Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409
NCT ID: NCT02255656
Last Updated: 2022-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1062 participants
INTERVENTIONAL
2015-01-07
2020-07-15
Brief Summary
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To evaluate long-term safety of alemtuzumab.
Secondary Objectives:
* To evaluate long term efficacy of alemtuzumab.
* To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment.
* To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab.
* To evaluate as needed re-treatment with alemtuzumab and other DMTs.
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Detailed Description
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As per Study Investigator discretion, participants can be treated with additional courses of alemtuzumab or any commercialized DMTs.
All participants who completed CAMMS03409 were allowed into the study, which might include specific vulnerable populations. If the investigator decided to treat a participant with a course of alemtuzumab, appropriate cautionary measures were applied as indicated in the approved labelling, or, in ex-European Union countries where Lemtrada was not approved, according to the investigator's brochure.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Alemtuzumab
All Participants who completed the study CAMMS03409 (extension study of CAMMS223 \[NCT00050778\], CAMMS323 \[NCT00530348\], or CAMMS324 \[NCT00548405\]) and received alemtuzumab within 48 months prior to enrollment were included in this LPS13649 study. Participants received alemtuzumab, intravenous infusion of 12 milligram per day (mg/day) for 3 consecutive days, at the study investigators' discretion; and at least 12 months after the prior treatment course in the current study (LPS13649).
alemtuzumab GZ402673
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
Interventions
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alemtuzumab GZ402673
Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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18 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 1086
Cullman, Alabama, United States
Investigational Site Number 1031
Phoenix, Arizona, United States
Investigational Site Number 1171
Phoenix, Arizona, United States
Investigational Site Number 1090
Tucson, Arizona, United States
Investigational Site Number 1040
Berkeley, California, United States
Investigational Site Number 1152
Fullerton, California, United States
Investigational Site Number 1093
Pasadena, California, United States
Investigational Site Number 1027
Fort Collins, Colorado, United States
Investigational Site Number 1078
Jacksonville, Florida, United States
Investigational Site Number 1059
Maitland, Florida, United States
Investigational Site Number 1173
Sarasota, Florida, United States
Investigational Site Number 1034
Sunrise, Florida, United States
Investigational Site Number 1005
Tampa, Florida, United States
Investigational Site Number 1049
Tampa, Florida, United States
Investigational Site Number 1008
Northbrook, Illinois, United States
Investigational Site Number 1001
Fort Wayne, Indiana, United States
Investigational Site Number 1024
Indianapolis, Indiana, United States
Investigational Site Number 1017
Des Moines, Iowa, United States
Investigational Site Number 1022
Kansas City, Kansas, United States
Investigational Site Number 1083
Lenexa, Kansas, United States
Investigational Site Number 1039
Lexington, Kentucky, United States
Investigational Site Number 1021
Louisville, Kentucky, United States
Investigational Site Number 1061
Wellesley, Massachusetts, United States
Investigational Site Number 1028
Worcester, Massachusetts, United States
Investigational Site Number 1025
Ann Arbor, Michigan, United States
Investigational Site Number 1020
Detroit, Michigan, United States
Investigational Site Number 1054
Traverse City, Michigan, United States
Investigational Site Number 1084
Kansas City, Missouri, United States
Investigational Site Number 1092
St Louis, Missouri, United States
Investigational Site Number 1073
Teaneck, New Jersey, United States
Investigational Site Number 1014
Albuquerque, New Mexico, United States
Investigational Site Number 1081
Mineola, New York, United States
Investigational Site Number 1026
New York, New York, United States
Investigational Site Number 1160
Patchogue, New York, United States
Investigational Site Number 1015
Rochester, New York, United States
Investigational Site Number 1053
Syracuse, New York, United States
Investigational Site Number 1095
Chapel Hill, North Carolina, United States
Investigational Site Number 1082
Winston-Salem, North Carolina, United States
Investigational Site Number 1035
Cleveland, Ohio, United States
Investigational Site Number 1058
Uniontown, Ohio, United States
Investigational Site Number 1067
Oklahoma City, Oklahoma, United States
Investigational Site Number 1097
Allentown, Pennsylvania, United States
Investigational Site Number 1057
Providence, Rhode Island, United States
Investigational Site Number 1163
Cordova, Tennessee, United States
Investigational Site Number 1055
Franklin, Tennessee, United States
Investigational Site Number 1009
