PLAN-A: Study to Predict Lanreotide-induced Disease Activity Normalization in Acromegaly
Study Details
Study Description
Brief Summary
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.
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Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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) [3, 6, 12 and 18 months]
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
- Changes in signs and symptoms (Numerical Rating Scale), patient's global impression of change (PGIC) [Baseline, 3, 6, 12 and 18 months]
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
- Quality of life between baseline and visits 2, 3, 4 and 5. [Baseline, 3, 6, 12 and 18 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female aged 18 years and older with the capacity to consent
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Signed written informed consent
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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
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Subject with the intention to be treated with lanreotide autogel according to the current local SmPC (Germany, Austria) prior to study enrolment
Exclusion Criteria:
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Participation in an interventional trial at the same time and/or within 3 months before baseline
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Subject represented by a legal guardian
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ipsen
Investigators
- Study Director: Ipsen Medical Director, Ipsen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A-DE-52030-368