NCT01181050 - Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA) | Crick

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

63

Conditions

Inflammation Rheumatoid Arthritis

Interventions

NNC0142-0002DRUG

A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin).

placeboDRUG

A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

Unnamed facility

Berlin, Germany

Unnamed facility

Moscow, Russia

Unnamed facility

Kiev, Ukraine

Outcomes

Primary Outcomes

Change in DAS28-CRP After 12 Weeks of Treatment

DAS28-CRP=0.56×sqrt(tender joints \[count:1-28\])+0.28×sqrt(swollen joints \[count:1-28\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \[100=most severe\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.

Time frame: Week 0, Week 12

Secondary Outcomes

Change in DAS28-CRP After 6 Weeks of Treatment.

DAS28-CRP=0.56×sqrt(tender joints \[count:1-28\])+0.28×sqrt(swollen joints \[count:1-28\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \[100=most severe\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 6 Weeks of treatment.

Time frame: Week 0, Week 6

Change in DAS28-CRP After 24 Weeks of Treatment.

DAS28-CRP=0.56×sqrt(tender joints \[count:1-28\])+0.28×sqrt(swollen joints \[count:1-28\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \[100=most severe\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 24 Weeks of treatment.

Time frame: Week 0, Week 24