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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Inflammation Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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4.0 mg/kg

Subjects received a single dose of 4 mg/kg NNC0142-0002

Group Type EXPERIMENTAL

NNC0142-0002

Intervention Type DRUG

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

Placebo

Subjects received a single dose of placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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NNC0142-0002

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No