drugset / Trial / NCT03813771
Targeted Treatment Early With Etanercept + Methotrexate vs.T2T Care for DMARD-naïve Early RA Patients Based on naïve T-cell Stratification
RandomizedParallel-groupOpen-labelTreatment
Summary
The main aim of the study is to determine the clinical utility of naive T-cell stratification for rationalising treatment with methotrexate (MTX), for DMARD-naive early RA patients. Thus, it aims to determine whether TNFi therapy (Benepali) instituted as first-line therapy in DMARD-naive early RA patients with poor T-cell prognostication confers better outcomes (clinical, structural and immunological). Hence, this would enable early targeted treatment for those with a poorer prognosis based on their immunological status.
Timeline
- Start
- 2019-03
- Primary completion
- 2023-02
- Completion
- 2023-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Etanercept | Protein / enzyme biologic | 50 mg | Subcutaneous |
| Subject | Methotrexate | Small molecule | 25 mg | Oral |
| Background | Hydroxychloroquine | Small molecule | 200 mg | Oral |
| Background | Sulfasalazine | Small molecule | 1 g | Oral |