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

Sponsored by:	Medarex
Information provided by:	Medarex
ClinicalTrials.gov Identifier:	NCT00639834

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 I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
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:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by Medarex:

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
1: Experimental 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

Contacts

Contact: Medarex Medical, Monitor

908-479-2400

Locations

United States, Arizona
Sun Valley Arthritis Center LTD.	Recruiting
Peoria, Arizona, United States, 85381
Principal Investigator: Joy Schechtman, DO
United States, California
Impact Clinical Trials	Recruiting
Los Angeles, California, United States, 90036
Principal Investigator: Lydie L Hazan, M.D.
United States, Florida
Coastal Medical Research, Inc	Recruiting
Port Orange, Florida, United States, 32127
Principal Investigator: Michael Kohen, MD
Lovelace Scientific Resources	Recruiting
Venice, Florida, United States, 34233
Principal Investigator: Jeffrey L Kaine, MD
Centre for Rheumatology, Immunology and Arthritis (CRIA)	Recruiting
Fort Lauderdale, Florida, United States, 33334
Principal Investigator: Yvonne S Sherrer, M.D.
United States, Maryland
Good Samaritan Hospital and Johns Hopkins Hospital	Recruiting
Baltimore, Maryland, United States, 21239
Principal Investigator: Peter Holt, M.D.
United States, Michigan
Justus Fiechtner	Recruiting
Lansing, Michigan, United States, 48910
Principal Investigator: Justus J Fiechtner, MD, MPH
United States, New York
Columbia University Medical Center	Recruiting
New York, New York, United States, 10032
Principal Investigator: Robert Winchester, MD
United States, Pennsylvania
Altoona Center for Clinical Research	Completed
Duncansville, Pennsylvania, United States, 16635
Germany
klinikum der Universitat zu Koln	Recruiting
Koln, Germany, 50924
Principal Investigator: Andrea Rubbert-Roth, Dr.Med
Universitatsklinikum "Carl Gustav Carus" an der Technischen Universtitat Dresden	Recruiting
Dresden, Germany, 01307
Principal Investigator: Martin Aringer, MD
Klinikum rechts der Isar der TU Munchen	Recruiting
Munich, Germany, 81675
Contact: Klaus Thuermel, MD 49-89-4140-5047 klaus.thuemel@arcor.de
Principal Investigator: Klaus Thuemel, MD
Hungary
DRC Gyógyszervizsgáló Központ Kft	Not yet recruiting
Balatonfüred, Hungary, H-8230
Principal Investigator: Péterfai Eva, MD
Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz	Not yet recruiting
Budapest, Hungary, H-1083
Contact: Peter Lakatos, MD
Principal Investigator: Peter Lakatos, MD
DEOEC Kinikai Farmakologiai Tanszek	Not yet recruiting
Debrecen, Hungary, H-4012
Contact: Peter Kovacs, MD
Principal Investigator: Peter Kovacs, MD
First Department of Medicine	Not yet recruiting
Szeged, Hungary
Contact: Andrea Tiszai, MD 36 52 545 185
United Kingdom
Welcome Trust Clinical Research Facility, Southampton General Hospital	Recruiting
Southampton, United Kingdom, SO16 6YD
Principal Investigator: Christopher Edwards, MD
The Kellgren Centre for Rheumatology	Recruiting
Manchester, United Kingdom
Contact: Christopher Denton, MD 44 186 5737544

Sponsors and Collaborators

Medarex

Investigators

Study Director:

Medarex Medical, Monitor

Medarex

More Information

No publications provided

Responsible Party:	Medarex, Inc. ( Medarex Inc. )
Study ID Numbers:	MDX1342-01
Study First Received:	January 10, 2008
Last Updated:	September 4, 2009
ClinicalTrials.gov Identifier:	NCT00639834 History of Changes
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 Medarex:

rheumatoid
arthritis
RA
joint inflammation

autoimmune
Medarex
Rheumatology

Study placed in the following topic categories:

Antimetabolites
Autoimmune Diseases
Immunologic Factors
Joint Diseases
Arthritis, Rheumatoid
Folate
Rheumatic Diseases
Folinic Acid
Folic Acid Antagonists
Immunosuppressive Agents
Vitamin B9

Inflammation
Folic Acid
Antibodies, Monoclonal
Antibodies
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate
Antirheumatic Agents
Immunoglobulins

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
Antibodies, Monoclonal
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Abortifacient Agents
Connective Tissue Diseases

Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Enzyme Inhibitors
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 10, 2009