REMission INDuction in very early Rheumatoid Arthritis

REMission INDuction in very early Rheumatoid Arthritis - REMINDRA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47431

Enrollment

267

Registered

2016-09-21

Start date

2017-05-23

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis RA

Interventions

Remission will be induced by a combination of MTX, hydroxychloroquine (HCQ), i.m. glucocorticoids (GC), and, if not in remission, the TNFi golimumab (GOL) (phase I). Patients in sustained remission

Eligibility

Age

18 Years to 99 Years

Inclusion 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

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Having used glucocorticoids

Design outcomes

Primary

Measure	Time frame
The primary end point is the proportion of patients in sustained remission at week 24 after start of tapering of either MTX or GOL first.	—

Secondary

Measure	Time frame
Phase I (Remission induction): - The proportion of patients on MTX/HCQ/GC in remission, defined as DAS28	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)