Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)

A Randomised, Single-dose, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0142-0002 in Subjects With Active Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy of a single dose of NNC0142-0002 administered to subjects with active rheumatoid arthritis (RA).

Inclusion Criteria:

• A diagnosis of RA meeting the American College of Rheumatology 1987 (ACR1987) criteria, obtained at least three months prior to dosing with the trial product
• Subjects with active RA having a Disease Activity Score (DAS28-CRP) of 4.5 or more, at least five tender and five swollen joints (can be the same), including one swollen wrist or at least two swollen ipsilateral metacarpophalangeal (MCP) joints (second to fifth)
• Concomitant treatment with methotrexate (MTX) (7.5-25 mg/week) for at least 12 weeks, with stable dose for at least 4 weeks prior to dosing
• Ability to be examined by Magnetic Resonance Imaging (MRI)
• Having failed no biologic therapies for RA and no more than two non-biologic disease modifying antirheumatic drugs

Exclusion Criteria:

• Chronic inflammatory autoimmune disease other than RA (rheumatoid arthritis)
• Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to trial start
• Body mass index (BMI) below or equal to 18 or above or equal to 40 kg/m^2