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	NCT04565431 (ClinicalTrials.gov)	October 2020	25/8/2020	Examining Effects of Tysabri on Cognitive Fatigue Using fMRI	Biomarker for Cognitive Fatigue Using Functional Imaging in Multiple Sclerosis	Multiple Sclerosis, Relapsing-Remitting	Drug: Tysabri	Kessler Foundation	St. Barnabas Medical Center	Not yet recruiting	18 Years	64 Years	All	25		United States
2	NCT04115488 (ClinicalTrials.gov)	October 1, 2019	10/9/2019	Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®	Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)	Relapsing-Remitting Multiple Sclerosis (RRMS)	Biological: Intravenous (IV) infusions	Polpharma Biologics S.A.	NULL	Active, not recruiting	18 Years	60 Years	All	260	Phase 3	Belarus;Croatia;Georgia;Moldova, Republic of;Poland;Serbia;Ukraine
3	EUCTR2018-004751-20-HR (EUCTR)	18/09/2019	02/12/2019	A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple Sclerosis	Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope	Relapsing-Remitting Multiple Sclerosis (RRMS) 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]	Product Code: PB006 INN or Proposed INN: NATALIZUMAB Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: NATALIZUMAB	Polpharma Biologics S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	260	Phase 3	Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of
4	EUCTR2018-004751-20-PL (EUCTR)	22/07/2019	25/04/2019	A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple Sclerosis	Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope	Relapsing-Remitting Multiple Sclerosis (RRMS) 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]	Product Code: PB006 INN or Proposed INN: NATALIZUMAB Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: NATALIZUMAB	Polpharma Biologics S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	260	Phase 3	Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of
5	EUCTR2018-002145-11-GB (EUCTR)	21/03/2019	11/10/2018	A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab Administration	A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration - BIIB 101MS329	Relapsing-remitting multiple sclerosis (RRMS) 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: TYSABRI Product Name: TYSABRI INN or Proposed INN: NATALIZUMAB Trade Name: TYSABRI Product Name: TYSABRI INN or Proposed INN: NATALIZUMAB Other descriptive name: BG00002	Biogen Idec Research Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	480	Phase 3	United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;New Zealand;Italy;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
6	EUCTR2018-002145-11-NL (EUCTR)	14/03/2019	05/11/2018	A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab Administration	A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration	Relapsing-remitting multiple sclerosis (RRMS) 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: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: BG00002	Biogen Idec Research Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	480	Phase 3	United States;France;Canada;Spain;Belgium;Australia;Israel;Germany;Netherlands;United Kingdom;New Zealand;Italy
7	EUCTR2018-002145-11-DE (EUCTR)	15/02/2019	17/10/2018	A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab Administration	A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration	Relapsing-remitting multiple sclerosis (RRMS) 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: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: TYSABRI Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: BG00002	Biogen Idec Research Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	480	Phase 3	United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;New Zealand;Italy
8	NCT03399981 (ClinicalTrials.gov)	January 24, 2018	9/1/2018	Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries	An Observational Study Utilising Data From the US Tysabri TOUCH Programme and Select EU MS Registries to Estimate the Risk of Progressive Multifocal Leukoencephalopathy (PML) and Other Serious Opportunistic Infections Among Patients Who Were Exposed to an MS Disease Modifying Treatment Prior to Treatment With Tysabri	Progressive Multifocal Leukoencephalopathy	Biological: Tysabri	Biogen	NULL	Active, not recruiting	N/A	N/A	All	72600		United States
9	EUCTR2017-002634-24-SE (EUCTR)	29/09/2017	06/07/2017	MultipleMS – a study with the aim to accelerate personalised medicine in multiple sclerosis.	MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMS	Newly diagnosed patients with Clinically Isolated Syndrome (CIS) and multiple sclerosis (MS) -both relapsing remitting and primary progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Gilenya INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA -1B Other descriptive name: INTERFERON BETA -1B Trade Name: Extavia INN or Proposed INN: INTERFERON BETA -1B Other descriptive name: INTERFERON BETA -1B Trade Name: Avonex INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A Other descriptive name:	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 4	Sweden
