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NCT00814307 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis
A Phase 3 study of Arthritis, Rheumatoid, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 611
- Enrollment target
- 20
- Study locations
NCT00814307: Completed Phase 3 study of Arthritis, Rheumatoid, sponsored by Pfizer.
NCT00814307 is a Phase 3 study of Arthritis, Rheumatoid that has completed, run by Pfizer. The registered enrollment target is 611 participants, roughly in line with the 619-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target. The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00814307, a Phase 3 study of Arthritis, Rheumatoid, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 611 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG CP-690,550
Study Locations (20)
Florida
- Pfizer Investigational Site - Jacksonville
- Pfizer Investigational Site - Sarasota
- Pfizer Investigational Site - Tampa
- Pfizer Investigational Site - Venice
- Pfizer Investigational Site - Zephyrhills
New York
- Pfizer Investigational Site - Albany
- Pfizer Investigational Site - Olean
- Pfizer Investigational Site - Rochester
North Carolina
- Pfizer Investigational Site - Charlotte
- Pfizer Investigational Site - Rocky Mount
- Pfizer Investigational Site - Winston-Salem
Arizona
- Pfizer Investigational Site - Gilbert
- Pfizer Investigational Site - Tucson
Arkansas
- Pfizer Investigational Site - Hot Springs
Illinois
- Pfizer Investigational Site - Rockford
Maryland
- Pfizer Investigational Site - Frederick
Massachusetts
- Pfizer Investigational Site - Hyannis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 611 participants |
| Start Date | 2009-02 |
| Est. Completion | 2010-06 |
| Phase | Phase 3 |
What the finished NCT00814307 record still lists
NCT00814307 is an interventional study that assigns participants to a tested intervention. The registered 611 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 619-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target.
The record links to 1 condition, with Arthritis, Rheumatoid appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00814307 names 20 study sites across 11 states, led by Florida, New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00814307 about?
NCT00814307 is a clinical study titled "A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis". 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 ph...
What is the current status of trial NCT00814307?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 611 participants. The study started on 2009-02. Estimated completion is 2010-06.
What conditions does trial NCT00814307 study?
This clinical trial studies the following conditions: Arthritis, Rheumatoid.
What interventions are being tested in trial NCT00814307?
The interventions under investigation include: Placebo (DRUG), CP-690,550 (DRUG).
Who is sponsoring clinical trial NCT00814307?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00814307 being conducted?
This trial has 20 study locations across Arizona, Arkansas, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00814307's enrollment target sits among peer trials
611 8th of 27 higher than 20 of 27 other Arthritis, Rheumatoid trials
participants (enrollment target), bucketed by value
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