Treatment of Rheumatoid Arthritis With Roxithromycin
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of this study is to evaluate the clinical efficacy, safety, and tolerability of roxithromycin in patients with rheumatoid arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 rheumatoid-arthritis
Started Jun 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 20, 2007
CompletedFirst Posted
Study publicly available on registry
February 22, 2007
CompletedFebruary 22, 2007
February 1, 2007
February 20, 2007
February 20, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- A patient could be withdrawn from the trial at any time after enrollment for the following reasons: the patient's request, severe or life-threatening adverse event, or inadequate control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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nazilli State Hospital
Nazilli, Aydın, 09800, Turkey (Türkiye)
Related Publications (1)
Ogrendik M, Karagoz N. Treatment of rheumatoid arthritis with roxithromycin: a randomized trial. Postgrad Med. 2011 Sep;123(5):220-7. doi: 10.3810/pgm.2011.09.2478.
PMID: 21904105DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mesut Ogrendik, MD
Nazilli State Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 20, 2007
First Posted
February 22, 2007
Study Start
June 1, 2006
Study Completion
June 1, 2006
Last Updated
February 22, 2007
Record last verified: 2007-02