drugset / Trial / NCT02466581
Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |