NCT01023256

Safety and Preliminary Efficacy of MOR103 in Patients With Active Rheumatoid Arthritis

A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Preliminary Clinical Activity and Immunogenicity of Multiple Doses of MOR103 Administered Intravenously to Patients With Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: MorphoSys AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	MOR103	MOR103 0.3 mg/kg or placebo iv x 4 doses
DRUG	MOR103	MOR103 1.0 mg/kg or placebo iv x 4 doses
DRUG	MOR103	MOR103 1.5 mg/kg or placebo iv x 4 doses

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-12-02
• Last updated: 2014-10-24
• Results posted: 2014-05-08

Locations

5 sites across 5 countries: Bulgaria, Germany, Netherlands, Poland, Ukraine