Clinical trial NCT00424294: A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8
timeFrame: Week 1, 2, 4, 8
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
timeFrame: Week 1, 2, 4, 8, 12
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
timeFrame: Week 1, 2, 4, 8, 12
measure: Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 8, 12
measure: Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 8, 12
measure: Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 8, 12
measure: Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 8, 12
measure: Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 8, 12
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 8, 12
measure: Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 8, 12
measure: Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 8, 12
measure: Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12
timeFrame: Baseline, Week 1, 2, 4, 8, 12
measure: Number of Participants Who Withdrew From Study Due to Lack of Efficacy
timeFrame: Baseline up to Week 12
measure: Time to Withdrawal Due to Lack of Efficacy
timeFrame: Baseline up to Week 12
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Baseline up to Week 13
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last dose
measure: Number of Adverse Events by Severity
timeFrame: Baseline up to 28 days after last dose
measure: Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91
timeFrame: Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91
measure: Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91
timeFrame: Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91
measure: Number of Participants With Abnormal Electrocardiogram (ECG)
timeFrame: Baseline up to Week 12
measure: Number of Participants With Categorical Vital Signs Data
timeFrame: Baseline, Week 12
Locations:
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Upland
country: United States
facility: Pfizer Investigational Site
state: California
city: Boca Raton
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Dunedin
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lake Mary
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miramar
country: United States
facility: Pfizer Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orange City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Port Richey
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Sarasota
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Venice
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Moline
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Munster
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Covington
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Frederick
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Tupelo
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Olean
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Philladelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Knoxville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Killeen
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Ogden
country: United States
facility: Pfizer Investigational Site
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: