TOward the Lowest Effective DOse of Abatacept or Tocilizumab

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT01557374
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab, Abatacept — DRUG
    Tocilizumab: Roactemra 4-8 mg/kg/month and 162 mg/week Abatacept: Orencia 500-1000 mg/month and 125 mg/week
  • Decrease Tocilizumab, Abatacept — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 30, 2012
Status verified
Aug 2020
Primary completion
Nov 8, 2019
Completion
Nov 8, 2019

Study Design

Enrollment
232 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Maintenance Tocilizumab, Abatacept
    No modification in biotherapy dose and administration frequency
  • Experimental: Decrease Tocilizumab, Abatacept
    Progressive decrease by predetermined pattern. Progressive injection interval increase (by stage)

Primary Outcome Measure

RA activity in a 2 years period of time, measured by repeated DAS44 [ Time Frame: Trimestrial visit (-5 days/ + 35 days) ]

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