Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Nazilli State Hospital |
---|---|
Information provided by: | Nazilli State Hospital |
ClinicalTrials.gov Identifier: | NCT00439062 |
The purpose of this study is to evaluate the clinical efficacy, safety, and tolerability of roxithromycin in patients with rheumatoid arthritis.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Drug: Roxithromycin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Rheumatoid Arthritis With Roxithromycin |
Estimated Enrollment: | 100 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2006 |
This was 6-month, monocentre, randomized, double-blind, placebo-controlled study. We treated 100 patients with rheumatoid arthritis with either once-daily oral roxithromycin (300 mg) or daily oral placebo for 6 months. The primary efficacy variable was the percentage of patients who had a 20 percent improvement according to American College of Rheumatology (ACR) criteria (an ACR 20 response) at six months. Secondary outcome measures were 50 percent improvement and 70 percent improvement according to ACR criteria (an ACR 50 response and an ACR 70 response, respectively).
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:RA according to the 1987 American Rheumatism Association criteria19, age between 18 and 70 years. Patients were required to have had an inadequate response to one to four DMARDs (such as azathioprine, methotrexate, sulfasalazine, penicillamine, hydroxychloroquine, or oral or injectable gold); an inadequate response was defined as discontinuation of therapy because of lack of effect. If patients were receiving DMARDs, they were required to complete a DMARD washout period that lasted at least 1 month before starting study drug treatment; no DMARDs were permitted during the study. Patients who were receiving nonsteroidal antiinflammatory drugs, prednisone (at 10 mg daily or less), or both were eligible if the doses had been stable for at least four weeks before the study period and continued to be stable during the study period. Patients were not allowed to receive intra-articular corticosteroids. Patients had to have active disease at enrollment (before the DMARD washout period), defined as 12 or more tender joints, 10 or more swollen joints, and at least one of the following: erythrocyte sedimentation rate(ESR) of at least 28 mm/hr, C-reactive protein(CRP) level greater than 2.0 mg/dL, or morning stiffness for at least 45 minutes.
-
Exclusion Criteria:
A patient could be withdrawn from the trial at any time after enrollment for the following reasons:
the patient's request, severe or life-threatening adverse event, or inadequate control of arthritis symptoms (>50 percent increase in the total number of swollen or tender joints) necessitating an increase in the systemic corticosteroid dosage or reinstitution of therapy with disease-modifying antirheumatic drugs.
Study ID Numbers: | RA-89861966 |
Study First Received: | February 20, 2007 |
Last Updated: | February 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00439062 History of Changes |
Health Authority: | Turkey: Ministry of Health |
Roxithromycin,Rheumatoid arthritis,Macrolides |
Anti-Infective Agents Anti-Bacterial Agents Autoimmune Diseases Musculoskeletal Diseases Roxithromycin |
Joint Diseases Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Anti-Infective Agents Autoimmune Diseases Immune System Diseases Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Pharmacologic Actions |
Anti-Bacterial Agents Musculoskeletal Diseases Roxithromycin Arthritis Therapeutic Uses Connective Tissue Diseases |