Evaluating the safety of fingolimod in Taiwanese adults with relapsing-remitting multiple sclerosis
A 12-month, Prospective, Multi-center Post-authorization Commitment (PAC) Study Monitoring Safety in Adult Patients With Relapsing-remitting Multiple Sclerosis Newly Initiated on Gilenya (Fingolimod) in Taiwan (SPRING)
This study is testing how safe the medication fingolimod is for adults in Taiwan who are starting treatment for relapsing-remitting multiple sclerosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 20 Years to 100 Years |
| Sex | All |
| Sponsor | Novartis Industry-sponsored |
| Locations | 6 sites (Kaohsiung City and 5 other locations) |
| Trial ID | NCT04480853 on ClinicalTrials.gov |
What this trial studies
This study is a 12-month, prospective, interventional, multi-center evaluation of the safety profile of fingolimod in adults with relapsing-remitting multiple sclerosis (RRMS) in Taiwan. It aims to monitor patients who are newly starting treatment with fingolimod, collecting safety data through protocol-mandated procedures and visits. A total of 34 patients will be enrolled, and they will continue to receive treatment based on local clinical practice while participating in the study.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 years and older who have been diagnosed with relapsing-remitting multiple sclerosis and are treatment naive to fingolimod.
Not a fit: Patients with conditions such as neuromyelitis optica or those with significant cardiac issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable safety data that may enhance treatment protocols for patients with relapsing-remitting multiple sclerosis.
How similar studies have performed: Other studies have shown success with fingolimod in treating multiple sclerosis, indicating that this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -Patients with relapsing-remitting multiple sclerosis that are fingolimod treatment naive at the time of study entry and are newly starting fingolimod based on physician judgement and according to Taiwan's fingolimod package insert (version TWI-090420) Exclusion Criteria: * Patients with the diagnosis of neuromyelitis optica. * Patients who are being treated with any investigational drug at the time of study entry. * In the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization or Class III/IV heart failure * A history or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient has a functioning pacemaker * A baseline QTc interval ≥ 500 msec * Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs * Patient with known immune deficiency, increased risk of opportunistic infection, severe active infection or chronic active infection. * Patients with severe active malignancies, except for basal cell epithelioma * Patients with severe hepatic insufficiency * Pregnant or nursing (lactating) women or women of childbearing potential unless on contraception
Where this trial is running
Kaohsiung City and 5 other locations
- Novartis Investigative Site — Kaohsiung City, Taiwan (Recruiting)
- Novartis Investigative Site — Taichung, Taiwan (Recruiting)
- Novartis Investigative Site — Tainan, Taiwan (Withdrawn)
- Novartis Investigative Site — Taipei, Taiwan (Recruiting)
- Novartis Investigative Site — Taipei, Taiwan (Withdrawn)
- Novartis Investigative Site — Taoyuan, Taiwan (Withdrawn)
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: +41613241111
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.