Status:
COMPLETED
Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Inflammation
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01181050
Start Date
August 1 2010
End Date
April 1 2012
Last Update
October 3 2016
Active Locations (3)
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1
Berlin, Germany, 13353
2
Moscow, Russia, 109240
3
Kiev, Ukraine, 03680