Rheumatoid Arthritis Clinical Trial
Official title:
Triple III Comparison of Leflunomide Alone Versus Two DMARD Combinations (Leflunomide-Hydroxychloroquine-Sulfasalazine or Methotrexate-Hydroxychloroquine-Sulfasalazine) in the Treatment of Rheumatoid Arthritis
Verified date | September 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | March 11, 2010 |
Est. primary completion date | March 11, 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | 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 assessment of function; the physician's global assessment of disease status; serum C-reactive protein levels. |
48 weeks |
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