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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294 United States
Contact
1-800-718-1021
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

- 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.

NCT00960440
Pfizer
Completed
Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

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Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • 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
  • 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
399
March 2011
March 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Brazil,   Canada,   France,   Germany,   Ireland,   Italy,   Korea, Republic of,   Puerto Rico,   Spain,   Taiwan,   United States
United Kingdom
 
NCT00960440
A3921032
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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