Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis (MDX1342-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00639834
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : May 22, 2013
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to determine if MDX-1342 given in combination with Methotrexate is a safe treatment for patients with active rheumatoid arthritis. In addition, changes in the severity patients' arthritis will also be analysed.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: MDX-1342 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Single-dose, Dose-escalation, Safety and Tolerability Study of MDX-1342 (Anti-CD19 Human Monoclonal Antibody) in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis
Study Start Date : February 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Active MDX-1342 given in combination with Methotrexate
Biological: MDX-1342
One dose of active MDX-1342 (anti-CD19 fully human monoclonal antibody) will be administered to patients as an i.v. infusion. Patients will receive one dose of MDX-1342 given in combination with Methotrexate treatment.

Primary Outcome Measures :
  1. incidence and severity of treatment-emergent adverse events [ Time Frame: all adverse events will be followed to resolution ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have met ACR criteria for the diagnosis of rheumatoid arthritis (RA)
  • Must have active RA
  • Must be treated with Methotrexate (MTX) (10 to 25 mg weekly) for at least 3 months and have received a stable dose for at least 28 days prior to the anticipated study drug administration date.
  • All other DMARDs or biologics must be discontinued at least 28 days prior to study drug administration and: 1) Leflunomide, which must be discontinued at least 60 days before study drug administration, 2) infliximab, adalimumab, and abatacept must be discontinued at least 56 days prior to study drug administration

Exclusion Criteria:

  • Both Rheumatoid factor and anti-CCP negative
  • Prior treatment with any B-cell depleting therapy
  • Any other mAb or Ig-based fusion proteins 56 days or less prior to Visit
  • History of or current inflammatory joint disease other than RA
  • Neuropathies or neurovasculopathies that might interfere with pain evaluation
  • Complications of RA or other disease
  • Any other autoimmune disease other than RA
  • Acute or chronic infection
  • Clinically significant disease requiring

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00639834

United States, Arizona
Sun Valley Arthritis Center LTD.
Peoria, Arizona, United States, 85381
United States, California
Impact Clinical Trials
Los Angeles, California, United States, 90036
United States, Florida
Centre for Rheumatology, Immunology and Arthritis (CRIA)
Fort Lauderdale, Florida, United States, 33334
Coastal Medical Research, Inc
Port Orange, Florida, United States, 32127
Lovelace Scientific Resources
Venice, Florida, United States, 34233
United States, Maryland
Good Samaritan Hospital and Johns Hopkins Hospital
Baltimore, Maryland, United States, 21239
United States, Michigan
Justus Fiechtner
Lansing, Michigan, United States, 48910
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Washington
Arthritis Northwest Rheumatology, PLLC
Spokane, Washington, United States, 99204
George Krick, MD
Tacoma, Washington, United States, 98405
Universitatsklinikum "Carl Gustav Carus" an der Technischen Universtitat Dresden
Dresden, Germany, 01307
klinikum der Universitat zu Koln
Koln, Germany, 50924
Klinikum rechts der Isar der TU Munchen
Munich, Germany, 81675
DRC Gyógyszervizsgáló Központ Kft
Balatonfüred, Hungary, H-8230
Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz
Budapest, Hungary, H-1083
DEOEC Kinikai Farmakologiai Tanszek
Debrecen, Hungary, H-4012
First Department of Medicine
Szeged, Hungary
V.K. Gusak Institute of Urgent & Reconstructive Surgery under UAMS, Hospital Therapy and Rehabilitaiton Clinic
Donetsk, Ukraine, 83045
Kharkiv Medical Academy of Postgraduate Education, City Clinical General Hospital #25
Kharkiv, Ukraine, 61115
Zaporizhya State Medical University, City Clinical Hopsital #6, Therapeutics Department
Zaporizhya, Ukraine, 69035
Zaporizhzhya Regional Clinical Hospital, Rheumatology Department
Zaporizhzhya, Ukraine, 69600
United Kingdom
The Kellgren Centre for Rheumatology
Manchester, United Kingdom
Welcome Trust Clinical Research Facility, Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT00639834     History of Changes
Other Study ID Numbers: MDX1342-01
IM130-001 ( Other Identifier: BMS )
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: May 2013

Keywords provided by Bristol-Myers Squibb:
joint inflammation

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors