Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

Novartis

Status and phase

Completed

Phase 3

Conditions

Relapsing Forms of Multiple Sclerosis

Treatments

Drug: Fingolimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT01201356

2010-020515-37 (EudraCT Number)

CFTY720D2399

Details and patient eligibility

About

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.

Full description

This study had two parts:

Part 1, collecting long-term safety, tolerability, efficacy and health outcomes data through approximately 30-Jun-2016 until all end of study (EOS) visits of Part 1 and last follow-up visit through Jan-2017 and
Part 2, collecting limited safety and tolerability data until approximately 30 Jun 2018, in a subset of patients who participated in Part 1, and other eligible patients from ongoing fingolimod trials.

Enrollment

4,125 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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:
- Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;
- Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
- Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide)
- History or presence of a third degree AV block
- Proven history of sick sinus syndrome or sino-atrial heart block
- Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon
Any of the following pulmonary conditions during the previous fingolimod study:
- Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study)
- Active tuberculosis
Alcohol abuse, chronic liver disease during the previous fingolimod study.