DDrare: Database of Drug Development for Rare Diseases

13. 多発性硬化症／視神経脊髄炎
［臨床試験数：3,050，薬物数：2,147（DrugBank：348），標的遺伝子数：244，標的パスウェイ数：228］

Searched query = "Multiple sclerosis/Neuromyelitis optica", "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = (-)-trans-delta-9-Tetrahydrocannabinol; (IM) AVONEX®; (R) 3-(5-Dimethylcarbamoyl-pent-1-enyl)-N-(2-hydroxy-1- methylethyl) benzamide; 0,5 mg Fingolimod; 0.25 mg RPC1063; 0.25mg RPC1063; 0.5 mg RPC1063; 0.5mg RPC1063; 1 - Andrographis paniculata p/st extract; 1 mg RPC1063; 1% Steroid Cream; 1-{6-[(3-cyclobutyl-2,3,4,5-tetrahydro-1H-3-benzazepin-7-yl)oxy]-3-pyridinyl}-2-pyrrolidinone; 1.0mg RPC1063; 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP); 10000IU vitamin D; 11C-ACETATE; 11C-PBR28; 11C-PIB; 13-PCV Booster; 13-valent pneumococcal conjugate vaccine (13-PCV); 1393641-34-3; 15 mg fampridine-SR (4-aminopyridine, 4-AP); 18F-DPA-714 and 18F-FDG; 18F-FDG; 18F-PM-PBB3; 19 nor vitamin d; 2 - Excipients; 2-(2-(2-Amino-9H-purin-9-yl)ethyl)-1,3-propanediol diacetate ester; 2-CdA; 2-CdA, 2-chloro-2'-deoxy-beta-D-adenosine; 2-CdA, 2-chloro-2'-deoxy-ß-D-adenosine; 2-CdA, 2-chloro-2?-deoxy-beta-D-adenosine; 2-CdA, 2-chloro-2?-deoxy-ß-D-adenosine; 2-CdA, 2-chloro-2’-deoxy-beta-D-adenosine; 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine; 2-chloro-2'-deoxy-beta-D-adenosine (2-CdA); 2-chloro-2'-deoxy-ß-D-adenosine (2-CdA); 2-chloro-2'-deoxyadenosine (2-CdA); 2-chloro-2'-deoxyadenosine, 2CdA; 2-chloro-2?-deoxy-beta-D-adenosine; 2-chloro-2?-deoxy-ß-D-adenosine; 2-chloro-2’-deoxy-beta-D-adenosine; 2-chloro-2’-deoxy-beta-D-adenosine (2-CdA); 2-chloro-2’-deoxy-ß-D-adenosine; 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA); 2-chloro-2’-deoxyadenosine (2-CdA); 20 mg GA; 20 mg MitoQ; 20 mg fampridine-SR (4-aminopyridine, 4-AP); 200106 or EMD 28162; 20mg/0.5ml GA; 20mg/0.5ml glatiramer acetate; 23-PPV; 23-valent pneumococcal polysaccharide vaccine; 23-valent pneumococcal polysaccharide vaccine (23-PPV); 25OH-Vitamin D; 2B3-201; 3 mg Melatonin; 3,4-diaminopyridine; 4-AP; 4-Aminopyridine; 4-aminopyridine; 4.5 mg Naltrexone; 40 mg GA; 40 mg Glatiramer Acetate; 40 mg Glatiramer acetato; 40 mg glatiramer acetate; 40mg of MitoQ; 5 mg Melatonin; 5000IU vitamin D; 52069.00.01; 9060X; 95% Pure ECGC capsules 200mg; A4I Antagonist; AB1010; ABR-215062; ABR-215062 sodium salt; ABT-555; ABT-874/Human monoclonal antibody against IL-12; ABX-1431; ABX-1431 HCl; ACETYLSALICYLIC ACID; ACT; ACT-1; ACT-128800; ACT-128800 Dose 1; ACT-128800 Dose 2; ACT-128800 Dose 3; ACTH; ACTHAR; ACTHAR Gel (ACTH); ACTHar; ACTOS (Pioglitazone); ADS-5102; ADS-5102, 137 mg; ADS-5102, 274 mg; AERT, (R)-Baclofen; AGEE cream; AHSC; AIMSPRO; AIN; AIN457; ALEMTUZUMAB; ALKS 8700; ALKS 8700 Delayed Release (DR); ALKS 8700 Delayed Release (DR) Capsule; ALTRI FARMACI DEL SISTEMA NERVOSO; ALXN1210; AMILORIDE HYDROCHLORIDE, 2 H2O; AMPYRA; AN100226; AN100226, BG00002; ANK-700; ANTITHYMOCYTE GAMMA IMMUNOGLOBULIN; ANTITHYMOCYTE IMMUNOGLOBULIN; AP; ARICEPT; ARN-6039; ASA; ASB-683699; ATA188; ATG; ATL1102; ATX-MS-1467; AUBAGIO; AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/ALU) - 28 COMPRESSE; AUTOLOGOUS T-LYMPHOCYTES; AV605; AVONEX; AVONEX 30 microgramos/0,5 ml (Interferón Beta - 1a) Solución inyectable; AVONEX 30 µg/0,5 ml solution for injection; AVONEX IM 4SIR 30MCG/0,5ML 4AG; AVONEX*IM 4SIR 30MCG/0,5ML+4AG; AVONEX®; AVP-923; AZATIOPRINA HEX. 50CPR 50MG BL; Abatacept; Abobotulinumtoxin A; Acetaminophen; Acetaminophen Tab 650mg; Acetate; Acetazolamide; Acetylcysteine; Acetylsalicylic acid; Acetylsalicylic acid at 1st visit,; Aciclovir; Aclasta; Aclasta 5 mg Infusionslösung; Aclasta 5mg solution for infusion; Acthar; Acthar Gel; Active Comparator receiving Extavia®; Active Control; Acyclovir; Adderall XR; Adderall XR 10 mg; Adderall XR 5mg; Adenosine; Adrenocorticotropic Hormone; Adrenocorticotropic hormone; Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®); Alanine; Albumin (Human) 25%, United States Pharmacopeia (USP); Albuterol; Alcohol; Alemtuzumab; Alemtuzumab (GZ402673); Alemtuzumab 12 mg; Alemtuzumab 24 mg; Alemtuzumab GZ402673; Alemtuzumab Injection; Alemtuzumab Injection [Lemtrada]; Alemtuzumab immunotherapy; Alfuzosin; Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells; Allogeneic fecal microbiota; Alpha Lipoic Acid; Alpha lipoic acid; Alpha-lipoic acid; Alpha1-antitrypsin; Amantadine; American Ginseng; American ginseng extract HT-1001; Amiloride; Amiloride Hydrochloride; Amilostad; Amilostad HCT; Amilostad HCT tablets; Ampyra; Amyvid; Amyvid radiopharmaceutical; Anakinra; AndroGel 1 % Topical Gel; Androgel 10 grams of gel containing 100 mg of testosterone; Andrographolides; Anesthetic Topical Adhesive Synera; Anti LP40 antibody, subclass IgG4 LA294; Anti-CD25 Humanized Monoclonal Antibody; Anti-CD52 monoclonal antibody; Anti-IL-12; Anti-Thymocyte Globulin; Anti-thymocyte globulin; Anticholinergic medication; Anticuerpo monoclonal anti-LINGO-1 humano; Antihistamine; Antimycotic; Antithymocyte; Antithymocyte immunoglobulin; Antithymocyte immunoglobulin (rabbit); Anxiety/depression and work and activities; Apitox - pure honeybee toxin; Arbaclofen; Arbaclofen ER Tablets; Arbaclofen Extended Release Tablets; Arbaclofen Placarbil; Arbaclofen placarbil; Arbaclofen placarbil 15 mg BID; Arbaclofen placarbil 30 mg BID; Arbaclofen placarbil 45 mg BID; Aricept 10 mg; Aricept 10 mg filmdragerade tabletter; Aricept 5 mg; Aricept 5 mg filmdragerade tabletter; Arm 1 - GEH120714 (18F) Injection; Armodafinil; Arzerra; Arzerra®; Aspirin; Aspirin 650mg Oral Capsule; Atacicept; Atacicept 150 mg; Atacicept 25 mg; Atacicept 75 mg; Atomoxetine; Atorvastatin; Aubagio; Aubagio®; Autologous Bone Marrow-Derived Mononuclear Stem Cells; Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope; Autologous Hematopoietic Stem Cell; Autologous Mesenchymal Cell Product; Autologous Mesenchymal Stem Cells; Autologous Stem Cells; Autologous VitD3 tolerogenic monocyte-derived dendritic cells loaded with a pool of myelin peptides (tolDC-VitD3); Autologous adipose derived mesenchymal cells; Autologous adult mesenchymal stem cells from bone marrow expanded and cryopreserved; Autologous hematopoietic stem cells; Autologous mesenchymal stem cell transplantation; Autologous mesenchymal stem cells; Avonex; Avonex (Interferon beta 1a); Avonex (interferon beta-1a), Biogen Idec Ltd; Avonex 30 microgram/0.5 ml Solution for Injection; Avonex 30 microgramos/0.5 ml Solución para inyección; Avonex and Topamax; Avonex/Betaseron/Copaxone/Rebif; Avonex/Zocor; Avonex®; Avonex® monotherapy (6.0 MIU administered i.m. each week); Azathioprine; Azathioprine (AZA); Azatioprina; Azithromycin; BACLOFEN; BAF312; BAF312 0,25 mg tablet; BAF312 1 mg tablet; BAF312 4 mg tablet; BAF312 hemifumarate; BAF312A; BAT4406F; BAY 79-4998; BAY86-5046; BAY86-5046_Interferon-beta-1b; BBR 2778; BCD-033 (interferon beta 1a); BCD-054 180 mcg; BCD-054 240 mcg; BCD-063; BCD-132; BCD-132, 125 mg; BCD-132, 500 mg; BCG20-0134; BEAM Regimen; BETACAROTENE; BETAFERON; BETAFERON 250 mcg; BETAFERON 500 mcg; BETAFERON SC 15F 0,25MG 15SIR; BETAFERON*15CONFEZ 0,25MG/ML+; BETAFERON® (interferon beta-1b); BG-12 120; BG00002; BG00002 (natalizumab); BG00002-E (natalizumab high titer); BG00012; BG00012 (DMF); BG00012 (DMF) (Tecfidera®.); BG0002 (natalizumab); BG9418 (interferon beta 1-a); BG9418 (interferon beta-1a); BGC20-0134; BGG492; BHT-3009; BHT-3009 0.5 mg; BHT-3009 1.5 mg; BHT-3009-01; BIIB017; BIIB017 (Peginterferon beta-1a); BIIB017 (peginterferon beta-1a); BIIB019; BIIB019 (Daclizumab High Yield Process); BIIB019 (Daclizumab); BIIB033; BIIB033 (ANTI-LINGO); BIIB033 (ANTI-LINGO) - EV Substance Code SUB118957; BIIB033 (opicinumab); BIIB041; BIIB041 (Fampridine-SR); BIIB041 (PR Fampridine); BIIB041 (fampridine); BIIB061; BIIB133; BIOTIN; BIRT 2584 XX; BIRT 2584XX; BMMNC; BMS 188667 (Abatacept); BORAGE OIL; BORAGE OIL 20% GLA; BOSWELAN; BOTOX; BOTOX®; BOTULINUM TOXIN A - HAEMAGGLUTININ COMPLEX; BOTULINUM TOXIN TYPE A; BX-1; Bacille Calmette-Guerin vaccine; Bacille of Calmette-Guerin; Baclofen; Baclofen 20 mg; Baclofen ER Capsules (GRS) 10 mg; Baclofen ER Capsules (GRS) 20 mg; Baclofen ER Capsules (GRS) 30mg; Baclofen ER Capsules (GRS) 40mg; Baclofen ER Capsules (GRS) 50 mg; Baclofen IR; Baclofen Tablets USP; Baclofen Tablets USP 10 mg; Bafiertam; Balance; Baminercept; Baseline Treatment; Bazedoxifene; Bazedoxifene Acetate; Beetainterferoni -1a; Behavioral: 6 months weight resistance and balance program; Behavioral: Adherence counseling; Behavioral: Assessment of disability; Behavioral: Assessment of impact of MS on cognition; Behavioral: Balance Training; Behavioral: Collaborative Care (CC); Behavioral: Medical Marijuana; Behavioral: Motivational Interviewing; Behavioral: Physical Activity Together for PwMS and their CGs (PAT-MS); Behavioral: Step Tracking; Behavioral: Telephone-based Cognitive Behavioral Therapy; Behavioral: Water Tracking; Behavioral: learning; Behavioral: meditation; Behavioral: self massage; Best Available Therapy (BAT); Beta-1b interferoni; Beta-Alanine; Beta-Carotene; Beta-Interferon; Beta-alanine; Beta-alanine supplementation; Beta-carotene; Beta-interferon; Betacarotene; Betaferon; Betaferon 250 microgram/mL, powder and solvent for solution for injection.; Betaferon 250 microgram/ml; Betaferon 250 microgram/ml, powder and solvent for solution for injection; Betaferon 250 microgramos; Betaferon 250mcg; Betaferon 250µg; Betaferon 500 µg; Betaferon 500mcg; Betaferon 500µg; Betaferon, BAY 86-5046; Betaferon/Betaseron; Betaferon®; Betaseron; Betaseron (Interferon beta-1b, BAY86-5046); Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG; Bevacizumab; Bexarotene; Biotin; Biotina; Bisacodyl; Blood sample; Blood samples; Blood sampling; Bone marrow autologous mesenchymal stem cells transplantation; Borage oil; Bortezomib; Bosentan; Boswellia Serrata; Boswellia Serrata Extract; Boswellia serrata extract PS0201Bo capsules; Boswellic acids (BOSWELAN); Botox; Botulinum Toxin Type A; Botulinum Toxin Type A 200U; Botulinum Toxin Type A 300U; Botulinum toxin; Botulinum toxin A; Botulinum toxin type A; Botulinum toxin type A infiltrations; Brimonidine; Brimonidine tartrate; C1-esterase inhibitor (Cinryze); C105; CALCIO FOLINATO DC.IT; CANNABIDIOL; CBD; CC; CCI-779; CDP323; CELLCEPT; CETIRIZINE HYDROCHLORIDE; CGP 77116; CHOLECALCIFEROL; CHR-1103 / GBR500; CIANOCOBALAMINA FU DC.IT; CISAPRIDE; CITOCHINE ED IMMUNOMODULATORI; CLADRIBINA; CLADRIBINE; CLOSTRIDIUM BOTULINUM TOXIN TYPE A; CNM-Au8; CNTO 1275; CO; CO-14; COLECALCIFEROL; COLECALCIFEROL CONCENTRATE (OILY FORM); COP; COP-1; COP-1/Copolymer-1; COPAXONE; COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE 30 SIRINGHE; COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO; COPAXONE 20 mg/ml solución inyectable en jeringa precargada; COPAXONE*SC 28SIR 20MG/ML; CS-0777 tablets; CT103A cells; CYCLOPHOSPHAMIDE; CYCLOPHOSPHAMIDE MONOHYDRATE; Caffeine; Calcio; Calcium; Calcium and Vitamin D combination; Calcium carbonate; Calcium levofolinate; Cannabidiol; Cannabidiol / Dronabinol capsule 5 mg+2,5 mg; Cannabidiol Botanical Drug Substance (CBD BDS); Cannabidiol capsule 5 mg; Cannabis; Cannabis Based Medicine Extract (Sativex); Cannabis, Medical; Cannador; Caprylic Triglyceride; Caprylic triglyceride; Capsules with 160 mg Teavigo (at least 94% EGCG); Carbamazepine; Carbidopa; Carbonate; Carmustine; Carmustine, etoposide, cytarabine, and melphalan (BEAM); Carnitine; Carnosine; Carnosine, capsulle, 2 g/day, 8 weeks; Cellular therapy with EBV specific autologous CTL infusion; Ceralifimod; Ceralifmod; Cesamet™ (nabilone); Ceterizine; Cetirizina; Cetirizina Mylan Generics; Cetirizine; Charcoal; Chloride; Cholecalciferol; Cholecalciferol (Vitamin D3); Cholecalciferol, Vitamin D3; Cholestyramine; Cianocobalamina; Ciclofosfamide; Cinryze; Circadin; Circadin ( INN= Melatonin); Cisapride; Citalopram; Cladribina; Cladribina oral; Cladribine; Cladribine 3.5 mg/kg; Cladribine 5.25 mg/kg; Cladribine Oral Tablet; Cladribine Tablet; Cladribine Tablets; Cladribine tablets; Clemastine; Clemastine fumarate; Clostridium botulinum; Cnp-MS-0601; Coconut; Coconut oil; Coconut oil and epigallocatechin gallate; Coenzyme Q; Colecalciferol; Combination Product: ofatumumab with AI; Combination Product: ofatumumab with PRF; Copaxone; Copaxone 20 mg; Copaxone 20 mg/ml; Copaxone 20 mg/ml Solution for Injection, pre-filled syringe; Copaxone 