Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis MT203 Human IgG1 monoclonal antibody GM-CSF monoclonal antibody
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 24
Healthy volunteers: no

Brief summary:
The purpose of this trial is primarily to investigate the safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis. Furthermore, the amount of MT203 in the blood will be measured and it will be investigated how the body responds to MT203 treatment and if MT203 is effective in the treatment of rheumatoid arthritis.

Detailed description:
The trial medication will be administered at 2 dose levels as subcutaneous injections. Each patient will receive three injections in total. The trial duration consists of a screening period (28 - 2 days prior to the first injection) and a treatment and observation period (4 months). The trial requires approximately 20 visits at the study site.

Arms:
arm 1: Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29. arm 2: Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29. arm 3: Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.

Interventions: intervention 1: namilumab (MT203) intervention 2: Placebo
Intervention descriptions: intervention 1: administered three times, subcutaneous in the abdomen intervention 2: administered three times, subcutaneous in the abdomen

Protocol document: