Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT01557374 |
Other study ID # |
AOM 11061 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
April 2012 |
Est. completion date |
November 8, 2019 |
Study information
Verified date |
August 2020 |
Source |
Assistance Publique - Hôpitaux de Paris |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
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 then stopping the injections of
anti-TNF(s). To date, no data concerning Abatacept or Tocilizumab has been published.
This is a Non inferiority, prospective, randomized, controlled study with PROBE (Prospective
Randomized, Open Blinded Evaluation) evaluating method.
The objectives of this study are:
- For patients with Rheumatoid Arthritis (RA) in remission under Abatacept or Tocilizumab,
to evaluate in terms of disease activity within a 2 years period, the impact of a
progressive decreasing biotherapy strategy (by progressively spacing the injections) in
comparison with usual treatment (maintaining the usual dose and injection frequency of
the biotherapeutic agent).
- To evaluate the impact of such decreasing strategy in terms of RA relapses and
structural progression in 1 and 2 years.
- To determine the cost-effectiveness ratio of decreasing in comparison with maintaining
the biological treatments.
Inclusion criteria:
Patients with RA, defined by ACR-EULAR 2010 criteria:
- Treated for at least 1 year with Abatacept or Tocilizumab with market authorized doses*,
and possibly with a DMARD and ≤ 5 mg per day of corticoids.
- In remission for at least 6 months according to ACR/ EULAR 2010 remission criteria or a
DAS 28 ≤ 2.6**
Patients are divided into 2 groups:
1. Maintaining strategy: to maintain the biological treatment and possibly the associated
DMARD and corticoids.
2. Decreasing strategy: to decrease progressively the biological agent via progressively
increasing the injection intervals, following a predetermined pattern, established
according to the RA activity level, during each trimestrial visit.
The primary judgment criterion is: RA activity in a 2 years period of time, measured by
repeated DAS44.
The secondary judgment criteria are:
- Percentage of relapse in 1 and 2 years.
- Radiographic structural progression in 1 and 2 years.
- Cost-effectiveness ratio difference between the 2 strategies in 2 years.
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.