20 mg/ml solución para inyección en jeringa precargada; Copaxone 20 mg/ml, Solution for Injection, pre-filled syringes; Copaxone 20mg/ml Solution for Injection, pre-filled syringe; Copaxone 40 mg/ml; Copaxone 40 mg/ml solution for injection, pre-filled syringe; Copaxone subcutaneous injection syringe; Copaxone-Teva; Copaxone®; Copolymer 1; Copolymer-1; Corticosteroid; Corticosteroids & tanCART19/20; Corticotropin; Cranberry; Creatine; Curcumin; Cyclophosfamide; Cyclophosphamide; Cyclophosphamide (drug); Cyclophosphamide and ATG; Cyclophosphamide and fludarabine; Cyclophosphamide monohydrate; Cyclophosphamide/Glatiramer acetate; Cymbalta; Cysteine; Cytarabine; Cytolytic CD4+ T cells; Cápsulas de Laquinimod 0.6 mg; Células madre mesenquimales; D Mannose; D-BIOTIN; D-BIOTINA; D-Biotin; D-aspartate; DAC; DAC HYP; DAC-HYP; DACLIZUMAB; DACLIZUMAB HYP; DAPIROLIZUMAB PEGOL; DC-TAB; DELTA-9-TETRAHYDROCANNABINOL; DEMESTRIL SEPTEM; DEXTROMETHORPHAN HYDROBROMIDE; DEXTROMETORFANO HIDROBROMURO; DEXTROMETORFANO HiDROBROMURO; DIBASE; DIMETHYL FUMARATE; DMT; DMT continuation; DPA; DPA-714 PET/MRI; DRONABINOL; DULOXETINE; DYDROGESTERONE; DYSPORT*SC IM 2FL 500U; DYSPORT®; Daclizumab; Daclizumab (Anti-CD25 Humanized Monoclonal Antibody); Daclizumab HYP; Daclizumab HYP (DAC HYP; Daclizumab HYP (DAC HYP); Daclizumab High Yield Process; Daclizumab wih Greek suffix; Daclizumab with Greek suufix; Dalfampridine; Dalfampridine ER; Dalfampridine-ER 10mg; Dalfampridine-ER 5mg; Dantrolene; Dapirolizumab Pegol; Dapirolizumab pegol; Darifenacin; Darifenacin (BAY79-4998); Dekristol; Dekristol 20000 IE; Dekristol® 400-Tabletten; Dekristol®-Tablette 1 (400 IE); Delta-9-tetrahydrocannabinol; Device: 2 mA Transcranial Direct Current Stimulation; Device: 4 mA Transcranial Direct Current Stimulation; Device: Avonex prefilled syringe via manual IM injection; Device: BETACONNECT; Device: BETACONNECT auto-injector.; Device: BETACONNECT device; Device: BIIB017 (peginterferon beta-1a) Autoinjector; Device: BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS); Device: Balance platform therapy; Device: Betaconnect Autoinjector; Device: Betaconnect auto-injector; Device: CIC using LoFric Primo; Device: Capacity of muscular oxygen extraction; Device: Dynamic Vessel Analyzer (DVA); Device: Extracorporeal Photopheresis; Device: Four-point cane (FPC); Device: Fourier Domain Doppler Optical Coherence Tomography (FDOCT); Device: Lokomat training; Device: Magnetic Resonance Imaging; Device: Medication Event Monitoring System (MEMS); Device: Metabolic fatigue; Device: NIRS after bosentan administration; Device: NIRS baseline; Device: Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV; Device: Nintendo Wii Fit Balance Board; Device: Optical coherence tomography (OCT); Device: Optical coherence tomography angiography (OCTA); Device: Paired associative stimulation (PAS); Device: Repetitive transcranial magnetic stimulation (rTMS); Device: Sham Transcranial Direct Current Stimulation (tDCS); Device: Single-point cane (SPC); Device: Single-pulse transcranial magnetic stimulation (spTMS); Device: Single-use autoinjector; Device: Sleep assessment; Device: TCD after bosentan administration; Device: TCD baseline; Device: Transcranial Magnetic Stimulation (TMS); Device: Trekking pole (TP).; Device: Video game therapy; Device: Wristband physical activity monitor; Device: interferon beta-1a; Device: myBETAapp; Device: single-use autoinjector with a prefilled liquid Avonex syringe; Dexamethason; Dexamethasone; Dexamethasone soduim phosphate; Dexchlorpheniramine; Dexrazoxane; Dexrazoxane (DRZ) plus Mitoxantrone (MX); Dextromethorphan; Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg; Dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg; Dextromethorphan/Quinidine; Dextrometorfano; Dextrometorfano/Quinidina; Diagnostic Test: Entire-body PET-CT scans; Diagnostic Test: Oral glucose tolerance test; Diagnostic Test: PET with [11C]Flumazenil; Diagnostic Test: Stroop test; Diagnostic Test: Testing of autonomous nervous system function; Diazoxide; Diclofenac; Diclofenac sodium topical gel; Dietary Supplement: vitamin A; Dimethyl Fumarate; Dimethyl Fumarate (DMF); Dimethyl fumarate; Dimethyl fumarate 240 mg; Dimethyl fumarate [DMF]; Dimetilfumarato; Diphenydramine; Diphtheria toxoid; Diroximel Fumarate (DRF); Diroximel fumarate; Dirucotide; Dirucotide acetate; Discontinuation of disease modifying therapy; Disease Modifying therapy; Domperidone; Donepezil; Donepezil HCI (drug); Dosing Interruption of Natalizumab; Dotarem; Dotarem 0,5mmol/ml,; Doxycycline; Dronabinol; Dronabinol 25 mg/ml, oral drops; Dronabinol capsule 2,5 mg; Duloxetine; Duloxetine Hydrochloride (HCI); Dydrogesterone; Dysport; Dysport®; EBIXA; ECP002A; ECULIZUMAB; EFALIZUMAB; EGCG; EGb 761® (Tanakan®); EK-12; ELND002; EMD 28162; EMSELEX 15 mg Retardtabletten; EMSELEX 7,5 mg Retardtabletten; ENA713; ENDOXAN; ENDOXAN BAXTER; EPARMEFOLIN 30 CPR 0,1/0,5MG; EPO; ESTRADIOL HEMIHYDRATE; ETHINYLESTRADIOL; ETIMS; ETIMS (EDC-fixed autologous PBMCs coupled with 7 immunodominant myelin peptides in MS patients); EU/1/08/454/001-002, EU/1/08/454/005-007; EU/1/95/003/005-010; EU/1/97/033/002; EU/1/98/063/001-003; EU/1/98/063/004-006; EVOBRUTINIB; EXTAVIA; EXTAVIA*SC 15FL 250MCG/ML+15SI; Early Highly Effective Therapies Group; Eculizumab; Efalizumab; Elezanumab; Emselex; Encapsulated Baclofen 20 mg; Encapsulated Simvastatin tablets; Endoxan; Endoxan - ciclofosfamide; Enriched Hematopoetic Stem Cell Infusion; Enspryng; Epigallocatechin; Epigallocatechin gallate; Epigallocatechin-gallate (Sunphenon); Epo; Epoetin alfa; Epoetin beta; Equal; Erypo/Erypo FS; Erythropoietin; Escalation Therapies Group; Escitalopram; Escitalopram oxalate antidepressant; Esomeprazole; Essential - hydroxytyrosol; Essential fatty acids; Estradiol; Estriol; Estroprogestins; Eszopiclone; Ethinylestradiol; Etifoxine; Etoposide; Evobrutinib; Evobrutinib 10mg; Evobrutinib 25mg; Exelon; Exelon transdermales Pflaster; Experimental Glatiramer Acetate; Exposure to one or more disease-modifying drug(s)(DMDs) used to treat MS; Extavia; Extavia (interferon beta-1b), Novartis Pharma AG; Extavia 250 microgram/ml; Extavia 250 micrograms/ml; Extavia®; Extended release fampridine; Extended-release oxycodone; Extended-release quetiapine fumarate; F-18 FEDAA1106 (BAY85-8101); FAMPRIDINA; FAMPRIDINE; FAMPYRA; FAMPYRA - 10 MG - COMPRESSA A RILASCIO PROLUNGATO - USO ORALE - FLACONE (HDPE) 56 COMPRESSE (4 FLACONI DA 14); FENEBRUTINIB; FINGOLIMOD; FINGOLIMOD HYDROCHLORIDE; FISH OIL, RICH IN OMEGA-3-ACIDS; FISH OIL,RICH IN OMEGA 3 ACIDS; FLUDARA; FLUOXETINE; FLUOXETINE HYDROCHLORIDE; FLURBIPROFEN; FMP30 Donor Stool; FORMISTIN - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE; FPC; FTY720; FTY720D; Famciclovir; Fampridina; Fampridine; Fampridine SR; Fampridine-SR; Fampridine-SR b.i.d. (Twice Daily); Fampyra; Fampyra 10 mg prolonged-release tablets; Fampyra 10mg prolonged release tablets; Fatigue; Febuxostat; Fecal Microbial Transplants; Fecal microbial transplant (FMT); Fecal microbiota; Femoston 1/10; Femoston 2/10; Fenebrutinib; Feraheme; Ferumoxytol; Filgrastim; Fingolimob (FTY); Fingolimod; Fingolimod (FTY720); Fingolimod 0.5 mg; Fingolimod 1.25 mg; Fingolimod Hydrochloride; Fingolimod hydrochloride; Fingolimodi; Fingolmod; Firategrast; Firategrast (USAN approved name); Firategrast 150 mg; Firategrast 300 mg; Firategrast gastro-retentive solution; Firategrast immediate release tablet; Firategrast modified release tablet; Fish Oil; Fish oil; Fish oil concentrate; Fludara; Fludarabine; Flumazenil; Fluoxetin; Fluoxetin Hexal; Fluoxetine; Fluoxetine hydrochloride; Flupirtin; Flupirtine; Flupirtinmaleat; Flurbiprofen; Folate; FolateScan (Technetium Tc 99mEC20); Formistin; Formistin 10 mg; Formulation A; Formulation B; Formulation C; Formulation D; Freshly-Pressed Extra Virgin Olive Oil; Full Spectrum vitamin; Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody; Fumaric Acid; G-CSF; G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process); GA; GA 20 mg/mL; GA 40 mg/mL; GA Depot; GA Depot 40 mg; GA Depot 40mg once monthly; GA Depot 80 mg; GABAPENTIN; GADOBUTROL; GADOVIST 1 mmol/ml solución inyectable en jeringa precargada/ cartucho precargado; GBP; GDC-0853 RO7010939; GILENYA; GLA; GLATIRAMER ACETATE; GLATIRAMER ACETATO; GLATIRAMERO ACETATO; GNbAC1; GNbAC1 Monoclonal Antibody; GSK1223249; GSK1841157; GSK2018682; GSK2018682 CD2 Capsule; GSK2018682 CD3 micronised Tablet; GSK2018682 CD3 non-micronised Tablet; GSK2018682 CD3 non-micronised Tablet in fed state; GSK239512; GSK2395612; GTR; GTR.ace; GW-1000-02; GYLENIA; GYLENIA 0,5 mg; GZ402668; GZ402673; Gabapentin; Gabapentine; Gabapentine 300mg; Gadobenate; Gadobenate Dimeglumine; Gadobutrol; Gadolinium; Gadolinium-based contrast; Gadopentetate; Gadoteric acid; Gadoteridol; Gadovist; Gadovist 1.0 mmol/ml Injektionslösung; Gamma-Tocopherol; Gamma-tocopherol; Genotropin; Gilenya; Gilenya / Imusera; Gilenya 0,5 mg Hartkapseln; Gilenya®; Gileyna; Ginkgo; Ginkgo biloba; Ginseng; Glatiramer; Glatiramer Acetate; Glatiramer Acetate (Copaxone®); Glatiramer Acetate (DB); Glatiramer Acetate (GA); Glatiramer Acetate (GA) 40 mg; Glatiramer Acetate (GTR); Glatiramer Acetate (OL); Glatiramer Acetate 20 mg/0.5 mL; Glatiramer Acetate [GA]; Glatiramer Acetate, IFN-beta 1a (IM), IFN-beta 1a (Subcutaneous), and IFN-beta 1b; Glatiramer Acetate, N-Acetylcysteine; Glatiramer acetate; Glatiramer acetate (GA); Glatiramer acetate 150mg enteric coated tablets; Glatiramer acetate 150mg enteric-coated (gastro-resistant) tablets; Glatiramer acetate 20 mg; Glatiramer acetate 20 mg, with mitoxantrone; Glatiramer acetate 20 mg/0.5 mL; Glatiramer acetate 40 mg; Glatiramer acetate injection with oral cetirizine hydrochloride; Glatiramer acetate with minocycline; Glatiramer acetate, (Copaxone®); Glatiramer acetato; Glicerol-1,3-didecanoato-2-octadeca-(6Z,9Z,12Z)-trienoato; Glucose; Glutamate and aspartate; Glycerol; Glycerol-1,3-didecanoate-2-octadeca-(6Z,9Z,12Z)-trienoate; Gold; Gold nanocrystals; Granulocyte-colony stimulating factor (G-CSF) and prednisone; Growth hormone; Guanabenz; H.P. Acthar Gel (repository corticotropin injection); H5G1.1-mAb; HBM9161 Injection; HMR 1726D; HMR1726; HMR1726D; HP184; HUMAN LEUCOCYTE INTERFERON-ALPHA; HYDROCHLOROTHIAZIDE; Helminth ova; Hematopoetic stem cell infusion; Hematopoietic stem cell transplantation; Hidrocloruro de fingolimod; High Dose Aspirin (1300 mg/day); High/Low Sodium Diet; Histamine; Histidine; Hookworm larvae; HuL001; HuMax-CD20; Human Neural Stem Cells; Human Umbilical Cord Mesenchymal Stem Cells; Human anti-IL-12 IgG1 Mab; Human anti-IL-12 Mab; Human anti-LINGO-1 monoclonal antibody; Human autologous mesenchymal stem cells; Human fetal-derived Neural Stem Cells (hNSCs); Human interferon beta; Human interferon beta 1a (Rebif); Human interferon beta-1a and glatiramer acetate; Human monoclonal antibody (CNTO 1275) to interleukin-12p40; Human normal immunoglobulin; Human recombinant growth hormone; Human umbilical cord mesenchymal stem cells; Hydrochlorothiazide; Hydrogen; Hydrogen peroxide; Hydroxychloroquine; Hydroxytyrosol; Hydroxyurea; Hyperimmune caprine serum against HIV lysate; IFA Incomplete Freund's Adjuvant; IFN beta 1a 44 mcg TIW; IFN beta-1a; IFN ß-1a; IFN-beta-1a (Rebif®); IFN-beta-1a, (Avonex®); IFN-ß-1a (Rebif®); IFN-ß-1a, (Avonex®); IL2; IMATINIB MESILATE; IMMUNOGLOBULIN G; IMMUNOSUPPRESSIVE AGENTS; IMU-838; IMU-838 (30 mg/day); IMU-838 (45 mg/day); IMUREL; INF beta-1a; INN COLECALCIFEROL; INT131; INTERFERON BETA-1A; INTERFERON BETA-1A (Avonex®); INTERFERON BETA-1B; INTERFERON BETA-1a; INTERFERON BETA-1b; INTERFERON BETA1A; IPX056; IPX056 10 mg; IPX056 20 mg; IPX056 30 mg; IPX056 35 mg; IPX056 40 mg; IPX056-10 mg; IPX056-20 mg; IPX056-25 mg; IPX056-30 mg; IPX056-35 mg; IPX056-40 mg; IR902; ISENTRESS; IV methylprednisolone; IV methylprednisolone (steroids); IVIg; Ibudilast; Ibuprofen; Ibuprofen Sandoz 400 mg Filmtabletten; Idebenone; Imatinib; Imatinib Mesylate; Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified; Immune globulin; Immunoglobulin; Impact; Imurel; IncabotulinumtoxinA; Incobotulinum toxin A; Inebilizumab; Influenza Vaccine; Influenza vaccine; Inhaled Cannabis; Injectable MS DMT; Injection of autologous stem cells; Injection of cell free media; Inosine; Insulin; Interferon Beta; Interferon Beta 1; Interferon Beta 1a; Interferon Beta 1a pegilado; Interferon Beta Therapy; Interferon Beta-1a; Interferon beta; Interferon beta - 1a (IFN); Interferon beta -1b; Interferon beta 1-A; Interferon beta 1-a; Interferon beta 1-b (Betaferon/Betaseron, BAY86-5046); Interferon beta 1B; Interferon beta 1a; Interferon beta 1a 30 ug IM once weekly; Interferon beta 1a, oral doxycycline; Interferon beta 1b; Interferon beta 1b (Betaseron, BAY86-5046); Interferon beta treatment to add-on atorvastatin treatment; Interferon beta type 1a; Interferon beta-1 a; Interferon beta-1a; Interferon beta-1a (Avonex); Interferon beta-1a (Avonex®); Interferon beta-1a (Rebif); Interferon beta-1a (Rebif®) alone; Interferon beta-1a (current approved manufacturing process invloving FBS); Interferon beta-1a (new process, manufactured without FBS); Interferon beta-1a 30 µg; Interferon beta-1a FBS-free/HSA free, RNF; Interferon beta-1a FBS-free/HSA-free; Interferon beta-1a FBS-free/HSA-free, RNF; Interferon beta-1a HSA+ biosimilar; Interferon beta-1a HSA-free biosimilar; Interferon beta-1a original; Interferon beta-1a, 30 µg/0.5 ml; Interferon beta-1b; Interferon beta-1b (Betaferon, BAY 86-5046); Interferon beta-1b (Betaferon, BAY86-5046); Interferon beta-1b (Betaferon/Betaseron, BAY86-5046); Interferon beta-1b (Betaferon®, BAY 86-5046); Interferon beta-1b (Betaseron, BAY86-5046); Interferon beta-1b (Betaseron, Betaferon, BAY86-5046); Interferon beta-1b (PF530, Betaferon); Interferon beta-1b and Tacrolimus; Interferon beta-1b group; Interferon beta-1b, (Betaseron BAY86-5046); Interferon beta-1b, FRP about 6 weeks after randomization; Interferon beta-1b, FRP within 15 days after randomization; Interferon beta-1b/Atorvastatin group; Interferon ß-1a; Interferon ß-1a (Avonex®); Interferon ß-1a 30 µg; Interferon ß-1b; Interferon-1beta (Betaseron, BAY86-5046); Interferon-Beta; Interferon-beta; Interferon-beta (IFN-beta); Interferon-beta 1a; Interferon-beta 1a FBS-free/HSA free, RNF; Interferon-beta 1a FBS-free/HSA-free, RNF; Interferon-beta 1b; Interferon-beta 1b (Betaseron); Interferon-beta [IFN-beta]; Interferon-beta and human leukocyte Interferon-a; Interferon-beta-1; Interferon-beta-1a; Interferon-beta-1a (Avonex) plus methylprednisolone; Interferon-beta-1a FBS-free/HSA free, RNF; Interferon-beta-1a FBS-free/HSA-free; Interferon-beta-1b; Interferon-beta-1b (BETASERON, BAY 86-5046); Interferon-beta1; Interferon-ß; Interferon-ß [IFN-ß]; Interferon-ß-1; Interferon-ß-1a; Interferon-ß-1b; Interferone; Interferón Beta-1a pegilado; Interferón beta 1a; Interferón beta 1a pegilado; Intradetrusor injection of Botulinum Toxin-A; Intratect; Intrathecal MSC-NP injection; Intrathecal administration of autologous MSC-NP; Intrathecal methotrexate; Intravenous (IV) infusions; Intravenous Immunoglobulin; Intravenous Methylprednisolone; Intravenous injection of mesenchymal stem cells; Intravenous steroid; Iron oxide; Isentress; Isoxsuprine; Isoxsuprine Hydrochloride; Ixazomib; Ixazomib (NINLARO®) capsules; JM; JM-4; KEPPRA; KLH; Kemstro; Kepivance; Keppra; Keppra 250mg; Keppra 500mg; Keppra ®; Ketamine; Ketoconazole; Keyhole limpet hemocyanin; Keyhole limpet hemocyanin (KLH); Keyhole limpet hemocyanin (KLH) neo-antigen; L acetyl carnitine; L-000124467; L-Carnitine; L-Histidine; L-carnitine; L01BB04; L03 AB; L03 AB 08; L03 AB07; L03AB13; L04AA04; L04AA04 - IMMUNOGLOBULINA ANTITIMOCITARIA (DI CONIGLIO) IMMUNOGLOBULINA DI CONIGLIO ANTITIMOCITI UMANI THYMOGLOBULINE; L04AA31; LA; LAQUINIMOD; LEMTRADA 12 mg Konzentrat zur Herstellung einer Infusionslösung; LEVOFOLENE 4 MG 30 CPR; LEVONORGESTREL; LFB-R603; LFB-R603, TGTX1101; LUTENYL; LY2127399; LY248686; Lactose; Lactose monohydrate; Lamotrigine; Lamotrigine extended release tablets; Laquinimod; Laquinimod 0.3; Laquinimod 0.6; Laquinimod 1.2; Laquinimod Capsulas 0.6 mg; Laquinimod Capsules 0.3 mg; Laquinimod Capsules 0.6 mg; Laquinimod Sodium (USAN); Laquinimod Tablets 0.3 mg; Laquinimod capsules 0.6 mg; Lemtrada; Lenograstim; Levetiracetam; Levitra; Levocarnil; Levofolene; Levonorgestrel; Lidocaine; Lidocaine patch 5%; Linoleic Acid/Oleic Acid; Linoleic acid; Liofen XL; Liothyronine; Liothyronine sodium; Lipoic Acid; Lipoic acid; Lipoic acid (LA) with fish oil and LA without fish oil; Lipoic acid and omega-3 fatty acids; Lisdexamfetamine; Lisdexamfetamine sulfate; Listed for each disorder below, up to three drugs per disorder (too many characters to list in this field; Lithium Carbonate; Lithium carbonate; Live Hookworm Larvae; Live Necator americanus larvae; Locally approved intravenous contrast medium for contrast enhanced MRI; Loperamide; Loratadine; Low Dose Aspirin (162 mg/day); Low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day; Low dose cannabis; Low immunogenic interferon-beta-1a; Lubiprostone; Lumbar puncture; Lysine; M2951; MABCAMPATH; MABCAMPATH 10 mg/ml concentrado para solución para perfusión; MABTHERA; MANTADAN*20CPR 100MG; MAVENCLAD; MAVENCLAD 10 mg tablets; MBP peptide; MBP8298; MBP8298 Synthetic Peptide; MD1003; MD1003 100mg capsule; MEDI-551; MEDI-551 100 MG-IV; MEDI-551 30 MG-IV; MEDI-551 300 MG-SC; MEDI-551 60 MG-SC; MEDI-551 600 MG-IV; MEMANTINE; MESNA; METHYLPHENIDATE HYDROCHLORIDE; METHYLPREDNISOLONE; METHYLPREDNISOLONE SODIUM HEMISUCCINATE; METHYLPREDNISOLONE SODIUM SUCCINATE; MIS416; MK0812; MLN1202; MMF; MOG peptide; MONITOR; MOR103; MSC2015; MSC2304479A; MSC2304480A; MSC2304481A; MSC2304482A; MSC2358825A; MSC2364447C; MSC2430913A or ONO-4641 (to be used as synonyms); MSC2491529A; MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046); MSTC-001 (MS-STAT); MT-1303; MT-1303 [0.1]; MT-1303 [0.2]; MT-1303 [0.4]; MT-1303-FormA; MT-1303-FormB; MT-1303-High; MT-1303-Low; MT-1303-Middle; MabCampath; MabCampath ®; MabCampath-1h; MabCampath®; MabThera; MabThera (Rituximab); Mabcampath; Mabthera; Mabthera or biosimilar rituximab product; Mabthera®; Magnesium; Maltodextrin; Maltodextrin fiber supplement; Mangafodipir; Mangafodipir (Teslascan); Mannose; Marijuana; Masitinb mesylate; Masitinib; Masitinib mesylate; Mastinib; Mavenclad; Mavenclad tabletter 10 mg; Mavenclad®; Mayzent; Medical Marijuana; Medrol; Megadose oral methylprednisolone; Melatonin; Melphalan; Memantine; Meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent); Menitorix; Mesenchymal Stem Cells; Mesenchymal stem cells; Mesenchymal stem cells (MSCs); Mesenchymal stem/stromal cells; Mesna; Metex; Metformin; Methelphenidate; Methotrexat; Methotrexate; Methyl B12; Methyl Prednisolonate; Methyl folate; Methyloprednisolone; Methylphenidate; Methylphenidate modified release; Methylphenidate modified release 20 mg; Methylphenidate modified release 30 mg; Methylphenidate modified release 40 mg; Methylprednisolon; Methylprednisolon-21-hydrogensuccinat, Natriumsalz; Methylprednisolone; Methylprednisolone (drug); Methylprednisolone 1250 mg/24h x3 days; Methylprednisolone IV; Methylprednisolone PO; Methylprednisolone hemisuccinate; Metilprednisolone sodio succinato; Mg; Microgynon; Microgynon®; Micropirin; Midazolam; Mild dose cannabis; Mineral boost (magnesium); Minocycline; Minocycline 100 mg Film-coated Tablets; Minocycline 100mg; Minocycline Hydrochloride; Mirabegron; MitoQ; Mitoquinone; Mitoxantrone; Modafinil; Monoclonal antibody M-T412; Monomethyl fumarate; Monomethyl fumarate 190 mg; Montelukast; Multiferon; Multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides); Mutagrip; Mycophenolate; Mycophenolate Mofetil (CellCept); Mycophenolate Mofetil (cellcept); Mycophenolate mofetil; Mycophenolate mofetil (Cellcept); Mycophenolate mofetil (MMF); Méthylprednisolone; Méthylprednisolone Mylan; N acetylcysteine; N-acetyl Cysteine; N-acetyl cysteine; N-acetylcysteine; N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine; N.A.; N.a.; N02BG10; N03AX12; N06DX01; NATALIZUMAB; NBI-5788; NBT-NM108 (60 g/day); ND; NEUPOGEN; NEUROASPIS PLP10®; NEURONTIN; NOVANTRONE*INF 2MG/ML 5ML; NOVATREX; NPB-01; NT-KO-003; NU100; NVF233; Nabilone; Nabiximols; Nabiximols - Sativex; Naltrexone; Namisol; Nanocort; Nanocurcumin; Naproxen; Natalizumab; Natalizumab (BG00002); Natalizumab (NTZ); Natalizumab (Tysabri); Natalizumab IV; Natalizumab Injection [Tysabri]; Natalizumab SC; Natalizumab for IV Infusion; Natalizumab for Subcutaneous Injection; Natalizumab treatment; Nd; Nebido; Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection; Necator americanus; NeoRecormon; Neorecormon; Neramexane; Neramexane mesylate; Nerispirdine; Nerispirdine (HP184); Nerispirdine hydrochloride; Neupogen; NeuroVax; NeuroVax 300ug/mL Dose for IM Injection; Neurontin 300 mg hard capsule; New Formulation of rebif - human interferon beta-1a; Niacinamide; Ninlaro; Nitrofurantoin; Nivolumab; Nomegestrol; Nomegestrol acetate; Non-pegylated interferon; Norethindrone; Normal Saline for Injection; Novantrone; Novartis Pharmaceuticals Corporation; Null; NurOwn (MSC-NTF cells); OCH-NCNP1; OCR; OCRELIZUMAB; OCREVUS; OFATUMUMAB; OMB157; OMB157G; ONO-4641; ONO-4641/ MSC2430913A; ONO-4641/MSC2430913A; ORY2001; OS440; OVASTAT; Oclelizumab; Ocrelizumab; Ocrelizumab 300 mg; Ocrelizumab 300mg; Ocrelizumab 300mg /10ml; Ocrelizumab 300mg/10 ml; Ocrelizumab 300mg/10ml; Ocrelizumab 600 mg; Ocrelizumab Dose 1; Ocrelizumab Dose 2 and Dose 3; Ocrelizumab at home; Ocrevus; Ocrrelizumab 300 mg; Octagam; Octagam 5%; Octagam 50 mg/ml; Ofatumumab; Ofatumumab 100; Ofatumumab 300; Ofatumumab 30mg; Ofatumumab 3mg; Ofatumumab 60mg; Ofatumumab 700; Ofatumumab subcutaneous injection; Oleic Acid; Oleovit D3 14.400 IU/ml oral drops, solution; Olesoxime (TRO19622); Olive; Olive oil; Omega 3; Omega 3 fatty acids; Omega-3; Omega-3 fatty acids; Omeprazole; OnabotulinumtoxinA; Opicinumab; Oral Methylprednisolone 625 mg/24h x3 days; Oral THC; Oral corticosteroids; Oral lipoic acid (LA); Other H1 antagonist; Other analgesics and antipyretics; Other disease-modifying therapy; Other nervous system drugs; Other: Balance; Other: Balance Trainer Balance Exercises; Other: Balance exercises; Other: Balance training; Other: Berg Balance Scale; Other: Caffeine; Other: Cardiopulmonary evaluation; Other: Cawthorne Cooksey exercises; Other: Classic, progressive endurance training; Other: CoDuSe balance training and step square exercises; Other: Core stability; Other: DMT withdrawal; Other: Determination of calcium intake by a dietician interview; Other: Dual Task Performance; Other: Dynamic Balance Training; Other: Evaluation of degree chronic fatigue.; Other: Exercise intervention; Other: Fear of falling; Other: Four Square Step Test; Other: Functional Reach Test; Other: Functional mobility; Other: Group balance training; Other: Histamine; Other: Hydrogen peroxide; Other: Imaging; Other: Incontinence Severity; Other: Intrathecal saline injection; Other: Laboratory Biomarker Analysis; Other: Liberation therapy; Other: Modified paleolithic diet; Other: NBT-NM108 (0 g/day); Other: Natalizumab; Other: Natalizumab discontinuation; Other: Neuromuscular evaluation; Other: Nintendo Wii Fit Balance exercises; Other: No MSDMDs therapy (control); Other: No Treatment Arm; Other: No device; Other: Non Impact Aerobics; Other: Observation of Ocrelizumab as Treatment in RRMS Patients; Other: Observational Control; Other: One-leg Stance Test; Other: Other: Disease modifying therapies (DMT); Other: PEAK; Other: PNF; Other: PSP; Other: Passive : lecture series; Other: Peanut Butter; Other: Periodized exercise training; Other: Position Sense; Other: Progressive exercise; Other: QALCIMUM questionnaire; Other: Questionnaires; Other: Rhythmic Auditory Stimulation (RAS); Other: Spinning grp; Other: Static Balance Test; Other: Strength training; Other: Supervised physical therapy; Other: Timed Up an Go Test; Other: Training groupe; Other: Trunk impairment; Other: Trunk position sense; Other: USPIO MRI - Gadolinium MRI; Other: Vestibular habituation exercises; Other: Vestibular rehabilitation: balance and eye movement exercises; Other: Virtual reality group; Other: Vitamin K; Other: Vitamin K Cream; Other: Withdrawal of dalfampridine-ER 10mg; Other: anxiety; Other: balance; Other: conventional balance training; Other: dual task performance; Other: fatigue; Other: fingolimod; Other: mitoxantrone - immunomodulator; Other: myBETAapp; Other: natalizumab; Other: normal saline; Other: pain; Other: plasticity-based computerized cognitive remediation program; Other: position sense; Other: propensity score; Other: specifically design 6 month resistance training program; Other: standard of care; Ovastat 