Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Efficacy and quality of life.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adverse events.
Secondary outcome
MRI, symptoms, adverse events, 9HPT, 25TWT, patient reported outcomes.
Background summary
Fingolimod (FTY720) is a new oral treatment for multiple sclerosis (MS). It has
recently been registered for the indication relapsing-remitting MS. The
development for the indication primary progressive MS (PPMS) is now ongoing.
Fingolimod is an immunosupperssant. Fingolimod decreases the number of
activated T-cells in blood and in the CNS by binding to the
sphingosin-1-phosphate receptor-1 (S1P1) on circulating lymfocytes. This
binding results in a reversible sequestration of T-cells, thus *trapping*
autoagressive T-cells in peripheral lymoid tissues. Therefore they are not able
to migrate to areas of inflammation in the CNS.
Fingolimod reduces the number of MS relapses and improves the MRI findings and
inflammatory markers.
The current study is a follow-up study of the double blind placebo-controlled
study CFTY720D2306 in patients with PPMS in order to collect additional
long-term safety data and to enable patients to continue fingolimod treatment
until the drug has obtained the registration for this indication. New patients
are not eligible.
Study objective
Primary: Safety and tolerability of fingolimod 0,5 mg.
Secundairy: Efficacy and quality of life.
Study design
Open, non-comparative phase IIIB safety study for patients coming from the
ongoing study CFTY720D2306, with fingolimod 0,5 mg daily until the drug has
obtained the registration for the indication PPMS and reimbursement status in
the Netherlands. 1st dose of study medication will be given in the clinic.
Monitoring during at least 6 h post intake of the 1st dose.
Approx. 700 patients.
Intervention
Treatment with fingolimod.
Study burden and risks
Risks: Adverse effects of study medication.
Burden: Visits day 1, month 1, thereafter every 3 months and after the 2nd year
every 6 months until registration and reimbursement in NL. Duration approx. 3h
(at first dose observation period of 6 h). First visit = last visit of
preceding study.
During all visits blood tests (approx. 10 ml, during screening incl. hepatitis
A-B-C-E, HIV) and urine testing once.
Physical examination and dermatological examination every year.
Ophthalmological examination (incl. OCT measurement) start, month 3.
ECG baseline and day 1.
25 ft walking test, 9 hole peg test and EDSS every 6 months thereafter.
MRI brain yearly.
Raapopseweg 1
Arnhem 6824 DP
NL
Raapopseweg 1
Arnhem 6824 DP
NL
Listed location countries
Age
Inclusion criteria
* Patients initially randomized to fingolimod 1.25 mg or placebo as part of the first study cohort of CFTY720D2306, who have completed at least 3 years on study drug treatment.
* Patients initially randomized to fingolimod 0.5 mg or placebo as part of the second study cohort of CFTY720D2306 who have continued on study drug treatment until such time as the last ongoing patient enrolled in the study has reached 3 years in study.
* Still on study medication at the start of the extension study.
Exclusion criteria
* Patients with a history of chronic disease of the immune system other than MS.
* Uncontrolled hypertension.
* Patients with active systemic bacterial, viral or fungal infections, positive testing for hepatitis A, B, C and E or HIV (see protocol page 8-9 for details).
* Macular edema.
* Any of the following cardiovascular conditions: MI in the last 6 months, unstable ischemic heart disease, cardiac failure (NYHA Class III), arrhythmia requiring current treatment with Class Ia and III antiarrhythmic drugs, 2nd (Mobitz II) or 3rd degree AV block, increased QTc interval >500 msec.
* Severe pulmonary disease, pulmonary fibrosis, active tuberculosis (see protocol page 9 for details).
* Uncontrolled diabetes mellitus.
* Hepatic conditions (see protocol page 16 for details)
* Pregnancy, lactation, inadequate contraception.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | clinicaltrials.gov; registratienummer NCT01779934 |
| EudraCT | EUCTR2012-000835-18-NL |
| CCMO | NL42677.029.12 |