10	EUCTR2016-003587-39-SE (EUCTR)	22/05/2017	23/03/2017	This is a long-term study of the safety, efficacy and patient satisfaction of the drug rituximab in comparison with other immunomodulatory treatments for multiple sclerosis. The study will use a national registry for both retrospective and prospective data retrieval.	COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)A prospective long-term cohort study of safety, efficacy and patient’s satisfaction of MS disease modulatory treatments in relapsing-remitting multiple sclerosis - COMparison Between All immunoTherapies for Multiple Sclerosis (COMBAT-MS)	Relapsing-remitting multiple sclerosis (RRMS) that has started on their first or second immunomodulatory drug at the earliest 2011-01-01 and at the latest 2018-06-30. The clinical course and response to treatment is thereafter followed until 2021-06-30;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE Trade Name: Gilenya INN or Proposed INN: FINGOLIMOD Other descriptive name: FINGOLIMOD Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: GLATIRAMER ACETATE Trade Name: Betaferon INN or Proposed INN: INTERFERON BETA -1B Other descriptive name: INTERFERON BETA -1B Trade Name: Extavia INN or Proposed INN: INTERFERON BETA -1B Other descriptive name: INTERFERON BETA -1B Trade Name: Avonex INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	3700	Phase 4	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
11	EUCTR2016-000345-31-NL (EUCTR)	30/09/2016	11/04/2016	Reduce the number of natalizumab infusions in patients with multiple sclerosis	Towards personalized dosing of natalizumab in multiple sclerosis - Personalised Dosing of Natalizumab in Multiple Sclerosis (The PDNMS trial)	multiple sclerosis MedDRA version: 18.1;Level: LLT;Classification code 10070425;Term: Multiple sclerosis exacerbation;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: tysabri Product Name: natalizumab INN or Proposed INN: NATALIZUMAB	VU medical center	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 4	Netherlands
12	EUCTR2013-004622-29-DE (EUCTR)	23/02/2015	11/11/2014	Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Multiple Sclerosis (MS) 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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 4	France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden
13	EUCTR2013-005586-39-DE (EUCTR)	29/01/2015	02/09/2014	Natalizumab (BG00002) as an Efficacy Switch in Subjects with Relapsing Multiple Sclerosis (MS) after Failure on Other Therapies	A Phase 4 Multicenter, Open-Label, Single Arm Study toEvaluate Switching from BRACET/Gilenya® to Natalizumabin Subjects with Relapsing Forms of Multiple Sclerosis (MS)	Multiple Sclerosis (MS) MedDRA version: 17.1;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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	United States;Germany;Italy
14	EUCTR2013-004622-29-DK (EUCTR)	29/01/2015	04/12/2014	Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Multiple Sclerosis (MS) MedDRA version: 19.0;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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 4	France;United States;Czech Republic;Spain;Australia;Denmark;Germany;Italy;United Kingdom;Sweden
15	EUCTR2013-004622-29-SE (EUCTR)	30/12/2014	29/09/2014	Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Multiple Sclerosis (MS) MedDRA version: 19.0;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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 4	France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;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
16	EUCTR2013-004622-29-ES (EUCTR)	03/12/2014	03/10/2014	Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Multiple Sclerosis (MS) 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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 4	France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden
17	EUCTR2013-004622-29-GB (EUCTR)	20/11/2014	28/08/2014	Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Multiple Sclerosis (MS) 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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 4	France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden
18	EUCTR2013-004622-29-IT (EUCTR)	10/11/2014	05/08/2014	Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Multiple Sclerosis (MS) 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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	540		France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Italy;Sweden
19	EUCTR2013-004622-29-CZ (EUCTR)	31/10/2014	13/08/2014	Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects	A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects	Multiple Sclerosis (MS) MedDRA version: 19.0;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: Tysabri ® Product Name: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Trade Name: Gilenya Product Name: Fingolimod INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	540	Phase 4	France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden
20	EUCTR2014-003669-97-BE (EUCTR)	27/10/2014	02/09/2014	A safety study for patients with Relapsing Forms of Multiple Sclerosis who participated STRATA.	A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA.	Relapsing Forms of Multiple Sclerosis MedDRA version: 17.0;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: Tysabri Product Name: Tysabri INN or Proposed INN: NATALIZUMAB	Biogen Idec	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 4	Belgium
