Status:
COMPLETED
Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapsing Forms of Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed 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 la...
Eligibility Criteria
Inclusion
- Key
- \- Patients who have completed selected ongoing or planned trials with FTY720.
- Key
Exclusion
- 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.
- The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial.
Key Trial Info
Start Date :
September 13 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2018
Estimated Enrollment :
4125 Patients enrolled
Trial Details
Trial ID
NCT01201356
Start Date
September 13 2010
End Date
October 19 2018
Last Update
April 21 2021
Active Locations (458)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Cullman, Alabama, United States, 35058
2
Novartis Investigative Site
Oceanside, California, United States, 92056
3
Novartis Investigative Site
Sacramento, California, United States, 95817
4
Novartis Investigative Site
San Francisco, California, United States, 94143