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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mesa, Arizona, 85208 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

- 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

NCT00550446
Pfizer
Completed
A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

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A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis
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
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.)
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • 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)
  • 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
386
January 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Bulgaria,   Chile,   Croatia,   Czech Republic,   Germany,   Greece,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Romania,   Slovakia,   Ukraine,   United States
 
 
NCT00550446
A3921035
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 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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[email protected]



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