1000; Ovastat 5000; Oxcarbazepine; Oxine; Oxybutynin; Oxybutynin Hydrochloride; Oxycodone; Oxygen; Ozanimod; Ozanimod 0.5 mg; Ozanimod 1 mg; Ozanimod HCI; Ozanimod HCl; Ozanimod hydrochloride; PAS; PAT; PB006; PCV; PEG; PEG-liposomal Prednisolone Sodium Phosphate; PEG-liposomal prednisolone sodium phosphate; PEGINTERFERON BETA-1A; PEGylated Intereron Beta-1a; PEGylated Interferon Beta-1a; PET with 11C-Flumazenil; PF-06342674 0.25 mg/kg; PF-06342674 1.5 mg/kg; PF-06342674 6.0 mg/kg; PHENYLCYCLOPROPYLAMINE DERIVATIVES AND DUAL LSD1/MAO-B (LYSINE-SPECIFIC DEMETHYLASE 1 AND MONOAMINE OXIDASE-B) INHIBITOR; PI-2301; PL 04515/0127; PL 12762/0049; PLEDIGRY; PLEGRIDY - 125 MCG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - PENNA PRERIEMPITA - 0,5 ML - 6 PENNE PRERIEMPITE; PLP; PLP peptide; PNU-215062 sodium salt; PO; PONESIMOD; PRD806998; PREDNISOLONE SODIUM PHOSPHATE; PRN2246; PRUCALOPRIDE; PTL201; PV; Palifermin; Pantoprazole; Paracetamol; Paracetamolo 500 mg; Paroxetine; Part A: 100 mg/mL GSK2618960; Part B: Dose of GSK2618960 decided from Part A; Part C: Dose of GSK2618960 decided from Part A and B; Peanut; Peginterferon Beta-1a; Peginterferon beta-1a; Pending; Personalized extended interval dosing of natalizumab; Phenytoin; Phosphate; Pioglitazone; Pixantrone; Placebo; Platelet transfusion; Platform; Plegridy; Plegridy (peginterferon beta-1a), Biogen Idec Ltd; Plegridy 125 micrograms; Plegridy 63 micrograms; Pleneva TM BGC20-0134; Plovamer acetate; Plovamer acetate 0.5 milligram (mg); Plovamer acetate 10 mg; Plovamer acetate 20 mg; Plovamer acetate 3 mg; Pneumovax II; Polyphenon E; Ponesimod; Ponesimod 10 mg; Ponesimod 20 mg; Ponesimod 40 mg; Pravastatin; Prebiotics (Prebiotin Prebiotic Fiber Stick Pac); Prednisolone; Prednisolone Sodium Phosphate; Prednisone; Pregabalin; Prepulsid; Probiotics (Visbiome®); Procedure: Alcohol Wipes vs. No Alcohol Wipes; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Autologous Stem Cell Transplantation; Procedure: Autologous bone marrow transplantation; Procedure: Autologous hematopoietic stem cell transplant; Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Procedure: Exergame; Procedure: Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool; Procedure: Hematopoietic Stem Cell Therapy; Procedure: Hematopoietic Stem Cell Transplantation; Procedure: Hematopoietic stem cell transplantation (HSCT); Procedure: Home based balance training; Procedure: Immunoadsorption; Procedure: Lumbar Puncture; Procedure: MRI; Procedure: Peripheral Blood Stem Cell Transplantation; Procedure: Plasma exchange; Procedure: Radiation therapy; Procedure: Syngeneic Bone Marrow Transplantation; Procedure: Warm compress prior to injection of glatiramer acetate; Procedure: irradiation; Procedure: peripheral blood stem cell transplantation; Prohance (Gadoteridol); Prolonged-release Fampridine; Prophylactic vaccine (tetanus, diphtheria, pertussis, poliomyelitis, influenza, hepatitis A, hepatitis B, tick-borne encephalitis, meningococcal, pneumococcal); Provigil; Provigil (modafinil); Prucalopride; Quadrivalent influenza vaccine; Quality of life; Quetiapine; Quinidina; Quinidina sulfato; Quinidine; Quinidine Sulfate; R lipoic acid; RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN; RAS; RATG; RAVULIZUMAB; RC18 160 mg; RC18 160mg; RC18 240mg; REBIF; REBIF 44 microgramos solución inyectable; REBIF 44 microgramos solución inyectable en jeringa precargada; REBIF SC 12SIR 12000000UI44MCG; REBIF SC 12SIR 6000000UI 22MCG; REBIF*SC 12SIR 12000000UI44MCG; REBIF*SC 12SIR 6000000UI 22MCG; RECOMBINANT INTERFERON BETA-1B; REVAXIS; RG2077 (CTLA4-IgG4m); RHB-104; RHIgM22; RHuPH20; RITUXIMAB; RNF; RNS60; RNS60 125 ml; RNS60 250 ml; RO0506997; RO4964913; RO4964913 F07; RO4964913/F03; RO4964913/F07; RO4964913/F07-01; RO4964913/F07-01 (commercial); RO4964913/F07-01 (development); RO5333787; RO7010939; RPC-1063; RPC1063; RTL1000 (recombinant T cell receptor ligand); Rabbit; Rabbit anti-human thymocyte immunoglobulin; Radiation: Gadopentetate Dimeglumine; Ralenova; Raltegravir; Ramatroban; Ranitidine; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; Ravulizumab; Rebif; Rebif (IFN beta-1a subcutaneous three times per week); Rebif (IFN ß-1a subcutaneous three times per week); Rebif (Interferon beta-1a); Rebif (interferon beta 1a); Rebif (interferon beta-1a), Merck Serono Europe Ltd; Rebif 22; Rebif 22 micrograms; Rebif 22 y 44 mcg; Rebif 22®; Rebif 44; Rebif 44 micrograms; Rebif 44 micrograms solution for injection; Rebif 44 micrograms solution for injection in pre-filled syringe; Rebif 44 µg; Rebif 44®; Rebif 8,8 µg, Rebif 22µg; Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack; Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack.; Rebif New Formulation + ibuprofen PRN; Rebif New Formulation + prophylactic Ibuprofen; Rebif New Formulation 44mcg multidose cartridge; Rebif New Formulation Non Titrated; Rebif New Formulation Titrated; Rebif®; Rebif® (clone 484-39); Rebif® New Formulation; Rebif® New Formulation (IFN-beta-1a, RNF); Rebif® New Formulation (RNF) using RebiSmartTM; Rebif® new formulation (RNF); Recombinant Human Erythropoietin; Recombinant Interferon Beta-1b; Recombinant human IFN beta; Recombinant human alpha B-crystallin; Recombinant human interferon beta; Recombinant humanized anti-alpha 4 integrin antibody; Recombinant interferon beta-1b; Repository Corticotropin Injection; Repository corticotropin injection; Revaxis; RhEPO; RhIFN beta-1b; RhIGF-1 (CEP-151); RhuMab 2H7; RhumAb to IL-17A igG1-k-class; RhumAb to Il-17A (IgG1-k-class); Riboflavin; Rifampin; Rilutek; Riluzole; Ritalin; Ritalin LA 20mg capsules; Ritalin LA 30mg capsules; Ritalin LA 40mg capsules; Rituximab; Rituximab IT; Rituximab IV; Rituximab Infusion; Rituximab konsentrat til infusjonsvaeske oppløsning 10 mg/ml; Rivastigmin; Rivastigmine; Rivastigmine transdermal patch; Ro 496-4913/F03; Ro 496-4913/F07; Rolipram; S-Warfarin; S-warfarin; SA237; SAR339658; SAR442168; SATIVEX; SB-683699; SB683699; SC Peginterferon beta-1a; SC interferon beta-1a; SC interferon beta-1b; SCLEROLYM; SCM; SCM-010; SECUKINUMAB; SH U 555 C; SIMVASTATIN; SMderpept; SOLIRIS; SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML; SOLU-MODERIN 1 g; SPARC0921; SR-fampridine; SUB0750MIG; SUB175614; SUB22282; Saline; Sativex; Sativex Oromucosal Spray; Sativex Oromucosal Spray (non-marketed); Sativex®; Satralizumab; Satralizumab (120 mg/PFS with NSD); Satralizumab (120 mg/vial); Satralizumab (120mg/vial); Satralizumab (RO5333787/Enspryng /SA237); Satralizumab (RO5333787/Enspryng/SA237); Satralizumab (RO5333787/SA237); Satralizumab (r-INN); Satrazlizumab (RO5333787/ Enspryng /SA237); Seasonal Quadrivalent influenza vaccine; Seasonal influenza vaccine; Second-generation fumaric acid; Secukinumab; See Intervention Description); Selenium; Sendoxan; Sendoxane; Serum Free Avonex; Serum containing Avonex; Silodyx; Simethicone; SimvaHEXAL® 40 mg Filmtabletten; Simvastatin; Simvastatin 40 mg film-coated tablets; Simvastatin Alternova; Simvastatin in relapsing remitting multiple sclerosis; Simvastatina; Simvastatina Sandoz 40 mg comprimidos recubiertos con película EFG; Simvastatine; Simvastatine Sandoz 40 mg filmomhulde tabletten; Simvastatine Sandoz 40mg deelbare filmomhulde tabletten; Sinvastatina Sandoz 40 mg comprimidos revestidos por película; Siponimod; Siponimod 0.25 mg tablet; Siponimod 0.5 mg tablet; Siponimod 1 mg tablet; Siponimod 2 mg tablet; Sirolimus; Sivatin; Sivatin 40 mg film-coated tablets; Sivelestat; Smoked Cannabis; Sodium Chloride solution; Sodium chlorid; Sodium chloride; Solifenacin; Solifenacin Succinate; Soliris; Solu-Medrol; Solu-medrol; SoluMedrol; Solumedrol IM 125mg/2ml; Somatorelin; Spiropent; Ss-interferon; Standard MS DMT; Standard MS DMTs; Standard gadolinium contrast; Standard interval dosing; Standard of Care; Standard treatment with a conventional drug; Standardized cannabis extract; Statin; Stem Cell Transplantation; Study Drug; Sublingual tizanidine 12 mg; Sulfate; Sunphenon; Sunphenon EGCG; Sunphenon EGCg; Sunphenon EGCg TM; Suspension media; Sustained-release oral dalfampridine; Suvorexant; T cell vaccination; T-Cell Vaccination; TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE; TACI-Fc5; TECFIDERA; TERIFLUNOMIDE; TERIFLUNOMIDE HMR1726; TETRAHYDROCANNABINOL Botanical Drug Substance (THC BDS); TG; TG-1101; THC; THIOPLEX; THYMOGLOBULINE; TMP001; TORVAST*10CPR 10MG; TREOSULFAN; TRO19622; TSO; TT Vaccine; TV-5010; TV-5600; TYSABRI; TYSABRI 300 mg concentrado para solución para perfusión; TYSABRI 300 mg concentrate for solution for infusion; TYSABRI 300 mg solution à diluer pour perfusion; TYSABRI and AVONEX; TYSABRI*IV 1FL 300MG 15ML; TYSABRI®; Tachipirina; Tacrolimus; Tanakan; Tarenflurbil; Targretin; Taurine; Tauroursodeoxycholic Acid; Tauroursodeoxycholic acid; Tcelna; Tecfidera; Tecfidera (BG00012); Tecfidera (BG12); Tecfidera®; Tecfidera® 120 mg; Tecfidera® 120mg magensaftresistente Hartkapseln; Tecfidera® 240 mg; Tecfidera® 240mg magensaftresistente Hartkapseln; Tecifdera (dimethyl fumarate); Temelimab; Temelimab 18 mg/kg; Temelimab 36 mg/kg; Temelimab 54 mg/kg; Temsirolimus; Temsirolimus Tablets; Teriflunomide; Teriflunomide (HMR1726); Teriflunomide 14 MG; Teriflunomide 14 MG Oral Tablet [Aubagio]; Teriflunomide HMR1726; Teriflunomide capsule; Testosterone; Testosterone undecanoate; Tetanus diphtheria toxoid vaccine (Td); Tetanus diphtheria toxoids vaccine; Tetanus toxoid; Tetanus toxoid (TT) containing vaccine (Td, Tdap); Tetanus toxoid vaccine; Tetracycline; Tetracycline - Statin - Antimycotic; Tetrahydrocannabinol; Tetrahydrocannabinol Botanical Drug Substance (THC BDS); Thiamine; Thioplex; Thiotepa; Thymoglobuline; Thymoglobuline®; Tissue Selective Estrogen Complex; Tizanidine; Tizanidine (sublingual or oral); Tizanidine hydrochloride capsule; Tocilizumab; Tocilizumab Injection; Tocopherol; Tolerogenic Dendritic cells loaded with myelin peptides; Tolerogenic dendritic cells (tolDC); Tolperisone; Tolperisone HC1; Tolperisone HCl; Tolpersan; Tolposan; Topical Preparation H arm; Torvast; Tovaxin; Tovaxin Autologous T Cell Vaccine; Tovaxin Autologous T cell vaccine; Tracleer; Trancopal; Trancopal Dolo; Treosulfan; Trichuris suis Ova; Trichuris suis eggs; Trichuris suis ova; Trichuris suis ova (eggs), embryonated, viable; Trileptal; Triomar™ (omega-3 fatty acids); Trivalent seasonal influenza vaccine; Trulicity; Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere; Trulicity 0,75 mg injekcný roztok naplnený v injekcnom pere.; Tylenol Pill; Tysabri; Tysabri ® (Natalizumab); Tysabri®; Tysabri® (natalizumab); UBLITUXIMAB; UK: Sativex Oromucosal Spray; UNDIFFERENTIATED AUTOLOGOUS MESENCHYMAL STEM CELLS; URBASON 40 mg comprimidos; URBASON FORTE; UVEDOSE 100 000 UI; UVEDOSE 100 000 UI, solution buvable en ampoule; Ublituximab; Ubltuximab; Ucb L059; Ultomiris; Ultra small particles of iron oxide (USPIO); Ultrasmall particles of iron oxide; Umbilical cord derived Mesenchymal Stem Cells; Umbilical cord mesenchymal stem cells; Untreated to atorvastatin treatment; Urbason; Urbason 40 mg; Urbason Forte; Urbason solubile forte 1000mg; Urbason® solubile forte 1000 mg; Urine samples; V08CA02; V08CA09; VARDENAFILO HIDROCLORURO; VAY736; VB13S1; VB5S2; VB6S5; VENLAFAXINE HYDROCHLORIDE; VIDOFLUDIMUS CALCIUM; VIGANTOL OIL; VITAMINA D3 KERN PHARMA SOLUCIÓN OLEOSA; VSN16R; VSN16R 100mg; VX15/2503; Vaginal estriol; Vardenafil; Vardenafil (hidrocloride); Vardenafilo; Vatelizumab; Vehicle Gel; Venlafaxin Hexal; Venlafaxine; Verum arm receiving Gilenya®; Verum arm receiving Vitamin D oil; Vessel; Vidofludimus; Vidofludimus calcium; VigantOL oil plus interferon beta-1a (Rebif); Vigantol; Vigantol Oel; Vigantol Oil; Vigantol® Oil; Vigantol® Öl 20.000 I.E./ml; Vitamin A; Vitamin D; Vitamin D3; Vitamin E; Vitamin E/Selenium; Vitamin K; WAY-130799; Warfarin; Water; XBD173; XCEL-MC-ALPHA; XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector; Xeomin; Xyosted; ZK 157046; ZOL446H; ZOLEDRONIC ACID MONOHYDRATE; Zenapax; Zinbryta; Zoledronic Acid; Zoledronic acid; [11C]flumazenil; [123I]CLINDE; [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration; [18F] PBR06; [18F]-FEPPA; [18F]DPA-714; [18F]Florbetapir and PET imaging; [C-11]Methylreboxetine; [C-11]PBR28; [C11]PK-1195 PET scan; [F-18]PBR06; [F-18]SDM-8; [Formistin 10 mg]; [MD1003]; [Metilprednisolone]; [OMB157]; [Tachipirina CPR 500mg]; [Zr-89]Oxine-labeled leukocytes PET/MR