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	EUCTR2014-003209-14-FR (EUCTR)	01/09/2014	18/06/2015	ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS	ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS - TYSADIFF	MULTIPLE SCLEROSIS;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: TYSABRI 300 mg solution à diluer pour perfusion INN or Proposed INN: NATALIZUMAB	Hôpitaux Universitaires de Strasbourg	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
22	NCT02159573 (ClinicalTrials.gov)	July 2014	19/5/2014	Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)	A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate)	Relapsing-Remitting Multiple Sclerosis	Biological: natalizumab;Drug: dimethyl fumarate	Biogen	NULL	Completed	18 Years	N/A	Both	530	N/A	United States
23	EUCTR2013-004616-21-DE (EUCTR)	13/03/2014	04/02/2014	A study to assess immune function and typical disease characteristics in patients with multiple sclerosis, when switching from the medication Natalizumab to the medication Gilenya.	A 32-week, monocentric, exploratory, single arm study to assess immune function and MRI disease activity in patients with relapsing remitting multiple sclerosis (RRMS) transferred from previous treatment with Natalizumab to Gilenya® (Fingolimod) - ToFingo Successor	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: Gilenya Product Name: Fingolimod Product Code: FTY720 INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB	Universitätsklinikum Münster	NULL	Not Recruiting			Female: yes Male: yes			Germany
24	NCT02137109 (ClinicalTrials.gov)	March 2014	1/5/2014	Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri	Meta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple Sclerosis	Multiple Sclerosis	Drug: natalizumab	Biogen	NULL	Completed	N/A	18 Years	Both	400	N/A	NULL
25	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
26	EUCTR2012-004165-41-GB (EUCTR)	04/11/2013	19/09/2013	Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study	Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - Hematopoietic Stem Cell Therapy for Inflammatory MS	Inflammatory Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Tysabri Product Name: Tysabri INN or Proposed INN: natalizumab Trade Name: Fingolimod Product Name: Gilenya INN or Proposed INN: Fingolimod Trade Name: Tecfidera Product Name: Tecfidera Product Code: BG-12 120 INN or Proposed INN: dimethyl fumarate	Northwestern University	NULL	Not Recruiting			Female: yes Male: yes	110	Phase 2	United States;United Kingdom
27	NCT03133403 (ClinicalTrials.gov)	November 2013	21/4/2016	Hematopoietic Stem Cell Therapy for Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy	Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study	Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting	Drug: Tecfidera (BG12);Drug: Gilenya;Drug: Tysabri ®;Drug: Avonex /Betaseron/Copaxone/Rebif;Procedure: Hematopoietic stem cell transplantation (HSCT)	Sheffield Teaching Hospitals NHS Foundation Trust	NULL	Recruiting	18 Years	55 Years	All	5	Phase 2;Phase 3	United Kingdom
28	EUCTR2012-005082-13-IT (EUCTR)	02/04/2013	18/02/2013	A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple Sclerosis	A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple Sclerosis	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: TYSABRI Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 1	Italy
29	EUCTR2011-001437-16-DE (EUCTR)	19/09/2012	09/02/2012	A 3 year study to determine if optical coherence tomography can be used to measure disease progression in patients with multiple sclerosis	A 3-year, multi-center study to evaluate optical coherence tomography as an outcome measure in patients with multiple sclerosis -	multiple sclerosis MedDRA version: 15.0;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: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Extavia INN or Proposed INN: Interferon beta -1b Other descriptive name: INTERFERON BETA -1B Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Avonex INN or Proposed INN: Interferon beta -1a Other descriptive name: INTERFERON BETA -1A	Novartis Pharma Services AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	420		Germany;Switzerland;Netherlands;France;Italy;Austria;Australia;Czech Republic;United Kingdom;Canada;Denmark;Spain;United States;Poland
30	EUCTR2010-021978-11-IE (EUCTR)	06/07/2012	14/05/2012	A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis	Secondary Progressive Multiple Sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	856	Phase 3	United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;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	NCT02142205 (ClinicalTrials.gov)	May 2012	16/5/2014	Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Participants With Relapsing Remitting Multiple Sclerosis (RRMS)	A Prospective, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety and Efficacy in RUSsian RRMS Patients on One Year Treatment With Natalizumab (TYSabri®).	Relapsing-Remitting Multiple Sclerosis	Biological: BG00002	Biogen Idec	Biogen Idec International GmbH	Completed	18 Years	60 Years	Both	100	Phase 4	Russian Federation
