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A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics

NCT01636817 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2018-09-05

No results posted yet for this study

Summary

This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa biologics and are on a stable background of methotrexate (MTX) therapy.

Conditions

Interventions

DRUG

NNC0109-0012

Administered subcutaneously (s.c., under the skin) once weekly.

DRUG

placebo

Administered subcutaneously (s.c., under the skin) once weekly.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States
  • Argentina
  • Belgium
  • Brazil
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01636817 on ClinicalTrials.gov