drugset / Trial / NCT02466581

Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity

NCT02466581

Phase 4 Unknown 25 enrolled Karolinska Institutet
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2015-02-03
Primary completion
2023-07-22
Completion
2023-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Abatacept Other / unclassified 125 mg Subcutaneous
Comparator Certolizumab Pegol Protein / enzyme biologic 200 mg Subcutaneous
Comparator Hydroxychloroquine Small molecule 35 mg/kg
Comparator Prednisolone Other / unclassified 5 mg
Comparator Sulfasalazine Small molecule 2 g
Comparator Tocilizumab Monoclonal antibody 8 mg/kg Intravenous
Comparator Tocilizumab Monoclonal antibody 162 mg Intravenous
Comparator Methotrexate Small molecule 25 mg

Indications