Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis (MDX1342-01)
This study has suspended participant recruitment.
(Clinical Hold)
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00639834
First received: January 10, 2008
Last updated: April 22, 2010
Last verified: April 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Biological: MDX-1342 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- incidence and severity of treatment-emergent adverse events [ Time Frame: all adverse events will be followed to resolution ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639834
Locations
| United States, Arizona | |
| Sun Valley Arthritis Center LTD. | |
| Peoria, Arizona, United States, 85381 | |
| United States, California | |
| Impact Clinical Trials | |
| Los Angeles, California, United States, 90036 | |
| United States, Florida | |
| Centre for Rheumatology, Immunology and Arthritis (CRIA) | |
| Fort Lauderdale, Florida, United States, 33334 | |
| Coastal Medical Research, Inc | |
| Port Orange, Florida, United States, 32127 | |
| Lovelace Scientific Resources | |
| Venice, Florida, United States, 34233 | |
| United States, Maryland | |
| Good Samaritan Hospital and Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21239 | |
| United States, Michigan | |
| Justus Fiechtner | |
| Lansing, Michigan, United States, 48910 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, Pennsylvania | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| United States, Washington | |
| Arthritis Northwest Rheumatology, PLLC | |
| Spokane, Washington, United States, 99204 | |
| George Krick, MD | |
| Tacoma, Washington, United States, 98405 | |
| Germany | |
| Universitatsklinikum "Carl Gustav Carus" an der Technischen Universtitat Dresden | |
| Dresden, Germany, 01307 | |
| klinikum der Universitat zu Koln | |
| Koln, Germany, 50924 | |
| Klinikum rechts der Isar der TU Munchen | |
| Munich, Germany, 81675 | |
| Hungary | |
| DRC Gyógyszervizsgáló Központ Kft | |
| Balatonfüred, Hungary, H-8230 | |
| Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz | |
| Budapest, Hungary, H-1083 | |
| DEOEC Kinikai Farmakologiai Tanszek | |
| Debrecen, Hungary, H-4012 | |
| First Department of Medicine | |
| Szeged, Hungary | |
| Ukraine | |
| V.K. Gusak Institute of Urgent & Reconstructive Surgery under UAMS, Hospital Therapy and Rehabilitaiton Clinic | |
| Donetsk, Ukraine, 83045 | |
| Kharkiv Medical Academy of Postgraduate Education, City Clinical General Hospital #25 | |
| Kharkiv, Ukraine, 61115 | |
| Zaporizhya State Medical University, City Clinical Hopsital #6, Therapeutics Department | |
| Zaporizhya, Ukraine, 69035 | |
| Zaporizhzhya Regional Clinical Hospital, Rheumatology Department | |
| Zaporizhzhya, Ukraine, 69600 | |
| United Kingdom | |
| The Kellgren Centre for Rheumatology | |
| Manchester, United Kingdom | |
| Welcome Trust Clinical Research Facility, Southampton General Hospital | |
| Southampton, United Kingdom, SO16 6YD | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Study Director, Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00639834 History of Changes |
| Other Study ID Numbers: | MDX1342-01, IM130-001 |
| Study First Received: | January 10, 2008 |
| Last Updated: | April 22, 2010 |
| Health Authority: | United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy |
Keywords provided by Bristol-Myers Squibb:
|
rheumatoid arthritis RA joint inflammation |
autoimmune Medarex Rheumatology |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Antibodies, Monoclonal Methotrexate Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Abortifacient Agents, Nonsteroidal |
Abortifacient Agents Reproductive Control Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013