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

NCT00424294 | Terminated Phase 2 Results DMC

• 1 other identifier: A7701005
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 39

Brief Summary

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

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

  ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

  Week 12

Secondary Outcomes (15)

• Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8

  Week 1, 2, 4, 8

• Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

  Week 1, 2, 4, 8, 12

• Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

  Week 1, 2, 4, 8, 12

• Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12

  Baseline, Week 1, 2, 4, 8, 12

• Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12

  Baseline, Week 1, 2, 4, 8, 12

Other Outcomes (6)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to 28 days after last dose

• Number of Adverse Events by Severity

  Baseline up to 28 days after last dose

• Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91

  Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91

Study Arms (3)

Celecoxib

ACTIVE COMPARATOR

Celecoxib with placebo therapy.

Drug: celecoxib

Methotrexate

OTHER

Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.

Drug: Methotrexate

CP-195,543

EXPERIMENTAL

CP-195,543 and Celecoxib dual therapy.

Drug: CP-195,543

Interventions

CP-195,543 DRUG

CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.

CP-195,543

celecoxib DRUG

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.

Celecoxib

Methotrexate DRUG

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.

Methotrexate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (39)

Pfizer Investigational Site

Huntsville, Alabama, 35801, United States

Location

Pfizer Investigational Site

Scottsdale, Arizona, 85251, United States

Location

Pfizer Investigational Site

Upland, California, 91786, United States

Location

Pfizer Investigational Site

Boca Raton, Florida, 33486, United States

Location

Pfizer Investigational Site

Clearwater, Florida, 33765, United States

Location

Pfizer Investigational Site

Dunedin, Florida, 34698, United States

Location

Pfizer Investigational Site

Fort Lauderdale, Florida, 33334, United States

Location

Pfizer Investigational Site

Lake Mary, Florida, 32746, United States

Location

Pfizer Investigational Site

Miramar, Florida, 33025, United States

Location

Pfizer Investigational Site

New Port Richey, Florida, 34652, United States

Location

Pfizer Investigational Site

Orange City, Florida, 32763, United States

Location

Pfizer Investigational Site

Orlando, Florida, 32804, United States

Location

Pfizer Investigational Site

Port Richey, Florida, 34668, United States

Location

Pfizer Investigational Site

Sarasota, Florida, 34233, United States

Location

Pfizer Investigational Site

Sarasota, Florida, 34239, United States

Location

Pfizer Investigational Site

Tampa, Florida, 33614-7118, United States

Location

Pfizer Investigational Site

Venice, Florida, 34292, United States

Location

Pfizer Investigational Site

Vero Beach, Florida, 32960, United States

Location

Pfizer Investigational Site

Moline, Illinois, 61265, United States

Location

Pfizer Investigational Site

Springfield, Illinois, 62704, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46250, United States

Location

Pfizer Investigational Site

Munster, Indiana, 46321, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40504, United States

Location

Pfizer Investigational Site

Covington, Louisiana, 70433, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70115, United States

Location

Pfizer Investigational Site

Frederick, Maryland, 21702, United States

Location

Pfizer Investigational Site

Kalamazoo, Michigan, 49009, United States

Location

Pfizer Investigational Site

Tupelo, Mississippi, 38801, United States

Location

Pfizer Investigational Site

Springfield, Missouri, 65807, United States

Location

Pfizer Investigational Site

Olean, New York, 14760, United States

Location

Pfizer Investigational Site

Rochester, New York, 14618, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73139, United States

Location

Pfizer Investigational Site

Philladelphia, Pennsylvania, 19118, United States

Location

Pfizer Investigational Site

Knoxville, Tennessee, 37909-1600, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38119, United States

Location

Pfizer Investigational Site

Houston, Texas, 77090, United States

Location

Pfizer Investigational Site

Killeen, Texas, 76549, United States

Location

Pfizer Investigational Site

San Antonio, Texas, 78217, United States

Location

Pfizer Investigational Site

Ogden, Utah, 84403, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Celecoxib; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The study was terminated early because it was determined that the dual therapy with CP-195543 and celecoxib had poor tolerability and a high discontinuation rate.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2007
• First Posted: January 19, 2007
• Study Start: June 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: February 1, 2008
• Last Updated: September 25, 2014
• Results First Posted: September 25, 2014

Record last verified: 2014-09

Locations

US (39)