REMission INDuction in Very Early Rheumatoid Arthritis

NCT02935387 | Terminated Phase 4

• 1 other identifier: REMINDRA
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

Rheumatoid arthritis (RA) patients in remission with a combination of TNFinhibitors (TNFi) and methotrexate (MTX) often express their wish to stop MTX treatment because of side effects. Given the efficacy of TNFi it is conceivable that in early RA patients in remission with methotrexate (MTX)/TNFi stepwise discontinuation of MTX prior to TNFi is superior in maintaining sustained remission and reaching drug free remission as compared to discontinuation of TNFi prior to MTX. Objective: To investigate whether tapering MTX first, then the TNFi golimumab (GOL), is more efficacious than tapering GOL first, then MTX, in sustaining remission and reaching drug free remission. Study design: multicenter, open label clinical trial in very early RA patients. Remission will be induced by an open label treat-to-target (T2T) remission induction protocol in clinical care: (MTX, hydroxychloroquine (HCQ), i.m. glucocorticoids (GC), and, if not in remission, the TNFi golimumab (GOL)) (phase I, 3/4th or 1 year). Patients in sustained remission on MTX/GOL (DAS28\<2.6 with max 4 swollen joints of the 44 swollen joint count (SJC) at 2 consecutive visits 3 months apart) will be randomized to taper either MTX first, then GOL or GOL first, then MTX with as primary endpoint sustained (drug free) remission (phase II, 1 year). During 1 year additional follow-up maintenance of drug-free sustained remission will be investigated (phase III). Study population: RA patients fulfilling 2010 American College of Rheumatology (ACR)/EUropean League Against Rheumatism (EULAR) criteria for RA, with symptom duration \<12 months; naïve for anti-rheumatic drugs and glucocorticoids for RA; DAS28 ≥3.2. Intervention: Patients in sustained remission (defined as DAS28\<2.6 with max 4 swollen joints of the 44SJC at ≥ 2 consecutive visits 3 months apart) on MTX/GOL at the end of phase I (after 24 weeks of treatment with MTX/GOL) will be randomized in a ratio of 1:1 to taper medication as follows:

• Taper and stop GOL first during 24 weeks, then, if still in sustained remission, taper and stop MTX during 24 weeks
• Taper and stop MTX first during 24 weeks, then, if still in sustained remission, taper and stop GOL during 24 weeks 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. The main secondary end point is the proportion of patients in drug-free sustained remission, at week 48 after start of tapering.

Conditions

Arthritis, Rheumatoid

Keywords

Very early rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• proportion of patients in sustained remission

  the proportion of patients in sustained remission at week 24 after start of tapering of either MTX or GOL first.

  At week 24 after start of tapering

Study Arms (2)

Taper methotrexate, then golimumab

EXPERIMENTAL

Taper methotrexate 25\>0mg/wk during 24 weeks, then, if still in sustained remission, taper golimumab 50\>0mg/month during 24 weeks.

Other: Taper

Taper golimumab, then methotrexate

ACTIVE COMPARATOR

Taper golimumab 50\>0mg/month during 24 weeks, then, if still in sustained remission, taper methotrexate 25\>0mg/wk during 24 weeks.

Other: Taper

Interventions

Taper OTHER

Taper

Taper golimumab, then methotrexate; Taper methotrexate, then golimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (2)

Reumazorg Zuidwest Nederland

Goes, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jacob M van Laar

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD PhD

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 17, 2016
• Study Start: April 21, 2017
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)