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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02187055




Registration number
NCT02187055
Ethics application status
Date submitted
8/07/2014
Date registered
10/07/2014
Date last updated
27/06/2018

Titles & IDs
Public title
An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate
Scientific title
A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis
Secondary ID [1] 0 0
2014-000358-13
Secondary ID [2] 0 0
A3921187
Universal Trial Number (UTN)
Trial acronym
ORAL STRATEGY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rhematoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tofacitinib with methotrexate
Treatment: Drugs - Tofacitinib without methotrexate
Other interventions - Adalimumab with methotrexate

Experimental: Tofacitinib 5 mg twice daily with methotrexate -

Experimental: Tofacitinib 5 mg twice daily monotherapy -

Active Comparator: Adalimumab with methotrexate -


Treatment: Drugs: Tofacitinib with methotrexate
Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months

Treatment: Drugs: Tofacitinib without methotrexate
Tofacitinib 5 mg twice daily, oral for 12 months Placebo for methotrexate (previous stable dose) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months

Other interventions: Adalimumab with methotrexate
Placebo for tofacitinib twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Adalimumab 40 mg every other week, subcutaneous for 12 months

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6 - ACR50 is a greater than or equal to (=) 50 percent (%) improvement in tender joint count (TJC) or swollen joint count (SJC) and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment (PGA) of disease activity, 2) participant's assessment (PtGA) of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein (CRP) at each visit.
Timepoint [1] 0 0
Month 6
Secondary outcome [1] 0 0
Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6 - SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 centimeter (cm) visual analogue scale (VAS) (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI less than or equal to (=) 3.3 indicates disease remission, >3.4 to 11 indicates low disease activity, >11 to 26 indicates moderate disease activity, and >26 indicates high disease activity.
Timepoint [1] 0 0
Month 6
Secondary outcome [2] 0 0
Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6 - CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI =2.8 indicates disease remission, >2.8 to 10 indicates low disease activity, >10 to 22 indicates moderate disease activity, and >22 indicates high disease activity.
Timepoint [2] 0 0
Month 6
Secondary outcome [3] 0 0
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6 - DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (millimeters [mm]) + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) =3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and less than (<) 2.6 indicates remission.
Timepoint [3] 0 0
Month 6
Secondary outcome [4] 0 0
Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6 - DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-3 (ESR) =3.2 indicates low disease activity, >3.2 to 5.1 indicates moderate to high disease activity, and <2.6 indicates remission.
Timepoint [4] 0 0
Month 6
Secondary outcome [5] 0 0
Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6 - To meet the ACR-EULAR Boolean remission criteria, a participant must satisfy all of the following: TJC =1 and SJC =1 (both based on a 28-joint assessment), CRP =1 mg/dL, and PtGA =1 on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity).
Timepoint [5] 0 0
Month 6
Secondary outcome [6] 0 0
Percentage of Participants Achieving SDAI =3.3 at Month 6 - SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI =3.3 indicates disease remission.
Timepoint [6] 0 0
Month 6
Secondary outcome [7] 0 0
Percentage of Participants Achieving CDAI =2.8 at Month 6 - CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI =2.8 indicates disease remission.
Timepoint [7] 0 0
Month 6
Secondary outcome [8] 0 0
Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6 - DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) <2.6 indicates disease remission.
Timepoint [8] 0 0
Month 6
Secondary outcome [9] 0 0
Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6 - DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA (mm) + 0.96. Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (CRP) <2.6 indicates remission.
Timepoint [9] 0 0
Month 6
Secondary outcome [10] 0 0
Percentage of Participants Achieving SDAI =11 at Month 6 - SDAI is the numerical sum of five outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity), and CRP (mg/dL). SDAI total score ranges from 0 to 86. SDAI =3.3 indicates disease remission, >3.4 to 11 indicates low disease activity.
Timepoint [10] 0 0
Month 6
Secondary outcome [11] 0 0
Percentage of Participants Achieving CDAI =10 at Month 6 - CDAI is the numerical sum of four outcome parameters: TJC and SJC both based on a 28-joint assessment, PtGA and PGA both assessed on a 0 to 10 cm VAS (higher scores indicate greater affection due to disease activity). CDAI total score ranges from 0 to 76. CDAI =2.8 indicates disease remission, >2.8 to 10 indicates low disease activity.
Timepoint [11] 0 0
Month 6
Secondary outcome [12] 0 0
Percentage of Participants Achieving DAS28-4 (ESR) =3.2 at Month 6 - DAS28-4 (ESR) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and ESR (mm/hour) using the following: DAS28-4(ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*ln(ESR) + 0.014* PtGA (mm). Total score range: 0 to 9.4, higher score indicates higher disease activity. DAS28-4 (ESR) =3.2 indicates low disease activity.
Timepoint [12] 0 0
Month 6
Secondary outcome [13] 0 0
Percentage of Participants Achieving DAS28-4 (CRP) =3.2 at Month 6 - DAS28-4 (CRP) was calculated from the SJC and TJC (both based on a 28-joint assessment), PtGA (assessed on a 0 to 10 cm VAS; higher scores indicate greater affection due to disease activity) and CRP (mg/L) using the following: DAS28-4(CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP+1) + 0.014* PtGA + 0.96. Total score range: 0 to 9.4, higher score indicated higher disease activity. DAS28-4 (CRP) =3.2 indicates low disease activity.
Timepoint [13] 0 0
Month 6
Secondary outcome [14] 0 0
Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6 - ACR20 response is a =20% improvement in TJC or SJC and 20% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.
Timepoint [14] 0 0
Month 6
Secondary outcome [15] 0 0
Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6 - ACR70 response is a =70% improvement in TJC or SJC and 70% improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit.
Timepoint [15] 0 0
Month 6
Secondary outcome [16] 0 0
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6 - The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty.
Timepoint [16] 0 0
Month 6
Secondary outcome [17] 0 0
Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6 - The HAQ-DI is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dressing and grooming, arising, eating, walking, reach, grip, hygiene and other activities over the past week. Each activity category consists of 2 to 3 items. Each item is scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Any activity requiring assistance from another individual or the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score ranges from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. A decrease of 0.22 or more is considered a positive response.
Timepoint [17] 0 0
Month 6
Secondary outcome [18] 0 0
Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6 - The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based scores for both the SF-36 version 2 (v2) and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status.
Timepoint [18] 0 0
Month 6
Secondary outcome [19] 0 0
Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6 - The SF-36 health survey is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better physical health status.
Timepoint [19] 0 0
Month 6
Secondary outcome [20] 0 0
Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6 - SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 10 items of the physical functioning scale represent levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher physical functioning domain score represents better physical functioning.
Timepoint [20] 0 0
Month 6
Secondary outcome [21] 0 0
Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6 - SF-36v2 acute is a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item role physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; and d) accomplishing less. Items in the role physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role physical domain score represents better role physical functioning.
Timepoint [21] 0 0
Month 6
Secondary outcome [22] 0 0
Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6 - The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher bodily pain domain score represents less bodily pain.
Timepoint [22] 0 0
Month 6
Secondary outcome [23] 0 0
Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6 - The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher general health domain score represents better general health perceptions.
Timepoint [23] 0 0
Month 6
Secondary outcome [24] 0 0
Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6 - The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher vitality domain score represents better vitality.
Timepoint [24] 0 0
Month 6
Secondary outcome [25] 0 0
Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6 - The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher social functioning domain score represents better social functioning.
Timepoint [25] 0 0
Month 6
Secondary outcome [26] 0 0
Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6 - The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 3-item role emotional scale assesses mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher role emotional domain score represents better role emotional functioning.
Timepoint [26] 0 0
Month 6
Secondary outcome [27] 0 0
Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6 - The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based scores for both the SF-36 v2 and SF-36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher mental health domain score represents better mental health functioning.
Timepoint [27] 0 0
Month 6
Secondary outcome [28] 0 0
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6 - The WPAI: Rheumatoid Arthritis is a 6 item questionnaire that is specific for rheumatoid arthritis and yields four types of scores: absenteeism, presenteesism (impairment at work/reduced job effectiveness), work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages ranging from 0 to 100, with higher numbers indicating greater impairment and less productivity.
Timepoint [28] 0 0
Month 6
Secondary outcome [29] 0 0
Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6 - The EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). This profile of scores across the 5-dimensions (e.g. 11231, 33212, etc.) is transformed into a single health utility score using a formula developed by the EuroQol Group that applies country specific preference weights. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. The VAS component rated the current health state on a scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicating a better health state.
Timepoint [29] 0 0
Month 6
Secondary outcome [30] 0 0
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6 - FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Timepoint [30] 0 0
Month 6

