Multiple SclerosisPASSAGENCT01442194
Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 238 sites in 7 countries.
Trial summary
The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further explore the incidence of selected safety- related outcomes and to further monitor the overall safety profile of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- other disease-modifying therapy and Fingolimod
- How many people
- 3,076 participants
- Where
- 238 sitesin 7 countries
- Study dates
- 1 Aug 2011to 10 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with relapsing forms of MS that have been recently initiated on fingolimod by their treating physician or patients that are treated with other disease-modifying therapies as part of their MS treatment in accordance with the respective local prescribing information and routine clinical practice
Who may be able to join
- Patients that as part of their routine clinical care and according to the locally approved label, are either;
- Starting fingolimod at time of study entry.
- Starting another approved DMT or started within maximum 6 months prior to study entry.
- Patients, or a able legal representative of the patient, who are willing to provide written informed consent.
- Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort
Who cannot join
- Patients previously or currently treated with a cytotoxic agent (e.g. mitoxantrone, cladribine, alemtuzumab) or natalizumab
- Patients participating simultaneously in another study with inclusion/exclusion criteria more restrictive than the label or an interventional study unless this is a study on fingolimod lasting 1 month maximum
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
238 sites in 7 countries.
238 sites in 7 countries
United States208 sites
Novartis Investigative Site
Albany, New York, 12208
Novartis Investigative Site
Alexandria, Virginia, 22310
Novartis Investigative Site
Amherst, New York, 14226
Novartis Investigative Site
Anderson, Indiana, 46011
Novartis Investigative Site
Arlington, Virginia, 22205
Novartis Investigative Site
Arlington Heights, Illinois, 60004
Novartis Investigative Site
Asheville, North Carolina, 28805
Novartis Investigative Site
Asheville, North Carolina, 28806
Novartis Investigative Site
Atlanta, Georgia, 30309
Novartis Investigative Site
Atlanta, Georgia, 30327
Novartis Investigative Site
Auburn, Maine, 04210
Novartis Investigative Site
Augusta, Georgia, 30912
Novartis Investigative Site
Aurora, Colorado, 80045
Novartis Investigative Site
Bakersfield, California, 93311
Novartis Investigative Site
Baltimore, Maryland, 21201
Novartis Investigative Site
Baltimore, Maryland, 21209
Novartis Investigative Site
Baltimore, Maryland, 21212
Novartis Investigative Site
Bangor, Maine, 04401
Novartis Investigative Site
Banning, California, 92220
Novartis Investigative Site
Basalt, Colorado, 81621
Novartis Investigative Site
Beaufort, South Carolina, 29902
Novartis Investigative Site
Beckley, West Virginia, 25801
Novartis Investigative Site
Bellevue, Ohio, 44811
Novartis Investigative Site
Bethesda, Maryland, 20814
Novartis Investigative Site
Birmingham, Alabama, 35209
Novartis Investigative Site
Birmingham, Alabama, 35233-0271
Novartis Investigative Site
Birmingham, Alabama, 35235
Novartis Investigative Site
Bismarck, North Dakota, 58501
Novartis Investigative Site
Boston, Massachusetts, 02135
Novartis Investigative Site
Boston, Massachusetts, 02215
Novartis Investigative Site
Bradenton, Florida, 34205
Novartis Investigative Site
Brooklyn, New York, 11220
Novartis Investigative Site
Brownwood, Texas, 76801
Novartis Investigative Site
Burbank, California, 91505
Novartis Investigative Site
Camden, South Carolina, 29020
Novartis Investigative Site
Carbondale, Illinois, 62901
Novartis Investigative Site
Caro, Michigan, 48723
