NL-OMON47431
Completed
Phase 4
REMission INDuction in very early Rheumatoid Arthritis - REMINDRA
niversitair Medisch Centrum Utrecht0 sites267 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Arthritis
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 267
- Status
- Completed
- Last Updated
- 2 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
- •\- DAS28 \<\=\>3\.2
- •\- Have sufficient knowledge of the Dutch language to be able to comply with the requirements of the study protocol
Exclusion Criteria
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •\- Having used glucocorticoids \< 6 weeks before the baseline visit
- •\- Being pregnant (based on anamnesis) 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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