In rheumatoid arthritis (RA) patients with insufficient response to disease modifying anti-rheumatic drugs (DMARDs) it is unknown whether addition of tocilizumab (TCZ) to conventional synthetic (cs) DMARDs has superior efficacy compared to addition…
ID
Source
Brief title
Condition
- Joint disorders
Health condition
Rheumatoid Arthritis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical Disease Activity Index (CDAI)
Secondary outcome
Drug retention, radiographic progression, remission rates, (serious) adverse events, several patients reported outcome measeures (HAQ, EQ5D, PSQI, HADS, FACIT-Fatigue)
Background summary
In this pragmatic, open-label, multicenter trial, 120 patients suffering from rheumatoid arthritis will be randomized to receive treatment with either tocilizumab (162mg/week subcutaneously), or prednisone (10mg/day orally) in addition to their treatment with conventional synthetic disease modifying antirheumatic drugs (csDMARDs). Follow-up is one year. The primary outcome will be disease activity measured by the clinical disease activity index (CDAI).
Study objective
In rheumatoid arthritis (RA) patients with insufficient response to disease modifying anti-rheumatic drugs (DMARDs) it is unknown whether addition of tocilizumab (TCZ) to conventional synthetic (cs) DMARDs has superior efficacy compared to addition of prednisone. If so, TCZ should be considered instead of prednisone. On the other hand, administration of prednisone may be a highly cost-effective treatment approach.
Study design
Baseline, 1, 2, 3, 6, 9, 12 months.
Intervention
Addition of either tocilizumab (162mg/week subcutaneously) OR prednisone (10mg/day orally)
Age
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 (Appendix A). • Active RA defined by CDAI>10 and at least 1 swollen joint of the 28 joint count. • On stable treatment with csDMARDs for ≥ 8 weeks prior to the screening visit. • Previous treatment with ≥2 csDMARDs OR previous treatment with ≥1 csDMARD in combination with a maximum of 1 TNF inhibitor (Wash out period: ≥2 weeks before first administration of study medication).
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. • Previous use of ≥ 2 TNF-inhibitors. • Previous use of any other bDMARD (beside 1 TNFi) or tsDMARD. • Treatment with any investigational agent within 4 weeks prior to the screening visit. • Having any other inflammatory rheumatic disease than RA, except for secondary Sjögren’s syndrome. • Female who is pregnant (by anamnesis) or breast feeding, or considering becoming pregnant during the study period.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8070 |
| CCMO | NL68492.041.19 |
| OMON | NL-OMON56342 |