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NCT00650078 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis
A Phase 3 study of Rheumatoid Arthritis, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
- 20
- Study locations
NCT00650078: Completed Phase 3 study of Rheumatoid Arthritis, sponsored by Amgen.
NCT00650078 is a Phase 3 study of Rheumatoid Arthritis that has completed, run by Amgen. The registered enrollment target is 350 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00650078, a Phase 3 study of Rheumatoid Arthritis, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to compare the safety and efficacy, with regards to the signs and symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease Modifying Anti-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.
Primary Outcome
Responders were defined as patients whose improvement from baseline to Visit 4 (Week 12) fulfilled all 3 of the following criteria: * \> 20% reduction in the tender joint count (0-28) * \> 20% reduction in the swollen joint count (0-28) * \> 20% reduction in 3 out of the 5 following additional measures: * Patient's assessment of pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Functional Disability Index of the Health Assessme
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MR prednisone
Study Locations (20)
California
- The National Institute of Clinical Research - Los Angeles
- University of California, Los Angeles - Los Angeles
- Blue Hill Medical Group - Pacific Palisades
- San Diego Arthritis Medical Clinic - San Diego
- Boling Clinical Trials - Upland
Florida
- Arthritis Center - Palm Harbor
- West Broward Rheumatology Associates, Inc. - Tamarac
- Southwest Florida Clinical Research Center - Tampa
- Tampa Medical Group, PA - Tampa
- Geodyssey Research, LLC - Vero Beach
Colorado
- Lynn Institute of the Rockies - Colorado Springs
- Front Range Clinical Research - Wheat Ridge
Alabama
- Rheumatology Associates of N. AL, P.C. - Huntsville
Arizona
- ArthoCare, Arthritis Care & Research, P.C. - Phoenix
Illinois
- The Arthritis Center - Springfield
Kentucky
- Center for Arthritis and Osteoporosis - Elizabethtown
Massachusetts
- Phase III Clinical Research - Fall River
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2008-03 |
| Est. Completion | 2009-05 |
| Phase | Phase 3 |
What the finished NCT00650078 record still lists
NCT00650078 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00650078 names 20 study sites across 11 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT00650078 about?
NCT00650078 is a clinical study titled "Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis". The purpose of the study is to compare the safety and efficacy, with regards to the signs and symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease Modifying Anti-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.
What is the current status of trial NCT00650078?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2008-03. Estimated completion is 2009-05.
What conditions does trial NCT00650078 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT00650078?
The interventions under investigation include: Placebo (DRUG), MR prednisone (DRUG).
Who is sponsoring clinical trial NCT00650078?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00650078 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00650078's enrollment target sits among peer trials
350 54th of 197 higher than 144 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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