Recruitment

Recruitment Status
Completed
Estimated Enrollment
1000

Exclusion Criterias

Participants with significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia,
Participants with severe active infection until resolution,
Male participants (only when required according to local labeling): unwilling to use reliable contraception during the course of the study,
...
Participants with significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia,
Participants with severe active infection until resolution,
Male participants (only when required according to local labeling): unwilling to use reliable contraception during the course of the study,
Participants with severe hypoproteinaemia, e.g. in nephrotic syndrome.
Hypersensitivity to the active substance or to any of the excipients,
Current or history of receiving teriflunomide,
Known history of severe immunodeficiency, acquired immunodeficiency syndrome (AIDS), bone marrow disease, acute or severe active infections,
Known history of active tuberculosis (TB) or latent TB infection, either diagnosed by standard medical practice or guidelines (including skin or blood test, chest X-ray, or as appropriate per local practice),
Women who were pregnant or breast-feeding,
Other additional contraindications per local labeling.
Participants with severe renal impairment undergoing dialysis, because insufficient clinical experience was available in this participant group,
Participants with preexisting acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN),
According to local labelling,
Female participants with a positive pregnancy test at screening or women of child-bearing potential who did not agree to use reliable contraception throughout the course of the study,
Less than 18 years of age,
Previous treatment with leflunomide within 6 months prior to baseline,

Summary

Conditions
Multiple Sclerosis
Type
Interventional
Phase
Phase 4
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The total duration of the study per participant was up to 50 or 54 weeks (if accelerated elimination procedure performed): Screening: up to 2 weeks Teriflunomide treatment: 48 weeks Accelerated elimination procedure: 4 weeks when performed An accelerated elimination procedure at any time after disco...

The total duration of the study per participant was up to 50 or 54 weeks (if accelerated elimination procedure performed): Screening: up to 2 weeks Teriflunomide treatment: 48 weeks Accelerated elimination procedure: 4 weeks when performed An accelerated elimination procedure at any time after discontinuation of teriflunomide treatment was possible and it was particularly recommended for women of child-bearing potential.

Exclusion Criterias

Participants with significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia,
Participants with severe active infection until resolution,
Male participants (only when required according to local labeling): unwilling to use reliable contraception during the course of the study,
...
Participants with significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia,
Participants with severe active infection until resolution,
Male participants (only when required according to local labeling): unwilling to use reliable contraception during the course of the study,
Participants with severe hypoproteinaemia, e.g. in nephrotic syndrome.
Hypersensitivity to the active substance or to any of the excipients,
Current or history of receiving teriflunomide,
Known history of severe immunodeficiency, acquired immunodeficiency syndrome (AIDS), bone marrow disease, acute or severe active infections,
Known history of active tuberculosis (TB) or latent TB infection, either diagnosed by standard medical practice or guidelines (including skin or blood test, chest X-ray, or as appropriate per local practice),
Women who were pregnant or breast-feeding,
Other additional contraindications per local labeling.
Participants with severe renal impairment undergoing dialysis, because insufficient clinical experience was available in this participant group,
Participants with preexisting acute or chronic liver disease, or those with serum alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN),
According to local labelling,
Female participants with a positive pregnancy test at screening or women of child-bearing potential who did not agree to use reliable contraception throughout the course of the study,
Less than 18 years of age,
Previous treatment with leflunomide within 6 months prior to baseline,

