Phase 3
N=42
Combination Antibiotic Treatment for Reactive Arthritis Caused by Chlamydia Bacteria
Arthritis, Reactive · Reiter Disease
Bottom Line
View on ClinicalTrials.gov: NCT00351273 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment. — 10; 7; 3 participants — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Doxycycline and Rifampin (Drug); Azithromycin and Rifampin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigate Whether a 6 Month Course of Combined Antibiotics Was Effective Treatment. |
10; 7; 3 | 0.01 sig |
| SECONDARY Number of Patients With a Complete Response (Resolution of All Symptoms) |
5; 1; 0 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) |
25.1; 18.9; 17.8; 25.2; 17.7; 19.8 | — |
| SECONDARY hsCRP |
1.07; 0.42; 0.56; 0.27; 0.63; 0.55 | — |
| SECONDARY HAQ DI Score |
0.84; 1.1; 0.79; 0.92; 0.68; 0.87 | — |
| SECONDARY PhGA Assessment |
63.9; 60.2; 35.2; 52.9; 23.2; 49.4 | — |
| SECONDARY Swollen 76 Joint Count (SJC) |
4.1; 4.5; 1.7; 3.5; 0.9; 4.3 | — |
| SECONDARY 78 Tender Joint Count (TJC) |
7.4; 9.6; 5.0; 10.6; 3.3; 10.8 | — |
Summary
Reactive arthritis, also known as Reiter's syndrome, is a form of arthritis that occurs as a reaction to an infection elsewhere in the body. It is characterized by inflammation of the joints, tendons, urogenital tract, and eyes. Pain and swelling in the knees, ankles, and feet are common. This study will determine the effectiveness of antibiotic therapy in treating people with chlamydia-induced reactive arthritis that has lasted for more than 6 months.
Eligibility Criteria
Inclusion Criteria
- Meet the following European Spondyloarthropathy Study Group Criteria:
- inflammatory spinal pain OR
- synovitis AND
- one or more of the following:
- positive family history
- urethritis or cervicitis within 1 month prior to onset of arthritis
- buttock pain
- enthesopathy
- sacroiliitis
- Disease duration of at least 6 months
- Negative pregnancy test at study baseline and willing to use an effective method of contraception other than combined oral contraceptives for the duration of the study (for women of childbearing age)
Exclusion Criteria
- Sensitivity or history of allergic reaction to rifampin, doxycycline, or azithromycin
- Currently taking any medications that may interact with the study medications, specifically rifampin
- Liver transaminases greater than or equal to two times the normal level
- Significant abnormalities in the complete blood count (CBC)
- Pregnant
- Current psoriasis
- Diagnosis of inflammatory bowel disease
- Diagnosis of ankylosing spondylitis
- Previous prolonged exposure to antibiotics (more than 2 weeks) as a potential treatment for reactive arthritis
Data sourced from ClinicalTrials.gov (NCT00351273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.