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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00413660
First received: December 18, 2006
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: CP-690,550
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response [ Time Frame: Week 2, 4, 6, 8, 16, 20, 24/Early Termination (ET) ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response [ Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response [ Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve [ Time Frame: Baseline up to Week 2, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
    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.

  • Tender Joints Count (TJC) [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Tender Joints Count (TJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Swollen Joints Count (SJC) [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Swollen Joints Count (SJC) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Patient Assessment of Arthritis Pain [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Patient Global Assessment (PtGA) of Arthritis [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Physician Global Assessment of Arthritis [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

  • Change From Baseline in Physician Global Assessment of Arthritis at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.

  • Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • C-Reactive Protein (CRP) [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in C-Reactive Protein (CRP) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Categorization of Disease Improvement Based on DAS28-3 (CRP) [ Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Disease Remission Based on DAS28-3 (CRP) [ Time Frame: Week 2, 4, 6, 8, 12, 16, 20, 24/ET ] [ Designated as safety issue: No ]
    DAS28-3 (CRP) defined remission was classified as a score of <2.6.

  • 36-Item Short-Form Health Survey (SF-36) [ Time Frame: Baseline, Week 12, 24/ET ] [ Designated as safety issue: No ]
    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).

  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET [ Time Frame: Baseline, Week 12, 24/ET ] [ Designated as safety issue: No ]
    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).

  • Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility Score [ Time Frame: Baseline, Week 12, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Euro Quality of Life-5 Dimentions (EQ-5D) - Health State Profile Utility at Week 12 and 24/ET [ Time Frame: Baseline, Week 12, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Medical Outcome Study- Sleep Scale (MOS-SS) [ Time Frame: Baseline, Week 2, 12, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET [ Time Frame: Baseline, Week 2, 12, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale [ Time Frame: Baseline, Week 2, 12, 24/ET ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET [ Time Frame: Baseline, Week 2, 12, 24/ET ] [ Designated as safety issue: No ]
    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.


Enrollment: 509
Study Start Date: January 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CP 690,550 1 mg BID Drug: CP-690,550
4 blinded tablets administered BID
Experimental: CP 690,550 10 mg BID Drug: CP-690,550
4 blinded tablets administered BID
Experimental: CP 690,550 15 mg Drug: CP-690,550
4 blinded tablets administered BID
Experimental: CP 690,550 3 mg BID Drug: CP-690,550
4 blinded tablets administered BID
Experimental: CP 690,550 5 mg BID Drug: CP-690,550
4 blinded tablets administered BID
Experimental: CP-690,550 20 mg QD Drug: CP-690,550
Oral tablets
Placebo Comparator: Placebo
Dummy tablets
Other: placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Active rheumatoid arthritis
  • Inadequate response to stably dosed methotrexate

Exclusion Criteria:

  • Current therapy with any DMARD or biologic other than methotrexate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413660

  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
Gilbert, Arizona, United States, 85234
United States, Arkansas
Pfizer Investigational Site
Hot Springs, Arkansas, United States, 71913
United States, California
Pfizer Investigational Site
Upland, California, United States, 91786
United States, Colorado
Pfizer Investigational Site
Denver, Colorado, United States, 80204
United States, Delaware
Pfizer Investigational Site
Newark, Delaware, United States, 19713
United States, Florida
Pfizer Investigational Site
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
United States, Illinois
Pfizer Investigational Site
Rockford, Illinois, United States, 61103-3692
Pfizer Investigational Site
Rockford, Illinois, United States, 61107
United States, Iowa
Pfizer Investigational Site
Dubuque, Iowa, United States, 52002
United States, Maryland
Pfizer Investigational Site
Frederick, Maryland, United States, 21702
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, New York
Pfizer Investigational Site
Albany, New York, United States, 12206-1043
Pfizer Investigational Site
Binghamton, New York, United States, 13905
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210
Pfizer Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
Pfizer Investigational Site
Dayton, Ohio, United States, 45402
United States, Pennsylvania
Pfizer Investigational Site
Philladelphia, Pennsylvania, United States, 19118
Pfizer Investigational Site
West Reading, Pennsylvania, United States, 19611-1124
United States, South Carolina
Pfizer Investigational Site
Greenville, South Carolina, United States, 29601
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Dallas, Texas, United States, 75235
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Pfizer Investigational Site
Mesquite, Texas, United States, 75150
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98122
Pfizer Investigational Site
Seattle, Washington, United States, 98104
Pfizer Investigational Site
Tacoma, Washington, United States, 98405-2308
Pfizer Investigational Site
Tacoma, Washington, United States, 98405
United States, Wisconsin
Pfizer Investigational Site
Onalaska, Wisconsin, United States, 54650
Argentina
Pfizer Investigational Site
Capital Federal, Buenos Aires, Argentina, (C1117ABH)
Pfizer Investigational Site
Buenos Aires, Argentina, C1013AAR
Pfizer Investigational Site
Buenos Aires, Argentina, C1034ACO
Pfizer Investigational Site
Buenos Aires, Argentina, C1426ABP
Brazil
Pfizer Investigational Site
Goiania, GO, Brazil, 74110-120
Pfizer Investigational Site
Goiânia, GO, Brazil, 74043-110
Pfizer Investigational Site
Curitiba, PR, Brazil, 80060-240
Pfizer Investigational Site
Curitiba, PR, Brazil, 80060-900
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04230-000
Pfizer Investigational Site
São Paulo, SP, Brazil, 05403-010
Bulgaria
Pfizer Investigational Site
Sofia, Bulgaria, 1612
Pfizer Investigational Site
Sofia, Bulgaria, 1709
Pfizer Investigational Site
Sofia 1606, Bulgaria
Chile
Pfizer Investigational Site
Providencia, RM, Chile
Pfizer Investigational Site
Santiago, RM, Chile, 7500922
Pfizer Investigational Site
Viña Del Mar, V Region, Chile, 2570017
Pfizer Investigational Site
Santiago, Chile
Czech Republic
Pfizer Investigational Site
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
Hungary
Pfizer Investigational Site
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
Mexico
Pfizer Investigational Site
Mexico, DF, Mexico, 14000
Pfizer Investigational Site
Morelia, Michoacan, Mexico, 58070
Poland
Pfizer Investigational Site
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
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 81109
Pfizer Investigational Site
Piestany, Slovakia, 921 01
Pfizer Investigational Site
Zilina, Slovakia, 012 07
Spain
Pfizer Investigational Site
Santiago de Compostela, A Coruña, Spain, 15706
Pfizer Investigational Site
Guadalajara, Spain, 19002
Pfizer Investigational Site
Madrid, Spain, 28046
Pfizer Investigational Site
Sevilla, Spain, 41014
Sweden
Pfizer Investigational Site
Jonkoping, Sweden, 551 85
Pfizer Investigational Site
Umea, Sweden, 901 85
Turkey
Pfizer Investigational Site
Ankara, Turkey, 06100
Pfizer Investigational Site
Istanbul, Turkey, 34098
Pfizer Investigational Site
Izmir, Turkey, 35340
Pfizer Investigational Site
Izmir, Turkey, 35100
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00413660     History of Changes
Other Study ID Numbers: A3921025
Study First Received: December 18, 2006
Results First Received: December 4, 2012
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
DMARD therapy

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Tofacitinib
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014