Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 91
Healthy volunteers: no

Brief summary:
This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.

Detailed description:

Arms:
arm 1: Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations. arm 2: Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.

Interventions: intervention 1: tocilizumab intervention 2: methotrexate intervention 3: 23-Valent Pneumococcal Polysaccharide Vaccine intervention 4: Tetanus Toxoid Adsorbed Vaccine
Intervention descriptions: intervention 1: Intravenous repeating dose intervention 2: A stable dose of between 7.5 and 25 mg/week, oral or parenteral. intervention 3: Intramuscular or subcutaneous injection intervention 4: Intramuscular injection

Protocol document: