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

Study Overview
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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).

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

Conditions
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Inflammation, Rheumatoid Arthritis

Intervention / Treatment
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* Drug: NNC0142-0002
* Drug: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4.0 mg/kg<br>Subjects received a single dose of 4 mg/kg NNC0142-0002 | Drug: NNC0142-0002<br>* A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin).<br>|
| Placebo Comparator: Placebo<br>Subjects received a single dose of placebo | Drug: placebo<br>* A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 0, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Week 0, Week 24 |