Multiple SclerosisPhase 3NCT01497262
Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
A Phase 3 study testing Fingolimod in people with Multiple Sclerosis, run by Novartis Pharmaceuticals at 29 sites in 8 countries.
Trial summary
This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data in Multiple Sclerosis (MS) patient population that closely resembles the clinical population seen in routine medical care. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Fingolimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 29 sitesin 8 countries
- Study dates
- Feb 2012to Apr 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with relapsing remitting Multiple Sclerosis
- Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.
Who cannot join
- Patients with MS other than relapsing remitting MS
- Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.
- Patients who have been treated with:
- systemic corticosteroids or immunoglobulins within 1 month prior to baseline;
- immunosuppressive medications within 3 months prior to baseline;
- monoclonal antibodies within 3 months prior to baseline;
Show all 15Show fewer
- cladribine, mitoxantrone or alemtuzumab at any time.
- Uncontrolled diabetes mellitus at screening
- Diagnosis of macular edema during Screening Phase
- Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
- Patients who have received total lymphoid irradiation or bone marrow transplantation.
- Patients with certain cardiovascular conditions and/or findings in the screening ECG
- Patients with certain liver conditions
- Pregnant confirmed by a positive pregnancy test t or nursing (lactating) women
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
29 sites in 8 countries.
29 sites in 8 countries
Argentina7 sites
Novartis Investigative Site
Caba, Buenos Aires, 1425
Novartis Investigative Site
Córdoba, X5004CDT
Novartis Investigative Site
Salta, Salta Province, A4400ANG
Novartis Investigative Site
Salta, Salta Province, A4400BKZ
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, 4000
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000DPB
Novartis Investigative Site
Villa Nueva, Mendoza Province, M5507XAD
Colombia5 sites
Novartis Investigative Site
Barranquilla, Atlántico
Novartis Investigative Site
Bogotá, Cundinamarca, 110111
Novartis Investigative Site
Bogotá, 00000
Novartis Investigative Site
Bogotá
Novartis Investigative Site
Cali
Mexico5 sites
Novartis Investigative Site
Mexico City, Mexico City, 06700
Novartis Investigative Site
Mexico City, Mexico City, 10700
Novartis Investigative Site
Monterrey, Nuevo León, 64060
Novartis Investigative Site
San Luis Potosí City, San Luis Potosí, 78240
Novartis Investigative Site
San Nicolás de los Garza, Nuevo León, 66480
Brazil3 sites
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90610-000
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20270-004
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 21941-590
Malaysia3 sites
Novartis Investigative Site
George Town, Pulau Pinang, 10990
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, 50586
Novartis Investigative Site
Kuala Lumpur, 59100
Peru3 sites
Novartis Investigative Site
Jesus Maria, Lima region, 11
Novartis Investigative Site
La Perla, Provincia Constitucional del Callao, 04
Novartis Investigative Site
San Isidro, Lima region, 27
Jordan2 sites
Novartis Investigative Site
Amman, Amman Governorate, 11942
Novartis Investigative Site
Irbid, 22110
About this study
Official title: A 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple Sclerosis
This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data in Multiple Sclerosis (MS) patient population that closely resembles the clinical population seen in routine medical care.
- Conditions
- Multiple Sclerosis
- Being tested
- Fingolimod
- Keywords
- Multiple Sclerosis, Relapsing-Remitting
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FingolimodDrug
Fingolimod will be supplied as 0.5mg capsules in bottles of 35.
| Study group | Role | What they receive |
|---|---|---|
| Fingolimod | Experimental | Open-label fingolimod 0.5 mg, taken orally once daily for 4 months Receives: Drug: Fingolimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity
Measured: 28 weeks
Secondary outcomes (1)
Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.
The incidence of events in special areas of safety interest (including bradyarrhythmias, BP increase, liver function, infections and macular oedema) were assessed by the nature and frequency of AE reporting. These areas of special interest have been identified and potential risks of fingolimod based on knowledge from clinical trials and post-marketing reporting.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01497262
- Sponsor's protocol ID
- CFTY720D2325
- Status last verified
- Mar 2015
- First submitted
- 5 Dec 2011
- Last updated
- 19 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ordonez-Boschetti L, Rey R, Cruz A, Sinha A, Reynolds T, Frider N, Alvarenga R. Safety and Tolerability of Fingolimod in Latin American Patients with Relapsing-Remitting Multiple Sclerosis: The Open-Label FIRST LATAM Study. Adv Ther. 2015 Jul;32(7):626-35. doi: 10.1007/s12325-015-0224-2. Epub 2015 Jul 14.
PubMed 26170105
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-month, Open-label, Multi-center Study to Explore the Safety and Tolerability of Fingolimod 0.5 mg in Patients With Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01497262
- Acronym / sponsor ID
- CFTY720D2325
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Relapsing-Remitting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Dec 2011 (estimated)
- Results
- Posted 19 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data in Multiple Sclerosis (MS) patient population that closely resembles the clinical population seen in routine medical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fingolimod | Experimental | Drug: FingolimodOpen-label fingolimod 0.5 mg, taken orally once daily for 4 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with relapsing remitting Multiple Sclerosis
- Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.
Key exclusion criteria (15 listed)
- Patients with MS other than relapsing remitting MS
- Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.
- Patients who have been treated with:
- Uncontrolled diabetes mellitus at screening
- Diagnosis of macular edema during Screening Phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FingolimodFingolimod will be supplied as 0.5mg capsules in bottles of 35. | Drug | Fingolimod |
Primary outcome
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 28 weeks
Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity
1 secondary outcome
Number (%) of Patients With AE of Special Interest Including Bradyarrhythmia, BP Increase, Liver Transaminase Elevations, Infections , Macula Oedema.
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26170105Ordonez-Boschetti L, Rey R, Cruz A, Sinha A, Reynolds T, Frider N, Alvarenga R. Safety and Tolerability of Fingolimod in Latin American Patients with Relapsing-Remitting Multiple Sclerosis: The Open-Label FIRST LATAM Study. Adv Ther. 2015 Jul;32(7):626-35. doi: 10.1007/s12325-015-0224-2. Epub 2015 Jul 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
29 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fingolimod in people with Multiple Sclerosis, run by Novartis Pharmaceuticals at 29 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Argentina, Colombia, Mexico, Brazil, Malaysia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01497262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.