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

This study has been terminated.
(See Detailed Description field)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00424294
First received: January 18, 2007
Last updated: March 24, 2011
Last verified: March 2011
  Purpose

To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in subjects with rheumatoid arthritis


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: CP-195,543
Drug: celecoxib
Drug: Methotrexate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • ACR 20 response rate after 12 weeks of treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ACR 20 response rate at Weeks 1, 2, 4 and 8 [ Time Frame: Weeks 1,2,4,8 ] [ Designated as safety issue: No ]
  • The following at Weeks 1, 2, 4, 8 and 12: [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • ACR 50/70 response rate [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Tender/painful Joint count (28) [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Swollen joint count (28) [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Physician's Global Assessment of Arthritic Condition [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Patient's Assessment of Arthritic Pain (VAS) [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Disease Activity Score (DAS28-3 (CRP)) [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Duration of Morning Stiffness [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Patient's Global Assessment of Arthritic Condition [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • CRP [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Overall incidence and time to withdrawal due to lack of efficacy will be analyzed. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: June 2006
Study Completion Date: February 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Celecoxib
Celecoxib with placebo therapy.
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.
Methotrexate
Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.
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.
Experimental: CP-195,543
CP-195,543 and Celecoxib dual therapy.
Drug: CP-195,543
CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424294

  Show 39 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00424294     History of Changes
Other Study ID Numbers: A7701005
Study First Received: January 18, 2007
Last Updated: March 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Celecoxib
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal

ClinicalTrials.gov processed this record on August 28, 2014