Novartis Investigative Site
Casper, Wyoming, 82601
Novartis Investigative Site
Cedarhurst, New York, 11516
Novartis Investigative Site
Centerville, Ohio, 45459
Novartis Investigative Site
Chapel Hill, North Carolina, 27599-9500
Novartis Investigative Site
Charleston, South Carolina, 29406
Novartis Investigative Site
Charlotte, North Carolina, 28202
Novartis Investigative Site
Charlotte, North Carolina, 28204
Novartis Investigative Site
Charlotte Hall, Maryland, 20622
Novartis Investigative Site
Charlottesville, Virginia, 22911
Novartis Investigative Site
Cincinnati, Ohio, 45219
Novartis Investigative Site
City of Saint Peters, Missouri, 63303
Novartis Investigative Site
Clermont, Florida, 34711
Novartis Investigative Site
Colorado Springs, Colorado, 80907
Novartis Investigative Site
Columbus, Ohio, 43210
Novartis Investigative Site
Columbus, Ohio, 43221
Novartis Investigative Site
Cullman, Alabama, 35058
Novartis Investigative Site
Dallas, Texas, 75214
Novartis Investigative Site
Dallas, Texas, 75390
Novartis Investigative Site
Dayton, Ohio, 45408
Novartis Investigative Site
Delray Beach, Florida, 33445
Novartis Investigative Site
Denver, Colorado, 80210
Novartis Investigative Site
Des Moines, Iowa, 50314-2611
Novartis Investigative Site
Detroit, Michigan, 48201
Novartis Investigative Site
Doral, Florida, 33136
Novartis Investigative Site
Dover, Delaware, 19901
Novartis Investigative Site
Durham, North Carolina, 27710
Novartis Investigative Site
Edina, Minnesota, 55435
Novartis Investigative Site
Fair Lawn, New Jersey, 07410
Novartis Investigative Site
Fairfield, Connecticut, 06824
Novartis Investigative Site
Flossmoor, Illinois, 60422
Novartis Investigative Site
Fort Collins, Colorado, 80524
Novartis Investigative Site
Foxborough, Massachusetts, 02035
Novartis Investigative Site
Fresno, California, 93710
Novartis Investigative Site
Fullerton, California, 92835
Novartis Investigative Site
Golden Valley, Minnesota, 55422
Novartis Investigative Site
Great Falls, Montana, 59405
Novartis Investigative Site
Green Bay, Wisconsin, 54311
Novartis Investigative Site
Greensburg, Pennsylvania, 15601
Novartis Investigative Site
Greer, South Carolina, 29650
Novartis Investigative Site
Hagerstown, Maryland, 21741
Novartis Investigative Site
Hammond, Louisiana, 70403
Novartis Investigative Site
Hartford, Connecticut, 6112
Novartis Investigative Site
Hastings, Nebraska, 68901
Novartis Investigative Site
Hickory, North Carolina, 28602
Novartis Investigative Site
Hollywood, Florida, 33021
Novartis Investigative Site
Houston, Texas, 77005
Novartis Investigative Site
Houston, Texas, 77025
Novartis Investigative Site
Huntington, West Virginia, 25701
Novartis Investigative Site
Huntington Beach, California, 92649
Novartis Investigative Site
Indianapolis, Indiana, 46227
Novartis Investigative Site
Indianapolis, Indiana, 46256
Novartis Investigative Site
Irvine, California, 92618
Novartis Investigative Site
Jackson, Michigan, 49201
Novartis Investigative Site
Johnson City, New York, 13790
Novartis Investigative Site
Jupiter, Florida, 33458
Novartis Investigative Site
Kansas City, Kansas, 66160
Novartis Investigative Site
Kingston, New York, 12401
Novartis Investigative Site
Kingwood, Texas, 77339
Novartis Investigative Site
Knoxville, Tennessee, 37922
Novartis Investigative Site
Lafayette, Indiana, 47905
Novartis Investigative Site
Lake Success, New York, 11042
Novartis Investigative Site
Las Vegas, Nevada, 89106
Novartis Investigative Site
Lebanon, New Hampshire, 03756
Novartis Investigative Site
Lenexa, Kansas, 66212
Novartis Investigative Site
Lexington, Kentucky, 40503
Novartis Investigative Site
Lexington, Kentucky, 40513
Novartis Investigative Site
Livingston, New Jersey, 07039
Novartis Investigative Site
Loma Linda, California, 92354
Novartis Investigative Site
