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

NCT02255656 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: LPS136492013-003884-71U1111-1148-2987
• Study Type: interventional
• Target: 1,062
• Locations: 19 countries
• Sites: 131

Brief 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.

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)

  An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed/worsened during the 'treatment period (time from Baseline until the end of the study LPS13649 \[i.e. up to a maximum of 5.6 years\]). Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.

  From Baseline until the end of the study (up to a maximum duration of 5.6 years)

• Number of Participants With Infusion-Associated Reactions (IAR)

  Infusion-associated reactions (IAR) was defined as any adverse event occurring during and within 24 hours of alemtuzumab infusion.

  Within 24 hours of any alemtuzumab infusion

• Number of Participants With Adverse Events of Special Interest (AESI)

  Adverse events of special interest included the following: hypersensitivity or anaphylaxis; pregnancy of a woman entered in the study; symptomatic overdose (serious or non-serious) with investigational medicinal Product (IMP); increase in alanine transaminase (ALT); autoimmune mediated conditions; hemophagocytic lymphohistiocytosis; progressive multifocal leukoencephalopathy; temporally associated AEs; serious infections; malignancy; and pneumonitis.

  From Baseline until the end of the study (up to a maximum duration of 5.6 years)

• Number of Participants With Potentially Clinically Significant Laboratory Abnormalities

  Criteria for potentially clinically significant laboratory abnormalities included: * Hemoglobin (Hb): less than or equal to (\<=)115 grams per liter (g/L)(Male \[M\]), \<= 95 g/L (Female\[ F\]); greater than or equal to (\>=)185 g/L (M), \>= 165 g/L (F); Decrease From Baseline (DFB) \>= 20 g/L. * Hematocrit: \<= 0.37 volume/volume (v/v) (M); \<= 0.32 v/v (F); \>= 0.55 v/v (M); \>= 0.5 v/v (F). * Red Blood Cells (RBCs): \>=6 \*10\^12/L. * Platelets: \<100 \*10\^9/L; \>=700 \*10\^9/L. As pre-specified, data collection and analysis for this outcome measure was done on the overall population along with 2 subgroups (DAT and IAT).

  From Baseline until the end of the study (up to a maximum duration of 5.6 years)

Secondary Outcomes (22)

• Annualized Relapse Rate

  Up to a maximum duration of 5.6 years

• Proportion of Participants Who Were Relapse Free

  Up to a maximum duration of 5.6 years

• Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60

  Baseline (Month 0 of LPS13649), Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60

• Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan

  Up to a maximum duration of 5.6 years

• Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan

  Up to a maximum duration of 5.6 years

Study Arms (1)

Alemtuzumab

EXPERIMENTAL

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).

Drug: alemtuzumab GZ402673

Interventions

alemtuzumab GZ402673 DRUG

Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous

Alemtuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (131)