32	NCT01591551 (ClinicalTrials.gov)	March 2012	22/4/2012	NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness	NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Relapsing Forms of Multiple Sclerosis Experiencing Fatigue or Sleepiness	Multiple Sclerosis, Relapsing-Remitting	Drug: Natalizumab (Tysabri)	Cornerstone Health Care, PA	Biogen Idec	Completed	18 Years	65 Years	Both	37	Phase 4	United States
33	NCT01485003 (ClinicalTrials.gov)	February 7, 2012	1/12/2011	Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants	A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients	Relapsing-Remitting Multiple Sclerosis	Biological: natalizumab	Biogen	NULL	Completed	18 Years	65 Years	All	231		United States
34	EUCTR2010-021978-11-BE (EUCTR)	03/02/2012	20/09/2011	A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis	Secondary Progressive Multiple Sclerosis MedDRA version: 16.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	856		United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Sweden
35	EUCTR2010-021978-11-IT (EUCTR)	14/12/2011	02/03/2012	A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis - 101MS326	Multiple Sclerosis MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: TYSABRI *IV 1FL 300MG 15ML INN or Proposed INN: NA Other descriptive name: NA	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	856		United States;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Belgium;Poland;Denmark;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
36	EUCTR2010-021978-11-PL (EUCTR)	07/12/2011	28/10/2011	A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension	Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	856		United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
37	EUCTR2010-021978-11-CZ (EUCTR)	02/12/2011	22/08/2011	A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension	Secondary Progressive Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	856	Phase 3	United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
38	NCT01943526 (ClinicalTrials.gov)	November 30, 2011	12/9/2013	Ireland Natalizumab (TYSABRI) Observational Program	Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)	Relapsing-Remitting Multiple Sclerosis	Biological: natalizumab	Biogen	NULL	Completed	N/A	N/A	All	191		Ireland
39	EUCTR2010-021978-11-ES (EUCTR)	21/11/2011	26/09/2011	A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis	Secondary Progressive Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	856	Phase 3	United States;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
40	EUCTR2010-024000-10-IT (EUCTR)	26/10/2011	27/12/2011	A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis	A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis	Relapsing-Remitting Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: TYSABRI IV 1FL 300MG 15ML Trade Name: TYSABRI IV 1FL 300MG 15ML	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Spain;Belgium;Germany;Italy
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	EUCTR2010-021978-11-FI (EUCTR)	28/09/2011	15/08/2011	A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension	Secondary Progressive Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	856		United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
42	EUCTR2010-021978-11-DK (EUCTR)	19/09/2011	23/08/2011	A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension	Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	856	Phase 3	United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
43	EUCTR2010-021978-11-DE (EUCTR)	19/08/2011	04/04/2011	A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, with Optional Open-LabelExtension	Secondary Progressive Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	856		United States;Finland;Spain;Ireland;Russian Federation;Israel;United Kingdom;Iraq;Italy;France;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
44	EUCTR2010-024000-10-ES (EUCTR)	08/08/2011	26/05/2011	A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple Sclerosis	A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE	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: TYSABRI Product Name: Natalizumab for IV Infusion Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB Product Name: Natalizumab for Subcutaneous Injection Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Belgium;Spain;Germany;Italy
45	EUCTR2010-024000-10-DE (EUCTR)	19/07/2011	21/04/2011	A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple Sclerosis	A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE	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: TYSABRI Product Name: Natalizumab for IV Infusion Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB Product Name: Natalizumab for Subcutaneous Injection Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Spain;Belgium;Germany;Italy
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	EUCTR2010-024000-10-BE (EUCTR)	28/06/2011	08/04/2011	A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple Sclerosis	A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE	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: TYSABRI Product Name: Natalizumab for IV Infusion Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB Product Name: Natalizumab for Subcutaneous Injection Product Code: AN100226; BG00002 INN or Proposed INN: NATALIZUMAB	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Spain;Belgium;Germany;Italy
