REMission INDuction in Very Early Rheumatoid Arthritis

Launched by UMC UTRECHT · Oct 13, 2016

Keywords

ClinConnect Summary

Secondary endpoints:

Phase I (Remission induction):

* The proportion of patients on MTX/HCQ/GC in remission, defined as DAS28\<2.6, at week 12 or week 24 after start of treatment.
* The proportion of patients on MTX/GOL in sustained remission, defined as DAS28\<2.6 with max 4 swollen joints of the 44SJC at 2 consecutive visits 3 months apart, at week 24 after start of GOL treatment.
* Predictors of remission upon treatment with MTX, HCQ and a single injection of i.m. GC (e.g. smoking status, BMI, alcohol use, sex, disease duration, DAS28, Rheumatoid Factor (RF) -status, Anti-citrullinated...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Fulfilling 2010 ACR/EULAR criteria for RA.
• • Patient reported symptom duration \< 12 months
• • Naïve for DMARD and biological treatment
• • Naïve for previous use of glucocorticoids for RA
• • DAS28 ≥3.2
• Exclusion Criteria:
• • Being pregnant or being 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