This is an international (Sweden, Finland, Norway, Denmark, Iceland and the Netherlands) trial designed to compare the safety and efficacy of active conventional therapy (ACT) and three biologic treatments in subjects with early rheumatoid arthritis (RA). The global aim of this study is to assess and compare 1. the proportion of subjects who achieve remission with ACT versus three different biologic therapies (Certolizumab-pegol, Abatacept or Tocilizumab) 2. two alternative de-escalation strategies in patients who respond to first-line therapy.
After completed enrollment a total of 812 patients were included in the study. 371 of the included patients have entered treatment part 2, 256 patients have exited the study after treatment part 1, 207 patients have had early termination and 322 patients have completed the full study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
812
Methotrexate: 25mg/week. SSZ: 2 g/day. HCQ: 35 mg/kg/week (Finland and Denmark) Methotrexate: 25mg/week. Prednisolone 20 mg/day tapered in 9 weeks to 5 mg/day, discontinued after 9 months. (Sweden, Norway, Iceland, and the Netherlands)
Certolizumab-pegol: 200 mg s.c. every other week. Methotrexate: 25mg/week
Abatacept: 125 mg s.c. every week. Methotrexate: 25mg/week
Tocilizumab is given as 4-weekly infusions at dosage 8 mg/kg or 162 mg in solution s.c. every week. Methotrexate: 25mg/week
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Silkeborg University Clinic
Silkeborg, Denmark
Svendborg Hospital OUH
Svendborg, Denmark
University Hospital of Southern Denmark
Sønderborg, Denmark
Helsinki University Central Hospital
Helsinki, Finland
Central Finland Central Hospital
Jyväskylä, Finland
Kuopio University Hospital
Kuopio, Finland
...and 20 more locations
The proportion of patients in remission at week 24 from baseline according to CDAI
Treatment Part 1: The primary efficacy outcome is the proportion of patients in remission at week 24 from BL according to CDAI
Time frame: 24 weeks from BL
The proportion of patients in remission at week 24 after dose-reduction according to CDAI
Treatment Part 2: The primary efficacy outcome is the proportion of patients in remission according to CDAI, at the time point 24 weeks after the dose was first reduced
Time frame: 24 weeks after dose-reduction
The radiographic progression of total Sharp van der Heijde score after 48 weeks from baseline
The primary efficacy outcome is the progression of total Sharp van der Heijde score after 48 weeks from BL
Time frame: 48 weeks from BL
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.