47	EUCTR2010-021978-11-SE (EUCTR)	04/05/2011	30/03/2011	A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis	Secondary Progressive Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Tysabri Product Code: AN100226, BG00002 INN or Proposed INN: NATALIZUMAB Other descriptive name: SUB22282	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	856		United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
48	EUCTR2010-023560-40-SE (EUCTR)	23/03/2011	21/12/2010	Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed.	Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST	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: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Sendoxan Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE Trade Name: Thymoglobuline Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN Trade Name: Neupogen Trade Name: Solu-Medrol	Uppsala l?ns landsting	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120		United States;Canada;Brazil;Sweden
49	NCT01455220 (ClinicalTrials.gov)	January 2011	10/10/2011	The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis	The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis	Multiple Sclerosis	Drug: Tysabri ® (Natalizumab)	University of South Florida	NULL	Completed	18 Years	60 Years	All	45	N/A	United States
50	EUCTR2009-015556-15-AT (EUCTR)	19/11/2010	07/06/2010	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
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	NCT01440101 (ClinicalTrials.gov)	November 2010	14/4/2011	Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)	Multicenter Study of BG00002 in Japanese Subjects With RRMS, Consisting of a Multiple-Dose, Open-Label Evaluation of Its Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Part A) and a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Evaluation of Safety and Efficacy (Part B)	Multiple Sclerosis	Drug: Natalizumab (BG00002);Drug: Placebo	Biogen	NULL	Completed	18 Years	65 Years	All	106	Phase 2;Phase 3	Japan;China
52	EUCTR2009-015556-15-GB (EUCTR)	02/09/2010	17/03/2010	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
53	EUCTR2009-015556-15-DK (EUCTR)	25/08/2010	17/06/2010	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden
54	EUCTR2009-015556-15-DE (EUCTR)	20/08/2010	19/03/2010	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
55	EUCTR2009-015556-15-NL (EUCTR)	13/08/2010	08/04/2010	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms solution for injection in pre-filled syringe Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
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	EUCTR2009-009503-19-BE (EUCTR)	20/07/2010	12/05/2009	A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMER	A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMER	Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: Natalizumab	Biogen Idec International GmbH	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 4	Belgium
57	EUCTR2009-015556-15-HU (EUCTR)	14/07/2010	07/04/2010	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Hungary;Portugal;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
58	EUCTR2009-015556-15-GR (EUCTR)	13/07/2010	14/12/2010	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
59	EUCTR2009-015556-15-PT (EUCTR)	02/07/2010	30/03/2010	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden
60	EUCTR2009-015556-15-LV (EUCTR)	11/06/2010	13/04/2010	Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis	A Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	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: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: Not available Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	76		United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;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
61	EUCTR2009-015556-15-CZ (EUCTR)	10/06/2010	29/03/2010	Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis	A Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	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: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: Not available Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	76		United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Germany;Netherlands;Latvia;Sweden
62	EUCTR2009-015556-15-IT (EUCTR)	07/06/2010	07/06/2010	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND	Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399	Trade Name: TYSABRI INN or Proposed INN: Natalizumab Trade Name: COPAXONE INN or Proposed INN: Glatiramer acetate Trade Name: REBIF INN or Proposed INN: Interferon beta -1a Trade Name: REBIF *SC 12SIR 6000000UI 22MCG INN or Proposed INN: Interferon beta -1a	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
63	EUCTR2009-015556-15-SI (EUCTR)	07/06/2010	12/04/2010	Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis	A Multicenter, Randomized, Open-label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	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: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: Not available Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	76		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Canada;Denmark;Slovenia;Spain;Greece;United States
