Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs.
- Conditions
- <p>Rheumatoid Arthritis</p>10023213
- Registration Number
- NL-OMON29402
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
• 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).
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Clinical Disease Activity Index (CDAI)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Drug retention, radiographic progression, remission rates, (serious) adverse events, several patients reported outcome measeures (HAQ, EQ5D, PSQI, HADS, FACIT-Fatigue)</p><br>