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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00639834
First received: January 10, 2008
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Biological: MDX-1342
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • incidence and severity of treatment-emergent adverse events [ Time Frame: all adverse events will be followed to resolution ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: February 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639834

Locations
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
Germany
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
Hungary
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
Ukraine
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
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00639834     History of Changes
Other Study ID Numbers: MDX1342-01, IM130-001
Study First Received: January 10, 2008
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy

Keywords provided by Bristol-Myers Squibb:
rheumatoid
arthritis
RA
joint inflammation
autoimmune
Medarex
Rheumatology

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

ClinicalTrials.gov processed this record on October 16, 2014