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

Phase 2

Completed

• Conditions: Inflammation; Rheumatoid Arthritis
• Interventions: Drug: NNC0142-0002; Drug: placebo

• Registration Number: NCT01181050
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Disposition First Submitted: 2012-05-10
• Disposition First Submitted QC: 2012-05-10
• Disposition First Posted: 2012-05-15
• Results First Submitted: 2013-04-25
• Results First Submitted QC: 2014-03-26
• Results First Posted: 2014-04-28
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-24
• Last Update Posted: 2016-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4.0 mg/kg	NNC0142-0002	Subjects received a single dose of 4 mg/kg NNC0142-0002
Placebo	placebo	Subjects received a single dose of placebo

Primary Outcome Measures

Name	Time	Method
Change in DAS28-CRP After 12 Weeks of Treatment	Week 0, Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Change in DAS28-CRP After 6 Weeks of Treatment.	Week 0, Week 6	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.
Change in DAS28-CRP After 24 Weeks of Treatment.	Week 0, Week 24	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.