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

Rheumatoid Arthritis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639834
• Other study ID #: MDX1342-01
• Secondary ID: IM130-001
• Status: Completed
• Phase: Phase 1
• First received: January 10, 2008
• Last updated: May 21, 2013
• Start date: February 2008
• Est. completion date: June 2010

Study information

• Verified date: May 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
Germany	Universitatsklinikum "Carl Gustav Carus" an der Technischen Universtitat Dresden	Dresden
Germany	klinikum der Universitat zu Koln	Koln
Germany	Klinikum rechts der Isar der TU Munchen	Munich
Hungary	DRC Gyógyszervizsgáló Központ Kft	Balatonfüred
Hungary	Semmelweis Egyetem Altalanos Orvostudomanyi Kar-I. sz	Budapest
Hungary	DEOEC Kinikai Farmakologiai Tanszek	Debrecen
Hungary	First Department of Medicine	Szeged
Ukraine	V.K. Gusak Institute of Urgent & Reconstructive Surgery under UAMS, Hospital Therapy and Rehabilitaiton Clinic	Donetsk
Ukraine	Kharkiv Medical Academy of Postgraduate Education, City Clinical General Hospital #25	Kharkiv
Ukraine	Zaporizhya State Medical University, City Clinical Hopsital #6, Therapeutics Department	Zaporizhya
Ukraine	Zaporizhzhya Regional Clinical Hospital, Rheumatology Department	Zaporizhzhya
United Kingdom	The Kellgren Centre for Rheumatology	Manchester
United Kingdom	Welcome Trust Clinical Research Facility, Southampton General Hospital	Southampton
United States	Good Samaritan Hospital and Johns Hopkins Hospital	Baltimore	Maryland
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Centre for Rheumatology, Immunology and Arthritis (CRIA)	Fort Lauderdale	Florida
United States	Justus Fiechtner	Lansing	Michigan
United States	Impact Clinical Trials	Los Angeles	California
United States	Columbia University Medical Center	New York	New York
United States	Sun Valley Arthritis Center LTD.	Peoria	Arizona
United States	Coastal Medical Research, Inc	Port Orange	Florida
United States	Arthritis Northwest Rheumatology, PLLC	Spokane	Washington
United States	George Krick, MD	Tacoma	Washington
United States	Lovelace Scientific Resources	Venice	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence and severity of treatment-emergent adverse events		all adverse events will be followed to resolution	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm