A Trial Investigating the Mechanism of Action of NNC0109-0012 (Anti-IL-20 mAb) Through Synovial Biopsies in Subjects With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

Sponsor
Novo Nordisk A/S
Study ID
NCT02097264
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • NNC0109-0012 — DRUG
    Solution for injection administered subcutaneously (s.c. - under the skin). 240 mg NNC0109-0012 will be administered weekly for 12 weeks
  • Adalimumab — DRUG
    Solution for injection administered subcutaneously (s.c. - under the skin). Administered every other week for 12 weeks; Each active treatment involves 1 (one) s.c. injection of adalimumab 40 mg/0,8 mL solution for injection for paediatric use (Humira®)
  • placebo — DRUG
    Solution for injection administered subcutaneously (s.c. - under the skin). 1 active adalimumab injection and 2 placebo injections per active treatment (every other week), and 3 placebo injections on placebo visits (alternative weeks).

Study Details

This trial is conducted in Europe. The aim of the trial is to investigate the mechanism of action of NNC0109-0012 (anti-IL-20 mAb) through synovial biopsies in subjects with rheumatoid arthritis (RA) and an inadequate response to Methotrexate.

Key Dates

Start date
Sep 30, 2014
Status verified
Aug 2014
Primary completion
Sep 30, 2015
Completion
Sep 30, 2015

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NNC0109-0012
  • Active Comparator: Adalimumab

Primary Outcome Measure

Change in the total histopathological synovitis score [ Time Frame: Week 0, week 12 ]

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