Los Angeles, California, 90073
Novartis Investigative Site
Louisville, Colorado, 80027
Novartis Investigative Site
Louisville, Kentucky, 40202
Novartis Investigative Site
Lutherville, Maryland, 21093
Novartis Investigative Site
Macon, Georgia, 31210
Novartis Investigative Site
Maitland, Florida, 32751
Novartis Investigative Site
Mansfield, Texas, 76063
Novartis Investigative Site
Marywood, Illinois, 60153
Novartis Investigative Site
McLean, Virginia, 22101
Novartis Investigative Site
Meadowbrook, Pennsylvania, 19046
Novartis Investigative Site
Merrillville, Indiana, 46410
Novartis Investigative Site
Miami, Florida, 33032
Novartis Investigative Site
Miami, Florida, 33144
Novartis Investigative Site
Miami, Florida, 33155
Novartis Investigative Site
Milwaukee, Wisconsin, 53211
Novartis Investigative Site
Mobile, Alabama, 36617
Novartis Investigative Site
Monroe, Wisconsin, 53566
Novartis Investigative Site
Mt. Pleasant, South Carolina, 29464
Novartis Investigative Site
Naples, Florida, 34102
Novartis Investigative Site
Nashville, Tennessee, 37205
Novartis Investigative Site
Nashville, Tennessee, 37212
Novartis Investigative Site
Neenah, Wisconsin, 54956
Novartis Investigative Site
New York, New York, 10003
Novartis Investigative Site
Newark, Delaware, 19713
Novartis Investigative Site
Newport Beach, California, 92660
Novartis Investigative Site
Newport News, Virginia, 23601
Novartis Investigative Site
Norfolk, Virginia, 23507
Novartis Investigative Site
Oceanside, California, 92056
Novartis Investigative Site
Oklahoma City, Oklahoma, 73102
Novartis Investigative Site
Oklahoma City, Oklahoma, 73104
Novartis Investigative Site
Old Point Station, South Carolina, 29707
Novartis Investigative Site
Omaha, Nebraska, 68198-2045
Novartis Investigative Site
Orlando, Florida, 32806
Novartis Investigative Site
Ormond Beach, Florida, 32174
Novartis Investigative Site
Overland Park, Kansas, 66210
Novartis Investigative Site
Owosso, Michigan, 48867
Novartis Investigative Site
Panama City, Florida, 32405
Novartis Investigative Site
Parker, Colorado, 80138
Novartis Investigative Site
Patchogue, New York, 11772
Novartis Investigative Site
Peoria, Illinois, 61637
Novartis Investigative Site
Philadelphia, Pennsylvania, 19107-5098
Novartis Investigative Site
Philadelphia, Pennsylvania, 19107
Novartis Investigative Site
Phoenix, Arizona, 85013
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15243
Novartis Investigative Site
Placentia, California, 92870
Novartis Investigative Site
Plainview, New York, 11803
Novartis Investigative Site
Pomona, California, 91767
Novartis Investigative Site
Port Charlotte, Florida, 33952
Novartis Investigative Site
Portland, Oregon, 97225
Novartis Investigative Site
Poughkeepsie, New York, 12601
Novartis Investigative Site
Provo, Utah, 84604
Novartis Investigative Site
Raleigh, North Carolina, 27607
Novartis Investigative Site
Redding, California, 96001
Novartis Investigative Site
Richland, Washington, 99352
Novartis Investigative Site
Richmond, Virginia, 23228
Novartis Investigative Site
Richmond, Virginia, 23924
Novartis Investigative Site
Rochester Hills, Michigan, 48301
Novartis Investigative Site
Salt Lake City, Utah, 84103
Novartis Investigative Site
Salt Lake City, Utah, 84132
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
Sanford, North Carolina, 27330
Novartis Investigative Site
Santa Monica, California, 90404
Novartis Investigative Site
Sarasota, Florida, 34233
Novartis Investigative Site
Somerset, New Jersey, 08873
Novartis Investigative Site
Sottsdale, Arizona, 85258
Novartis Investigative Site
Southfield, Michigan, 48034
Novartis Investigative Site
Spartanburg, South Carolina, 29303
Novartis Investigative Site
Spartanburg, South Carolina, 29307
Novartis Investigative Site
Spokane, Washington, 99208
Novartis Investigative Site
