A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis
A Single Arm, Open-label, Multicenter Study Evaluating the Long-term Safety and Tolerability of 0.5 mg Fingolimod (FTY720) Administered Orally Once Daily in Patients With Relapsing Forms of Multiple Sclerosis
The purpose of this study was to collect long-term safety and tolerability, long-term efficacy, and health outcome data in all patients currently ongoing in the fingolimod multiple sclerosis clinical development program. This study combined all currently ongoing Phase II and III fingolimod extension studies as well as ongoing and newly planned studies into one single long-term extension protocol that provided patients with continuous treatment until fingolimod was registered, commercially available, and reimbursed in the respective countries.
This study had two parts:
Key Inclusion Criteria:
- Patients who have completed selected ongoing or planned trials with FTY720.
Key Exclusion Criteria:
Premature permanent discontinuation of a previous fingolimod study.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device.
Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment.
Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.
Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
Previous treatment with cladribine, cyclophosphamide or mitoxantrone.
Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study:
Any of the following cardiovascular conditions that have developed during the previous fingolimod study:
Any of the following pulmonary conditions during the previous fingolimod study:
Alcohol abuse, chronic liver disease during the previous fingolimod study.
The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial.
CABA, Buenos Aires 1425, Argentina
CABA, Buenos Aires C1181ACH, Argentina
CABA, Buenos Aires C1428AQK, Argentina
Capital Federal, Buenos Aires C1192AAW, Argentina
Fraiture En Condroz, Belgium 4557, Belgium
Rio de Janiero, Rio de Janeiro 20221-161, Brazil
Ostrava-Poruba, 708 00, Czechia
Plzen - Lochotin, 30460, Czechia
Heraklion Crete, Greece 711 10, Greece
Sefad, 13100, Israel
Sittard-Geleen, 6162 BG, Netherlands
Haseki / Istanbul, 34096, Turkey (Türkiye)
Yenisehir / Izmir, Turkey (Türkiye)
Essex, RM7 0BE, United Kingdom