Investigational Site Number 1086

Cullman, Alabama, 00000, United States

Location

Investigational Site Number 1031

Phoenix, Arizona, 85013, United States

Location

Investigational Site Number 1171

Phoenix, Arizona, 85018, United States

Location

Investigational Site Number 1090

Tucson, Arizona, 85704, United States

Location

Investigational Site Number 1040

Berkeley, California, 94705, United States

Location

Investigational Site Number 1152

Fullerton, California, 92835, United States

Location

Investigational Site Number 1093

Pasadena, California, 91105, United States

Location

Investigational Site Number 1027

Fort Collins, Colorado, 80528, United States

Location

Investigational Site Number 1078

Jacksonville, Florida, 32209, United States

Location

Investigational Site Number 1059

Maitland, Florida, 32751, United States

Location

Investigational Site Number 1173

Sarasota, Florida, 34239, United States

Location

Investigational Site Number 1034

Sunrise, Florida, 33351, United States

Location

Investigational Site Number 1005

Tampa, Florida, 33609, United States

Location

Investigational Site Number 1049

Tampa, Florida, 33612, United States

Location

Investigational Site Number 1008

Northbrook, Illinois, 60062, United States

Location

Investigational Site Number 1001

Fort Wayne, Indiana, 46845, United States

Location

Investigational Site Number 1024

Indianapolis, Indiana, 46202, United States

Location

Investigational Site Number 1017

Des Moines, Iowa, 50314, United States

Location

Investigational Site Number 1022

Kansas City, Kansas, 66160, United States

Location

Investigational Site Number 1083

Lenexa, Kansas, 66214, United States

Location

Investigational Site Number 1039

Lexington, Kentucky, 40513, United States

Location

Investigational Site Number 1021

Louisville, Kentucky, 40202, United States

Location

Investigational Site Number 1061

Wellesley, Massachusetts, 02481, United States

Location

Investigational Site Number 1028

Worcester, Massachusetts, 01655, United States

Location

Investigational Site Number 1025

Ann Arbor, Michigan, 48105-2945, United States

Location

Investigational Site Number 1020

Detroit, Michigan, 48201, United States

Location

Investigational Site Number 1054

Traverse City, Michigan, 49684, United States

Location

Investigational Site Number 1084

Kansas City, Missouri, 64111, United States

Location

Investigational Site Number 1092

St Louis, Missouri, 63131, United States

Location

Investigational Site Number 1073

Teaneck, New Jersey, 07666, United States

Location

Investigational Site Number 1014

Albuquerque, New Mexico, 87131, United States

Location

Investigational Site Number 1081

Mineola, New York, 11501, United States

Location

Investigational Site Number 1026

New York, New York, 10029, United States

Location

Investigational Site Number 1160

Patchogue, New York, 11772, United States

Location

Investigational Site Number 1015

Rochester, New York, 14642, United States

Location

Investigational Site Number 1053

Syracuse, New York, 13202, United States

Location

Investigational Site Number 1095

Chapel Hill, North Carolina, 27599, United States

Location

Investigational Site Number 1082

Winston-Salem, North Carolina, 27103, United States

Location

Investigational Site Number 1035

Cleveland, Ohio, 44195, United States

Location

Investigational Site Number 1058

Uniontown, Ohio, 44685, United States

Location

Investigational Site Number 1067

Oklahoma City, Oklahoma, 73104, United States

Location

Investigational Site Number 1097

Allentown, Pennsylvania, 18103, United States

Location

Investigational Site Number 1057

Providence, Rhode Island, 02905, United States

Location

Investigational Site Number 1163

Cordova, Tennessee, 38018, United States

Location

Investigational Site Number 1055

Franklin, Tennessee, 37064, United States

Location

Investigational Site Number 1009

Knoxville, Tennessee, 37922, United States

Location

Investigational Site Number 1042

Nashville, Tennessee, 37215, United States

Location

Investigational Site Number 1018

Houston, Texas, 77030, United States

Location

Investigational Site Number 1002

Round Rock, Texas, 78681, United States

Location

Investigational Site Number 1046

San Antonio, Texas, United States

Location

Investigational Site Number 1037

Vienna, Virginia, 22182, United States

Location

Investigational Site Number 1068

Seattle, Washington, 98122, United States

Location

Investigational Site Number 03208

CABA, C1061ABD, Argentina

Location

Investigational Site Number 2013

Auchenflower, 4066, Australia

Location

Investigational Site Number 2001

Heidelberg, 3084, Australia

Location

Investigational Site Number 2011

Hobart, 7000, Australia

Location

Investigational Site Number 2012

Kogarah, 2217, Australia

Location

Investigational Site Number 2003

Melbourne, 3065, Australia

Location

Investigational Site Number 2002

Parkville, 3050, Australia

Location

Investigational Site Number 2005

Southport, 4215, Australia

Location

Investigational Site Number 2009

Sydney, Australia

Location

Investigational Site Number 2006

Westmead, 2145, Australia

Location

Investigational Site Number 5005

Brussels, 1200, Belgium

Location

Investigational Site Number 5004

Esneux, 4130, Belgium

Location

Investigational Site Number 5001

Leuven, 3000, Belgium

Location

Investigational Site Number 3006

Porto Alegre, 90110000, Brazil

Location

Investigational Site Number 3002

Recife, 52010-040, Brazil

Location

Investigational Site Number 3001

