Phase 2 Completed N=63 Randomized Double-blind Treatment

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

Inflammation · Rheumatoid Arthritis

Source: ClinicalTrials.gov NCT01181050 ↗

Enrolled (actual)

Serious AEs

6.4%

Results posted

Apr 2014

Primary outcomePrimary: Change in DAS28-CRP After 12 Weeks of Treatment — -1.0; -1.0 scores — p=0.9334

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in DAS28-CRP After 12 Weeks of Treatment	-1.0; -1.0	0.9334
SECONDARY Change in DAS28-CRP After 6 Weeks of Treatment.	-0.9; -1.0	0.8293
SECONDARY Change in DAS28-CRP After 24 Weeks of Treatment.	-1.3; -1.3	0.8867

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01181050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.