Back to resultsStudy of Long-Term Antibiotic Treatment in Reactive Arthritis
Primary Purpose
Reactive Arthritis
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
ofloxacin and roxithromycin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Reactive Arthritis focused on measuring reactive arthritis, antibiotics
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of acute reactive arthritis
- Preceding infection confirmed by positive culture and/or serology, or with a history of urethritis or gastroenteritis within the preceding 2 months
- Age 18 or older
Exclusion Criteria:
- Allergy to quinolones or macrolides
- Treatment with systemic corticosteroids within 2 weeks
- Serum creatinine level elevated over the reference limit
- Alanine aminotransferase or alkaline phosphatase levels elevated over twice the reference limit
- Current or planned pregnancy, or lack of contraception
- Known HIV positivity
- Blood leukocyte count less than 4.0x109/l
- Blood platelet count less than 100x109/l
- Lack of co-operation.
Sites / Locations
- Division of Rheumatology, Department of Medicine
- Peijas Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
ofloxacin and roxithromycin
placebo
Outcomes
Primary Outcome Measures
Proportion of patients recovered from arthritis
Secondary Outcome Measures
Swollen joint count
Tender joint count
Ritchie index
Joint pain (visual analogue scale)
Serum C-reactive protein level
Blood erythrocyte sedimentation rate
Full Information
NCT ID
NCT00621387
First Posted
February 11, 2008
Last Updated
February 11, 2008
Sponsor
University of Helsinki
1. Study Identification
Unique Protocol Identification Number
NCT00621387
Brief Title
Study of Long-Term Antibiotic Treatment in Reactive Arthritis
Official Title
Double-Blind, Placebo-Controlled Study of Three-Month Treatment With the Combination of Ofloxacin and Roxithromycin in Recent-Onset Reactive Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
November 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1998 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Helsinki
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a randomized, double-blind, placebo-controlled trial of the effect of 3-month treatment with the combination of 200 mg ofloxacin twice daily and 150 mg roxithromycin twice daily on clinical course of recent-onset reactive arthritis. Patients are followed-up at regular intervals until 6 months. The main outcome measure is recovery from arthritis, and secondary outcome measures include swollen and tender joint counts, Ritchie index, joint pain, serum C-reactive protein level and blood erythrocyte sedimentation rate. The study will also address the safety and tolerability of long-term antibiotic treatment. 56 patients are enrolled and the enrollment of patients has been completed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reactive Arthritis
Keywords
reactive arthritis, antibiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ofloxacin and roxithromycin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
ofloxacin and roxithromycin
Other Intervention Name(s)
Tarivid and Surlid
Intervention Description
150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months
Primary Outcome Measure Information:
Title
Proportion of patients recovered from arthritis
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Swollen joint count
Time Frame
6 months
Title
Tender joint count
Time Frame
6 months
Title
Ritchie index
Time Frame
6 months
Title
Joint pain (visual analogue scale)
Time Frame
6 months
Title
Serum C-reactive protein level
Time Frame
6 months
Title
Blood erythrocyte sedimentation rate
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of acute reactive arthritis
Preceding infection confirmed by positive culture and/or serology, or with a history of urethritis or gastroenteritis within the preceding 2 months
Age 18 or older
Exclusion Criteria:
Allergy to quinolones or macrolides
Treatment with systemic corticosteroids within 2 weeks
Serum creatinine level elevated over the reference limit
Alanine aminotransferase or alkaline phosphatase levels elevated over twice the reference limit
Current or planned pregnancy, or lack of contraception
Known HIV positivity
Blood leukocyte count less than 4.0x109/l
Blood platelet count less than 100x109/l
Lack of co-operation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjatta Leirisalo-Repo, MD
Organizational Affiliation
Division of Rheumatology, Department of Medicine, Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Rheumatology, Department of Medicine
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Peijas Hospital
City
Vantaa
ZIP/Postal Code
01400
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Study of Long-Term Antibiotic Treatment in Reactive Arthritis
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