Eligibility
Key inclusion criteria
- Have moderate to severe rheumatoid arthritis

- On methotrexate but inadequately controlled

- Subjects must not have active tuberculosis or an inadequately treated tuberculosis
infection

- Subjects must use contraception
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects who have been previously treated with adalimumab or Tofacitinib

- Subjects with any current malignancy or a history of malignancy, with the exception of
adequately treated or excised non metastatic basal cell or squamous cell cancer of the
skin or cervical carcinoma in situ.

- Subjects with specific laboratory test abnormalities

- Subjects with specific types of infections

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Pacific Private Clinic - Southport
Recruitment hospital [3] 0 0
QML Pathology - Southport
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [5] 0 0
Emeritus Research - Malvern East
Recruitment hospital [6] 0 0
RK Will Pty Ltd - Victoria Park
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment postcode(s) [3] 0 0
5011 - Woodville South
Recruitment postcode(s) [4] 0 0
3145 - Malvern East
Recruitment postcode(s) [5] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
North Dakota
Country [17] 0 0
United States of America
State/province [17] 0 0
Oklahoma
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Tucuman
Country [25] 0 0
Argentina
State/province [25] 0 0
San Juan
Country [26] 0 0
Bosnia and Herzegovina
State/province [26] 0 0
Republika Srpska
Country [27] 0 0
Bosnia and Herzegovina
State/province [27] 0 0
Tuzla
Country [28] 0 0
Bulgaria
State/province [28] 0 0
Pleven
Country [29] 0 0
Bulgaria
State/province [29] 0 0
Plovdiv
Country [30] 0 0
Bulgaria
State/province [30] 0 0
Ruse
Country [31] 0 0
Bulgaria
State/province [31] 0 0
Shumen
Country [32] 0 0
Bulgaria
State/province [32] 0 0
Sofia
Country [33] 0 0
Bulgaria
State/province [33] 0 0
Targovisthe
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Chile
State/province [36] 0 0
Metropolitana
Country [37] 0 0
Chile
State/province [37] 0 0
Valparaiso
Country [38] 0 0
Chile
State/province [38] 0 0
X Region
Country [39] 0 0
Czechia
State/province [39] 0 0
Czech Republic
Country [40] 0 0
Czechia
State/province [40] 0 0
Brno
Country [41] 0 0
Czechia
State/province [41] 0 0
Ceska Lipa
Country [42] 0 0
Czechia
State/province [42] 0 0
Ostrava- Moravska Ostrava
Country [43] 0 0
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as
compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy
compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes
measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab.
To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or
adalimumab.
Trial website
https://clinicaltrials.gov/show/NCT02187055
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications