Issue	39 Participants

Secondary

Percentage of Participants in Remission According to CDAI<=2.8

CDAI is a composite end point, calculated as TJC + SJC (both using 28 joints) + PtGA (0-10 cm scale) + PhGA (0-10 cm scale). The CDAI score is classified into four categories: remission (\<=2.8), low (\>2.8-10), moderate (\>10-22), and high (\>22) disease activity. The CDAI score ranges from 0 to 76, where higher scores indicates high disease activity. CDAI score of \<=2.8 indicates LDA. Percentage of participants with CDAI \<=2.8 is presented in this outcome measure.