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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1: MOR103, experimental

Biological: MOR103 0.3 mg/kg or placebo

Group Type EXPERIMENTAL

MOR103

Intervention Type DRUG

MOR103 0.3 mg/kg or placebo iv x 4 doses

Group 2: MOR103, experimental

Biological: MOR103 1.0 mg/kg or placebo

Group Type EXPERIMENTAL

MOR103

Intervention Type DRUG

MOR103 1.0 mg/kg or placebo iv x 4 doses

Group 3: MOR103, experimental

Biological: MOR103 1.5 mg/kg or placebo

Group Type EXPERIMENTAL

MOR103

Intervention Type DRUG

MOR103 1.5 mg/kg or placebo iv x 4 doses

Interventions

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MOR103

MOR103 0.3 mg/kg or placebo iv x 4 doses

Intervention Type DRUG

MOR103

MOR103 1.0 mg/kg or placebo iv x 4 doses

Intervention Type DRUG

MOR103

MOR103 1.5 mg/kg or placebo iv x 4 doses

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No