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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MorphoSys AG
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• Rheumatoid arthritis (RA) per revised 1987 ACR criteria

• Active RA: ≥3 swollen and 3 tender joints with at least 1 swollen joint in the hand, excluding the PIP joint

• CRP > 5.0 mg/L (RF and anti-CCP seronegative); CRP >2 mg/l (RF and/or anti-CCP seropositive)

• DAS28 ≤ 5.1

• Stable regimen of concomitant RA therapy (NSAIDs, steroids, non- biological DMARDs).

• Negative PPD tuberculin skin test

Exclusion Criteria:

• Previous therapy with B or T cell depleting agents other than Rituximab (e.g. Campath). Prior treatment with Rituximab, TNF-inhibitors, other biologics (e.g. anti-IL-1 therapy) and systemic immunosuppressive agents is allowed with a washout period.

• Any history of ongoing, significant or recurring infections

• Any active inflammatory diseases other than RA

• Treatment with a systemic investigational drug within 6 months prior to screening

• Women of childbearing potential, unless receiving stable doses of methotrexate or leflunomide

• Significant cardiac or pulmonary disease (including methotrexate- associated lung toxicity)

• Hepatic or renal insufficiency