São Paulo, 01221-000, Brazil

Location

Investigational Site Number 3003

São Paulo, 05403-000, Brazil

Location

Investigational Site Number 1102

Calgary, T2N 2T9, Canada

Location

Investigational Site Number 1105

Gatineau, J8Y1W2, Canada

Location

Investigational Site Number 1104

Greenfield Park, J4V2J2, Canada

Location

Investigational Site Number 1109

Kingston, K7L2V7, Canada

Location

Investigational Site Number 1110

London, N6A5A5, Canada

Location

Investigational Site Number 1101

Ottawa, K1H8L6, Canada

Location

Investigational Site Number 1106

Vancouver, V6T1Z3, Canada

Location

Investigational Site Number 4803

Brno, 65691, Czechia

Location

Investigational Site Number 4804

Hradec Králové, 50005, Czechia

Location

Investigational Site Number 4801

Prague, 12808, Czechia

Location

Investigational Site Number 4802

Teplice, 41501, Czechia

Location

Investigational Site Number 5302

Aarhus N, 8200, Denmark

Location

Investigational Site Number 5301

København Ø, 2100, Denmark

Location

Investigational Site Number 4602

Berlin, 13347, Germany

Location

Investigational Site Number 4607

Dresden, 01307, Germany

Location

Investigational Site Number 4634

Frankfurt am Main, 60590, Germany

Location

Investigational Site Number 4622

Hamburg, 22307, Germany

Location

Investigational Site Number 4605

Hanover, 30625, Germany

Location

Investigational Site Number 4609

Hennigsdorf, 16761, Germany

Location

Investigational Site Number 4608

München, 81675, Germany

Location

Investigational Site Number 4610

Rostock, 18147, Germany

Location

Investigational Site Number 4613

Wermsdorf, 04779, Germany

Location

Investigational Site Number 5501

Ramat Gan, 52621, Israel

Location

Investigational Site Number 5505

Tel Aviv, Israel

Location

Investigational Site Number 4112

Cagliari, 09126, Italy

Location

Investigational Site Number 4102

Gallarate (VA), 21013, Italy

Location

Investigational Site Number 4106

Orbassano (TO), 10043, Italy

Location

Investigational Site Number 4110

Roma, 00189, Italy

Location

Investigational Site Number 3105

Chihuahua City, 31203, Mexico

Location

Investigational Site Number 3102

México, 14260, Mexico

Location

Investigational Site Number 4202

Sittard-Geleen, 6162BG, Netherlands

Location

Investigational Site Number 4902

Krakow, 31-505, Poland

Location

Investigational Site Number 4901

Lodz, 90-324, Poland

Location

Investigational Site Number 4903

Lublin, 20-090, Poland

Location

Investigational Site Number 4904

Poznan, 60-355, Poland

Location

Investigational Site Number 4905

Warsaw, 02-957, Poland

Location

Investigational Site Number 6009

Kazan', 420097, Russia

Location

Investigational Site Number 6001

Moscow, 1217015, Russia

Location

Investigational Site Number 6005

Moscow, 1217015, Russia

Location

Investigational Site Number 6003

Moscow, Russia

Location

Investigational Site Number 6006

Nizhny Novgorod, Russia

Location

Investigational Site Number 6010

Pyatigorsk, Russia

Location

Investigational Site Number 6002

Saint Petersburg, Russia

Location

Investigational Site Number 6004

Saint Petersburg, Russia

Location

Investigational Site Number 6008

Saint Petersburg, Russia

Location

Investigational Site Number 6013

Samara, Russia

Location

Investigational Site Number 6016

Ufa, Russia

Location

Investigational Site Number 4301

Barcelona, 08035, Spain

Location

Investigational Site Number 4303

Madrid, 28040, Spain

Location

Investigational Site Number 4305

Málaga, 29010, Spain

Location

Investigational Site Number 4304

Seville, 41071, Spain

Location

Investigational Site Number 4701

Gothenburg, 41345, Sweden

Location

Investigational Site Number 4702

Umeå, 90185, Sweden

Location

Investigational Site Number 6102

Kharkiv, Ukraine

Location

Investigational Site Number 6104

Kiev, Ukraine

Location

Investigational Site Number 6103

Lviv, Ukraine

Location

Investigational Site Number 4004

Bristol, BS105NB, United Kingdom

Location

Investigational Site Number 4001

Cambridge, CB50QQ, United Kingdom

Location

Investigational Site Number 4005

Cardiff, CF44XN, United Kingdom

Location

Investigational Site Number 4006

London, E12AT, United Kingdom

Location

Investigational Site Number 4008

Salford, M68HD, United Kingdom

Location

Investigational Site Number 4007

Sheffield, S102JF, United Kingdom

Location

Related Publications (9)

• 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.

  PMID: 39935588 DERIVED

• 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.

  PMID: 37745914 DERIVED

• 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.

  PMID: 34882037 DERIVED

• 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.

  PMID: 34378446 DERIVED

• 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.

  PMID: 33476880 DERIVED

• 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.

  PMID: 32710396 DERIVED

• 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.

  PMID: 32583052 DERIVED

• 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.

  PMID: 31762387 DERIVED

• 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.

  PMID: 31654272 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 2, 2014
• Study Start: January 7, 2015
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: March 28, 2022
• Results First Posted: July 23, 2021

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

PL (5); US (52); AU (9); DK (2); ME (2); IT (4); RU (11); GB (6); DE (9); ES (4); BE (3); CZ (4); BR (4); UA (3); AR (1); SE (2); CA (7); IL (2); NL (1)