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NCT00551707 · ClinicalTrials.gov registry record · Phase 2
Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis
A Phase 2 study of Rheumatoid Arthritis, sponsored by Zalicus.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 20
- Study locations
NCT00551707: Completed Phase 2 study of Rheumatoid Arthritis, sponsored by Zalicus.
NCT00551707 is a Phase 2 study of Rheumatoid Arthritis that has completed, run by Zalicus. The registered enrollment target is 51 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00551707, a Phase 2 study of Rheumatoid Arthritis, has completed, sponsored by Zalicus.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 20
- Study locations
Study Summary
CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects. CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand Osteoarthritis (OA) and Rheumatoid Arthritis (RA). In this trial, CRx-102 will be given to subjects with active RA as an add-on therapy to existing stable doses of Disease Modifying Anti-Rheumatic Drugs (DMARDs) including methotrexate (MTX), sulfasalazine, hydroxychloroquine, leflunomide or azathioprine. MTX in combination with other DMARDs (e.g., sulfasalazine or hydroxychloroquine) will be permitted to reflect the current standard of care practices within rheumatology.
Primary Outcome
Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.
Conditions Studied
Interventions
- DRUG placebo
- DRUG CRx-102 (2.7/180)
- DRUG prednisolone
- DRUG dipyridamole
- DRUG CRx-102 (2.7/360)
Study Locations (20)
California
- - Anaheim
- - La Jolla
- - Westlake Village
Alabama
- - Birmingham
- - Huntsville
Other
- - San Jan
- - San Miguel de Tucumán
Arizona
- - Phoenix
Arkansas
- - Little Rock
Florida
- - Palm Harbor
Kentucky
- - Elizabethtown
New Jersey
- - Haddon Heights
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
What the finished NCT00551707 record still lists
NCT00551707 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 5 interventions - of which placebo is the first listed.
NCT00551707 names 20 study sites across 16 states, led by California, Alabama, Other.
Frequently Asked Questions
What is clinical trial NCT00551707 about?
NCT00551707 is a clinical study titled "Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis". CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone. CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodu...
What is the current status of trial NCT00551707?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2007-10. Estimated completion is 2009-01.
What conditions does trial NCT00551707 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT00551707?
The interventions under investigation include: placebo (DRUG), CRx-102 (2.7/180) (DRUG), prednisolone (DRUG), dipyridamole (DRUG), CRx-102 (2.7/360) (DRUG).
Who is sponsoring clinical trial NCT00551707?
This trial is sponsored by Zalicus, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00551707 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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