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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 1 February 2021
Main ID:  NCT01557374
Date of registration: 16/03/2012
Prospective Registration: Yes
Primary sponsor: Assistance Publique - Hôpitaux de Paris
Public title: TOward the Lowest Effective DOse of Abatacept or Tocilizumab TOLEDO
Scientific title: Tapering Abatacept or Tocilizumab in Rheumatoid Arthritis in Remission. An Evaluation of Disease Activity, Relapse Risk, Structural Progression and the Economic Impact of a Tapering Strategy
Date of first enrolment: April 2012
Target sample size: 232
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01557374
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
France
Contacts
Name:     Bruno FAUTREL, Pr
Address: 
Telephone:
Email:
Affiliation:  APHP
Key inclusion & exclusion criteria

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).

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

Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Decrease Tocilizumab, Abatacept
Drug: Tocilizumab, Abatacept
Primary Outcome(s)
RA activity in a 2 years period of time, measured by repeated DAS44 [Time Frame: Trimestrial visit (-5 days/ + 35 days)]
Secondary Outcome(s)
Radiographic structural progression evaluation and cost-efficiency measure [Time Frame: 2 years]
Secondary ID(s)
AOM 11061
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ministry of Health, France
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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