TOward the Lowest Effective DOse of Abatacept or Tocilizumab

NCT01557374 | Completed Phase 4

• 1 other identifier: AOM 11061
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Disease activity; Remission; Lowest Effective DOse; Abatacept Tocilizumab; ACR-EULAR 2010

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Radiographic structural progression evaluation and cost-efficiency measure

  2 years

Study Arms (2)

Maintenance Tocilizumab, Abatacept

ACTIVE COMPARATOR

No modification in biotherapy dose and administration frequency

Drug: Tocilizumab, Abatacept

Decrease Tocilizumab, Abatacept

EXPERIMENTAL

Progressive decrease by predetermined pattern. Progressive injection interval increase (by stage)

Drug: Decrease Tocilizumab, Abatacept

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

Also known as: Tocilizumab: Roactemra 4-8 mg/kg/month (IV injections) and 162 mg/week (SC injections), Abatacept: Orencia 500-1000 mg/month (IV injections) and 125 mg/week (SC injections)

Maintenance Tocilizumab, Abatacept

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.

Also known as: Tocilizumab: Roactemra, Abatacept: Orencia

Decrease Tocilizumab, Abatacept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• An increase in inflammatory parameters and pain due to an intercurrent event must be distinguished from the RA activity increasing.

You may not qualify if:

• Already included in another treatment evaluation trial for the same pathology.
• Surgical intervention programmed for in the next 24 months to come.
• Pregnancy or it's anticipation in the next 24 months to come.
• Non comprehension of French language.
• Non affiliation to social security.
• Patients under legal guardianship.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator

Study Sites (1)

CHU Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab; Abatacept; Injections

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Bruno FAUTREL, Pr

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 19, 2012
• Study Start: April 1, 2012
• Primary Completion: November 8, 2019
• Study Completion: November 8, 2019
• Last Updated: January 26, 2021

Record last verified: 2020-08

Locations

FR (1)