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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ofloxacin and roxithromycin |
|
| 2 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ofloxacin and roxithromycin | Drug | 150 mg roxithromycin tablet twice daily and 200mg ofloxacin tablet twice daily for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients recovered from arthritis | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Swollen joint count | 6 months | |
| Tender joint count | 6 months | |
| Ritchie index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marjatta Leirisalo-Repo, MD | Division of Rheumatology, Department of Medicine, Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Rheumatology, Department of Medicine | Helsinki | 00029 | Finland | |||
| Peijas Hospital |
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| ID | Term |
|---|---|
| D016918 | Arthritis, Reactive |
| ID | Term |
|---|---|
| D001170 | Arthritis, Infectious |
| D007239 | Infections |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
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| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D015575 | Roxithromycin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| placebo | Drug | placebo tablets identical to ofloxacin and roxithromycin twice daily for 3 months |
|
| 6 months |
| Joint pain (visual analogue scale) | 6 months |
| Serum C-reactive protein level | 6 months |
| Blood erythrocyte sedimentation rate | 6 months |
| Vantaa |
| 01400 |
| Finland |
| D013166 |
| Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |