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NCT00405275 · ClinicalTrials.gov registry record · NA
Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy
A NA study of Rheumatoid Arthritis, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- NA
- Development phase
- 353
- Enrollment target
- 20
- Study locations
NCT00405275 is a NA study of Rheumatoid Arthritis that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 353 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT00405275, a NA study of Rheumatoid Arthritis, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- NA
- Development phase
- 353 participants
- Enrollment target
- 20
- Study locations
Study Summary
Rheumatoid arthritis (RA) is a chronic inflammatory disease of the joints leading to joint destruction, with significant long-term morbidity and mortality. Early treatment of RA patients with disease-modifying antirheumatic drugs (DMARDs) significantly decreases these complications. Methotrexate (MTX) is an excellent, economical first-line DMARD used to treat a majority of RA patients. While most patients respond well to MTX, many continue to have active disease. Therefore, understanding how to best treat RA patients with active disease despite MTX therapy is critically important. Although a number of therapies with significantly different economic implications have been shown to be effective when added to MTX, no trial has directly compared active therapies. This study will compare therapeutic strategies using two regimens with proven efficacy when added to MTX therapy; a) hydroxychloroquine and sulfasalazine (cost \~ $1000 per year); b) the tumor necrosis factor inhibitor, etanercept (cost \~ $12,000 per year). We propose a bi-national multi-center randomized, double-blind equivalency trial comparing (A) the strategy of initially adding hydroxychloroquine and sulfasalazine to MTX in patients with active disease despite MTX, with a switch at 24 weeks to etanercept in nonresponders to (B) a strategy of adding etanercept to MTX, with a switch to hydroxychloroquine and sulfasalazine in nonresponders at 24 weeks. If we find that the strategy of first adding hydroxychloroquine and sulfasalazine to MTX identifies a subset of responsive patients and that there is no harm to nonresponders because of early rescue with etanercept, then this less expensive option should become the standard treatment for MTX resistant patients. Four hundred and fifty RA patients with active disease despite treatment with MTX as indicated by a Disease Activity Score with 28 joints (DAS28) of \>4.4 units will be randomized. A DAS improvement of \<1.2 (validated as clinically significant) at 24
Conditions Studied
Interventions
- DRUG Hydroxychloroquine
- DRUG Sulfasalazine
- DRUG methotrexate
- DRUG Etanercept
- DRUG Placebo, triple
Study Locations (20)
California
- VA Medical Center, Loma Linda - Loma Linda
- VA Medical Center, Long Beach - Long Beach
- VA Medical Center, San Francisco - San Francisco
- Pacific Arthritis Center (RAIN) - Santa Maria
- VA Greater Los Angeles HCS, Sepulveda - Sepulveda
Minnesota
- St. Mary's/ Duluth Clinic Health System (RAIN) - Duluth
- Park Nicollet (RAIN) - Minneapolis
- VA Medical Center, Minneapolis - Minneapolis
- Mayo Clinic - Rochester
Nebraska
- Lincoln Medical Center - Lincoln
- VA Medical Center, Omaha - Omaha
- Univesity of Nebraska Medical Center - Omaha
Pennsylvania
- Geisinger Medical Center - Danville
- VA Medical Center, Philadelphia - Philadelphia
- VA Pittsburgh Health Care System - Pittsburgh
North Dakota
- Bone, Spine Sports Clinic (RAIN) - Bismarck
- VA Medical Center, Fargo - Fargo
District of Columbia
- VA Medical Center, DC - Washington D.C.
Missouri
- VA Medical Center, St Louis - St Louis
Oregon
- VA Medical Center, Portland - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 353 participants |
| Start Date | 2007-07 |
| Est. Completion | 2012-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00405275
The ClinicalTrials.gov registry entry for NCT00405275 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 353 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (92% lower). The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 5 interventions - of which Hydroxychloroquine is the first listed.
NCT00405275 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Minnesota, Nebraska.
Frequently Asked Questions
What is clinical trial NCT00405275 about?
NCT00405275 is a clinical study titled "Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy". Rheumatoid arthritis (RA) is a chronic inflammatory disease of the joints leading to joint destruction, with significant long-term morbidity and mortality. Early treatment of RA patients with disease-modifying antirheumatic drugs (DMARDs) significantly decreases these complications. Methotrexate (MT...
What is the current status of trial NCT00405275?
This trial is currently completed. It is a NA study. The enrollment target is 353 participants. The study started on 2007-07. Estimated completion is 2012-05.
What conditions does trial NCT00405275 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT00405275?
The interventions under investigation include: Hydroxychloroquine (DRUG), Sulfasalazine (DRUG), methotrexate (DRUG), Etanercept (DRUG), Placebo, triple (DRUG).
Who is sponsoring clinical trial NCT00405275?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00405275 being conducted?
This trial has 20 study locations across California, District of Columbia, Minnesota, Missouri, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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