Randomised double-blind trial of combination antibiotic therapy in rheumatoid arthritis
- Conditions
- Patients with medical diagnosis of Rheumatoid Arthritis
- Registration Number
- EUCTR2004-004893-96-GB
- Lead Sponsor
- Hammersmith Hospitals NHS trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Age 18 -30
Classical Rheumatoid Arthritis
Erosions on joint radiographs
Rheumatoid factor posiyive
Disease duration>6 months
Active disease 6 or more inflamed joints: ESR>20mm/hr or CRP>12 mg/ml
Failed on methotrexate> or= 7.5 mg/week
No anti-TNF therapy for at least three months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Severe disease
Chronic recurrent infection
Immunodeficiency
Malignancy
Inflammatory bowel disease
Other diarrhoeal states
Other major illnessess
History of adverse reactions to tetracycline, clindamycin or similar antibiotics
Pregnancy or lactation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To perform a double-blind, randomised, controlled trial comparing the effect of intravenous clindamycin plus oral tetracycline with placebo as an addition to conventional treatment(second line therapy with or without prednisolone) with placebo in the management of active rheumatoid arthritis.;Secondary Objective: ;Primary end point(s): The primary outcome measure will be the achievement of an ACR20% response in 6 months
- Secondary Outcome Measures
Name Time Method