Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly (PLAN-A)

Non-interventional, Prospective Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly

The purpose of the study is to collect data about predictive factors for the efficacy of Lanreotide Autogel in patients with acromegaly in routine clinical practice.

Study Overview

• Status: Withdrawn
• Conditions: Acromegaly

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with biochemically active acromegaly, without previous treatment (medical treatment or radiotherapy) except for surgery and/or dopamine agonists (treatment terminated at or before baseline) who are already planned within the medical routine to be treated with lanreotide autogel.

Description

Inclusion Criteria:

• Male or female aged 18 years and older with the capacity to consent
• Signed written informed consent
• Subject with hormonally active acromegaly defined by locally measured IGF-I levels 1.3 times above the age- and sex-adjusted normal range as determined at the last routine visit before baseline and after surgery
• Subject with the intention to be treated with lanreotide autogel according to the current local SmPC (Germany, Austria) prior to study enrolment

Exclusion Criteria:

• Participation in an interventional trial at the same time and/or within 3 months before baseline
• Subject represented by a legal guardian

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with normalization of centrally assessed age and sex adjusted IGF-I levels at visit 4 (about 12 months) after treatment start with lanreotide autogel.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with normalization of centrally assessed age- and sex-adjusted IGF-I levels at visit 2, 3, and 5 after treatment start with lanreotide autogel		3 , 6 and 18 months
Changes from baseline of centrally assessed IGF-I levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel		3, 6, 12 and 18 months
Changes from baseline of centrally assessed random GH-levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel		3, 6, 12 and 18 months
Changes from baseline of centrally assessed GH-BP levels at visit 2, 3, 4, 5 after treatment start with lanreotide autogel		3, 6, 12 and 18 months
Proportion of subjects with GH-normalization - defined as centrally assessed random GH-levels (GH < 1 μg/L) - at visits 2, 3, 4, and 5 during treatment with lanreotide autogel.		3, 6, 12 and 18 months
Predictors for reduction of age- and sex-adjusted IGF-I to normal levels (control of acromegaly) at visits 4 compared to baseline and Last Visit Available (LVA) compared to baseline.		baseline and 12 months
Predictors of change in IGF-I between baseline compared to visit 4 and baseline compared to LVA.		baseline and 12 months
Predictors of change in random GH-levels between baseline compared to visit 4 and baseline compared to LVA		baseline and 12 months
Patient's global impression of change (PGIC)	Scale is used to assess the validity of Patient Global Impression of Change (PGIC). the score ranges between 1= very much worse and 7 = very much improved	3, 6, 12 and 18 months
Changes in signs and symptoms (Numerical Rating Scale), patient's global impression of change (PGIC)	It will be measured using Numerical Rating Scale to assess the average presence or severity of the symptoms. The score ranges from 0 = no symptom at all to 10 = maximum intensity of the symptom	Baseline, 3, 6, 12 and 18 months
Quality of life between baseline and visits 2, 3, 4 and 5.	Measured by a generic, multipurpose short-form survey with 12 questions (SF-12). Scale provides information about mental and physical functioning and overall health-related-QoL. ". Higher scores indicate a better QoL.	Baseline, 3, 6, 12 and 18 months

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2020
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Hyperpituitarism; Pituitary Diseases; Acromegaly
• Other Study ID Numbers: A-DE-52030-368

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No