Expired Study
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Port Richey, Florida


Purpose:

The immune system normally fights infection, but in diseases like RA, the immune system may be overactive or act incorrectly, leading to inflammation, seen as such things as swelling and pain. Pfizer is developing CP-690,550 as a disease-modifying antirheumatic drug (DMARD-pronounced DEE-mard) for the treatment of RA. The purpose of this type of treatment is to control disease activity, improve symptoms (like swelling and pain), maintain normal, every-day functions and activities, improve physical, emotional, and mental well-being, and slow down joint damage.


Criteria:

Inclusion Criteria: - Subjects With Active RA Who Have Failed Therapy With Either Methotrexate Or A TNF Inhibitor Exclusion Criteria: - Current Therapy With Any DMARD Or Biologic


Study is Available At:


Original ID:

A3921019


NCT ID:

NCT00147498


Secondary ID:


Study Acronym:


Brief Title:

Comparison Of 3 Dose Levels Of CP-690,550 VS. Placebo For Treatment Of Rheumatoid Arthritis


Official Title:

A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheuma


Overall Status:

Completed


Study Phase:

Phase 2


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:

0


Number of Groups:

0


Total Enrollment:

312


Enrollment Type:


Overall Contact Information

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

Study Dates

Start Date:January 2005
Verification Date:November 2006
Last Changed Date:November 10, 2006
First Received Date:September 2, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:The American College of Rheumatology 20 (ACR 20) Responder rate at Week 6
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The American College of Rheumatology 20, 50 and 70 (ACR 20, 50 and 70) Responder rates at Weeks 1, 2, 4, 6 (except for the ACR 20) and 8
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:CP-690,550

Study Arms

There are no available Study Arms

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: January 21, 2020

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