Knoxville, Tennessee, United States
Investigational Site Number 1042
Nashville, Tennessee, United States
Investigational Site Number 1018
Houston, Texas, United States
Investigational Site Number 1002
Round Rock, Texas, United States
Investigational Site Number 1046
San Antonio, Texas, United States
Investigational Site Number 1037
Vienna, Virginia, United States
Investigational Site Number 1068
Seattle, Washington, United States
Investigational Site Number 03208
CABA, , Argentina
Investigational Site Number 2013
Auchenflower, , Australia
Investigational Site Number 2001
Heidelberg, , Australia
Investigational Site Number 2011
Hobart, , Australia
Investigational Site Number 2012
Kogarah, , Australia
Investigational Site Number 2003
Melbourne, , Australia
Investigational Site Number 2002
Parkville, , Australia
Investigational Site Number 2005
Southport, , Australia
Investigational Site Number 2009
Sydney, , Australia
Investigational Site Number 2006
Westmead, , Australia
Investigational Site Number 5005
Brussels, , Belgium
Investigational Site Number 5004
Esneux, , Belgium
Investigational Site Number 5001
Leuven, , Belgium
Investigational Site Number 3006
Porto Alegre, , Brazil
Investigational Site Number 3002
Recife, , Brazil
Investigational Site Number 3001
São Paulo, , Brazil
Investigational Site Number 3003
São Paulo, , Brazil
Investigational Site Number 1102
Calgary, , Canada
Investigational Site Number 1105
Gatineau, , Canada
Investigational Site Number 1104
Greenfield Park, , Canada
Investigational Site Number 1109
Kingston, , Canada
Investigational Site Number 1110
London, , Canada
Investigational Site Number 1101
Ottawa, , Canada
Investigational Site Number 1106
Vancouver, , Canada
Investigational Site Number 4803
Brno, , Czechia
Investigational Site Number 4804
Hradec Králové, , Czechia
Investigational Site Number 4801
Prague, , Czechia
Investigational Site Number 4802
Teplice, , Czechia
Investigational Site Number 5302
Aarhus N, , Denmark
Investigational Site Number 5301
København Ø, , Denmark
Investigational Site Number 4602
Berlin, , Germany
Investigational Site Number 4607
Dresden, , Germany
Investigational Site Number 4634
Frankfurt am Main, , Germany
Investigational Site Number 4622
Hamburg, , Germany
Investigational Site Number 4605
Hanover, , Germany
Investigational Site Number 4609
Hennigsdorf, , Germany
Investigational Site Number 4608
München, , Germany
Investigational Site Number 4610
Rostock, , Germany
Investigational Site Number 4613
Wermsdorf, , Germany
Investigational Site Number 5501
Ramat Gan, , Israel
Investigational Site Number 5505
Tel Aviv, , Israel
Investigational Site Number 4112
Cagliari, , Italy
Investigational Site Number 4102
Gallarate (VA), , Italy
Investigational Site Number 4106
Orbassano (TO), , Italy
Investigational Site Number 4110
Roma, , Italy
Investigational Site Number 3105
Chihuahua City, , Mexico
Investigational Site Number 3102
México, , Mexico
Investigational Site Number 4202
Sittard-Geleen, , Netherlands
Investigational Site Number 4902
Krakow, , Poland
Investigational Site Number 4901
Lodz, , Poland
Investigational Site Number 4903
Lublin, , Poland
Investigational Site Number 4904
Poznan, , Poland
Investigational Site Number 4905
Warsaw, , Poland
Investigational Site Number 6009
Kazan', , Russia
Investigational Site Number 6001
Moscow, , Russia
Investigational Site Number 6005
Moscow, , Russia
Investigational Site Number 6003
Moscow, , Russia
Investigational Site Number 6006
Nizhny Novgorod, , Russia
Investigational Site Number 6010
Pyatigorsk, , Russia
Investigational Site Number 6002
Saint Petersburg, , Russia
Investigational Site Number 6004
Saint Petersburg, , Russia
Investigational Site Number 6008
Saint Petersburg, , Russia
Investigational Site Number 6013
Samara, , Russia
Investigational Site Number 6016
Ufa, , Russia
Investigational Site Number 4301
Barcelona, , Spain
Investigational Site Number 4303
Madrid, , Spain
Investigational Site Number 4305
Málaga, , Spain
Investigational Site Number 4304
Seville, , Spain
Investigational Site Number 4701
Gothenburg, , Sweden
Investigational Site Number 4702
Umeå, , Sweden
Investigational Site Number 6102
Kharkiv, , Ukraine
Investigational Site Number 6104
Kiev, , Ukraine
Investigational Site Number 6103
Lviv, , Ukraine
Investigational Site Number 4004
Bristol, , United Kingdom
Investigational Site Number 4001
Cambridge, , United Kingdom
Investigational Site Number 4005
Cardiff, , United Kingdom
Investigational Site Number 4006
London, , United Kingdom
Investigational Site Number 4008
Salford, , United Kingdom
Investigational Site Number 4007
Sheffield, , United Kingdom
Countries
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References
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Ziemssen T, Bass AD, Van Wijmeersch B, Eichau S, Richter S, Hoffmann F, Armstrong NM, Chirieac M, Cunha-Santos J, Singer BA. Long-term efficacy and safety of alemtuzumab in participants with highly active MS: TOPAZ clinical trial and interim analysis of TREAT-MS real-world study. Ther Adv Neurol Disord. 2025 Feb 10;18:17562864241306575. doi: 10.1177/17562864241306575. eCollection 2025.
