Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
NCT ID: NCT00639834
Last Updated: 2013-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2008-02-29
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Active MDX-1342 given in combination with Methotrexate
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Sun Valley Arthritis Center LTD.
Peoria, Arizona, United States
Impact Clinical Trials
Los Angeles, California, United States
Centre for Rheumatology, Immunology and Arthritis (CRIA)
Fort Lauderdale, Florida, United States
Coastal Medical Research, Inc
Port Orange, Florida, United States
Lovelace Scientific Resources
Venice, Florida, United States
Good Samaritan Hospital and Johns Hopkins Hospital
Baltimore, Maryland, United States
Justus Fiechtner
Lansing, Michigan, United States
Columbia University Medical Center
New York, New York, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Arthritis Northwest Rheumatology, PLLC
Spokane, Washington, United States
George Krick, MD
Tacoma, Washington, United States
klinikum der Universitat zu Koln
Cologne, , Germany
Universitatsklinikum "Carl Gustav Carus" an der Technischen Universtitat Dresden
Dresden, , Germany
Klinikum rechts der Isar der TU Munchen
Munich, , Germany
DRC Gyógyszervizsgáló Központ Kft
Balatonfüred, , Hungary
Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz
Budapest, , Hungary
DEOEC Kinikai Farmakologiai Tanszek
Debrecen, , Hungary
First Department of Medicine
Szeged, , Hungary
V.K. Gusak Institute of Urgent & Reconstructive Surgery under UAMS, Hospital Therapy and Rehabilitaiton Clinic
Donetsk, , Ukraine
Kharkiv Medical Academy of Postgraduate Education, City Clinical General Hospital #25
Kharkiv, , Ukraine
Zaporizhya State Medical University, City Clinical Hopsital #6, Therapeutics Department
Zaporizhya, , Ukraine
Zaporizhzhya Regional Clinical Hospital, Rheumatology Department
Zaporizhzhya, , Ukraine
The Kellgren Centre for Rheumatology
Manchester, , United Kingdom
Welcome Trust Clinical Research Facility, Southampton General Hospital
Southampton, , United Kingdom
Countries
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Other Identifiers
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IM130-001
Identifier Type: OTHER
Identifier Source: secondary_id
MDX1342-01
Identifier Type: -
Identifier Source: org_study_id
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