Treatment of Rheumatoid Arthritis With Roxithromycin

This study has been completed.
Sponsor:
Information provided by:
Nazilli State Hospital
ClinicalTrials.gov Identifier:
NCT00439062
First received: February 20, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment of Rheumatoid Arthritis With Roxithromycin

Resource links provided by NLM:


Further study details as provided by Nazilli State Hospital:

Primary Outcome Measures:
  • 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:
  • 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).

Estimated Enrollment: 100
Study Start Date: June 2006
Estimated Study Completion Date: June 2006
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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Exclusion Criteria:

  • A negative pregnancy test result was required for non-menopausal female patients. In female patients of childbearing potential a urine pregnancy test was done at baseline and any pregnant women were excluded. Other exclusion criteria included impaired hepatic enzyme tests, impaired renal function, chronic/recurrent infection (e.g., chronic bronchitis, recurrent sinusitis), other infections(e.g., Borrelia burgdorferi, Chlamydia trachomatis, Ureaplasma) , history of adverse reactions to macrolides, roxithromycin, or similar antibiotics.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439062

Locations
Turkey
Nazilli State Hospital
Nazilli, Aydin, Turkey, 09800
Sponsors and Collaborators
Nazilli State Hospital
Investigators
Principal Investigator: Mesut Ogrendik, MD Nazilli State Hospital
  More Information

No publications provided by Nazilli State Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00439062     History of Changes
Other Study ID Numbers: RA-89861966
Study First Received: February 20, 2007
Last Updated: February 20, 2007
Health Authority: Turkey: Ministry of Health

Keywords provided by Nazilli State Hospital:
Roxithromycin,Rheumatoid arthritis,Macrolides

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Roxithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014