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A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis

Last updated on August 9, 2018

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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

- A diagnosis of RA based upon the American college of Rheumatology 1987 revised
criteria

- Active disease at Screening

- Stable dose of methotrexate between 10-25 mg/week oral or parenteral

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

- A diagnosis of any other inflammatory or secondary, noninflammatory arthritis that, in
the opinion of the Investigator, would interfere with disease activity assessments

- A history of hypersensitivity or allergic type reactions to cyclooxygenase inhibitors,
opiates, aspirin or sulfonamides

NCT00424294
Pfizer
Terminated
A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis

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A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CP-195543 And Celecoxib Dual Therapy In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On Methotrexate
To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in subjects with rheumatoid arthritis
Trial enrollment was prematurely discontinued on December 3, 2007. The results of an interim efficacy and safety analysis demonstrated an overall poor tolerability profile and high discontinuation rate when dual therapy with CP-195543 and Celecoxib was administered. The decision to discontinue further enrollment in the trial was not based on any efficacy or serious safety concerns. Previously enrolled study participants continued in the study and the trial completed on February 27, 2008.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: CP-195,543
    CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.
  • Drug: celecoxib
    Celecoxib is a nonsteroidal anit-inflammatory drug (NSAID) marketed worldwide (in the United States [US] as Celeberex) and approved for the relief of signs and symptoms of osteoarthritis.
  • Drug: Methotrexate
    Methotrexate is a folate analogue that, based on it efficacy and safety in RA, is commonly used as frontline DMARD treatment in patients with moderate to severe disease who do not respond to NSAIDs alone.
  • Active Comparator: Celecoxib
    Celecoxib with placebo therapy.
    Intervention: Drug: celecoxib
  • Methotrexate
    Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.
    Intervention: Drug: Methotrexate
  • Experimental: CP-195,543
    CP-195,543 and Celecoxib dual therapy.
    Intervention: Drug: CP-195,543
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
February 2008
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • A diagnosis of RA based upon the American college of Rheumatology 1987 revised criteria
  • Active disease at Screening
  • Stable dose of methotrexate between 10-25 mg/week oral or parenteral

Exclusion Criteria:

  • A diagnosis of any other inflammatory or secondary, noninflammatory arthritis that, in the opinion of the Investigator, would interfere with disease activity assessments
  • A history of hypersensitivity or allergic type reactions to cyclooxygenase inhibitors, opiates, aspirin or sulfonamides
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00424294
A7701005
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

ICMJE     Data element required by the

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

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