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

Completed · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00639834

Run by

Bristol-Myers Squibb

People needed

26

Starts

2008-02-01

Expected to finish

2010-06-01

Last updated by the study team

2013-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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