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TOward the Lowest Effective DOse of Abatacept or Tocilizumab

NCT01557374 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2021-01-26

No results posted yet for this study

Summary

Ever since the biotherapy agents have entered the market, the recommended therapeutic objective in Rheumatoid arthritis, has been remission. Once obtained, it is advised to try to reduce or cease these biotherapy agents, for which, their efficacy is counterbalanced to their tolerance in the medium and long term as well as their high price. Nevertheless, we do not dispose considerable data on the risks of relapse or structural progression during such a step down strategy. A few studies on anti-TNF agents have shown the possibility of such therapy reduction. A national study, " STRASS ", coordinated by Bruno FAUTREL, has evaluated the possibility of spacing or even stopping the injections of anti-TNF(s). To date, no data concerning Abatacept or Tocilizumab has been published.

As the expected result, this study is aimed to test the feasibility of a step down strategy on 2 biological agents, Abatacept and Tocilizumab, in RA patients in remission.

Conditions

Interventions

DRUG

Tocilizumab, Abatacept

Tocilizumab: Roactemra 4-8 mg/kg/month and 162 mg/week Abatacept: Orencia 500-1000 mg/month and 125 mg/week

DRUG

Decrease Tocilizumab, Abatacept

The decrease pattern is established on 4 consecutive stages : IV Abatacept (500-1000 mg/month) and Tocilizumab(4-8 mg/kg/month): Stage 0 : Perfusion /30 days Stage 1 :Perfusion/45 days Stage 2 :Perfusion/60 days Stage 3 :Perfusion/90 days Stage 4 :Stop SC Abatacept (125 mg/week) and Tocilizumab (162 mg/week): Stage 0 :Injection/7 days Stage 1 :Injection/10 days Stage 2 :Injection/14 days Stage 3 :Injection/21 days Stage 4 :Stop * If DAS 28 ≤ 2,6 (remission DAS persistent) on trimestrial visit: transfer to next stage for 3 months before next evaluation. * If DAS 28 \> 2,6 et ≤ 3,2 (weak activity) : maintain ongoing stage * If DAS 28 \> 3,2 : return to previous stage, (relapse according to European expert consensus) In the case of relapse while the patient is in stage 0, the therapy modification is left to the investigator's free will, but the patient will be followed till the end of the study.

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Bruno FAUTREL, Pr · APHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2019-11-08
Completion
2019-11-08

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01557374 on ClinicalTrials.gov