This is an international (Nordic) trial designed to compare the safety and efficacy of active conventional therapy (ACT) and three biologic treatments (Certolizumab-pegol, Abatacept or Tocilizumab) in subjects with early rheumatoid arthritis (RA). The global aim of this study is to assess and compare two alternative de-escalation strategies in patients who achieved low disease activity during first-line therapy in the NORD-STAR study.
25 patients have been included in the study of which 1 has had an early termination an 22 have completed the full study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
25
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, and Iceland)
Certolizumab-pegol: 200 mg s.c. every other week. Methotrexate: 25mg/week
Abatacept: 125 mg s.c. every week. Methotrexate: 25mg/week
Sahlgrenska University Hospital
Gothenburg, Sweden
The Karolinska University Hospital
Huddinge, Sweden
Linköping University Hospital
Linköping, Sweden
Skåne University Hospital
Lund, Sweden
Proportion of patients maintaining low disease activity after dose reduction
The proportion of patients, with early dose reduction vs late dose reduction, who maintain low disease activity (2.8 \< CDAI ≤ 10.0) at the time point 24 weeks after the dose was first reduced.
Time frame: 24 weeks after dose reduction
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tocilizumab is given as 4-weekly infusions at dosage 8 mg/kg or 162 mg in solution s.c. every week. Methotrexate: 25mg/week
Skåne University Hospital
Malmö, Sweden
The Karolinska University Hospital
Solna, Sweden
Karolinska Institutet
Stockholm, Sweden
Academic Specialist Center
Stockholm, Sweden