Patients with medical diagnosis of Rheumatoid Arthritis
Conditions
Interventions
Trade Name: Dalacin C phosphate
Product Name: Clindamycin
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Int
Sponsors
Hammersmith Hospitals NHS trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed