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Trial record 1 of 2 for:    a3921040
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Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan

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ClinicalTrials.gov Identifier: NCT00687193
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : December 25, 2012
Last Update Posted : March 25, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 22, 2008
First Posted Date  ICMJE May 30, 2008
Results First Submitted Date  ICMJE November 26, 2012
Results First Posted Date  ICMJE December 25, 2012
Last Update Posted Date March 25, 2013
Study Start Date  ICMJE March 2009
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2012)
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: Week 12 ]
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; 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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2008)
ACR 20 responder rate at Week 12 [ Time Frame: At week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2013)
  • Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 2, 4 and 8 [ Time Frame: Week 2, 4, and 8 ]
    ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in painful and tender joint count; >= 20% improvement in swollen joint count; 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)at each visit.
  • Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response [ Time Frame: Week 2, 4, 8 and 12 ]
    ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in painful and tender joint count; >= 50% improvement in swollen joint count; 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 Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.
  • Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response [ Time Frame: Week 2, 4, 8 and 12 ]
    ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in painful and tender joint count; >= 70% improvement in swollen joint count; 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 Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP) at each visit.
  • Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response [ Time Frame: Week 2, 4, 8 and 12 ]
    ACR90 response: greater than or equal to (>=) 90 percent (%) improvement in painful and tender joint count; >= 90% improvement in swollen joint count; and >= 90% 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) at each visit.
  • Change From Baseline in Disease Activity Score Based on 28-Joints Count Using C-reactive Protein [DAS28-3(CRP)] [ Time Frame: Baseline, Week 2, 4, 8 and 12 ]
    The DAS28-3 (CRP) score is a measure of the perticipant's disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints) and CRP. DAS28-3 (CRP) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity. Change = value at observation minus value at baseline
  • Change From Baseline in Disease Activity Score Based on 28-Joints Count Using Erythrocyte Sedimentation Rate [DAS28-4(ESR)] [ Time Frame: Baseline, Week 2, 4, 8 and 12 ]
    The DAS28-4 (ESR) score is a measure of the participant's disease activity. It is based on the painful and tender joint count (28 joints), swollen joint count (28 joints), participant's global assessment of disease activity (mm), and ESR. DAS28-4(ESR) scores range from 0 - 10; higher scores indicated greater affectation due to disease activity. Change = score at observation minus score at baseline.
  • Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, Week 2, 4, 8 and 12 ]
    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 = score at observation minus score at baseline.
  • Change From Baseline in Painful and Tender Joint Counts [ Time Frame: Baseline, Weeks 2, 4, 8 and 12 ]
    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. Change = value at observation minus value at baseline.
  • Change From Baseline in Swollen Joint Count (SJC) [ Time Frame: Baseline, Week 2, 4, 8 and 12 ]
    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. Change = value at observation minus value at baseline.
  • Change From Baseline in Patient's Assessment of Pain [ Time Frame: Baseline, Week 2, 4, 8 and 12 ]
    Change from Baseline in Patient's Assessment of Arthritis Pain -VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) was computed as Week 2, 4, 8 or 12 values minus baseline value. A negative value in change from baseline indicates an improvement. Change = value at observation minus value at baseline.
  • Change From Baseline in Patient's Global Assessment of Arthritis [ Time Frame: Baseline, Week 2, 4, 8 and 12 ]
    Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm Visual Analog Scale where 0 = very well and 100 = very poorly. Change = score at observation minus score at baseline.
  • Change From Baseline in Physician's Global Assessment of Arthritis [ Time Frame: Baseline, Week 2, 4, 8 and 12 ]
    Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity; very good and 100 mm = worst disease activity; very poor. Change = score at observation minus score at baseline.
  • Change From Baseline in C- Reactive Protein (CRP) (mg/L) [ Time Frame: Baseline, Week 2, 4, 8 and 12 ]
    The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change = value at observation minus value at baseline.
  • Area Under Curve (AUC) for Change From Baseline in American College of Rheumatology-N (ACR-N) [ Time Frame: Baseline, Week 12 ]
    ACR-N = calculated for each participant by taking lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of remaining 5 components of 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 AUC for ACR-N is measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute AUC.
  • Change From Baseline in Euro Quality of Life (EQ-5D) [ Time Frame: Baseline, Week 12 ]
    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 = score at Week 12 minus score at baseline.
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Physical Functioning Domain [ Time Frame: Baseline, Week 12 ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Physical Domain [ Time Frame: Baseline, Week 12 ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Bodily Pain Domain [ Time Frame: Baseline, Week 12 ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -General Health Domain [ Time Frame: Baseline, Week 12 ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Vitality Domain [ Time Frame: Baseline, Week 12 ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change =score at Week 12 minus score at baseline
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Social Functioning Domain [ Time Frame: Baseline, Week 12 ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Role-Emotional Domain [ Time Frame: Baseline, Week 12 ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) -Mental Health Domain [ Time Frame: Baseline, Week 12 ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Physical Component Summary (PCS) [ Time Frame: Baseline, Week 12 ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
  • Change From Baseline in 36-Item Short-Form Health Survey (SF-36) - Mental Component Summary (MCS) [ Time Frame: Baseline, Week 12 ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Change = score at Week 12 minus score at baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2008)
  • DAS28-3 (CRP), DAS28-4 (ESR) [ Time Frame: At multiple time ]
  • ACR 20, 50, 70, and 90 Responder rates , area under the ACR-N curve at all timepoints. Observed values and changes from baseline of the 7 components of the ACR Core set. [ Time Frame: At multiple time ]
  • QOL assessments (SF-36, HAQ-DI, EQ-5D) [ Time Frame: At multiple time ]
  • Incidence and severity of AEs and lab test abnormalities, vital signs, ECG [ Time Frame: At multiple time ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARD
Brief Summary To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for the treatment of signs and symptoms in patients with active RA who failed an adequate trial of therapy with at least 1 DMARD in a 12-week therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: Placebo
    Placebo BID, 3 blinded tablets administered BID for 12 weeks
  • Drug: CP-690,550
    10mg BID, 3 blinded tablets administered BID for 12 weeks
  • Drug: CP-690,550
    15mg BID, 3 blinded tablets administered BID for 12 weeks
  • Drug: CP-690,550
    1mg BID, 3 blinded tablets administered BID for 12 weeks
  • Drug: CP-690,550
    3mg BID, 3 blinded tablets administered BID for 12 weeks
  • Drug: CP-690,550
    5mg BID, 3 blinded tablets administered BID for 12 weeks
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: CP-690,550, 10mg
    Intervention: Drug: CP-690,550
  • Experimental: CP-690,550, 15mg
    Intervention: Drug: CP-690,550
  • Experimental: CP-690,550, 1mg
    Intervention: Drug: CP-690,550
  • Experimental: CP-690,550, 3mg
    Intervention: Drug: CP-690,550
  • Experimental: CP-690,550, 5mg
    Intervention: Drug: CP-690,550
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2010)
318
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2008)
300
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have failed an adequate trial of therapy with at least 1 DMARD due to lack of efficacy or toxicity.

Exclusion Criteria:

  • Current therapy with any DMARD
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00687193
Other Study ID Numbers  ICMJE A3921040
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP