Phase 3
Completed N=69
Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00579878 ↗Enrolled (actual)
69
Serious AEs
1.5%
Results posted
May 2019
Primary outcomePrimary: Measuring the Safety and Efficacy of a New DMARD, Leflunomide Alone or in Combination With Traditional DMARD's. Participants Reaching ACR 20 Response. at 48 Weeks — 8; 20; 12 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measuring the Safety and Efficacy of a New DMARD, Leflunomide Alone or in Combination With Traditional DMARD's. Participants Reaching ACR 20 Response. at 48 Weeks |
8; 20; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Age greater or 19 years and less than or 80 years old
- Duration of disease greater or equal to 6 months
- Diagnosis of RA with criteria
- Negative urine pregnancy test
- Be capable of understanding and giving written, voluntary informed consent
- Must present with at least six swollen and six tender joints at the screening evaluation
Exclusion Criteria
- Patients treated previously with leflunomide
- Patients that have been treated with methotrexate in combination with any of the study drugs
- Patients with a history of allergy to, or any history of significant clinical or laboratory adverse experience associated with any of the study drugs
- Doses of oral steroids that are either unstable or greater than 10mg/day
- Stage IV disease or other significant disease including chest x-rays that show evidence of rheumatoid lung disease. Stage IV disease is defined as x-ray evidence of cartilage/bone destruction with fibrous or bony ankylosis; creatinine greater than 2.0mg/dL, AST or ALT greater normal
- Any significant liver, renal , hematologic, pulmonary, cardiovascular disease (including uncontrolled hypertension), any active peptic ulcer disease, or visual problems including a recent decrease in acuity, retinal disease, or macular degeneration
- Patients who are not willing to abstain from alcohol consumption
- Women of childbearing potential who are not practicing a successful method of contraception, or wish to become pregnant
- Patients that are unable to understand the study procedures and/or give written informed consent.
Data sourced from ClinicalTrials.gov (NCT00579878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.