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

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

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

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