Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis

A Phase 2B, Randomized, Double Blind, Placebo-Controlled, Multicenter Study To Compare 6 Dose Regimens Of CP-690,550 Vs. Placebo, Each Combined With Methotrexate, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate Alone

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with active rheumatoid arthritis.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Other: placebo; Drug: CP-690,550; Drug: CP-690,550

• Study Type: Interventional
• Enrollment (Actual): 509
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Pfizer Investigational Site
  • Buenos Aires, Argentina, C1034ACO
    • Pfizer Investigational Site
  • Buenos Aires, Argentina, C1013AAR
    • Pfizer Investigational Site
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, (C1117ABH)
      • Pfizer Investigational Site
• Brazil
  • GO
    • Goiania, GO, Brazil, 74110-120
      • Pfizer Investigational Site
    • Goiânia, GO, Brazil, 74043-110
      • Pfizer Investigational Site
  • PR
    • Curitiba, PR, Brazil, 80060-900
      • Pfizer Investigational Site
    • Curitiba, PR, Brazil, 80060-240
      • Pfizer Investigational Site
  • SP
    • Sao Paulo, SP, Brazil, 04230-000
      • Pfizer Investigational Site
    • São Paulo, SP, Brazil, 05403-010
      • Pfizer Investigational Site
• Bulgaria
  • Sofia, Bulgaria, 1709
    • Pfizer Investigational Site
  • Sofia, Bulgaria, 1612
    • Pfizer Investigational Site
  • Sofia 1606, Bulgaria
    • Pfizer Investigational Site
• Chile
  • Santiago, Chile
    • Pfizer Investigational Site
  • RM
    • Providencia, RM, Chile
      • Pfizer Investigational Site
    • Santiago, RM, Chile, 7500922
      • Pfizer Investigational Site
  • V Region
    • Viña Del Mar, V Region, Chile, 2570017
      • Pfizer Investigational Site
• Czech Republic
  • Brno, Czech Republic, 656 91
    • Pfizer Investigational Site
  • Ceske Budejovice, Czech Republic, 370 01
    • Pfizer Investigational Site
  • Praha 11 - Chodov, Czech Republic, 148 00
    • Pfizer Investigational Site
  • Praha 2, Czech Republic, 128 50
    • Pfizer Investigational Site
  • Praha 4, Czech Republic, 140 59
    • Pfizer Investigational Site
  • Zlin, Czech Republic, 760 01
    • Pfizer Investigational Site
• Hungary
  • Budapest, Hungary, H-1036
    • Pfizer Investigational Site
  • Komarom, Hungary, H-2921
    • Pfizer Investigational Site
  • Szolnok, Hungary, H-5000
    • Pfizer Investigational Site
  • Veszprem, Hungary, H-8200
    • Pfizer Investigational Site
• Mexico
  • DF
    • Mexico, DF, Mexico, 14000
      • Pfizer Investigational Site
  • Michoacan
    • Morelia, Michoacan, Mexico, 58070
      • Pfizer Investigational Site
• Poland
  • Bialystok, Poland, 15-461
    • Pfizer Investigational Site
  • Bialystok, Poland, 15-950
    • Pfizer Investigational Site
  • Grudziadz, Poland, 86-300
    • Pfizer Investigational Site
  • Poznan, Poland, 60-773
    • Pfizer Investigational Site
  • Sopot, Poland, 81-759
    • Pfizer Investigational Site
  • Warszawa, Poland, 02-256
    • Pfizer Investigational Site
  • Wroclaw, Poland, 50-088
    • Pfizer Investigational Site
• Slovakia
  • Bratislava, Slovakia, 81109
    • Pfizer Investigational Site
  • Piestany, Slovakia, 921 01
    • Pfizer Investigational Site
  • Zilina, Slovakia, 012 07
    • Pfizer Investigational Site
• Spain
  • Guadalajara, Spain, 19002
    • Pfizer Investigational Site
