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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00639834

Acronym

MDX1342-01

Enrollment

Registered

2008-03-20

Start date

2008-02-29

Completion date

2010-06-30

Last updated

2013-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid, arthritis, RA, joint inflammation, autoimmune, Medarex, Rheumatology

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.

Interventions

BIOLOGICALMDX-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
incidence and severity of treatment-emergent adverse events	all adverse events will be followed to resolution

Countries

Germany, Hungary, Ukraine, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026