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2019-001549-42-GB (EUCTR)	27/03/2020	03/02/2020	Stem cell transplantation versus disease modifying therapy (alemtuzumab or ocrelizumab) for patients with highly active relapsing remitting MS	A multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis. - StarMS	Highly active relapsing remitting multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Cyclophosphamide INN or Proposed INN: Cyclophosphamide monohydrate INN or Proposed INN: Cyclophosphamide monohydrate Product Name: Filgrastim INN or Proposed INN: Filgrastim Trade Name: Thymoglobuline Product Name: Thymoglobuline INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin Trade Name: Alemtuzumab Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Product Name: Lenograstim INN or Proposed INN: Lenograstim Trade Name: Ocrelizumab Product Name: Ocrelizumab	Sheffield Teaching Hospitals	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	198	Phase 3	United Kingdom
2	EUCTR2016-001166-29-DE (EUCTR)	18/03/2020	12/08/2019	A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST)	A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST) - COAST	relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Lemtrada Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: ALEMTUZUMAB Trade Name: Ocrevus Product Name: ocrelizumab INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB Product Name: autologous hematopoietic stem cells Product Code: aHSC	University Medical Centre Hamburg-Eppendorf	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 2	Germany
3	EUCTR2017-001362-25-NL (EUCTR)	30/09/2019	10/09/2019	Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis.	Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS	Relapsing remitting multiple sclerosis. MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Helse Bergen HF, Haukeland University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 3	Denmark;Netherlands
4	NCT03983252 (ClinicalTrials.gov)	July 2019	31/5/2019	Effect of Alemtuzumab on Microglial Activation Positron Emission Tomography (PET) in Multiple Sclerosis	Effect of Alemtuzumab on Microglial Activation Assessed Using Novel [F-18]-Based Positron Emission Tomography (PET) Ligand in Multiple Sclerosis	Multiple Sclerosis	Drug: [F-18]PBR06	Brigham and Women's Hospital	Genzyme, a Sanofi Company	Not yet recruiting	18 Years	60 Years	All	10	Phase 1;Phase 2	United States
5	EUCTR2017-001362-25-DK (EUCTR)	27/06/2018	21/03/2018	Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis.	Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS	Relapsing remitting multiple sclerosis. MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Helse Bergen HF, Haukeland University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 3	Denmark;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT03477500 (ClinicalTrials.gov)	March 21, 2018	13/2/2018	RCT Comparing Autologous Hematopoietic Stem Cell Transplantation Versus Alemtuzumab in MS	Randomized Autologous Hematopoietic Stem Cell Transplantation Versus Alemtuzumab for Patients With Relapsing Remitting Multiple Sclerosis	Multiple Sclerosis	Drug: Cyclophosphamide and ATG;Drug: Alemtuzumab	Haukeland University Hospital	NULL	Recruiting	18 Years	50 Years	All	100	Phase 3	Denmark;Netherlands;Norway;Sweden
7	NCT03135249 (ClinicalTrials.gov)	January 1, 2018	12/4/2017	Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis	Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis (SUPPRESS)	Multiple Sclerosis (MS)	Drug: Alemtuzumab	University of Texas Southwestern Medical Center	Genzyme, a Sanofi Company	Active, not recruiting	18 Years	60 Years	All	40	Phase 4	United States
8	EUCTR2016-003100-30-DE (EUCTR)	29/11/2017	07/03/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
9	EUCTR2016-003100-30-GR (EUCTR)	27/10/2017	21/04/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway;Sweden
10	NCT03368664 (ClinicalTrials.gov)	October 24, 2017	2/11/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis	Drug: Alemtuzumab GZ402673;Drug: Glatiramer acetate;Drug: Beta-Interferon;Drug: Methylprednisolone;Drug: Ranitidine;Drug: Ceterizine;Drug: Dexchlorpheniramine;Drug: Paracetamol;Drug: Acyclovir;Drug: Prednisolone;Drug: Diphenydramine;Drug: Other H1 antagonist	Genzyme, a Sanofi Company	NULL	Active, not recruiting	10 Years	17 Years	All	50	Phase 3	Austria;Belgium;Bulgaria;Czechia;France;Germany;Greece;Italy;Netherlands;Poland;Portugal;Russian Federation;Spain;Turkey;United Kingdom;Norway;Switzerland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2016-003100-30-NO (EUCTR)	12/10/2017	12/04/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Norway;Germany;Sweden
12	EUCTR2016-003100-30-NL (EUCTR)	28/09/2017	11/05/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Norway;Sweden
13	EUCTR2016-003100-30-PT (EUCTR)	28/08/2017	04/05/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
14	EUCTR2016-003100-30-AT (EUCTR)	03/08/2017	10/08/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
15	EUCTR2016-003100-30-BE (EUCTR)	14/07/2017	22/05/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT03250169 (ClinicalTrials.gov)	July 1, 2017	19/7/2017	Neurofilaments for NEDA Assessing in MS	Neurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker Study	Multiple Sclerosis	Drug: Alemtuzumab	Queen Mary University of London	NULL	Recruiting	18 Years	55 Years	All	60	N/A	United Kingdom
17	EUCTR2016-003100-30-GB (EUCTR)	05/06/2017	27/03/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
18	EUCTR2016-003100-30-IT (EUCTR)	11/04/2017	14/05/2019	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) - na	Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		GENZYME CORPORATION	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
19	EUCTR2016-003100-30-ES (EUCTR)	04/04/2017	22/02/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
20	NCT03806387 (ClinicalTrials.gov)	March 1, 2017	9/1/2019	Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment	Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment - a Prospective Observational Study	Multiple Sclerosis	Drug: Alemtuzumab	University of Aarhus	Genzyme, a Sanofi Company	Recruiting	18 Years	65 Years	All	60		Denmark
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	NCT03193086 (ClinicalTrials.gov)	January 1, 2017	14/6/2017	The Effect of Alemtuzumab on the Blood-brain-barrier and the Brain's Metabolism in Multiple Sclerosis Patients	The Effect of Alemtuzumab on the Blood-brain-barrier and Cerebral Metabolism in Multiple Sclerosis Patients; a New MRI Method for Treatment Response Evaluation in Multiple Sclerosis	Multiple Sclerosis	Drug: Alemtuzumab	Glostrup University Hospital, Copenhagen	Genzyme, a Sanofi Company	Recruiting	18 Years	60 Years	All	35	N/A	Denmark
22	NCT04082260 (ClinicalTrials.gov)	January 2017	28/8/2019	Signatures of Immune Reprogramming in Anti-CD52 Therapy of MS: Markers for Risk Stratification and Treatment Response	Signatures of Immune Reprogramming in Anti-CD52 Therapy of MS: Markers for Risk Stratification and Treatment Response	Multiple Sclerosis	Drug: Alemtuzumab Injection [Lemtrada]	University Hospital Muenster	NULL	Recruiting	18 Years	N/A	All	150		Germany
23	EUCTR2016-000464-42-DE (EUCTR)	13/06/2016	11/04/2016	The Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab	A Prospective, Open-label, Interventional Phase IIIb Clinical Trial to Investigate the Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab - LemCourse	Relapsing-remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Genzyme GmbH	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 3	Germany
24	NCT04633967 (ClinicalTrials.gov)	May 15, 2016	26/10/2020	Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting.	Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting.	Frequency of Infusion Reactions in Novel Versus Standard Protocol in Multiple Sclerosis	Drug: Alemtuzumab Injection	Maritime Neurology	NULL	Active, not recruiting	18 Years	65 Years	All	30		Canada
25	NCT02583594 (ClinicalTrials.gov)	December 6, 2015	16/10/2015	A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis	A Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple Sclerosis	Progressive Multiple Sclerosis	Drug: Acyclovir;Drug: Methylprednisolone;Drug: alemtuzumab GZ402673;Drug: Paracetamol;Drug: Loratadine;Drug: Ceterizine;Drug: Dexchlorpheniramine	Genzyme, a Sanofi Company	NULL	Active, not recruiting	18 Years	N/A	All	24	Phase 1	Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	NCT02529839 (ClinicalTrials.gov)	October 2015	10/6/2015	Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation (BMT) in Patients With Multiple Sclerosis (MS)	Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation in Patients With Multiple Sclerosis	Multiple Sclerosis	Procedure: Autologous bone marrow transplantation;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Alemtuzumab	Hadassah Medical Organization	NULL	Not yet recruiting	18 Years	65 Years	Both	20	N/A	NULL
27	NCT03774914 (ClinicalTrials.gov)	September 1, 2015	11/12/2018	LEMTRADA Pregnancy Registry in Multiple Sclerosis	International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis	Multiple Sclerosis	Drug: Alemtuzumab (GZ402673)	Genzyme, a Sanofi Company	NULL	Recruiting	18 Years	55 Years	Female	204		United States;Austria;Belgium;Canada;Denmark;Germany;Italy;Spain;Sweden;United Kingdom
28	NCT02419378 (ClinicalTrials.gov)	May 2015	31/3/2015	Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential	Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential	Multiple Sclerosis, Relapsing-Remitting	Drug: Alemtuzumab	University Hospital Muenster	Genzyme, a Sanofi Company	Recruiting	18 Years	55 Years	Both	15	Phase 4	Germany
29	EUCTR2013-003884-71-DK (EUCTR)	30/04/2015	24/02/2015	Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409	A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ	Relapsing-remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1248	Phase 3;Phase 4	United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Germany;Netherlands;Sweden
30	EUCTR2009-010788-18-PL (EUCTR)	17/02/2015	18/08/2009	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study	Relapsing Remitting Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Alemtuzumab INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	EUCTR2013-003884-71-BE (EUCTR)	05/02/2015	04/08/2014	Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409	A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ	Relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	799	Phase 3B;Phase 4	Serbia;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
32	EUCTR2013-003884-71-NL (EUCTR)	02/02/2015	11/08/2014	Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409	A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ	Relapsing-remitting multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	799	Phase 3;Phase 4	United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
33	NCT02255656 (ClinicalTrials.gov)	January 7, 2015	30/9/2014	Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409	A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)	Relapsing Remitting Multiple Sclerosis	Drug: alemtuzumab GZ402673	Genzyme, a Sanofi Company	NULL	Active, not recruiting	18 Years	N/A	All	812	Phase 4	United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Denmark;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Spain;Sweden;Ukraine;United Kingdom;Czech Republic
34	EUCTR2013-003884-71-HR (EUCTR)	30/12/2014	30/03/2015	Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409	A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ	Relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	799	Phase 3;Phase 4	Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;Netherlands;Sweden;United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom
35	EUCTR2013-003884-71-DE (EUCTR)	23/12/2014	27/10/2014	Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409	A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ	Relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1248	Phase 3;Phase 4	United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;Netherlands;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	EUCTR2013-003884-71-IT (EUCTR)	22/12/2014	28/10/2014	Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409	A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ	Relapsing-remitting multiple sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	799	Phase 3;Phase 4	Serbia;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
37	EUCTR2014-000709-10-DE (EUCTR)	19/12/2014	13/10/2014	Investigation on how alemtuzumab acts in patients with relapsing remitting multiple sclerosis.	Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential - ALAIN01	relapsing-remitting multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: LEMTRADA 12 mg Konzentrat zur Herstellung einer Infusionslösung INN or Proposed INN: Alemtuzumab Other descriptive name: ALEMTUZUMAB	Universitätsklinikum Münster	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	15	Phase 4	Germany
38	EUCTR2013-003884-71-ES (EUCTR)	01/12/2014	03/10/2014	Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409	A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ	Relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	799	Phase 3B;Phase 4	Serbia;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden
39	EUCTR2013-003884-71-CZ (EUCTR)	06/10/2014	11/08/2014	Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409	A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ	Relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1248	Phase 3;Phase 4	United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;Netherlands;Sweden
40	NCT02205489 (ClinicalTrials.gov)	October 2014	29/7/2014	Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA	Single Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADA	Relapsing-remitting Multiple Sclerosis	Drug: Alemtuzumab GZ402673;Drug: cetirizine;Drug: ranitidine;Drug: methylprednisolone;Drug: aciclovir;Drug: esomeprazole;Drug: ibuprofen;Drug: paracetamol	Genzyme, a Sanofi Company	NULL	Completed	18 Years	N/A	Both	58	Phase 4	Belgium;France;Netherlands;Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2014-000092-62-NL (EUCTR)	04/09/2014	30/06/2014	Management of the infusion-associated reactions in RRMS patients treated with Lemtrada	Single arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD	Relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 4	France;Belgium;Spain;Netherlands;Switzerland
42	EUCTR2014-000092-62-ES (EUCTR)	28/08/2014	04/07/2014	Management of the infusion-associated reactions in RRMS patients treated with Lemtrada	Single arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD	Relapsing-remitting multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 4	France;Belgium;Spain;Netherlands;Switzerland
43	EUCTR2014-000092-62-FR (EUCTR)	22/08/2014	18/06/2015	Management of the infusion-associated reactions in RRMS patients treated with Lemtrada	Single arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD	Relapsing-remitting multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	56		France;Belgium;Spain;Netherlands;Switzerland
44	EUCTR2014-000092-62-BE (EUCTR)	30/07/2014	10/06/2014	Management of the infusion-associated reactions in RRMS patients treated with Lemtrada	Single arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD	Relapsing-remitting multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	56	Phase 4	France;Spain;Belgium;Netherlands;Switzerland
45	EUCTR2013-004626-28-FI (EUCTR)	20/12/2013	20/11/2013	Does targeting of S1P receptors reduce microglial activation in multiple sclerosis?	Does targeting of S1P receptors reduce microglial activation in multiple sclerosis?	Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders	Trade Name: REBIF Product Name: beetainterferoni -1a Other descriptive name: INTERFERON BETA -1A Trade Name: Gilenya Product Name: Fingolimodi Other descriptive name: FINGOLIMOD Trade Name: Avonex Trade Name: Betaferon Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Lemtrada Other descriptive name: ALEMTUZUMAB	Turku University Hospital	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 4	Finland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	NCT01679041 (ClinicalTrials.gov)	November 2012	29/8/2012	High Dose Chemo With Stem Cell Transplant as Treatment for Multiple Sclerosis That Failed Prior Treatment	A Phase II Study of High Dose Chemotherapy With Autologous Hematopoietic Progenitor Cell Transplant for Multiple Sclerosis That Failed at Least Two Lines of Therapy	Multiple Sclerosis	Drug: Alemtuzumab;Drug: Fludarabine;Drug: Cyclophosphamide	Seah Lim M.D.	NULL	Terminated	18 Years	60 Years	Both	1	Phase 2	United States
