EUCTR2015-004858-17-NL
Active, not recruiting
Phase 1
REMission INDuction in very early Rheumatoid Arthritis - REMINDRA
niversity Medical Center Utrecht (UMCU)0 sites267 target enrollmentSeptember 28, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity Medical Center Utrecht (UMCU)
- Enrollment
- 267
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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