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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Solution for injection administered subcutaneously (s.c. - under the skin). 240 mg NNC0109-0012 will be administered weekly for 12 weeks
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®)
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).
Change in the total histopathological synovitis score
Time frame: Week 0, week 12
Change in dynamic contrast enhanced MRI (DCE-MRI) measures of initial rate of enhancement (IRE)
Time frame: Week 0, week 12
Change in dynamic contrast enhanced MRI (DCE-MRI) measures of maximal enhancement (ME)
Time frame: Week 0, week 12
Changes in RA-MRI scores (RAMRIS (Rheumatoid arthritis magnetic resonance imaging)) of synovitis
Time frame: Week 0, week 12
Changes in RA-MRI scores (RAMRIS) of oedema
Time frame: Week 0, week 12
Changes in RA-MRI scores (RAMRIS) of erosion
Time frame: Week 0, week 12
Change in high frequency ultrasound with Power Doppler measures of total synovitis
Time frame: Week 0, week 12
Change in high frequency ultrasound with Power Doppler measures of total tenosynovitis scores
Time frame: Week 0, week 12
Change in disease activity 28 - C-reactive protein (DAS28 (CRP)
Time frame: Week 0, week 12
Incidence of Adverse Events (AE)
Time frame: Week 0, week 24
Incidence of local intolerability at the injection site
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Time frame: Week 0, week 24