A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis
This study has been terminated.
(See Detailed Description field)
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00424294
First received: January 18, 2007
Last updated: March 24, 2011
Last verified: March 2011
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424294
Show 39 Study Locations
Show 39 Study LocationsSponsors 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 May 22, 2013