Optimisation of Therapeutic Strategies in Acromegalic Subjects Treated With Lanreotide 120mg

简要总结

主要结局

次要结局

• Raw values at each visit and change from baseline in the Acromegaly Quality of Life Questionnaire (ACROQoL total score and each dimension) of the monotherapy phase(Baseline, month 5, 12 and 18)
• Number of alternative strategies used during the alternative strategy phase(Month 18)
• Treatments received at least once during the alternative strategy phase(Month 18)
• Proportion of subjects with clinically relevant tumor shrinkage (tumor volume decrease of ≥ 20% versus V1 (month 0) of the monotherapy phase) at V6 (month 18 time point) of the alternative strategy phase(Month 18)
• Change in clinical score (PASQ) between baseline (month 0) of the monotherapy phase and month 18 time point of the alternative strategy phase(Month 18)
• Change in Acromegaly Quality of Life Questionnaire (ACROQoL total score and dimensions) between baseline (month 0) of the monotherapy phase and Month 18 time point of the alternative strategy phase(Month 18)
• Profile of subjects(Baseline)
• Achievement of safe concentration of random GH (≤2.5 ng/mL) and normal age- and sex-matched IGF-1 concentrations of the monotherapy phase(Month 12 and 18)
• Raw values at each visit and change from baseline in random Growth Hormone (GH)(Baseline, month 5, 12 and 18)
• Proportion of subjects achieving biochemical control (random GH ≤2.5 ng/mL and normal age- and sex-matched IGF-1 concentrations) at month 18 time point of the alternative strategy phase (18 months after the start of the first alternative strategy)(Month 18)
• History of acromegaly(Baseline)
• History of treatment(Baseline)
• Raw values at each visit and change from baseline in overall health status (Patient-Assessed Acromegaly Symptom Questionnaire - PASQ) of the monotherapy phase(Baseline, month 5, 12 and 18)
• Description of the GH and Insulin-like Growth Factor-1 (IGF-1) levels when the physician decides to start the first alternative strategy(Day 1 (Visit 5))
• Change in overall health status (PASQ) between baseline (month 0) of the monotherapy phase and month 18 time point of the alternative phase(Month 18)