Coles AJ, Achiron A, Traboulsee A, Singer BA, Pozzilli C, Oreja-Guevara C, Giovannoni G, Comi G, Freedman MS, Ziemssen T, Shiota D, Rawlings AM, Wong AT, Chirieac M, Montalban X. Safety and efficacy with alemtuzumab over 13 years in relapsing-remitting multiple sclerosis: final results from the open-label TOPAZ study. Ther Adv Neurol Disord. 2023 Sep 21;16:17562864231194823. doi: 10.1177/17562864231194823. eCollection 2023.
Coles AJ, Jones JL, Vermersch P, Traboulsee A, Bass AD, Boster A, Chan A, Comi G, Fernandez O, Giovannoni G, Kubala Havrdova E, LaGanke C, Montalban X, Oreja-Guevara C, Piehl F, Wiendl H, Ziemssen T. Autoimmunity and long-term safety and efficacy of alemtuzumab for multiple sclerosis: Benefit/risk following review of trial and post-marketing data. Mult Scler. 2022 Apr;28(5):842-846. doi: 10.1177/13524585211061335. Epub 2021 Dec 9.
Kuhle J, Daizadeh N, Benkert P, Maceski A, Barro C, Michalak Z, Sormani MP, Godin J, Shankara S, Samad TA, Jacobs A, Chung L, Rӧsch N, Kaiser C, Mitchell CP, Leppert D, Havari E, Kappos L. Sustained reduction of serum neurofilament light chain over 7 years by alemtuzumab in early relapsing-remitting MS. Mult Scler. 2022 Apr;28(4):573-582. doi: 10.1177/13524585211032348. Epub 2021 Aug 11.
Bass AD, Arroyo R, Boster AL, Boyko AN, Eichau S, Ionete C, Limmroth V, Navas C, Pelletier D, Pozzilli C, Ravenscroft J, Sousa L, Tintore M, Uitdehaag BMJ, Baker DP, Daizadeh N, Choudhry Z, Rog D; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Alemtuzumab outcomes by age: Post hoc analysis from the randomized CARE-MS studies over 8 years. Mult Scler Relat Disord. 2021 Apr;49:102717. doi: 10.1016/j.msard.2020.102717. Epub 2020 Dec 24.
Ziemssen T, Bass AD, Berkovich R, Comi G, Eichau S, Hobart J, Hunter SF, LaGanke C, Limmroth V, Pelletier D, Pozzilli C, Schippling S, Sousa L, Traboulsee A, Uitdehaag BMJ, Van Wijmeersch B, Choudhry Z, Daizadeh N, Singer BA; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ investigators. Efficacy and Safety of Alemtuzumab Through 9 Years of Follow-up in Patients with Highly Active Disease: Post Hoc Analysis of CARE-MS I and II Patients in the TOPAZ Extension Study. CNS Drugs. 2020 Sep;34(9):973-988. doi: 10.1007/s40263-020-00749-x.
Steingo B, Al Malik Y, Bass AD, Berkovich R, Carraro M, Fernandez O, Ionete C, Massacesi L, Meuth SG, Mitsikostas DD, Pardo G, Simm RF, Traboulsee A, Choudhry Z, Daizadeh N, Compston DAS; CAMMS223, CAMMS03409, and TOPAZ Investigators. Long-term efficacy and safety of alemtuzumab in patients with RRMS: 12-year follow-up of CAMMS223. J Neurol. 2020 Nov;267(11):3343-3353. doi: 10.1007/s00415-020-09983-1. Epub 2020 Jun 24.
Comi G, Alroughani R, Boster AL, Bass AD, Berkovich R, Fernandez O, Kim HJ, Limmroth V, Lycke J, Macdonell RA, Sharrack B, Singer BA, Vermersch P, Wiendl H, Ziemssen T, Jacobs A, Daizadeh N, Rodriguez CE, Traboulsee A; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies. Mult Scler. 2020 Dec;26(14):1866-1876. doi: 10.1177/1352458519888610. Epub 2019 Nov 25.
Okai AF, Amezcua L, Berkovich RR, Chinea AR, Edwards KR, Steingo B, Walker A, Jacobs AK, Daizadeh N, Williams MJ; CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators. Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurol Ther. 2019 Dec;8(2):367-381. doi: 10.1007/s40120-019-00159-2. Epub 2019 Oct 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-003884-71
Identifier Type: -
Identifier Source: secondary_id
U1111-1148-2987
Identifier Type: OTHER
Identifier Source: secondary_id
LPS13649
Identifier Type: -
Identifier Source: org_study_id
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