Multiple Sclerosis Clinical Trial

Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409

Summary

Primary Objective:

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.

View Full Description

Full Description

The total duration per participants was up to 5.6 years.

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

Participant had completed at least 48 months of the Extension Study CAMMS03409. Signed written informed consent form.

Exclusion criteria:

Participant participating in another investigational interventional study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

1062

Study ID:

NCT02255656

Recruitment Status:

Completed

Sponsor:

Genzyme, a Sanofi Company

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There are 116 Locations for this study

See Locations Near You

Investigational Site Number 1086
Cullman Alabama, 00000, United States
Investigational Site Number 1031
Phoenix Arizona, 85013, United States
Investigational Site Number 1171
Phoenix Arizona, 85018, United States
Investigational Site Number 1090
Tucson Arizona, 85704, United States
Investigational Site Number 1040
Berkeley California, 94705, United States
Investigational Site Number 1152
Fullerton California, 92835, United States
Investigational Site Number 1093
Pasadena California, 91105, United States
Investigational Site Number 1027
Fort Collins Colorado, 80528, United States
Investigational Site Number 1078
Jacksonville Florida, 32209, United States
Investigational Site Number 1059
Maitland Florida, 32751, United States
Investigational Site Number 1173
Sarasota Florida, 34239, United States
Investigational Site Number 1034
Sunrise Florida, 33351, United States
Investigational Site Number 1005
Tampa Florida, 33609, United States
Investigational Site Number 1049
Tampa Florida, 33612, United States
Investigational Site Number 1008
Northbrook Illinois, 60062, United States
Investigational Site Number 1001
Fort Wayne Indiana, 46845, United States
Investigational Site Number 1024
Indianapolis Indiana, 46202, United States
Investigational Site Number 1017
Des Moines Iowa, 50314, United States
Investigational Site Number 1022
Kansas City Kansas, 66160, United States
Investigational Site Number 1083
Lenexa Kansas, 66214, United States
Investigational Site Number 1039
Lexington Kentucky, 40513, United States
Investigational Site Number 1021
Louisville Kentucky, 40202, United States
Investigational Site Number 1061
Wellesley Massachusetts, 02481, United States
Investigational Site Number 1028
Worcester Massachusetts, 01655, United States
Investigational Site Number 1025
Ann Arbor Michigan, 48105, United States
Investigational Site Number 1020
Detroit Michigan, 48201, United States
Investigational Site Number 1054
Traverse City Michigan, 49684, United States
Investigational Site Number 1084
Kansas City Missouri, 64111, United States
Investigational Site Number 1092
Saint Louis Missouri, 63131, United States
Investigational Site Number 1073
Teaneck New Jersey, 07666, United States
Investigational Site Number 1014
Albuquerque New Mexico, 87131, United States
Investigational Site Number 1081
Mineola New York, 11501, United States
Investigational Site Number 1026
New York New York, 10029, United States
Investigational Site Number 1160
Patchogue New York, 11772, United States
Investigational Site Number 1015
Rochester New York, 14642, United States
Investigational Site Number 1053
Syracuse New York, 13202, United States
Investigational Site Number 1095
Chapel Hill North Carolina, 27599, United States
Investigational Site Number 1082
Winston-Salem North Carolina, 27103, United States
Investigational Site Number 1035
Cleveland Ohio, 44195, United States
Investigational Site Number 1058
Uniontown Ohio, 44685, United States
Investigational Site Number 1067
Oklahoma City Oklahoma, 73104, United States
Investigational Site Number 1097
Allentown Pennsylvania, 18103, United States
Investigational Site Number 1057
Providence Rhode Island, 02905, United States
Investigational Site Number 1163
Cordova Tennessee, 38018, United States
Investigational Site Number 1055
Franklin Tennessee, 37064, United States
Investigational Site Number 1009
Knoxville Tennessee, 37922, United States
Investigational Site Number 1042
Nashville Tennessee, 37215, United States
Investigational Site Number 1018
Houston Texas, 77030, United States
Investigational Site Number 1002
Round Rock Texas, 78681, United States
Investigational Site Number 1046
San Antonio Texas, , United States
Investigational Site Number 1037
Vienna Virginia, 22182, United States
Investigational Site Number 1068
Seattle Washington, 98122, United States
Investigational Site Number 03208
Caba , C1061, Argentina
Investigational Site Number 2013
Auchenflower , 4066, Australia
Investigational Site Number 2001
