A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

NCT00550446

Last updated date
Study Location
Pfizer Investigational Site
Mesa, Arizona, 85208, United States
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects must have active rheumatoid arthritis

- Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)

- Subjects must not be currently taking any DMARD other than an antimalarial

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects who discontinued any previous TNF inhibitor therapy for either lack of
benefit or safety.


- Subjects who previously received adalimumab (Humira®) therapy for any reason.


- Subjects with evidence of blood disorders, chronic infections or untreated
tuberculosis

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis
Official Title  ICMJE A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis
Brief Summary The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)
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: Adalimumab
    40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.
  • Drug: CP-690-550
    15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
  • Drug: CP-690-550
    10 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
  • Drug: CP-690-550
    5 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
  • Drug: CP-690,550
    3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
  • Drug: CP-690,550
    1 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
  • Drug: Placebo
    Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: Adalimumab
  • Experimental: 2
    Intervention: Drug: CP-690-550
  • Experimental: 3
    Intervention: Drug: CP-690-550
  • Experimental: 4
    Intervention: Drug: CP-690-550
  • Experimental: 5
    Intervention: Drug: CP-690,550
  • Experimental: 6
    Intervention: Drug: CP-690,550
  • Placebo Comparator: 7
    Intervention: Drug: Placebo
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: November 29, 2012)
386
Original Enrollment  ICMJE
 (submitted: October 25, 2007)
350
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have active rheumatoid arthritis
  • Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)
  • Subjects must not be currently taking any DMARD other than an antimalarial

Exclusion Criteria:

  • Subjects who discontinued any previous TNF inhibitor therapy for either lack of benefit or safety.
  • Subjects who previously received adalimumab (Humira®) therapy for any reason.
  • Subjects with evidence of blood disorders, chronic infections or untreated tuberculosis
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 Brazil,   Bulgaria,   Chile,   Croatia,   Czech Republic,   Germany,   Greece,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Romania,   Slovakia,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00550446
Other Study ID Numbers  ICMJE A3921035
Has Data Monitoring Committee No
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 CenterPfizer
PRS Account Pfizer
Verification Date November 2012

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