Frederick, Maryland 21702

  • Arthritis, Rheumatoid

Purpose:

This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 Rheumatoid Arthritis studies.


Criteria:

Inclusion Criteria: - The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria. - The patient has active disease at both Screening and Baseline, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory - Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity. - No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis. - Patient has washed out of all DMARDs other that antimalarials Exclusion Criteria: - Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3.0 x 109/L; 3. Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/L - History of any other autoimmune rheumatic disease other than Sjogren's syndrome - No malignancy or history of malignancy. - History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug


Study is Available At:


Original ID:

A3921045


NCT ID:

NCT00814307


Secondary ID:


Study Acronym:


Brief Title:

A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis


Official Title:

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

4


Number of Groups:

0


Total Enrollment:

652


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:February 2009
Completion Date:June 2010
Completion Type:Actual
Primary Completion Date:June 2010
Primary Completion Type:Actual
Verification Date:November 2010
Last Changed Date:November 18, 2010
First Received Date:December 22, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:American College of Rheumatology 20 (ACR20) responder rate versus placebo
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Mean change from baseline in vital signs (blood pressure, heart rate, and oral, temporal or tympanic temperature preferred) measurements
Time Frame:All time points
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:MOS Sleep scale
Time Frame:Months 1 ,3,6 and early termination
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:FACIT Fatigue scale
Time Frame:Months 1 ,3,6 and early termination
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Euro Qol EQ 5D scale
Time Frame:Months 1 ,3,6 and early termination
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:RA Healthcare Resource Utilization Questionnaire
Time Frame:Months 1 ,3,6 and early termination
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Work Limitations Questionnaire
Time Frame:Months 1 ,3,6 and early termination
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of Days required for a >1 day CONSECUTIVE sequential decrease in: - Patient Assessment of Arthritis Pain; - Patient Global Assessment of Arthritis.
Time Frame:2 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Summary of changes in physical examination compared to baseline by subject
Time Frame:All time points
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Incidence and severity of clinical laboratory abnormalities
Time Frame:All time points
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:SF-36
Time Frame:Months 1 ,3, 6 nd early termination
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:HAQ-DI
Time Frame:All time points
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:DAS 28
Time Frame:All time points
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:ACR70 responder rates
Time Frame:All time points
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:ACR50 responder rates
Time Frame:All time points
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:ACR20 responder rates
Time Frame:All time points
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence and severity of adverse events
Time Frame:All time points
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Compare the rate of achieving DAS28DAS28 4(ESR) <2.6 with placebo
Time Frame:3 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change from baseline in the Health Assessment Questionnaire (HAQ DI)
Time Frame:3 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:CP-690,550
Description:5mg CP-690,550 BID PO for 6 months
Arm Name:Active 5mg
Intervention Type:Drug
Name:CP-690,550
Description:10 mg CP-690,550 BID PO for 6 months
Arm Name:Active 10 mg
Intervention Type:Drug
Name:Placebo
Description:Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit
Arm Name:Placebo Sequence 1
Intervention Type:Drug
Name:Placebo
Description:Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit
Arm Name:Placebo Sequence 2

Study Arms

Study Arm Type:Experimental
Arm Name:Active 5mg
Study Arm Type:Experimental
Arm Name:Active 10 mg
Study Arm Type:Placebo Comparator
Arm Name:Placebo Sequence 1
Study Arm Type:Placebo Comparator
Arm Name:Placebo Sequence 2

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.