Springfield, Massachusetts, 01104
Novartis Investigative Site
Springfield, Missouri, 65807
Novartis Investigative Site
Springfield, Oregon, 97477
Novartis Investigative Site
St Louis, Missouri, 63104
Novartis Investigative Site
St Louis, Missouri, 63128
Novartis Investigative Site
Stafford, Texas, 77477
Novartis Investigative Site
Staten Island, New York, 10306
Novartis Investigative Site
Sugar Land, Texas, 77479
Novartis Investigative Site
Suwanee, Georgia, 30024
Novartis Investigative Site
Syracuse, New York, 13210
Novartis Investigative Site
Tacoma, Washington, 98405
Novartis Investigative Site
Temecula, California, 92591
Novartis Investigative Site
The Bronx, New York, 10467
Novartis Investigative Site
Toledo, Ohio, 43614
Novartis Investigative Site
Toledo, Ohio, 43623
Novartis Investigative Site
Topeka, Kansas, 66606
Novartis Investigative Site
Traverse City, Michigan, 49684-2340
Novartis Investigative Site
Tucson, Arizona, 85718
Novartis Investigative Site
Vienna, Virginia, 22182
Novartis Investigative Site
Waldorf, Maryland, 20603
Novartis Investigative Site
Washington D.C., District of Columbia, 20007
Novartis Investigative Site
Washington D.C., District of Columbia, 20037
Novartis Investigative Site
Waterbury, Connecticut, 06708
Novartis Investigative Site
Wellesley, Massachusetts, 02481
Novartis Investigative Site
Wellington, Florida, 33414
Novartis Investigative Site
Wenatchee, Washington, 98801
Novartis Investigative Site
West Long Branch, New Jersey, 07764
Novartis Investigative Site
West Palm Beach, Florida, 33407
Novartis Investigative Site
Weston, Florida, 33331
Novartis Investigative Site
Willow Grove, Pennsylvania, 19090
Novartis Investigative Site
Wilmington, North Carolina, 28401
Novartis Investigative Site
Winchester, Virginia, 22601
Novartis Investigative Site
Wisconsin Rapids, Wisconsin, 54495
Novartis Investigative Site
Worcester, Massachusetts, 01608
Canada13 sites
Novartis Investigative Site
Chicoutimi, Quebec, G7H 5H6
Novartis Investigative Site
Edmonton, Alberta, T6G 2G3
Novartis Investigative Site
Guelph, Ontario, N1H 4J4
Novartis Investigative Site
Halifax, Nova Scotia, B3H 4K4
Novartis Investigative Site
Kingston, Ontario, K7L 2V7
Novartis Investigative Site
Montreal, Quebec, H1T 2M4
Novartis Investigative Site
Montreal, Quebec, H2L 4M1
Novartis Investigative Site
Montreal, Quebec, H3A 2B4
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
Novartis Investigative Site
Saint Catharine's, Ontario, L2R 2P7
Novartis Investigative Site
Saint John, New Brunswick, E2L 4L2
Novartis Investigative Site
Trois-Rivières, Quebec, G8Z 3R9
Argentina6 sites
Novartis Investigative Site
Buenos Aires, 1061
Novartis Investigative Site
Ciudad Autonoma de Bs As
Novartis Investigative Site
Córdoba, X5004CDT
Novartis Investigative Site
Jenin, Buenos Aires, 6000
Novartis Investigative Site
Salta, A4400BKZ
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000DPB
Australia4 sites
Novartis Investigative Site
Box Hill, Victoria, 3128
Novartis Investigative Site
Kogarah, New South Wales, 2217
Novartis Investigative Site
Melbourne, Victoria, 3004
Novartis Investigative Site
Parkville, Victoria, 3050
Mexico4 sites
Novartis Investigative Site
Culiacan, State of Mexico, 80020
Novartis Investigative Site
Distrito Federal, 10700
Novartis Investigative Site
Guadalajara, Jalisco, 44130
Novartis Investigative Site
Monterrey, Nuevo León, 64710
Puerto Rico2 sites
Novartis Investigative Site
Guaynabo, 00968
Novartis Investigative Site
San Juan, 00935
About this study
Official title: Long-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy
The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further explore the incidence of selected safety- related outcomes and to further monitor the overall safety profile of fingolimod under conditions of routine medical practice.
