Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis GM-CSF MOR103
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 96
Healthy volunteers: no

Brief summary:
GM-CSF is considered to have a key role in the initiation and progression of arthritic inflammation. The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics, and immunogenicity of multiple doses of MOR103, a human antibody to GM-CSF, in patients with active rheumatoid arthritis.

Detailed description:
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease that affects 0.5% to 1% of the adult population world wide. RA primarily affects the joints and is characterized by chronic inflammation of the synovial tissue, which eventually leads to the destruction of cartilage, bone and ligaments and can cause joint deformity.

Pro-inflammatory cytokines, such as tumor necrosis factor-alpha (TNFα), interleukin (IL)-1, IL-6 and granulocyte macrophage colony stimulating factor (GM-CSF), which lead to the activation and proliferation of immune cells, are found to be increased in the inflamed joint. Several preclinical findings support an anti-GM-CSF therapy for RA.

Arms:
arm 1: Biological: MOR103 0.3 mg/kg or placebo arm 2: Biological: MOR103 1.0 mg/kg or placebo arm 3: Biological: MOR103 1.5 mg/kg or placebo

Interventions: intervention 1: MOR103 intervention 2: MOR103 intervention 3: MOR103
Intervention descriptions: intervention 1: MOR103 0.3 mg/kg or placebo iv x 4 doses intervention 2: MOR103 1.0 mg/kg or placebo iv x 4 doses intervention 3: MOR103 1.5 mg/kg or placebo iv x 4 doses

Protocol document: