To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in France (ECOS FRA)
This is a National, Multicentre, Observational Registry to study adherence and long term outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospitals in France and to assess the level of adherence of subjects receiving SAIZEN® via Easypod™.
|Study Design:||Observational Model: Cohort|
|Official Title:||Easypod Connect: A National, Multicentre, Observational Registry to Study Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using Easypod™ Electromechanical Device for Growth Hormone Treatment|
- Mean percent of recorded adherence [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
- Correlation of adherence and growth outcome (change in height velocity (HV), change in HV-Standard Deviation Score (HV-SDS), change in height-Standard Deviation Score) after each year of Saizen® treatment with Easypod™ [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
- Subject adherence profile [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment, administration regimen (6 or 7 days/ week), combination of pituitary hormone deficiencies, previous and/or concomitant treatments, socio-economic data
- Correlation of adherence with IGF-1 levels/ranges [ Time Frame: At least 6 months and up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Subjects will be enrolled in this observational, multi-center study to assess adherence and treatment outcomes. Parents will provide their written agreement to upload their child's data in the study electronic CRF.
Easypod™ is an electromechanical device that delivers growth hormone and also records injections' date and time. Adherence data will be primarily derived from injections recorded in the Easypod™ device combined with physician data entry of outcome measures (i.e. height & weight). This will allow the establishment of adherence profiles and evaluate the link with subsequent clinical outcomes.
Since this is an observational study, there will be no study-specific clinical interventions and subjects will be treated according to the clinical and laboratory findings as routinely evaluated by the physician. Auxological and laboratory data will be reported prospectively throughout the duration of the study. At baseline, available data can be recorded retrospectively from the subjects' medical file and Easypod™ device Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.
• To assess the level of adherence of subjects receiving Saizen® via Easypod™
- To describe the impact of adherence on clinical outcomes for subject receiving Saizen® via Easypod™
- To identify adherence subject profiling
- To asses the Impact of adherence on insulin-like growth factor-1 (IGF1) ranges/levels
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291394
|Contact Merck KGaA|
|Communication Center, France|
|Study Director:||Medical Director||MGS Division, Merck Serono s.a.s, France, an affiliate of Merck KGaA, Darmstadt, Germany|