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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Biological: MDX-1342

Study type: Interventional

Funder types: Industry

Identifiers

NCT00639834

IM130-001 (Other Identifier)

MDX1342-01

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

1

Experimental group

Description:

Active MDX-1342 given in combination with Methotrexate

Treatment:

Biological: MDX-1342