TOward the Lowest Effective DOse of Abatacept or Tocilizumab

PHASE4CompletedINTERVENTIONAL
Enrollment

232

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

November 8, 2019

Study Completion Date

November 8, 2019

Conditions
Rheumatoid Arthritis
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."

Trial Locations (1)

75013

CHU Pitié Salpêtrière, Paris

All Listed Sponsors
collaborator

Ministry of Health, France

OTHER_GOV

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT01557374 - TOward the Lowest Effective DOse of Abatacept or Tocilizumab | Biotech Hunter | Biotech Hunter