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

May 21, 2013 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Universitatsklinikum "Carl Gustav Carus" an der Technischen Universtitat Dresden
      • Koln, Germany, 50924
        • Klinikum der Universität zu Köln
      • Munich, Germany, 81675
        • Klinikum rechts der Isar der TU München
  • Hungary
      • Balatonfüred, Hungary, H-8230
        • DRC Gyogyszervizsgalo Kozpont Kft
      • Budapest, Hungary, H-1083
        • Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz
      • Debrecen, Hungary, H-4012
        • DEOEC Kinikai Farmakologiai Tanszek
      • Szeged, Hungary
        • First Department of Medicine
  • Ukraine
      • Donetsk, Ukraine, 83045
        • V.K. Gusak Institute of Urgent & Reconstructive Surgery under UAMS, Hospital Therapy and Rehabilitaiton Clinic
      • Kharkiv, Ukraine, 61115
        • Kharkiv Medical Academy of Postgraduate Education, City Clinical General Hospital #25
      • Zaporizhya, Ukraine, 69035
        • Zaporizhya State Medical University, City Clinical Hopsital #6, Therapeutics Department
      • Zaporizhzhya, Ukraine, 69600
        • Zaporizhzhya Regional Clinical Hospital, Rheumatology Department
  • United Kingdom
      • Manchester, United Kingdom
        • The Kellgren Centre for Rheumatology
      • Southampton, United Kingdom, SO16 6YD
        • Welcome Trust Clinical Research Facility, Southampton General Hospital
  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Sun Valley Arthritis Center LTD.
    • California
      • Los Angeles, California, United States, 90036
        • Impact Clinical Trials
    • Florida
      • Fort Lauderdale, Florida, United States, 33334
        • Centre for Rheumatology, Immunology and Arthritis (CRIA)
      • Port Orange, Florida, United States, 32127
        • Coastal Medical Research, Inc
      • Venice, Florida, United States, 34233
        • Lovelace Scientific Resources
    • Maryland
      • Baltimore, Maryland, United States, 21239
        • Good Samaritan Hospital and Johns Hopkins Hospital
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Justus Fiechtner
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
    • Washington
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest Rheumatology, PLLC
      • Tacoma, Washington, United States, 98405
        • George Krick, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence and severity of treatment-emergent adverse events
Time Frame: all adverse events will be followed to resolution
all adverse events will be followed to resolution

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 10, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 20, 2008

Study Record Updates

Last Update Posted (Estimate)

May 22, 2013

Last Update Submitted That Met QC Criteria

May 21, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDX1342-01
  • IM130-001 (Other Identifier: BMS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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