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Rheumatoid Arthritis: Comparison of Active Therapies in Patients With Active Disease Despite Methotrexate Therapy
NCT00405275 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 353 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 158 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00405275 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Minnesota, Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00405275?
The interventions under investigation include: Hydroxychloroquine (DRUG), Sulfasalazine (DRUG), methotrexate (DRUG), Etanercept (DRUG), Placebo, triple (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00405275?
This trial is sponsored by US Department of Veterans Affairs, which has 158 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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