Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: MDX-1342

• Registration Number: NCT00639834
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-01-10
• Study Start: 2008-02
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-20
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-21
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MDX-1342	Active MDX-1342 given in combination with Methotrexate

Primary Outcome Measures

Name	Time	Method
incidence and severity of treatment-emergent adverse events	all adverse events will be followed to resolution

Trial Locations

Locations (24)

Impact Clinical Trials; 🇺🇸 Los Angeles, California, United States

Good Samaritan Hospital and Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Coastal Medical Research, Inc; 🇺🇸 Port Orange, Florida, United States

Arthritis Northwest Rheumatology, PLLC; 🇺🇸 Spokane, Washington, United States

V.K. Gusak Institute of Urgent & Reconstructive Surgery under UAMS, Hospital Therapy and Rehabilitaiton Clinic; 🇺🇦 Donetsk, Ukraine

klinikum der Universitat zu Koln; 🇩🇪 Koln, Germany

George Krick, MD; 🇺🇸 Tacoma, Washington, United States

Lovelace Scientific Resources; 🇺🇸 Venice, Florida, United States

Kharkiv Medical Academy of Postgraduate Education, City Clinical General Hospital #25; 🇺🇦 Kharkiv, Ukraine

Klinikum rechts der Isar der TU Munchen; 🇩🇪 Munich, Germany

Justus Fiechtner; 🇺🇸 Lansing, Michigan, United States

Welcome Trust Clinical Research Facility, Southampton General Hospital; 🇬🇧 Southampton, United Kingdom

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Centre for Rheumatology, Immunology and Arthritis (CRIA); 🇺🇸 Fort Lauderdale, Florida, United States

Sun Valley Arthritis Center LTD.; 🇺🇸 Peoria, Arizona, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Zaporizhya State Medical University, City Clinical Hopsital #6, Therapeutics Department; 🇺🇦 Zaporizhya, Ukraine

Zaporizhzhya Regional Clinical Hospital, Rheumatology Department; 🇺🇦 Zaporizhzhya, Ukraine

First Department of Medicine; 🇭🇺 Szeged, Hungary

The Kellgren Centre for Rheumatology; 🇬🇧 Manchester, United Kingdom

Universitatsklinikum "Carl Gustav Carus" an der Technischen Universtitat Dresden; 🇩🇪 Dresden, Germany

DRC Gyógyszervizsgáló Központ Kft; 🇭🇺 Balatonfüred, Hungary

DEOEC Kinikai Farmakologiai Tanszek; 🇭🇺 Debrecen, Hungary

Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz; 🇭🇺 Budapest, Hungary