REMission INDuction in very early Rheumatoid Arthritis
- Conditions
- Very early Rheumatoid arthritisMedDRA version: 19.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2015-004858-17-NL
- Lead Sponsor
- niversity Medical Center Utrecht (UMCU)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 267
To be eligible to participate in this study, a subject must meet all of the following criteria:
-Able and willing to give written informed consent
-At least 18 years of age
-Fulfilling 2010 ACR/EULAR criteria for RA (Appendix A.)
-Patient reported symptom duration (joint stiffness, tenderness, pain, and/or swelling) < 12 months
-Naïve for DMARD and biological treatment
-Naïve for previous use of glucocorticoids for RA
-DAS28 =>3.2
-Have sufficient knowledge of the Dutch language to be able to comply with the requirements of the study protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 267
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 267
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Being pregnant or a nursing women or a women of child bearing potential without (adequate) use of contraception
-Having any other inflammatory rheumatic disease than RA, except for secondary Sjögren’s syndrome
-Having contraindications for the use of MTX/HCQ/methylprednisolone/GOL.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method