Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

NCT00960440

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arthritis, Rheumatoid
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

- Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.

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


- Pregnancy, severe acute or chronic medical conditions, including serious infections or
clinically significant laboratory abnormalities.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors
Official Title  ICMJE Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors
Brief Summary This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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: CP-690,550
    Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.
  • Drug: CP-690,550
    Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.
  • Drug: Placebo
    Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.
    Other Name: double-blind, placebo-controlled phase
  • Drug: CP-690,550
    Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period.
    Other Name: double-blind, extension phase
  • Drug: Placebo
    Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period.
    Other Name: double-blind, placebo-controlled phase
  • Drug: CP-690,550
    Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.
    Other Name: double-blind, extension phase
Study Arms  ICMJE
  • Experimental: Sequence 1
    Intervention: Drug: CP-690,550
  • Experimental: Sequence 2
    Intervention: Drug: CP-690,550
  • Placebo Comparator: Sequence 3
    Interventions:
    • Drug: Placebo
    • Drug: CP-690,550
  • Placebo Comparator: Sequence 4
    Interventions:
    • Drug: Placebo
    • 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: November 5, 2012)
399
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2009)
400
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.

Exclusion Criteria:

  • Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
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 Australia,   Austria,   Belgium,   Brazil,   Canada,   France,   Germany,   Ireland,   Italy,   Korea, Republic of,   Puerto Rico,   Spain,   Taiwan,   United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00960440
Other Study ID Numbers  ICMJE A3921032
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 CenterPfizer
PRS Account Pfizer
Verification Date November 2018

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