This trial is conducted in Europe. The aim of the trial is to evaluate the change in disease activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
Two i.v. (intravenous) doses administered 6 weeks apart.
Two i.v. (intravenous) doses administered 6 weeks apart.
Change in disease activity score based on 28 joints and c-reactive protein (DAS28-CRP)
Time frame: Week 0, week 12
ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)
Time frame: Week 12
Incidence of adverse events (AEs)
Time frame: Up to week 24
Incidence of antibodies against NNC0114-0006
Time frame: Up to Week 24
Terminal serum half-life (t½)
Time frame: After second dose administration at week 6
Change in serum levels of total interleukin-21 (IL-21)
Time frame: Up to week 12
Change in Health Assessment Questionnaire - Disability Index score (HAQ-DI)
Time frame: Week 0, week 12
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Novo Nordisk Investigational Site
Plovdiv, Bulgaria
Novo Nordisk Investigational Site
Sevlievo, Bulgaria
Novo Nordisk Investigational Site
Sofia, Bulgaria
Novo Nordisk Investigational Site
Sofia, Bulgaria
Novo Nordisk Investigational Site
Sofia, Bulgaria
Novo Nordisk Investigational Site
Budapest, Hungary
Novo Nordisk Investigational Site
Debrecen, Hungary
Novo Nordisk Investigational Site
Debrecen, Hungary
Novo Nordisk Investigational Site
Szikszó, Hungary
Novo Nordisk Investigational Site
Veszprém, Hungary
...and 23 more locations