Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
MDX1342-01
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
2 other identifiers
interventional
26
5 countries
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 rheumatoid-arthritis
Started Feb 2008
Typical duration for phase_1 rheumatoid-arthritis
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
March 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedMay 22, 2013
May 1, 2013
2.3 years
January 10, 2008
May 21, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
incidence and severity of treatment-emergent adverse events
all adverse events will be followed to resolution
Study Arms (1)
1
EXPERIMENTALActive MDX-1342 given in combination with Methotrexate
Interventions
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 Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Sun Valley Arthritis Center LTD.
Peoria, Arizona, 85381, United States
Impact Clinical Trials
Los Angeles, California, 90036, United States
Centre for Rheumatology, Immunology and Arthritis (CRIA)
Fort Lauderdale, Florida, 33334, United States
Coastal Medical Research, Inc
Port Orange, Florida, 32127, United States
Lovelace Scientific Resources
Venice, Florida, 34233, United States
Good Samaritan Hospital and Johns Hopkins Hospital
Baltimore, Maryland, 21239, United States
Justus Fiechtner
Lansing, Michigan, 48910, United States
Columbia University Medical Center
New York, New York, 10032, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Arthritis Northwest Rheumatology, PLLC
Spokane, Washington, 99204, United States
George Krick, MD
Tacoma, Washington, 98405, United States
klinikum der Universitat zu Koln
Cologne, 50924, Germany
Universitatsklinikum "Carl Gustav Carus" an der Technischen Universtitat Dresden
Dresden, 01307, Germany
Klinikum rechts der Isar der TU Munchen
Munich, 81675, Germany
DRC Gyógyszervizsgáló Központ Kft
Balatonfüred, H-8230, Hungary
Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz
Budapest, H-1083, Hungary
DEOEC Kinikai Farmakologiai Tanszek
Debrecen, H-4012, Hungary
First Department of Medicine
Szeged, Hungary
V.K. Gusak Institute of Urgent & Reconstructive Surgery under UAMS, Hospital Therapy and Rehabilitaiton Clinic
Donetsk, 83045, Ukraine
Kharkiv Medical Academy of Postgraduate Education, City Clinical General Hospital #25
Kharkiv, 61115, Ukraine
Zaporizhya State Medical University, City Clinical Hopsital #6, Therapeutics Department
Zaporizhya, 69035, Ukraine
Zaporizhzhya Regional Clinical Hospital, Rheumatology Department
Zaporizhzhya, 69600, Ukraine
The Kellgren Centre for Rheumatology
Manchester, United Kingdom
Welcome Trust Clinical Research Facility, Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2008
First Posted
March 20, 2008
Study Start
February 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
May 22, 2013
Record last verified: 2013-05