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

Sponsor

Merck KGaA, Darmstadt, Germany (Industry)

Overall Status

Completed

CT.gov ID

NCT01555528

Collaborator

Merck S.A. de C.V., Mexico (Industry)

193

Enrollment

Location

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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™.

Condition or Disease	Intervention/Treatment	Phase
Growth Disorders	Device: easypod™

Detailed 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"

Study Design

Study Type:

Observational

Actual Enrollment :

193 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Easypod Connect: A National, Multicentre, Observational Registry to Evaluate Adherence and Long Term Outcomes of Therapy in Paediatric Subjects Using "Easypod™" Electromechanical Device for Growth Hormone Treatment in Mexico

Actual Study Start Date :

Apr 30, 2012

Actual Primary Completion Date :

Dec 31, 2015

Actual Study Completion Date :

Dec 31, 2015

Arms and Interventions

Arm	Intervention/Treatment
Growth Disorders	Device: easypod™ Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™ Other Names: Somatotropin

Arm

Intervention/Treatment

Growth Disorders

Device: easypod™

Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™

Other Names:

Somatotropin

Outcome Measures

Primary Outcome Measures

Mean percent of daily recorded adherence [At least 6 months and up to 4 years]

Secondary Outcome Measures

Correlation of adherence and growth outcome after each year of SAIZEN® treatment with easypod™ [At least 6 months and up to 4 years]
Correlation of adherence and growth outcome (change in: height velocity (HV), height velocity-standard deviation score (HV-SDS), height, height-standard deviation score(height SDS)) after each year of SAIZEN® treatment with easypod™
Subject adherence profile based on age, gender, indication, self-injection or not, time on treatment [At least 6 months and up to 4 years]
Correlation of adherence with current IGF-1 status (i.e. above, below or within normal ranges) [At least 6 months and up to 4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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