Switching from first to second-line treatment in acromegaly
The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly ( RAPSODIA )
This study looks at how switching from first-line treatments to second-line therapies helps people with acromegaly who haven't been well controlled by their current medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06597383 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the impact and efficacy of switching from first-generation somatostatin analogues to second-line therapies in patients with acromegaly. It will retrospectively collect clinical, laboratory, and anamnestic data from approximately 100 patients who have been inadequately controlled with first-line therapy over the past five and a half years. The study focuses on the time taken to switch therapies after the disease is no longer biochemically controlled. The goal is to better understand the effectiveness of second-line treatments in managing acromegaly.
Who should consider this trial
Good fit: Ideal candidates include adult men and women aged 18 and older with acromegaly who have not achieved disease control with first-generation somatostatin analogues.
Not a fit: Patients who are under 18 years old, pregnant, breastfeeding, or unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective treatment strategies for patients with acromegaly who do not respond to first-line therapies.
How similar studies have performed: Other studies have explored treatment switches in acromegaly, but this specific approach focusing on the timing of the switch is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult men and women (age ≥ 18 years) affected by acromegaly, including those of childbearing age * Patients inadequately controlled with first generation somatostatin analogues (GH ≥1 μg/L and IGF-1 \>1.3×ULN) * Second line medical treatment (Pasireotide; Pegvisomant only; combination Pegvisomant + 1st generation SSA) after use of first-line medical treatment * At least 12 months of follow up during 2nd line therapy * Signature of the informed consent to the study Exclusion Criteria: * age ≤18 years * Pregnant and/or breastfeeding women * Patients unable to understand and sign the Informed Consent
Where this trial is running
Milan
- Andrea Giustina — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Luigi Di Filippo, medical doctor
- Email: difilippo.luigi@hsr.it
- Phone: +39 0226435062
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.