47	NCT01624714 (ClinicalTrials.gov)	September 2012	18/6/2012	Study of Alemtuzumab in Treatment Refractory MS Subjects/Alemtuzumab Naive & Alemtuzumab Experienced Subjects	Phase I Trial Monitoring Efficacy and Safety in Treatment of Alemtuzumab Naive Subjects and Data Collecting and Monitoring of Alemtuzumab Experienced Subjects With Refractory Multiple Sclerosis	Multiple Sclerosis	Drug: Alemtuzumab;Drug: Alemtuzumab immunotherapy	Samuel Forrester Hunter, MD, PhD	NULL	Active, not recruiting	18 Years	75 Years	Both	60	Phase 1	United States
48	NCT01712945 (ClinicalTrials.gov)	June 2012	19/10/2012	Keratinocyte Growth Factor to Prevent Autoimmunity After Alemtuzumab Treatment of Multiple Sclerosis	Keratinocyte Growth Factor - Promoting Thymic Reconstitution and Preventing Autoimmunity After Alemtuzumab (Campath-1H) Treatment of Multiple Sclerosis	Multiple Sclerosis	Drug: Palifermin;Drug: Alemtuzumab	Cambridge University Hospitals NHS Foundation Trust	NULL	Terminated	18 Months	50 Years	All	40	Phase 1;Phase 2	United Kingdom
49	EUCTR2011-005606-30-GB (EUCTR)	25/04/2012	02/04/2012	Preventing patients with multiple sclerosis from developing side effects following treatment with alemtuzumab (Campath-1H).	Keratinocyte Growth Factor - promoting thymic reconstitution and preventing autoimmunity after alemtuzumab (Campath-1H) treatment of multiple sclerosis. CAM-THY - CAM-THY	This trial will test the efficacy of Kepivance in the prevention of new autoimmune diseases in patients who have multiple sclerosis (MS)who are being treated with alemtuzumab. MedDRA version: 14.1;Level: PT;Classification code 10058948;Term: Nephritis autoimmune;System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 14.1;Classification code 10049046;Term: Autoimmune thyroiditis;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.1;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders MedDRA version: 14.1;Level: LLT;Classification code 10068004;Term: Autoimmune hyperthyroidism;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Cambridge University Hospitals NHS Foundation Trust and University of Cambridge	NULL	Not Recruiting			Female: yes Male: yes	86	Phase 2	United Kingdom
50	NCT01395316 (ClinicalTrials.gov)	June 2011	13/7/2011	Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis	Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis	Multiple Sclerosis	Drug: Alemtuzumab	University of Chicago	Genzyme, a Sanofi Company	Completed	18 Years	50 Years	All	8	Phase 4	NULL
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	NCT01333358 (ClinicalTrials.gov)	May 2011	8/4/2011	Evaluating Alemtuzumab as a Treatment in Stabilizing Neurocognitive Function In Relapsing Remitting Multiple Sclerosis Patients	Phase III A Prospective, Longitudinal, Rater-blinded Single-arm Study to Evaluate Alemtuzumab as an Effective Treatment in Stabilizing Overall Neurocognitive Function in RRMS Subjects at Specified Timepoints	Multiple Sclerosis	Drug: Alemtuzumab	Central Texas Neurology Consultants	Genzyme, a Sanofi Company	Not yet recruiting	N/A	N/A	Both	30	Phase 3	NULL
52	NCT01307332 (ClinicalTrials.gov)	March 2011	26/1/2011	Advanced MRI Measures of Repair in Alemtuzumab Treated Patients	Advanced Magnetic Resonance Imaging Measures of Repair in Alemtuzumab Treated Patients	Relapsing Remitting Multiple Sclerosis	Drug: MabCampath -1h	University of British Columbia	Genzyme, a Sanofi Company	Completed	18 Years	50 Years	All	27	Phase 3	Canada
53	EUCTR2009-010788-18-IT (EUCTR)	03/02/2011	31/05/2011	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - ND	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - ND	Relapsing Remitting Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders	Trade Name: MABCAMPATH INN or Proposed INN: Alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Czech Republic;Spain;Poland;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
54	EUCTR2009-010788-18-AT (EUCTR)	21/12/2010	17/08/2009	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study	Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MabCampath Product Name: alemtuzumab INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Serbia;United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
55	EUCTR2009-010788-18-SE (EUCTR)	29/11/2010	12/08/2009	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study	Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: alemtuzumab INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
56	EUCTR2009-010788-18-ES (EUCTR)	27/09/2010	08/01/2010	Protocolo de extensión para pacientes con esclerosis múltiple que participaron en los estudios de alemtuzumab patrocinados por Genzyme./An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab.	Protocolo de extensión para pacientes con esclerosis múltiple que participaron en los estudios de alemtuzumab patrocinados por Genzyme./An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab.	Esclerosis Multiple de Recaida-Remision/Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: MABCAMPATH 10 mg/ml concentrado para solución para perfusión INN or Proposed INN: ALEMTUZUMAB Other descriptive name: ALEMTUZUMAB	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Czech Republic;Poland;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
57	EUCTR2009-010788-18-NL (EUCTR)	07/06/2010	18/09/2009	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study	Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MabCampath ® Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: N.A.	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Serbia;United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Sweden
58	EUCTR2009-010788-18-BE (EUCTR)	16/03/2010	12/08/2009	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study	Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: alemtuzumab INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
59	EUCTR2009-010788-18-DE (EUCTR)	08/01/2010	11/08/2009	An Extension Protocol For Multiple Sclerosis Patients Who Participated inGenzyme-Sponsored Studies of Alemtuzumab	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study	Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MabCampath ® Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: N/A	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
60	EUCTR2009-010788-18-DK (EUCTR)	24/11/2009	05/10/2009	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study	Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Alemtuzumab INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500		United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
61	EUCTR2009-010788-18-CZ (EUCTR)	02/11/2009	14/09/2009	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study	Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MabCampath ® Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: N.A.	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Sweden
62	NCT00930553 (ClinicalTrials.gov)	August 2009	26/6/2009	An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab	An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab	Multiple Sclerosis, Relapsing-Remitting	Biological: alemtuzumab	Genzyme, a Sanofi Company	Bayer	Completed	N/A	N/A	All	1314	Phase 3	United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Croatia;Czechia;Denmark;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom;Czech Republic
63	EUCTR2009-010788-18-GB (EUCTR)	01/07/2009	13/07/2009	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab	An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study	Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
64	EUCTR2009-011523-31-GB (EUCTR)	23/06/2009	16/04/2009	A study of the immune response to vaccination in MS patients treated with alemtuzumab - CAM-VAC	A study of the immune response to vaccination in MS patients treated with alemtuzumab - CAM-VAC	The vaccinations are being used to investigate immunological memory following treatment of multiple sclerosis with the lympho-depleting humanised monoclonal antibody alemtuzumab. MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10046859;Term: Vaccination	Trade Name: Menitorix Trade Name: Pneumovax II Trade Name: REVAXIS	R & D, Cambridge University Hospitals	NULL	Not Recruiting			Female: yes Male: yes	60		United Kingdom
65	EUCTR2007-001162-32-AT (EUCTR)	23/10/2008	14/07/2008	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	573	Phase 3	Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
66	EUCTR2007-001161-14-PL (EUCTR)	21/10/2008	12/05/2008	?Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis	A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I	Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MabCampath ® Product Name: MabCampath ® INN or Proposed INN: Alemtuzumab Trade Name: Rebif Product Name: Rebif ® INN or Proposed INN: INTERFERON BETA -1A	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Germany;France;Australia;Brazil;Sweden;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland
67	EUCTR2007-001162-32-PL (EUCTR)	21/10/2008	24/10/2008	Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MabCampath ® INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 3	Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland
68	EUCTR2007-001162-32-DK (EUCTR)	20/08/2008	25/07/2008	Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	Relapsing Remitting Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MabCampath ® Product Name: alemtuzumab INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 3	Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Belgium;Denmark;Argentina;Mexico;Spain;Croatia;United States;Poland
69	EUCTR2007-001162-32-IT (EUCTR)	06/08/2008	14/07/2008	A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High- Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed On Therapy - CARE MS-II	A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High- Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed On Therapy - CARE MS-II	Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MABCAMPATH INN or Proposed INN: Alemtuzumab Trade Name: REBIF INN or Proposed INN: Interferon beta -1a	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	573	Phase 3	France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
70	EUCTR2007-001162-32-CZ (EUCTR)	30/07/2008	31/03/2008	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	573	Phase 3	Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	EUCTR2007-001162-32-SE (EUCTR)	28/07/2008	28/12/2007	Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	Relapsing Remitting Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MabCampath ® INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 3	Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland
72	EUCTR2007-001162-32-DE (EUCTR)	02/06/2008	02/01/2008	Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MabCampath ® INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	840	Phase 3	Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland
73	EUCTR2007-001162-32-BE (EUCTR)	26/05/2008	22/01/2008	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	573	Phase 3	France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
74	EUCTR2007-001161-14-SE (EUCTR)	21/05/2008	18/12/2007	Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis	A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I	Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Germany;France;Sweden;Australia;Brazil;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland
75	EUCTR2007-001162-32-NL (EUCTR)	06/05/2008	19/12/2007	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
76	EUCTR2007-001161-14-FR (EUCTR)	11/04/2008	08/01/2008	A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I	A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I	Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	525	Phase 3	Czech Republic;Germany;United Kingdom;France;Poland;Sweden
77	EUCTR2007-001162-32-FR (EUCTR)	11/04/2008	08/01/2008	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1200	Phase 3	Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden
78	EUCTR2007-001161-14-CZ (EUCTR)	09/04/2008	11/09/2007	Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis	A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Sclerosis. - CARE MS-I	Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif ® INN or Proposed INN: INTERFERON BETA -1A	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Germany;France;Australia;Brazil;Sweden;Czech Republic;Russian Federation;United Kingdom;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland
79	EUCTR2007-001162-32-ES (EUCTR)	22/02/2008	14/02/2008	Estudio aleatorio ciego para el evaluador y de dosis ciega de fase 3 que compara dos ciclos anuales intravenosos de dosis baja y alta de alemtuzumab con interferón beta-1a (Rebif®) subcutáneo tres veces a la semana en pacientes con esclerosis múltiple de recaída-remisión que han recaído durante el tratamiento - CARE MS-II	Estudio aleatorio ciego para el evaluador y de dosis ciega de fase 3 que compara dos ciclos anuales intravenosos de dosis baja y alta de alemtuzumab con interferón beta-1a (Rebif®) subcutáneo tres veces a la semana en pacientes con esclerosis múltiple de recaída-remisión que han recaído durante el tratamiento - CARE MS-II	Esclerosis Múltiple de recaída-remisión MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A	Genzyme Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1200		Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden
80	EUCTR2007-001161-14-DE (EUCTR)	06/02/2008	23/08/2007	Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis	A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I	Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Germany;France;Australia;Brazil;Sweden;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
81	EUCTR2007-001162-32-GB (EUCTR)	24/12/2007	04/10/2007	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II	Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis		Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	573	Phase 3	France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
82	NCT00548405 (ClinicalTrials.gov)	October 2007	22/10/2007	Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two	A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy	Multiple Sclerosis, Relapsing-Remitting	Biological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mg;Biological: Interferon beta -1a	Genzyme, a Sanofi Company	Bayer	Completed	18 Years	55 Years	All	840	Phase 3	United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Croatia;Czech Republic;Denmark;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom
83	EUCTR2007-001161-14-GB (EUCTR)	24/08/2007	01/08/2007	A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I	A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I	Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	525	Phase 3	Czech Republic;Germany;United Kingdom;France;Poland;Sweden
84	NCT00530348 (ClinicalTrials.gov)	August 2007	13/9/2007	Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One	A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis	Multiple Sclerosis, Relapsing-Remitting	Biological: Alemtuzumab;Biological: Interferon beta -1a	Genzyme, a Sanofi Company	Bayer	Completed	18 Years	50 Years	All	581	Phase 3	United States;Argentina;Australia;Brazil;Canada;Croatia;Czech Republic;France;Germany;Mexico;Poland;Russian Federation;Serbia;Sweden;Ukraine;United Kingdom;Former Serbia and Montenegro
85	NCT00050778 (ClinicalTrials.gov)	December 2002	19/12/2002	A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis	A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis	Multiple Sclerosis, Relapsing-Remitting	Biological: Interferon beta -1a;Biological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mg	Genzyme, a Sanofi Company	Bayer	Completed	18 Years	50 Years	All	334	Phase 2	United States;Croatia;Poland;Russian Federation;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
86	EUCTR2016-003100-30-Outside-EU/EEA (EUCTR)		16/06/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	NA			Female: yes Male: yes	65	Phase 3	Spain;Sweden;Switzerland;Turkey;United Kingdom;Austria;Belgium;Bulgaria;Czech Republic;France;Germany;Greece;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation
87	EUCTR2016-003100-30-BG (EUCTR)		02/06/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
88	EUCTR2016-003100-30-FR (EUCTR)		17/07/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	NA			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
89	EUCTR2016-003100-30-PL (EUCTR)		21/07/2017	A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT	A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)	Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Lemtrada Product Name: Lemtrada Product Code: GZ402673 INN or Proposed INN: alemtuzumab	Genzyme Corporation	NULL	Not Recruiting			Female: yes Male: yes	65	Phase 3	Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-001549-42-GB
(EUCTR)

