Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs.
- Conditions
- ArthritisRA10013361
- Registration Number
- NL-OMON56342
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- 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 - Active RA defined by CDAI>10 and at least 1
swollen joint of the 28 joint count - For patients < 65 years of age: On stable
treatment with csDMARDs for >= 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.
• 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in CDAI from baseline to 6, 9, and 12 months</p><br>
- Secondary Outcome Measures
Name Time Method