To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Mexico (ECOS MEX)

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Growth Disorders

Treatments: Device: easypod™

Study type: Observational

Funder types: Industry

Identifiers

NCT01555528

EMR200104_535

Details and patient eligibility

About

This is a Mexican, Multicentre, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.

Full description

Subjects will be enrolled in a multicenter longitudinal observational study. Parents and patients will provide their Informed Consent to upload their data for population-based analyses and optionally to adhere to a patient adherence support program "AUMENTA" designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

-To assess the level of adherence of subjects receiving SAIZEN® via easypod™

Secondary Objectives:

• 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 IGF1 (i.e. above, below or within normal ranges)
• To assess/describe the impact of Mexico patient support program "AUMENTA"

Enrollment: 193 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Administered growth hormone via the easypod™ electromechanical device according to local Prescribing information
• Over the age of > 2 years
• Under < 18 years of age, or over 18 without fusion of growth plates
• Parents' or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parents/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old (over 18 without fusion of growth plates) or able to give written informed consent, a separate assent form will be given
• Patient signed informed consent if has 7-17 years old
• Patient signed informed consent if has 18 years old

Exclusion criteria

• Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
• Contra-indications to SAIZEN® as defined in the local prescribing information
• Use of an investigational drug or participation in another interventional clinical study

Trial design

193 participants in 1 patient group

Growth Disorders

Treatment:

Device: easypod™