Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations in the Treatment of Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2010-03-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Treatments: Hydroxychloroquine; Leflunomide; Methotrexate; Sulfasalazine

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.