Arthritis Clinical Trials

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 mean 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. An ongoing national study, " STRASS ", coordinated by Bruno FAUTREL, evaluates the possibility of spacing or even stopping the injections of anti-TNF(s). To this day, 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 perfusion) in comparison with usual treatment (maintaining the usual dose and perfusion 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 since 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 since 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 perfusion 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 intravenous biological agents, Abatacept and Tocilizumab, in RA patients in remission.