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 repeat subcutaneous (under the skin) injections in to patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
298
Administered subcutaneously (s.c., under the skin), once weekly.
Administered subcutaneously (s.c., under the skin), once weekly.
ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures)
Time frame: At week 12 (responder or non-responder)
ACR20, ACR50 and ACR70 improvement of ACR score from baseline
Time frame: At weeks 12 and 24
Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline
Time frame: At weeks 12 and 24
Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below)
Time frame: At weeks 12 and 24
European League Against Rheumatism (EULAR) criteria response
Time frame: At weeks 12 and 24
Change from baseline in the overall scores of Short Form Health Survey (SF-36v2)
Time frame: At weeks 12 and 24
Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time frame: At weeks 12 and 24
Incidence and type of adverse events (AEs)
Time frame: At weeks 12 and 24
Change from baseline in van der Heijde modified Sharp score
Time frame: At weeks 12 and 24
ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)
Time frame: Week 52
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Novo Nordisk Investigational Site
Huntington Beach, California, United States
Novo Nordisk Investigational Site
La Mesa, California, United States
Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
Placentia, California, United States
Novo Nordisk Investigational Site
Upland, California, United States
Novo Nordisk Investigational Site
Palm Harbor, Florida, United States
Novo Nordisk Investigational Site
Rock Island, Illinois, United States
Novo Nordisk Investigational Site
Springfield, Illinois, United States
Novo Nordisk Investigational Site
South Bend, Indiana, United States
Novo Nordisk Investigational Site
Cedar Rapids, Iowa, United States
...and 129 more locations
Incidence and type of adverse events (AEs)
Time frame: Week 52