search
Back to results

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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
MDX-1342
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid, arthritis, RA, joint inflammation, autoimmune, Medarex, Rheumatology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Valley Arthritis Center LTD.
  • Impact Clinical Trials
  • Centre for Rheumatology, Immunology and Arthritis (CRIA)
  • Coastal Medical Research, Inc
  • Lovelace Scientific Resources
  • Good Samaritan Hospital and Johns Hopkins Hospital
  • Justus Fiechtner
  • Columbia University Medical Center
  • Altoona Center for Clinical Research
  • Arthritis Northwest Rheumatology, PLLC
  • George Krick, MD
  • Universitatsklinikum "Carl Gustav Carus" an der Technischen Universtitat Dresden
  • klinikum der Universitat zu Koln
  • Klinikum rechts der Isar der TU Munchen
  • DRC Gyógyszervizsgáló Központ Kft
  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz
  • DEOEC Kinikai Farmakologiai Tanszek
  • First Department of Medicine
  • V.K. Gusak Institute of Urgent & Reconstructive Surgery under UAMS, Hospital Therapy and Rehabilitaiton Clinic
  • Kharkiv Medical Academy of Postgraduate Education, City Clinical General Hospital #25
  • Zaporizhya State Medical University, City Clinical Hopsital #6, Therapeutics Department
  • Zaporizhzhya Regional Clinical Hospital, Rheumatology Department
  • The Kellgren Centre for Rheumatology
  • Welcome Trust Clinical Research Facility, Southampton General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Active MDX-1342 given in combination with Methotrexate

Outcomes

Primary Outcome Measures

incidence and severity of treatment-emergent adverse events

Secondary Outcome Measures

Full Information

First Posted
January 10, 2008
Last Updated
May 21, 2013
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT00639834
Brief Title
Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
Acronym
MDX1342-01
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid, arthritis, RA, joint inflammation, autoimmune, Medarex, Rheumatology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Active MDX-1342 given in combination with Methotrexate
Intervention Type
Biological
Intervention Name(s)
MDX-1342
Intervention Description
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.
Primary Outcome Measure Information:
Title
incidence and severity of treatment-emergent adverse events
Time Frame
all adverse events will be followed to resolution

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Sun Valley Arthritis Center LTD.
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Impact Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Centre for Rheumatology, Immunology and Arthritis (CRIA)
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Coastal Medical Research, Inc
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Lovelace Scientific Resources
City
Venice
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Good Samaritan Hospital and Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States
Facility Name
Justus Fiechtner
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Arthritis Northwest Rheumatology, PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
George Krick, MD
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Universitatsklinikum "Carl Gustav Carus" an der Technischen Universtitat Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
klinikum der Universitat zu Koln
City
Koln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Klinikum rechts der Isar der TU Munchen
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
DRC Gyógyszervizsgáló Központ Kft
City
Balatonfüred
ZIP/Postal Code
H-8230
Country
Hungary
Facility Name
Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz
City
Budapest
ZIP/Postal Code
H-1083
Country
Hungary
Facility Name
DEOEC Kinikai Farmakologiai Tanszek
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
Facility Name
First Department of Medicine
City
Szeged
Country
Hungary
Facility Name
V.K. Gusak Institute of Urgent & Reconstructive Surgery under UAMS, Hospital Therapy and Rehabilitaiton Clinic
City
Donetsk
ZIP/Postal Code
83045
Country
Ukraine
Facility Name
Kharkiv Medical Academy of Postgraduate Education, City Clinical General Hospital #25
City
Kharkiv
ZIP/Postal Code
61115
Country
Ukraine
Facility Name
Zaporizhya State Medical University, City Clinical Hopsital #6, Therapeutics Department
City
Zaporizhya
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Zaporizhzhya Regional Clinical Hospital, Rheumatology Department
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
The Kellgren Centre for Rheumatology
City
Manchester
Country
United Kingdom
Facility Name
Welcome Trust Clinical Research Facility, Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs