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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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:
Inclusion criteria:
Patients with RA, defined by ACR-EULAR 2010 criteria:
Patients are divided into 2 groups:
The primary judgment criterion is: RA activity in a 2 years period of time, measured by repeated DAS44.
The secondary judgment criteria are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maintenance Tocilizumab, Abatacept | Active Comparator | No modification in biotherapy dose and administration frequency |
|
| Decrease Tocilizumab, Abatacept | Experimental | Progressive decrease by predetermined pattern. Progressive injection interval increase (by stage) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab, Abatacept | Drug | Tocilizumab: Roactemra 4-8 mg/kg/month and 162 mg/week Abatacept: Orencia 500-1000 mg/month and 125 mg/week |
|
| Measure | Description | Time Frame |
|---|---|---|
| RA activity in a 2 years period of time, measured by repeated DAS44 | The primary judgment criterion is: RA activity in a 2 years period of time, measured by repeated DAS44. | Trimestrial visit (-5 days/ + 35 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic structural progression evaluation and cost-efficiency measure | RA relapse percentage in 1 and 2 years. Radiographic structural progression evaluation by annual radiography.(Sharp score) Cost- efficiency ratio difference between the 2 strategies of maintenance and decrease. | 2 years |
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Inclusion Criteria:
Patients of at least 18 years old.
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 since at least 6 months according to ACR/ EULAR 2010 remission criteria or a DAS 28 ≤ 2.6**
Without destructive structural progression during the previous year on the hand and feet x-rays (judged by the reference rheumatologist)
Informed on the study and have given their acknowledged written consent to participate in the study.
Having had a prior medical visit.
Prescribed dose stability (a spacing related to an infection or a surgery is not a prescribed dose spacing).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno FAUTREL, Pr | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Pitié Salpêtrière | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
| D000069594 | Abatacept |
| D007267 | Injections |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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|
| 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
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. |
|
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |