reumatoid arthritis MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Enbrel
Product Name: Enbrel
Product Code: EMEA/H/C000262
Pharmaceutical Form: Solution for injection in pre-filled syringe
Sponsors
University Hospitals Leuven
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;Timepoint(s) of evaluation of this end point: Month 3, 6, 9 and 12 | — |
Countries
Belgium
Contacts
Public ContactRene Westhovens
University Hospitals Leuven
Outcome results
None listed