27/03/2020

03/02/2020

Stem cell transplantation versus disease modifying therapy (alemtuzumab or ocrelizumab) for patients with highly active relapsing remitting MS

A multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis. - StarMS

Highly active relapsing remitting multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Sheffield Teaching Hospitals

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

198

Phase 3

United Kingdom

EUCTR2016-001166-29-DE
(EUCTR)

18/03/2020

12/08/2019

A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST)

A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST) - COAST

relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Lemtrada
Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab
Other descriptive name: ALEMTUZUMAB
Trade Name: Ocrevus
Product Name: ocrelizumab
INN or Proposed INN: ocrelizumab
Other descriptive name: OCRELIZUMAB
Product Name: autologous hematopoietic stem cells
Product Code: aHSC

University Medical Centre Hamburg-Eppendorf

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany

EUCTR2017-001362-25-NL
(EUCTR)

30/09/2019

10/09/2019

Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis.

Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS

Relapsing remitting multiple sclerosis.
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Helse Bergen HF, Haukeland University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 3

Denmark;Netherlands

NCT03983252
(ClinicalTrials.gov)

July 2019

31/5/2019

Effect of Alemtuzumab on Microglial Activation Positron Emission Tomography (PET) in Multiple Sclerosis

Effect of Alemtuzumab on Microglial Activation Assessed Using Novel [F-18]-Based Positron Emission Tomography (PET) Ligand in Multiple Sclerosis

Multiple Sclerosis

Drug: [F-18]PBR06

Brigham and Women's Hospital

Genzyme, a Sanofi Company

Not yet recruiting

18 Years

60 Years

All

Phase 1;Phase 2

United States

EUCTR2017-001362-25-DK
(EUCTR)

27/06/2018

21/03/2018

Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis.

Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS

Relapsing remitting multiple sclerosis.
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Helse Bergen HF, Haukeland University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 3

Denmark;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03477500
(ClinicalTrials.gov)

March 21, 2018

13/2/2018

RCT Comparing Autologous Hematopoietic Stem Cell Transplantation Versus Alemtuzumab in MS

Randomized Autologous Hematopoietic Stem Cell Transplantation Versus Alemtuzumab for Patients With Relapsing Remitting Multiple Sclerosis

Multiple Sclerosis

Drug: Cyclophosphamide and ATG;Drug: Alemtuzumab

Haukeland University Hospital

NULL

Recruiting

18 Years

50 Years

All

100

Phase 3

Denmark;Netherlands;Norway;Sweden

NCT03135249
(ClinicalTrials.gov)

January 1, 2018

12/4/2017

Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis

Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis (SUPPRESS)

Multiple Sclerosis (MS)

Drug: Alemtuzumab

University of Texas Southwestern Medical Center

Genzyme, a Sanofi Company

Active, not recruiting

18 Years

60 Years

All

Phase 4

United States

EUCTR2016-003100-30-DE
(EUCTR)

29/11/2017

07/03/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)

Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden

EUCTR2016-003100-30-GR
(EUCTR)

27/10/2017

21/04/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Multiple Sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway;Sweden

NCT03368664
(ClinicalTrials.gov)

October 24, 2017

2/11/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT

A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)

Multiple Sclerosis

Drug: Alemtuzumab GZ402673;Drug: Glatiramer acetate;Drug: Beta-Interferon;Drug: Methylprednisolone;Drug: Ranitidine;Drug: Ceterizine;Drug: Dexchlorpheniramine;Drug: Paracetamol;Drug: Acyclovir;Drug: Prednisolone;Drug: Diphenydramine;Drug: Other H1 antagonist

Genzyme, a Sanofi Company

NULL

Active, not recruiting

10 Years

17 Years

All

Phase 3

Austria;Belgium;Bulgaria;Czechia;France;Germany;Greece;Italy;Netherlands;Poland;Portugal;Russian Federation;Spain;Turkey;United Kingdom;Norway;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-003100-30-NO
(EUCTR)

12/10/2017

12/04/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Multiple Sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Norway;Germany;Sweden

EUCTR2016-003100-30-NL
(EUCTR)

28/09/2017

11/05/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Norway;Sweden

EUCTR2016-003100-30-PT
(EUCTR)

28/08/2017

04/05/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Multiple Sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden

EUCTR2016-003100-30-AT
(EUCTR)

03/08/2017

10/08/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway

EUCTR2016-003100-30-BE
(EUCTR)

14/07/2017

22/05/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03250169
(ClinicalTrials.gov)

July 1, 2017

19/7/2017

Neurofilaments for NEDA Assessing in MS

Neurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker Study

Multiple Sclerosis

Drug: Alemtuzumab

Queen Mary University of London

NULL

Recruiting

18 Years

55 Years

All

N/A

United Kingdom

EUCTR2016-003100-30-GB
(EUCTR)

05/06/2017

27/03/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway

EUCTR2016-003100-30-IT
(EUCTR)

11/04/2017

14/05/2019

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Multiple Sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

GENZYME CORPORATION

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden

EUCTR2016-003100-30-ES
(EUCTR)

04/04/2017

22/02/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden

NCT03806387
(ClinicalTrials.gov)

March 1, 2017

9/1/2019

Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment

Physical and Cognitive Performance During the Two First Years of Lemtrada Treatment - a Prospective Observational Study

Multiple Sclerosis

Drug: Alemtuzumab

University of Aarhus

Genzyme, a Sanofi Company

Recruiting

18 Years

65 Years

All

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03193086
(ClinicalTrials.gov)

January 1, 2017

14/6/2017

The Effect of Alemtuzumab on the Blood-brain-barrier and the Brain's Metabolism in Multiple Sclerosis Patients

The Effect of Alemtuzumab on the Blood-brain-barrier and Cerebral Metabolism in Multiple Sclerosis Patients; a New MRI Method for Treatment Response Evaluation in Multiple Sclerosis

Multiple Sclerosis

Drug: Alemtuzumab

Glostrup University Hospital, Copenhagen

Genzyme, a Sanofi Company

Recruiting

18 Years

60 Years

All

N/A

Denmark

NCT04082260
(ClinicalTrials.gov)

January 2017

28/8/2019

Signatures of Immune Reprogramming in Anti-CD52 Therapy of MS: Markers for Risk Stratification and Treatment Response

Multiple Sclerosis

Drug: Alemtuzumab Injection [Lemtrada]

University Hospital Muenster

NULL

Recruiting

18 Years

N/A

All

150

Germany

EUCTR2016-000464-42-DE
(EUCTR)

13/06/2016

11/04/2016

The Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab

A Prospective, Open-label, Interventional Phase IIIb Clinical Trial to Investigate the Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab - LemCourse

Relapsing-remitting multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Genzyme GmbH

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 3

Germany

NCT04633967
(ClinicalTrials.gov)

May 15, 2016

26/10/2020

Observational Study of a Novel Peri Infusion Regimen on the Infusion Associated Reactions With Alemtuzumab Infusion in Patients With Multiple Sclerosis in a Canadian Clinical Setting.

Frequency of Infusion Reactions in Novel Versus Standard Protocol in Multiple Sclerosis

Drug: Alemtuzumab Injection

Maritime Neurology

NULL

Active, not recruiting

18 Years

65 Years

All

Canada

NCT02583594
(ClinicalTrials.gov)

December 6, 2015

16/10/2015

A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple Sclerosis

A Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple Sclerosis

Progressive Multiple Sclerosis

Drug: Acyclovir;Drug: Methylprednisolone;Drug: alemtuzumab GZ402673;Drug: Paracetamol;Drug: Loratadine;Drug: Ceterizine;Drug: Dexchlorpheniramine

Genzyme, a Sanofi Company

NULL

Active, not recruiting

18 Years

N/A

All

Phase 1

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02529839
(ClinicalTrials.gov)

October 2015

10/6/2015

Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation (BMT) in Patients With Multiple Sclerosis (MS)

Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation in Patients With Multiple Sclerosis

Multiple Sclerosis

Procedure: Autologous bone marrow transplantation;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Alemtuzumab

Hadassah Medical Organization

NULL

Not yet recruiting

18 Years

65 Years

Both

N/A

NULL

NCT03774914
(ClinicalTrials.gov)

September 1, 2015

11/12/2018

LEMTRADA Pregnancy Registry in Multiple Sclerosis

International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis

Multiple Sclerosis

Drug: Alemtuzumab (GZ402673)

Genzyme, a Sanofi Company

NULL

Recruiting

18 Years

55 Years

Female

204

United States;Austria;Belgium;Canada;Denmark;Germany;Italy;Spain;Sweden;United Kingdom

NCT02419378
(ClinicalTrials.gov)

May 2015

31/3/2015

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential

Multiple Sclerosis, Relapsing-Remitting

Drug: Alemtuzumab

University Hospital Muenster

Genzyme, a Sanofi Company

Recruiting

18 Years

55 Years

Both

Phase 4

Germany

EUCTR2013-003884-71-DK
(EUCTR)

30/04/2015

24/02/2015

Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409

A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ

Relapsing-remitting multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1248

Phase 3;Phase 4

United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Germany;Netherlands;Sweden

EUCTR2009-010788-18-PL
(EUCTR)

17/02/2015

18/08/2009

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study

Relapsing Remitting Multiple Sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Alemtuzumab
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-003884-71-BE
(EUCTR)

05/02/2015

04/08/2014

Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409

A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ

Relapsing-remitting multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

799

Phase 3B;Phase 4

Serbia;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden

EUCTR2013-003884-71-NL
(EUCTR)

02/02/2015

11/08/2014

Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409

A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ

Relapsing-remitting multiple sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

799

Phase 3;Phase 4

United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden

NCT02255656
(ClinicalTrials.gov)

January 7, 2015

30/9/2014

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

A Long-term Follow-up Study for Multiple Sclerosis Patients Who Have Completed the Alemtuzumab Extension Study (CAMMS03409)

Relapsing Remitting Multiple Sclerosis

Drug: alemtuzumab GZ402673

Genzyme, a Sanofi Company

NULL

Active, not recruiting

18 Years

N/A

All

812

Phase 4

United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Denmark;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Spain;Sweden;Ukraine;United Kingdom;Czech Republic

EUCTR2013-003884-71-HR
(EUCTR)

30/12/2014

30/03/2015

Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409

A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ

Relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

799

Phase 3;Phase 4

Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;Netherlands;Sweden;United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom

EUCTR2013-003884-71-DE
(EUCTR)

23/12/2014

27/10/2014

Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409

A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1248

Phase 3;Phase 4

United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2013-003884-71-IT
(EUCTR)

22/12/2014

28/10/2014

Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409

A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ

Relapsing-remitting multiple sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

799

Phase 3;Phase 4

Serbia;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden

EUCTR2014-000709-10-DE
(EUCTR)

19/12/2014

13/10/2014

Investigation on how alemtuzumab acts in patients with relapsing remitting multiple sclerosis.

Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential - ALAIN01

relapsing-remitting multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: LEMTRADA 12 mg Konzentrat zur Herstellung einer Infusionslösung
INN or Proposed INN: Alemtuzumab
Other descriptive name: ALEMTUZUMAB

Universitätsklinikum Münster

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Germany

EUCTR2013-003884-71-ES
(EUCTR)

01/12/2014

03/10/2014

Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409

A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

799

Phase 3B;Phase 4

Serbia;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Netherlands;Germany;Sweden

EUCTR2013-003884-71-CZ
(EUCTR)

06/10/2014

11/08/2014

Phase IIIB-IV long term follow-up study for patients who participated in CAMMS03409

A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409) - TOPAZ

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1248

Phase 3;Phase 4

United States;Serbia;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Australia;Denmark;Germany;Netherlands;Sweden

NCT02205489
(ClinicalTrials.gov)

October 2014

29/7/2014

Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA

Single Arm Study To Assess Comprehensive Infusion Guidance For The Management Of The Infusion- Associated Reactions (IARs) In Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With LEMTRADA

Relapsing-remitting Multiple Sclerosis

Drug: Alemtuzumab GZ402673;Drug: cetirizine;Drug: ranitidine;Drug: methylprednisolone;Drug: aciclovir;Drug: esomeprazole;Drug: ibuprofen;Drug: paracetamol

Genzyme, a Sanofi Company

NULL

Completed

18 Years

N/A

Both

Phase 4

Belgium;France;Netherlands;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2014-000092-62-NL
(EUCTR)

04/09/2014

30/06/2014

Management of the infusion-associated reactions in RRMS patients treated with Lemtrada

Single arm study to assess comprehensive infusion guidance for the management of the infusion associated reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada. - EMERALD

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

France;Belgium;Spain;Netherlands;Switzerland

EUCTR2014-000092-62-ES
(EUCTR)

28/08/2014

04/07/2014

Management of the infusion-associated reactions in RRMS patients treated with Lemtrada

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

France;Belgium;Spain;Netherlands;Switzerland

EUCTR2014-000092-62-FR
(EUCTR)

22/08/2014

18/06/2015

Management of the infusion-associated reactions in RRMS patients treated with Lemtrada

Relapsing-remitting multiple sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France;Belgium;Spain;Netherlands;Switzerland

EUCTR2014-000092-62-BE
(EUCTR)

30/07/2014

10/06/2014

Management of the infusion-associated reactions in RRMS patients treated with Lemtrada

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

France;Spain;Belgium;Netherlands;Switzerland

EUCTR2013-004626-28-FI
(EUCTR)

20/12/2013

20/11/2013

Does targeting of S1P receptors reduce microglial activation in multiple sclerosis?

Multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders

Trade Name: REBIF
Product Name: beetainterferoni -1a
Other descriptive name: INTERFERON BETA -1A
Trade Name: Gilenya
Product Name: Fingolimodi
Other descriptive name: FINGOLIMOD
Trade Name: Avonex
Trade Name: Betaferon
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Lemtrada
Other descriptive name: ALEMTUZUMAB

Turku University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Finland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01679041
(ClinicalTrials.gov)

November 2012

29/8/2012

High Dose Chemo With Stem Cell Transplant as Treatment for Multiple Sclerosis That Failed Prior Treatment

A Phase II Study of High Dose Chemotherapy With Autologous Hematopoietic Progenitor Cell Transplant for Multiple Sclerosis That Failed at Least Two Lines of Therapy

Multiple Sclerosis

Drug: Alemtuzumab;Drug: Fludarabine;Drug: Cyclophosphamide

Seah Lim M.D.

NULL

Terminated

18 Years

60 Years

Both

Phase 2

United States

NCT01624714
(ClinicalTrials.gov)

September 2012

18/6/2012

Study of Alemtuzumab in Treatment Refractory MS Subjects/Alemtuzumab Naive & Alemtuzumab Experienced Subjects

Phase I Trial Monitoring Efficacy and Safety in Treatment of Alemtuzumab Naive Subjects and Data Collecting and Monitoring of Alemtuzumab Experienced Subjects With Refractory Multiple Sclerosis

Multiple Sclerosis

Drug: Alemtuzumab;Drug: Alemtuzumab immunotherapy

Samuel Forrester Hunter, MD, PhD

NULL

Active, not recruiting

18 Years

75 Years

Both

Phase 1

United States

NCT01712945
(ClinicalTrials.gov)

June 2012

19/10/2012

Keratinocyte Growth Factor to Prevent Autoimmunity After Alemtuzumab Treatment of Multiple Sclerosis

Keratinocyte Growth Factor - Promoting Thymic Reconstitution and Preventing Autoimmunity After Alemtuzumab (Campath-1H) Treatment of Multiple Sclerosis

Multiple Sclerosis

Drug: Palifermin;Drug: Alemtuzumab

Cambridge University Hospitals NHS Foundation Trust

NULL

Terminated

18 Months

50 Years

All

Phase 1;Phase 2

United Kingdom

EUCTR2011-005606-30-GB
(EUCTR)

25/04/2012

02/04/2012

Preventing patients with multiple sclerosis from developing side effects following treatment with alemtuzumab (Campath-1H).

Keratinocyte Growth Factor - promoting thymic reconstitution and preventing autoimmunity after alemtuzumab (Campath-1H) treatment of multiple sclerosis. CAM-THY - CAM-THY

This trial will test the efficacy of Kepivance in the prevention of new autoimmune diseases in patients who have multiple sclerosis (MS)who are being treated with alemtuzumab.
MedDRA version: 14.1;Level: PT;Classification code 10058948;Term: Nephritis autoimmune;System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1;Classification code 10049046;Term: Autoimmune thyroiditis;System Organ Class: 10014698 - Endocrine disorders
MedDRA version: 14.1;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10068004;Term: Autoimmune hyperthyroidism;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United Kingdom

NCT01395316
(ClinicalTrials.gov)

June 2011

13/7/2011

Alemtuzumab on Surrogate Markers of Disease Activity and Repair Using Advanced MRI Measures in Subjects With Relapsing Remitting Multiple Sclerosis

Multiple Sclerosis

Drug: Alemtuzumab

University of Chicago

Genzyme, a Sanofi Company

Completed

18 Years

50 Years

All

Phase 4

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01333358
(ClinicalTrials.gov)

May 2011

8/4/2011

Evaluating Alemtuzumab as a Treatment in Stabilizing Neurocognitive Function In Relapsing Remitting Multiple Sclerosis Patients

Phase III A Prospective, Longitudinal, Rater-blinded Single-arm Study to Evaluate Alemtuzumab as an Effective Treatment in Stabilizing Overall Neurocognitive Function in RRMS Subjects at Specified Timepoints

Multiple Sclerosis

Drug: Alemtuzumab

Central Texas Neurology Consultants

Genzyme, a Sanofi Company

Not yet recruiting

N/A

Both

Phase 3

NULL

NCT01307332
(ClinicalTrials.gov)

March 2011

26/1/2011

Advanced MRI Measures of Repair in Alemtuzumab Treated Patients

Advanced Magnetic Resonance Imaging Measures of Repair in Alemtuzumab Treated Patients

Relapsing Remitting Multiple Sclerosis

Drug: MabCampath -1h

University of British Columbia

Genzyme, a Sanofi Company

Completed

18 Years

50 Years

All

Phase 3

Canada

EUCTR2009-010788-18-IT
(EUCTR)

03/02/2011

31/05/2011

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - ND

Relapsing Remitting Multiple Sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders

Trade Name: MABCAMPATH
INN or Proposed INN: Alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

Czech Republic;Spain;Poland;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden

EUCTR2009-010788-18-AT
(EUCTR)

21/12/2010

17/08/2009

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study

Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: MabCampath
Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

Serbia;United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden

EUCTR2009-010788-18-SE
(EUCTR)

29/11/2010

12/08/2009

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study

Relapsing Remitting Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: alemtuzumab
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2009-010788-18-ES
(EUCTR)

27/09/2010

08/01/2010

Protocolo de extensión para pacientes con esclerosis múltiple que participaron en los estudios de alemtuzumab patrocinados por Genzyme./An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab.

Esclerosis Multiple de Recaida-Remision/Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: MABCAMPATH 10 mg/ml concentrado para solución para perfusión
INN or Proposed INN: ALEMTUZUMAB
Other descriptive name: ALEMTUZUMAB

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

Czech Republic;Poland;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

EUCTR2009-010788-18-NL
(EUCTR)

07/06/2010

18/09/2009

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study

Trade Name: MabCampath ®
Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab
Other descriptive name: N.A.

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

Serbia;United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Sweden

EUCTR2009-010788-18-BE
(EUCTR)

16/03/2010

12/08/2009

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study

Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

EUCTR2009-010788-18-DE
(EUCTR)

08/01/2010

11/08/2009

An Extension Protocol For Multiple Sclerosis Patients Who Participated inGenzyme-Sponsored Studies of Alemtuzumab

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study

Trade Name: MabCampath ®
Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab
Other descriptive name: N/A

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

EUCTR2009-010788-18-DK
(EUCTR)

24/11/2009

05/10/2009

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study

Product Name: Alemtuzumab
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2009-010788-18-CZ
(EUCTR)

02/11/2009

14/09/2009

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study

Trade Name: MabCampath ®
Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab
Other descriptive name: N.A.

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Sweden

NCT00930553
(ClinicalTrials.gov)

August 2009

26/6/2009

An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

Multiple Sclerosis, Relapsing-Remitting

Biological: alemtuzumab

Genzyme, a Sanofi Company

Bayer

Completed

N/A

All

1314

Phase 3

United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Croatia;Czechia;Denmark;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom;Czech Republic

EUCTR2009-010788-18-GB
(EUCTR)

01/07/2009

13/07/2009

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab

An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study

Relapsing Remitting Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1500

Phase 3

United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Denmark;Australia;Netherlands;Germany;Sweden

EUCTR2009-011523-31-GB
(EUCTR)

23/06/2009

16/04/2009

A study of the immune response to vaccination in MS patients treated with alemtuzumab - CAM-VAC

The vaccinations are being used to investigate immunological memory following treatment of multiple sclerosis with the lympho-depleting humanised monoclonal antibody alemtuzumab.
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10063400;Term: Secondary progressive multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10046859;Term: Vaccination

Trade Name: Menitorix
Trade Name: Pneumovax II
Trade Name: REVAXIS

R & D, Cambridge University Hospitals

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom

EUCTR2007-001162-32-AT
(EUCTR)

23/10/2008

14/07/2008

A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II

Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

573

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-001161-14-PL
(EUCTR)

21/10/2008

12/05/2008

?Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis

A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I

Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: MabCampath ®
Product Name: MabCampath ®
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
Product Name: Rebif ®
INN or Proposed INN: INTERFERON BETA -1A

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

Germany;France;Australia;Brazil;Sweden;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland

EUCTR2007-001162-32-PL
(EUCTR)

21/10/2008

24/10/2008

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.

Trade Name: MabCampath ®
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 3

Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland

EUCTR2007-001162-32-DK
(EUCTR)

20/08/2008

25/07/2008

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.

Relapsing Remitting Multiple Sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: MabCampath ®
Product Name: alemtuzumab
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 3

Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Belgium;Denmark;Argentina;Mexico;Spain;Croatia;United States;Poland

EUCTR2007-001162-32-IT
(EUCTR)

06/08/2008

14/07/2008

A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High- Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed On Therapy - CARE MS-II

Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: MABCAMPATH
INN or Proposed INN: Alemtuzumab
Trade Name: REBIF
INN or Proposed INN: Interferon beta -1a

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

573

Phase 3

France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden

EUCTR2007-001162-32-CZ
(EUCTR)

30/07/2008

31/03/2008

Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

573

Phase 3

Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-001162-32-SE
(EUCTR)

28/07/2008

28/12/2007

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.

Trade Name: MabCampath ®
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 3

EUCTR2007-001162-32-DE
(EUCTR)

02/06/2008

02/01/2008

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.

Trade Name: MabCampath ®
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

840

Phase 3

EUCTR2007-001162-32-BE
(EUCTR)

26/05/2008

22/01/2008

Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

573

Phase 3

France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden

EUCTR2007-001161-14-SE
(EUCTR)

21/05/2008

18/12/2007

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis

Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

Germany;France;Sweden;Australia;Brazil;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland

EUCTR2007-001162-32-NL
(EUCTR)

06/05/2008

19/12/2007

Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

1200

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-001161-14-FR
(EUCTR)

11/04/2008

08/01/2008

Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

525

Phase 3

Czech Republic;Germany;United Kingdom;France;Poland;Sweden

EUCTR2007-001162-32-FR
(EUCTR)

11/04/2008

08/01/2008

Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden

EUCTR2007-001161-14-CZ
(EUCTR)

09/04/2008

11/09/2007

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis

Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif ®
INN or Proposed INN: INTERFERON BETA -1A

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

Germany;France;Australia;Brazil;Sweden;Czech Republic;Russian Federation;United Kingdom;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland

EUCTR2007-001162-32-ES
(EUCTR)

22/02/2008

14/02/2008

Estudio aleatorio ciego para el evaluador y de dosis ciega de fase 3 que compara dos ciclos anuales intravenosos de dosis baja y alta de alemtuzumab con interferón beta-1a (Rebif®) subcutáneo tres veces a la semana en pacientes con esclerosis múltiple de recaída-remisión que han recaído durante el tratamiento - CARE MS-II

Esclerosis Múltiple de recaída-remisión
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A

Genzyme Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1200

Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden

EUCTR2007-001161-14-DE
(EUCTR)

06/02/2008

23/08/2007

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis

Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

Germany;France;Australia;Brazil;Sweden;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2007-001162-32-GB
(EUCTR)

24/12/2007

04/10/2007

Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

573

Phase 3

France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden

NCT00548405
(ClinicalTrials.gov)

October 2007

22/10/2007

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two

A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On Therapy

Multiple Sclerosis, Relapsing-Remitting

Biological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mg;Biological: Interferon beta -1a

Genzyme, a Sanofi Company

Bayer

Completed

18 Years

55 Years

All

840

Phase 3

United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Croatia;Czech Republic;Denmark;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom

EUCTR2007-001161-14-GB
(EUCTR)

24/08/2007

01/08/2007

Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

525

Phase 3

Czech Republic;Germany;United Kingdom;France;Poland;Sweden

NCT00530348
(ClinicalTrials.gov)

August 2007

13/9/2007

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One

A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Biological: Alemtuzumab;Biological: Interferon beta -1a

Genzyme, a Sanofi Company

Bayer

Completed

18 Years

50 Years

All

581

Phase 3

United States;Argentina;Australia;Brazil;Canada;Croatia;Czech Republic;France;Germany;Mexico;Poland;Russian Federation;Serbia;Sweden;Ukraine;United Kingdom;Former Serbia and Montenegro

NCT00050778
(ClinicalTrials.gov)

December 2002

19/12/2002

A Phase II Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Rebif® in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis

A Phase II, Randomized, Open-Label, Three-Arm Study Comparing Low- and High-Dose Alemtuzumab and High-Dose Subcutaneous Interferon Beta-1a (Rebif®) in Patients With Early, Active Relapsing-Remitting Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Biological: Interferon beta -1a;Biological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mg

Genzyme, a Sanofi Company

Bayer

Completed

18 Years

50 Years

All

334

Phase 2

United States;Croatia;Poland;Russian Federation;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-003100-30-Outside-EU/EEA
(EUCTR)

16/06/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Female: yes
Male: yes

Phase 3

Spain;Sweden;Switzerland;Turkey;United Kingdom;Austria;Belgium;Bulgaria;Czech Republic;France;Germany;Greece;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation

EUCTR2016-003100-30-BG
(EUCTR)

02/06/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway

EUCTR2016-003100-30-FR
(EUCTR)

17/07/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden

EUCTR2016-003100-30-PL
(EUCTR)

21/07/2017

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT

Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab

Genzyme Corporation

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway