REMission INDuction in very early Rheumatoid Arthritis

Phase 4

Completed

• Conditions: Arthritis; RA; 10013361

• Registration Number: NL-OMON47431
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 267

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary end point is the proportion of patients in sustained remission at<br /><br>week 24 after start of tapering of either MTX or GOL first. </p><br>