  • Madrid, Spain, 28046
    • Pfizer Investigational Site
  • Sevilla, Spain, 41014
    • Pfizer Investigational Site
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • Pfizer Investigational Site
• Sweden
  • Jonkoping, Sweden, 551 85
    • Pfizer Investigational Site
  • Umea, Sweden, 901 85
    • Pfizer Investigational Site
• Turkey
  • Ankara, Turkey, 06100
    • Pfizer Investigational Site
  • Istanbul, Turkey, 34098
    • Pfizer Investigational Site
  • Izmir, Turkey, 35340
    • Pfizer Investigational Site
  • Izmir, Turkey, 35100
    • Pfizer Investigational Site
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Pfizer Investigational Site
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Pfizer Investigational Site
  • California
    • Upland, California, United States, 91786
      • Pfizer Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80204
      • Pfizer Investigational Site
  • Delaware
    • Newark, Delaware, United States, 19713
      • Pfizer Investigational Site
  • Florida
    • Debary, Florida, United States, 32713
      • Pfizer Investigational Site
    • Lake Mary, Florida, United States, 32746
      • Pfizer Investigational Site
    • Ocala, Florida, United States, 34474
      • Pfizer Investigational Site
    • Orlando, Florida, United States, 32804
      • Pfizer Investigational Site
    • Tampa, Florida, United States, 33614
      • Pfizer Investigational Site
    • Zephyrhills, Florida, United States, 33540
      • Pfizer Investigational Site
  • Illinois
    • Rockford, Illinois, United States, 61107
      • Pfizer Investigational Site
    • Rockford, Illinois, United States, 61103-3692
      • Pfizer Investigational Site
  • Iowa
    • Dubuque, Iowa, United States, 52002
      • Pfizer Investigational Site
  • Maryland
    • Frederick, Maryland, United States, 21702
      • Pfizer Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Pfizer Investigational Site
  • New York
    • Albany, New York, United States, 12206-1043
      • Pfizer Investigational Site
    • Binghamton, New York, United States, 13905
      • Pfizer Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Pfizer Investigational Site
    • Raleigh, North Carolina, United States, 27609
      • Pfizer Investigational Site
  • Ohio
    • Dayton, Ohio, United States, 45402
      • Pfizer Investigational Site
  • Pennsylvania
    • Philladelphia, Pennsylvania, United States, 19118
      • Pfizer Investigational Site
    • West Reading, Pennsylvania, United States, 19611-1124
      • Pfizer Investigational Site
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78705
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75231
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75235
      • Pfizer Investigational Site
    • Mesquite, Texas, United States, 75150
      • Pfizer Investigational Site
  • Washington
    • Seattle, Washington, United States, 98104
      • Pfizer Investigational Site
    • Seattle, Washington, United States, 98122
      • Pfizer Investigational Site
    • Tacoma, Washington, United States, 98405
      • Pfizer Investigational Site
    • Tacoma, Washington, United States, 98405-2308
      • Pfizer Investigational Site
  • Wisconsin
    • Onalaska, Wisconsin, United States, 54650
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Active rheumatoid arthritis
• Inadequate response to stably dosed methotrexate

