Conditions: Rheumatoid Arthritis
Keywords: Adalimumab added to inadequate standard anti-rheumatic therapy in patients with active Rheumatoid Arthritis
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 100
Healthy volunteers: no

Brief summary:
A total of 100 participants diagnosed with active rheumatoid arthritis were enrolled at 5 sites in Russia. Adalimumab was administered by subcutaneous injection every other week, with dose escalation to weekly dosing available for participants not receiving concomitant disease-modifying antirheumatic drugs (DMARDs) who did not achieve American College of Rheumatology 20 (ACR20) criteria after 12 weeks of treatment. Efficacy and safety measurements were performed throughout the study.

Detailed description:
This is an open-label, multicenter study designed to establish the safety and efficacy of adalimumab in the treatment of moderate to severely active rheumatoid arthritis. A total of 100 subjects with inadequate preexisting standard anti-rheumatic therapy were enrolled at 5 sites in Russia.

Arms:
arm 1: Adalimumab / pre-filled syringe 40 mg/0.8 ml

Interventions: intervention 1: adalimumab
Intervention descriptions: intervention 1: Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.

Protocol document: