TapERA: Tapering Etanercept in Reumatoid Artritis.

• Register: EUCTR
• Last refreshed on: 28 March 2022
• Main ID: EUCTR2012-004631-22-BE
• Date of registration: 11/12/2012
• Prospective Registration: Yes
• Primary sponsor: University Hospitals Leuven
• Public title: TapERA: Tapering Etanercept in Reumatoid Artritis.
• Scientific title: TapERA: Maintaining remission in RA while tapering Etanercept. - TapERA
• Date of first enrolment: 15/01/2013
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004631-22
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: comperator is the standard dose of the same product (Enbrel 50 mg weekly versus every other week); Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium

Contacts

• Name: Rene Westhovens
• Affiliation: University Hospitals Leuven

• Name: Rene Westhovens
• Affiliation: University Hospitals Leuven

Key inclusion & exclusion criteria

Inclusion criteria:
Patients eligible for enrolment in the study must meet the following inclusion criteria:
- Established RA patients in remission according to DAS remission criteria for at least 6 months
- Treated with Etanercept 50mg weekly for at least one year
- DMARD treatment is allowed at a stable dose for at least 3m prior to baseline
- Stable oral corticosteroids treatment is allowed at a daily dose equal to or less than 5 mg prednisone equivalent for at least 1 month prior to randomisation
- Able and willing to give written informed consent and to participate in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion criteria:
Patients will be excluded from participating in the study if they meet any of the following exclusion criteria:
- Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency, addiction to analgesics and all diseases which in the opinion of the investigator places the patient at an unacceptable risk for continuing therapy and participation in the study
- Pregnancy, breastfeeding or no use of a reliable method of contraception
- Alcohol or drug abuse



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

reumatoid arthritis
MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Trade Name: Enbrel
Product Name: Enbrel
Product Code: EMEA/H/C000262
Pharmaceutical Form: Solution for injection in pre-filled syringe

Primary Outcome(s)

Primary end point(s): The proportion of patients maintaining remission 6 months after decreasing the dose of Etanercept to 50mg every 2 weeks compared to the proportion of patients maintaining remission while continuing the established dose of 50mg weekly.

Timepoint(s) of evaluation of this end point: month 6

Main Objective: The aim of the current study is to explore the potential of a dose reduction of Etanercept on safety and persisting remission in RA patients.

Secondary Objective: Secondary, possible baseline predictors for the maintenance of remission will be explored and the percentage of patients regaining remission after a flare will be investigated.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Month 3, 6, 9 and 12

Secondary end point(s): - Exploring baseline predictors for the maintenance of remission (including ultrasound)
- Proportion of patients maintaining remission for 1 year
- Proportion of patients maintaining remission for 6 months and 1 year according to the Boolean definition
- Proportion of patients maintaining remission for 6 months and 1 year according to the SDAI definition
- Proportion of patients regaining remission status when retreated with their original dose of Etanercept
- Evaluating the usefulness the FLARE questionnaire
- Safety: number and type of (serious) adverse events.

Secondary ID(s)

TapERA2012

Source(s) of Monetary Support

department of rheumatology, University Hospitals Leuven

Ethics review

Status: Approved
Approval date: 15/01/2013
Contact:

Results

• Results available: Yes
• Date Posted: 16/04/2021
• Date Completed: 31/12/2015
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-004631-22/results