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NCT00579878 · ClinicalTrials.gov registry record · Phase 3
Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis
A Phase 3 study of Rheumatoid Arthritis, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 3
- Development phase
- 69
- Enrollment target
- 1
- Study location
NCT00579878: Completed Phase 3 study of Rheumatoid Arthritis, sponsored by University of Nebraska.
NCT00579878 is a Phase 3 study of Rheumatoid Arthritis that has completed, run by University of Nebraska. The registered enrollment target is 69 participants, below the 4,690-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00579878, a Phase 3 study of Rheumatoid Arthritis, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 69 participants
- Enrollment target
- 1
- Study location
Study Summary
The study has been designed as a 48-week, double-blind, randomized, controlled study comparing the use of leflunomide alone to combinations of leflunomide-sulfasalazine-HCQ, and methotrexate-sulfasalazine-HCQ.
Primary Outcome
The combination of Methotrexate-Sulfasalazine-Hydroxychloroquine has been shown to be more effective than Methotrexate alone or the double combination of Methotrexate-Hydroxychloroquine. Primary outcome is ACR 20 response at 48 weeks. An ACR 20 Response is a measure of at least 20% improvement in the number of tender and swollen joints. and a 20% improvement in at least 3 of the following: the patient's global assessment of disease status; the patient's assessment of pain; the patient's assess
Conditions Studied
Interventions
- DRUG Leflunomide
- DRUG Methotrexate-Sulfasalazine-Hydroxychloroquine
- DRUG Leflunomide-Sulfasalazine-Hydroxychloroquine
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2001-03-27 |
| Est. Completion | 2010-03-11 |
| Phase | Phase 3 |
What the finished NCT00579878 record still lists
NCT00579878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 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 3 interventions - of which Leflunomide is the first listed.
NCT00579878 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT00579878 about?
NCT00579878 is a clinical study titled "Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis". The study has been designed as a 48-week, double-blind, randomized, controlled study comparing the use of leflunomide alone to combinations of leflunomide-sulfasalazine-HCQ, and methotrexate-sulfasalazine-HCQ.
What is the current status of trial NCT00579878?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 69 participants. The study started on 2001-03-27. Estimated completion is 2010-03-11.
What conditions does trial NCT00579878 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT00579878?
The interventions under investigation include: Leflunomide (DRUG), Methotrexate-Sulfasalazine-Hydroxychloroquine (DRUG), Leflunomide-Sulfasalazine-Hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT00579878?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00579878 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00579878's enrollment target sits among peer trials
69 134th of 197 higher than 64 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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