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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00424294

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Celecoxib

U.S. FDA Resources

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 ]

Estimated Enrollment:	120
Study Start Date:	June 2006
Estimated Study Completion Date:	March 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Celecoxib: Active Comparator 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.
CP-195,543: Experimental 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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A7701005
Study First Received:	January 18, 2007
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00424294 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Anti-Inflammatory Agents
Immunologic Factors
Arthritis, Rheumatoid
Folate
Vitamin B9
Signs and Symptoms
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Celecoxib
Autoimmune Diseases
Joint Diseases
Cyclooxygenase Inhibitors
Rheumatic Diseases
Folic Acid Antagonists
Folinic Acid
Immunosuppressive Agents
Folic Acid
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Abortifacient Agents
Connective Tissue Diseases

Methotrexate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Celecoxib
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 02, 2009