- Conditions
- Multiple Sclerosis
- Being tested
- other disease-modifying therapy, Fingolimod
- Keywords
- Multiple sclerosis, fingolimod, observational study
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
other disease-modifying therapyDrug
FingolimodDrug
| Study group | Role | What they receive |
|---|---|---|
| Fingolimod | non-interventional Receives: Drug: Fingolimod | |
| parallel cohort | non-interventional Receives: Drug: other disease-modifying therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
For each of the selected safety outcomes, number of patients with a reported event since study start
Incidence of AEs for bradyarrhythmias, liver toxicity, macular edema, infections
Measured: Patients will be followed for an expected average of 5 years
Secondary outcomes (5)
Number of patients SAEs since study start
Measured: Patients will be followed for an expected average of 5 years
PRIMUS activities, comparison of mean change between the 2 cohorts
Measured: Patients will be followed for an expected average of 5 years
TSQM-9, comparison between the 2 cohorts
Measured: Patients will be followed for an expected average of 5 years
WPAI-GH, comparison of mean change between the 2 cohorts
Measured: Patients will be followed for an expected average of 5 years
MSIS-29, comparison of mean change between the 2 cohorts
Measured: Patients will be followed for an expected average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study start1 Aug 2011
- Primary completion10 Jul 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,076 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
- NCT01442194
- Sponsor's protocol ID
- CFTY720D2403
- Acronym
- PASSAGE
- Status last verified
- Dec 2021
- First submitted
- 21 Aug 2011
- Last updated
- 14 Jan 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy
- ClinicalTrials.gov ID
- NCT01442194
- Acronym / sponsor ID
- PASSAGE / CFTY720D2403
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, fingolimod, observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,076 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2011 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 28 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further explore the incidence of selected safety- related outcomes and to further monitor the overall safety profile of fingolimod under conditions of routine medical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fingolimod | – | Drug: Fingolimodnon-interventional |
| parallel cohort | – | Drug: other disease-modifying therapynon-interventional |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with relapsing forms of MS that have been recently initiated on fingolimod by their treating physician or patients that are treated with other disease-modifying therapies as part of their MS treatment in accordance with the respective local prescribing information and routine clinical practice
Key inclusion criteria (5 listed)
- Patients that as part of their routine clinical care and according to the locally approved label, are either;
- Starting fingolimod at time of study entry.
- Starting another approved DMT or started within maximum 6 months prior to study entry.
- Patients, or a able legal representative of the patient, who are willing to provide written informed consent.
- Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort
Key exclusion criteria (3 listed)
- Patients previously or currently treated with a cytotoxic agent (e.g. mitoxantrone, cladribine, alemtuzumab) or natalizumab
- Patients participating simultaneously in another study with inclusion/exclusion criteria more restrictive than the label or an interventional study unless this is a study on fingolimod lasting 1 month maximum
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| other disease-modifying therapy | Drug | parallel cohort |
| Fingolimod | Drug | Fingolimod |
Primary outcome
For each of the selected safety outcomes, number of patients with a reported event since study start
Time frame: Patients will be followed for an expected average of 5 years
Incidence of AEs for bradyarrhythmias, liver toxicity, macular edema, infections
5 secondary outcomes
Number of patients SAEs since study start
Time frame: Patients will be followed for an expected average of 5 years
PRIMUS activities, comparison of mean change between the 2 cohorts
Time frame: Patients will be followed for an expected average of 5 years
TSQM-9, comparison between the 2 cohorts
Time frame: Patients will be followed for an expected average of 5 years
WPAI-GH, comparison of mean change between the 2 cohorts
Time frame: Patients will be followed for an expected average of 5 years
MSIS-29, comparison of mean change between the 2 cohorts
Time frame: Patients will be followed for an expected average of 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Study ResultsLink provided by the sponsor.
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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
238 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 238 sites in 7 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 5 inclusion and 3 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 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 238 sites in United States, Canada, Argentina, Australia, Mexico and 2 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
For each of the selected safety outcomes, number of patients with a reported event since study start (time frame: Patients will be followed for an expected average of 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2022.