Heidelberg , 3084, Australia
Investigational Site Number 2011
Hobart , 7000, Australia
Investigational Site Number 2012
Kogarah , 2217, Australia
Investigational Site Number 2003
Melbourne , 3065, Australia
Investigational Site Number 2002
Parkville , 3050, Australia
Investigational Site Number 2005
Southport , 4215, Australia
Investigational Site Number 2009
Sydney , , Australia
Investigational Site Number 2006
Westmead , 2145, Australia
Investigational Site Number 5005
Bruxelles , 1200, Belgium
Investigational Site Number 5004
Esneux , 4130, Belgium
Investigational Site Number 5001
Leuven , 3000, Belgium
Investigational Site Number 3006
Porto Alegre , 90110, Brazil
Investigational Site Number 3002
Recife , 52010, Brazil
Investigational Site Number 3001
São Paulo , 01221, Brazil
Investigational Site Number 3003
São Paulo , 05403, Brazil
Investigational Site Number 1102
Calgary , T2N 2, Canada
Investigational Site Number 1105
Gatineau , J8Y1W, Canada
Investigational Site Number 1104
Greenfield Park , J4V2J, Canada
Investigational Site Number 1109
Kingston , K7L2V, Canada
Investigational Site Number 1110
London , N6A5A, Canada
Investigational Site Number 1101
Ottawa , K1H8L, Canada
Investigational Site Number 1106
Vancouver , V6T1Z, Canada
Investigational Site Number 4803
Brno , 65691, Czechia
Investigational Site Number 4804
Hradec Kralove , 50005, Czechia
Investigational Site Number 4801
Praha 2 , 12808, Czechia
Investigational Site Number 4802
Teplice , 41501, Czechia
Investigational Site Number 5302
Aarhus N , 8200, Denmark
Investigational Site Number 5301
København Ø. , 2100, Denmark
Investigational Site Number 4602
Berlin , 13347, Germany
Investigational Site Number 4607
Dresden , 01307, Germany
Investigational Site Number 4634
Frankfurt am Main , 60590, Germany
Investigational Site Number 4622
Hamburg , 22307, Germany
Investigational Site Number 4605
Hannover , 30625, Germany
Investigational Site Number 4609
Hennigsdorf , 16761, Germany
Investigational Site Number 4608
München , 81675, Germany
Investigational Site Number 4610
Rostock , 18147, Germany
Investigational Site Number 4613
Wermsdorf , 04779, Germany
Investigational Site Number 5501
Ramat Gan , 52621, Israel
Investigational Site Number 5505
Tel Aviv , , Israel
Investigational Site Number 4112
Cagliari , 09126, Italy
Investigational Site Number 4102
Gallarate (VA) , 21013, Italy
Investigational Site Number 4106
Orbassano (TO) , 10043, Italy
Investigational Site Number 4110
Roma , 00189, Italy
Investigational Site Number 3105
Chihuahua , 31203, Mexico
Investigational Site Number 3102
Mexico , 14260, Mexico
Investigational Site Number 4202
Sittard-Geleen , 6162B, Netherlands
Investigational Site Number 4902
Krakow , 31-50, Poland
Investigational Site Number 4901
Lodz , 90-32, Poland
Investigational Site Number 4903
Lublin , 20-09, Poland
Investigational Site Number 4904
Poznan , 60-35, Poland
Investigational Site Number 4905
Warszawa , 02-95, Poland
Investigational Site Number 6009
Kazan , 42009, Russian Federation
Investigational Site Number 6001
Moscow , 12170, Russian Federation
Investigational Site Number 6005
Moscow , 12170, Russian Federation
Investigational Site Number 6003
Moscow , , Russian Federation
Investigational Site Number 6006
Nizhny Novgorod , , Russian Federation
Investigational Site Number 6010
Pyatigorsk , , Russian Federation
Investigational Site Number 6002
Saint-Petersburg , , Russian Federation
Investigational Site Number 6004
Saint-Petersburg , , Russian Federation
Investigational Site Number 6008
Saint-Petersburg , , Russian Federation
Investigational Site Number 6013
Samara , , Russian Federation
Investigational Site Number 6016
Ufa , , Russian Federation
Investigational Site Number 4301
Barcelona , 08035, Spain
Investigational Site Number 4303
Madrid , 28040, Spain
Investigational Site Number 4305
Málaga , 29010, Spain
Investigational Site Number 4304
Sevilla , 41071, Spain
Investigational Site Number 4701
Göteborg , 41345, Sweden
Investigational Site Number 4702
Umeå , 90185, Sweden
Investigational Site Number 6102
Kharkov , , Ukraine
Investigational Site Number 6104
Kiev , , Ukraine
Investigational Site Number 6103
Lviv , , Ukraine
Investigational Site Number 4004
Bristol , BS105, United Kingdom
Investigational Site Number 4001
Cambridge , CB50Q, United Kingdom
Investigational Site Number 4005
Cardiff , CF44X, United Kingdom
Investigational Site Number 4006
London , E12AT, United Kingdom
Investigational Site Number 4008
Salford , M68HD, United Kingdom
Investigational Site Number 4007
Sheffield , S102J, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

1062

Study ID:

NCT02255656

Recruitment Status:

Completed

Sponsor:


Genzyme, a Sanofi Company

How clear is this clinincal trial information?

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