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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 2

Conditions

Inflammation

Rheumatoid Arthritis

Treatments

Drug: NNC0142-0002

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01181050

NN8555-3796

2010-019261-28 (EudraCT Number)

U1111-1114-9194 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

63 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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