Exclusion Criteria:

• Current therapy with any DMARD or biologic other than methotrexate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CP 690,550 1 mg BID	Drug: CP-690,550; 4 blinded tablets administered BID; Drug: CP-690,550; Oral tablets
Experimental: CP 690,550 10 mg BID	Drug: CP-690,550; 4 blinded tablets administered BID; Drug: CP-690,550; Oral tablets
Experimental: CP 690,550 15 mg	Drug: CP-690,550; 4 blinded tablets administered BID; Drug: CP-690,550; Oral tablets
Experimental: CP 690,550 3 mg BID	Drug: CP-690,550; 4 blinded tablets administered BID; Drug: CP-690,550; Oral tablets
Experimental: CP 690,550 5 mg BID	Drug: CP-690,550; 4 blinded tablets administered BID; Drug: CP-690,550; Oral tablets
Experimental: CP-690,550 20 mg QD	Drug: CP-690,550; 4 blinded tablets administered BID; Drug: CP-690,550; Oral tablets
Placebo Comparator: Placebo; Dummy tablets	Other: placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12	ACR20 response: >= 20% improvement in tender joints count (TJC); >= 20% improvement in swollen joints count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	ACR20 response: >= 20% improvement in TJC; >= 20% improvement in SJC; and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.	Week 2, 4, 6, 8, 16, 20, 24/Early Termination (ET)
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response	ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.	Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.	Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve	ACR-n: calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. The area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.	Baseline up to Week 2, 4, 6, 8, 12
Tender Joints Count (TJC)	Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET	Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicates an improvement.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Swollen Joints Count (SJC)	Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET	Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from baseline indicates an improvement.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Patient Assessment of Arthritis Pain	Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET	Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Patient Global Assessment (PtGA) of Arthritis	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Physician Global Assessment of Arthritis	Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET	Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Health Assessment Questionnaire-Disability Index (HAQ-DI)	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Change = scores at observation minus score at Baseline, and total possible score ranged from -3 to 3. A negative value in change from baseline indicates an improvement.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
C-Reactive Protein (CRP)	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per deciliter (mg/dL) to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. Normal range of CRP is 0 mg/dL to 10 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and more than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) less than (<) 2.6 = remission.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET	DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.	Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP)	Disease improvement was classified as good, moderate, and none based on improvement in DAS 28-3 (CRP) from baseline and present DAS 28-3 (CRP) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.	Week 2, 4, 6, 8, 12, 16, 20, 24/ET
Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)	DAS28-3 (CRP) defined remission was classified as a score of <2.6.	Week 2, 4, 6, 8, 12, 16, 20, 24/ET
36-Item Short-Form Health Survey (SF-36)	SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).	Baseline, Week 12, 24/ET
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET	SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).	Baseline, Week 12, 24/ET
Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score	EQ-5D: 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). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Baseline, Week 12, 24/ET
Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET	EQ-5D: 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). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Baseline, Week 12, 24/ET
Medical Outcome Study- Sleep Scale (MOS-SS)	Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.	Baseline, Week 2, 12, 24/ET
Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET	Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range*100); total score range: 0 to 100; higher score = greater intensity of attribute.	Baseline, Week 2, 12, 24/ET
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale	FACIT-Fatigue scale (FS) is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the 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-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.	Baseline, Week 2, 12, 24/ET
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET	FACIT-FS is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the 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-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.	Baseline, Week 2, 12, 24/ET

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:
• Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
• Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.
• Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.
• Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14. Erratum In: Ann Rheum Dis. 2017 Mar;76(3):611.
• Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
• Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2.
• Wallenstein GV, Kanik KS, Wilkinson B, Cohen S, Cutolo M, Fleischmann RM, Genovese MC, Gomez Reino J, Gruben D, Kremer J, Krishnaswami S, Lee EB, Pascual-Ramos V, Strand V, Zwillich SH. Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: results of two Phase 2 randomised controlled trials. Clin Exp Rheumatol. 2016 May-Jun;34(3):430-42. Epub 2016 Apr 28.
• Kremer JM, Cohen S, Wilkinson BE, Connell CA, French JL, Gomez-Reino J, Gruben D, Kanik KS, Krishnaswami S, Pascual-Ramos V, Wallenstein G, Zwillich SH. A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone. Arthritis Rheum. 2012 Apr;64(4):970-81. doi: 10.1002/art.33419. Epub 2011 Oct 17.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: December 18, 2006
• First Submitted That Met QC Criteria: December 18, 2006
• First Posted (Estimate): December 20, 2006

Study Record Updates

• Last Update Posted (Estimate): January 18, 2013
• Last Update Submitted That Met QC Criteria: January 14, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: DMARD therapy
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: A3921025