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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00639834
• Date of registration: 10/01/2008
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Study of the Safety of MDX-1342 in Combination With Methotrexate in Patients With Rheumatoid Arthritis MDX1342-01
• Scientific 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
• Date of first enrolment: February 2008
• Target sample size: 26
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00639834
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

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

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: MDX-1342

Primary Outcome(s)

incidence and severity of treatment-emergent adverse events [Time Frame: all adverse events will be followed to resolution]

Secondary ID(s)

IM130-001

MDX1342-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors