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A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Huntsville, Alabama, 35801 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

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.

NCT00847613
Pfizer
Completed
A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

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A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.
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 (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
    Other Name: Double-blind, placebo-controlled period
  • Drug: CP-690,550
    Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.
    Other Name: Double-blind, Active Extension Period
  • Drug: CP-690,550
    Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
    Other Name: Double-blind, placebo-controlled period
  • Drug: CP-690,550
    Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.
    Other Name: Double-blind, Active Extension Period
  • Drug: Placebo
    Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
    Other Name: Double-blind, placebo-controlled period
  • Drug: Placebo
    Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
    Other Name: Double-blind, Active Extension Period
  • Drug: CP-690,550
    Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.
    Other Name: Double-blind, placebo-controlled period
  • Experimental: Sequence 1
    Interventions:
    • Drug: CP-690,550
    • Drug: CP-690,550
  • Experimental: Sequence 2
    Interventions:
    • Drug: CP-690,550
    • 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
800
February 2012
April 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate

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,   Brazil,   Bulgaria,   Canada,   Colombia,   Czech Republic,   Greece,   India,   Japan,   Korea, Republic of,   Mexico,   Poland,   Taiwan,   Ukraine,   United States
Venezuela
 
NCT00847613
A3921044
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the

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

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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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