Arthritis RA
Conditions
Interventions
Arm 1: Tocilizumab subcutaneously 162 mg/ week
Arm 2: Prednison orally 10 mg/day
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Able and willing to give written informed consent - Have sufficient knowledge of the Dutch language to be able to comply with the requirements of the study protocol - At least 18 years of age - Diagnosed as having RA and meeting the 2010 ACR/EULAR criteria for RA - Active RA defined by CDAI>10 and at least 1 swollen joint of the 28 joint count - For patients = 8 weeks prior to the screening visit - Are eligible to start with a biological according to the 2019 EULAR guidelines for management of RA: previous treatment with >=2 csDMARDs OR previous treatment with >=1 csDMARD with presence of a prognostically unfavorable factor.
Exclusion criteria
Exclusion criteria: • Having a contraindication for treatment with systemic GCs (as determined by the treating rheumatologist, in line with regular care). • Having a contraindication for treatment with TCZ, as determined by the treating rheumatologist or as described in the Summary of Product Characteristics (SPC) Paragraph 4.3, page 33. *Special warnings and precautions for use* as described in the SPC Paragraph 4.4, page 33, should be strictly followed. • Use of systemic GCs (including i.a. GCs) within 4 weeks before the screening visit. • Current use of a bDMARD or tsDMARD;i.e. these need to be discontinued before start of study medication. Wash out periods for bDMARDs and tsDMARDs should follow routine care. • Treatment with any investigational agent within 4 weeks prior to the screening visit. • Having any other inflammatory rheumatic disease than RA. Secondary Sjögren*s syndrome will be allowed, as well as RA-overlap syndromes that are primarily treated as RA at the time of screening. • Female who is pregnant (by anamnesis) or breast feeding, or considering becoming pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in CDAI from baseline to 6, 9, and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in CDAI from baseline to 6 months - Change in SDAI and change in DAS28 from baseline to 12 months. - Drug retention rate, defined as the proportion of patients at 12 months on the treatment (TCZ/prednisone) to which they were allocated. - Switch rate, defined as the proportion of patients who switched during the study period to treatment of the other arm. - Average dose of TCZ or prednisone from baseline up to 12 months. - ACR20, ACR50, and ACR70 response (using 28 joint counts), and EULAR good or moderate response (Appendix C.) - Proportion of patients reaching a state of clinical remission at any time during the study defined by different criteria: CDAI | — |
Countries
Netherlands
Outcome results
None listed