Locations

Fort Wayne, Indiana
Karlstad, 65185
Bruxelles, 1200
NY, New York, 14203
Glasgow, G116NT
...
Fort Wayne, Indiana
Karlstad, 65185
Bruxelles, 1200
NY, New York, 14203
Glasgow, G116NT
Sunrise, Florida, 33351
Dijon, 21000
Oceanside, California, 92056
Dayton, Ohio
Montbeliard, 25200
Valenciennes, 59322
Nancy
Coconut Creek, Florida, 33073
Leicester, LE54PW
Brighton, BN25BE
Milwaukee, Wisconsin, 53215
Santiago
Cranston, Rhode Island, 02920
Phoenix, Arizona, 85008
Motala, 59185
Reims, 51100
Freiburg, 79098
Pau, 64000
Liège, 4000
Golden Valley, Minnesota, 55422
VICHY Cedex, 03201
Phoenix, Arkansas
La Coruña, 15006
Raliegh, North Carolina
Canton, Ohio, 44718
Fullerton, California, 92835
Macon, Georgia, 31210
Strasbourg, 67091
Bergisch-Gladbach, 51429
Liège, 4000
Kortrijk, 8500
Gallarate (VA), 21013
Nimes, 30029
Córdoba, 14004
Edegem, 2650
Milano, 20133
El Palmar (MURCIA), 30120
Athens, 11521
Leuven, 3000
Berlin, 12099
Ormond Beach, Florida
St Germain En Laye, 78100
Foxboro, Massachusetts, 02035
Larissa, 41110
Romford, RM70AG
East Setauket, New York, 11733-345
Salford, M68HD
Oslo, 0407
Colorado Springs, Colorado, 80907
Le Mans Cedex 9, 72037
Bergen, 5021
Toulouse, 31200
Sarasota, Florida, 34239
MONTPELLIER Cedex 5, 34295
Wien
Fort Collins, Colorado, 80528
Santiago
Wilmington, North Carolina, 28401
Clinton Township, Michigan, 48035
CAHORS Cedex 9, 46005
Toms River, New Jersey, 08755
Englewood, Colorado, 80113
Bordeaux, 33000
Spokane, Washington, 99220-3649
Marseille, 13008
Nashville, Tennessee, 37215
Amiens Cedex 1, 80054
Kuopio
Nantes, 44093
Mansfield, Texas, 76063
Newport Beach, California, 92663
GRENOBLE cedex, 38043
Milwaukee, Wisconsin
Freehold, New Jersey, 07728
Richmond, Virginia, 23298
Springfield, Massachusetts, 01104
Bradenton, Florida, FL
Chesterfield, Missouri, 63017
St. John, E2L 4L2
Colmar, 68024
Oulu, 90220
Norwich, nr34dg
Syracuse, New York, 13202
Neenah, Wisconsin, 54956
Philadelphia, Pennsylvania, 19107
Hialeah, Florida, 33013
Caen, 14000
Turku, 20520
Clearwater, Florida, 33756
Leeds, LS13EX
Albi, 81000
Namsos, 7800
Brasschaat, 2930
Metz-Tessy, 74370
Barcelona, 08035
Concepcion
Bari, 70124
Fullerton, California, 92835
Tours, 37044
Melsbroek, 1820
Lincoln, Nebraska, 68521
Vienna, Virginia, 22182
Tucson, Arizona, 85704
Golden Valley, Minnesota, 55422
Long Beach, California, 90806
Henderson, Nevada, 89012
Charlotte, North Carolina, 28204
Chambery, 73000
Bismarck, North Dakota
PARIS Cedex 13, 75013
Ancona, 60126
Aix En Provence, 13616
Miami Lakes, Florida, 33014
Boulder, Colorado, 80304
Valencia, 46009
Rouen, 76000
Quimper, 29000
Indianapolis, Indiana
Monaca, Pennsylvania, 15061
Dallas, Texas, 75246
Sanford, North Carolina
Bayonne, 64109
New York, New York
Cambridge, N1R7L6
Rockport, Maine, 04843
Hämeenlinna, 13530
Schenectady, New York, 12308
Linz
Atlanta, Georgia, 30318
Athens, 11525
St. Petersburg, Florida
Tullahoma, Tennessee, 37388
Cullman, Alabama
Valladolid, 47011
Birmingham, Alabama, 35209
Napoli, 80138
Lille Cedex, 59037
Staten Island, New York, 10306
London, SW170QT
Denver, Colorado, CO
Birmingham, B152TH
Santiago de Compostela, 15706
Valence Cedex 9, 26953
St. Louis, Missouri, 63110
Orbassano (TO), 10043
San Antonio, Texas, 78229
Louisville, Kentucky, 40207
Kungsbacka, 43480
Scottsdale, Arizona, 85258
Winston Salem, North Carolina, 27103
Milano, 20132
Turku, 20520
Lyon Cedex 03, 69275
Henrico, Virginia, 23226
Morgantown, West Virginia, 26506-9180
Roanoke, Virginia, 24018
Asheville, North Carolina, 28806
Thessaloniki, 546 36
Donostia, 20014
Mulhouse, 68100
PARIS Cedex 20, 75970
Agen Cedex, 47923
Phoenix, Arizona, 85004
Limoges Cedex, 87000

Tracking Information

NCT #
NCT01895335
Collaborators
Not Provided
Investigators
Study Director: Clinical Sciences & Operations Sanofi