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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01201356




Registration number
NCT01201356
Ethics application status
Date submitted
10/09/2010
Date registered
14/09/2010

Titles & IDs
Public title
Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis
Scientific title
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
Secondary ID [1] 0 0
2010-020515-37
Secondary ID [2] 0 0
CFTY720D2399
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Forms of Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fingolimod

Experimental: Fingolimod 0.5 mg/day - Open-label fingolimod 0.5 mg, taken orally once daily


Treatment: Drugs: Fingolimod
0.5 mg/day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Parts I and II: Number of Participants With Adverse Events, Serious Adverse Event, and Death
Timepoint [1] 0 0
Baseline (Part I) to Month 6 Follow-up (Part II), up to 8 years
Secondary outcome [1] 0 0
Part I: Aggregate Annualized Relapse Rates (ARR) From First Dose of Fingolimod
Timepoint [1] 0 0
Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
Secondary outcome [2] 0 0
Part I: Number of Participants With Relapses (Confirmed and Unconfirmed) From First Dose of Fingolimod
Timepoint [2] 0 0
Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)
Secondary outcome [3] 0 0
Part I: Annualized Rates of New or Newly Enlarging T2 Lesions (ARneT2) Compared With First Dose of Fingolimod
Timepoint [3] 0 0
Month 0 (Core Baseline) to End of Study (an average of Month 156)
Secondary outcome [4] 0 0
Part I: Change From First Dose of Fingolimod in Total T2 Lesions Volume
Timepoint [4] 0 0
Month 3 to End of Study (Study Completion Visit)
Secondary outcome [5] 0 0
Part I: Change From First Dose of Fingolimod in Total T1 Hypointense Lesions Volume
Timepoint [5] 0 0
Month 3 to End of Study (Study Completion Visit)
Secondary outcome [6] 0 0
Part I: Percent Brain Volume Change (PBVC) Relative to First Dose of Fingolimod
Timepoint [6] 0 0
Month 3 to Month 156
Secondary outcome [7] 0 0
Part I: Annualized Rate of Brain Atrophy (ARBA) Relative to First Dose of Fingolimod
Timepoint [7] 0 0
Month 3 to Month 156
Secondary outcome [8] 0 0
Part I: Number of Participants With Confirmed 6-month Disability Progression After First Dose of Fingolimod
Timepoint [8] 0 0
Month 12 to Month 156
Secondary outcome [9] 0 0
Part I: Number of Participants With Categorized Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS) Overall Score
Timepoint [9] 0 0
Month 3 to Month 6 Follow-up
Secondary outcome [10] 0 0
Part I: Change From First Dose of Fingolimod in Expanded Disability Status Scale (EDSS)
Timepoint [10] 0 0
Month 0 (Core Baseline) to End of Follow-up Visit (an average of 162 months)

Eligibility
Key inclusion criteria
Key

- Patients who have completed selected ongoing or planned trials with FTY720.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/10/2018
Sample size
Target
Accrual to date
Final
4125
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Camperdown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Chatswood
Recruitment hospital [3] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [4] 0 0
Novartis Investigative Site - Liverpool
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Novartis Investigative Site - North Gosford
Recruitment hospital [6] 0 0
Novartis Investigative Site - Woodville
Recruitment hospital [7] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [8] 0 0
Novartis Investigative Site - Fitzroy
Recruitment hospital [9] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [10] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
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2067 - Chatswood
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2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
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2250 - North Gosford
Recruitment postcode(s) [6] 0 0
5011 - Woodville
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3128 - Box Hill
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3065 - Fitzroy
Recruitment postcode(s) [9] 0 0
3084 - Heidelberg
Recruitment postcode(s) [10] 0 0
3050 - Parkville
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CT
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State/province [214] 0 0
FG
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GE
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IS
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TO
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UD
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VA
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VI
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VR
Country [231] 0 0
Italy
State/province [231] 0 0
VT
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Napoli
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Jordan
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Irbid
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Korea
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Korea, Republic of
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Seoul
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CK
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Spain
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Turkey
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United Kingdom
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Bristol
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Dundee
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United Kingdom
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Edinburgh
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United Kingdom
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Essex
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Great Yarmouth
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Liverpool
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United Kingdom
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United Kingdom
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Swindon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01201356