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Trial record 1 of 2 for:    MOR103
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A Study of the Safety and Preliminary Efficacy of MOR103, a Human Antibody to Granulocyte Macrophage Colony-stimulating Factor (GM-CSF), in Patients With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MorphoSys AG
ClinicalTrials.gov Identifier:
NCT01023256
First received: November 19, 2009
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: MOR103
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MorphoSys AG:

Primary Outcome Measures:
  • Adverse event rate and safety profile [ Time Frame: weekly or bi-weekly up to 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DAS28, ACR core set measures and EULAR28 response criteria, hematology, blood chemistry, Ig levels, cytokines, synovitis, bone edema [ Time Frame: weekly or bi-weekly up to 16 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • MRI related endpoints [ Time Frame: 3 times in the course of the study ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: December 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: MOR103, experimental
Biological: MOR103 0.3 mg/kg or placebo
 Drug: MOR103
MOR103 0.3 mg/kg or placebo iv x 4 doses
Experimental: Group 2: MOR103, experimental
Biological: MOR103 1.0 mg/kg or placebo
 Drug: MOR103
MOR103 1.0 mg/kg or placebo iv x 4 doses
Experimental: Group 3: MOR103, experimental
Biological: MOR103 1.5 mg/kg or placebo
 Drug: MOR103
MOR103 1.5 mg/kg or placebo iv x 4 doses

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023256

Locations
Bulgaria
MorphoSys Investigative sites, Bulgaria
Germany
MorphoSys Investigative sites, Germany
Netherlands
MorphoSys Investigative sites, Netherlands
Poland
MorphoSys Investigative sites, Poland
Ukraine
MorphoSys investigatíve sites, Ukraine
Sponsors and Collaborators
MorphoSys AG
Investigators
Study Director: Roman P Korolkiewicz, MD, PhD MorphoSys AG
  More Information

No publications provided

Responsible Party: MorphoSys AG
ClinicalTrials.gov Identifier: NCT01023256     History of Changes
Other Study ID Numbers: MSC-1001
Study First Received: November 19, 2009
Last Updated: July 18, 2012
Health Authority: Germany: Paul-Ehrlich-Institut
Bulgaria: Bulgarian Drug Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Ukraine: Ministry of Health

Keywords provided by MorphoSys AG:
Rheumatoid arthritis
GM-CSF
MOR103

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013