64	EUCTR2009-015556-15-ES (EUCTR)	24/05/2010	24/03/2010	Estudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	Estudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	Esclerosis Múltiple Recidivante-RemitenteRelapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: TYSABRI 300 mg concentrado para solución para perfusión INN or Proposed INN: NATALIZUMAB Other descriptive name: NATALIZUMAB Trade Name: COPAXONE 20 mg/ml solución inyectable en jeringa precargada INN or Proposed INN: GLATIRAMERO ACETATO Other descriptive name: GLATIRAMER ACETATE Trade Name: REBIF 44 microgramos solución inyectable en jeringa precargada INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
65	EUCTR2009-015556-15-FI (EUCTR)	07/05/2010	24/02/2010	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	Relapsing-Remitting Multiple Sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif Other descriptive name: INTERFERON BETA -1A Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack Other descriptive name: INTERFERON BETA -1A Trade Name: Copaxone Other descriptive name: GLATIRAMER ACETATE	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	1800		Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
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	EUCTR2009-015556-15-SE (EUCTR)	06/05/2010	09/03/2010	Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis	A Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS	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: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available Trade Name: Rebif INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: Not available Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack. INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: Not available Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: Not available	Biogen Idec Limited	NULL	Not Recruiting			Female: yes Male: yes	76		United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Canada;Denmark;Germany;Netherlands;Sweden
67	EUCTR2009-017490-38-DE (EUCTR)	03/05/2010	01/02/2010	Randomized Treatment Interruption of Natalizumab - RESTORE	Randomized Treatment Interruption of Natalizumab - RESTORE	Natalizumab is a highly efficacious therapy used in the treatment of patients with relapsing multiple sclerosis (MS).This is a prospective randomized study in subjects with relapsing forms of MS who have been receiving natalizumab treatment for at least 12 months with no MS relapses during these 12 months. MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Other descriptive name: TYSABRI Trade Name: Copaxone INN or Proposed INN: GLATIRAMER ACETATE Other descriptive name: COPAXONE Trade Name: AVONEX INN or Proposed INN: INTERFERON BETA -1A Other descriptive name: AVONEX Trade Name: Urbason Forte INN or Proposed INN: METHYLPREDNISOLONE Other descriptive name: URBASON FORTE	Biogen Idec	NULL	Not Recruiting			Female: yes Male: yes	200		Germany;Spain
68	NCT01071512 (ClinicalTrials.gov)	April 2010	17/2/2010	Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis	Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis	Multiple Sclerosis	Drug: Tysabri	University of Chicago	Biogen	Completed	18 Years	60 Years	All	20	N/A	United States
69	NCT01070823 (ClinicalTrials.gov)	March 2010	17/2/2010	JC-Virus (JCV) Antibody Program	JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1	Multiple Sclerosis	Drug: Tysabri® (natalizumab)	Biogen	United BioSource Corporation;Elan Pharmaceuticals;United BioSource Corporation;Elan Pharmaceuticals	Completed	N/A	N/A	Both	1096	N/A	United States
70	NCT01058005 (ClinicalTrials.gov)	March 2010	26/1/2010	Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis	A Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple Sclerosis	Relapsing Remitting Multiple Sclerosis	Drug: BG00002 (natalizumab);Drug: interferon beta -1a;Drug: glatiramer acetate	Biogen	Elan Pharmaceuticals	Terminated	18 Years	60 Years	All	84	Phase 3	United States;Australia;Canada;Czech Republic;Finland;France;Hungary;Italy;Latvia;Poland;Slovenia;Spain;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	NCT01070836 (ClinicalTrials.gov)	March 2010	17/2/2010	JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab	JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2	Relapsing Multiple Sclerosis	Drug: natalizumab	Biogen	NULL	Completed	N/A	N/A	Both	35895	N/A	United States;Puerto Rico
72	EUCTR2009-016703-35-DK (EUCTR)	08/01/2010	27/11/2009	Natalizumabbehandling af progressiv multipel sklerose - NAPMS	Natalizumabbehandling af progressiv multipel sklerose - NAPMS	Secondary progressive multiple sclerosis and primary progressive multiple sclerosis MedDRA version: 12.0;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis MedDRA version: 12.0;Classification code 10063401;Term: Primary progressive multiple sclerosis	Trade Name: Tysabri Product Name: Natalizumab INN or Proposed INN: NATALIZUMAB Other descriptive name: Tysabri	Dansk Multipel Sclerose Center	NULL	Not Recruiting			Female: yes Male: yes	24		Denmark
73	NCT00871780 (ClinicalTrials.gov)	August 2009	26/3/2009	A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients	A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients TIMER Study	Relapsing Remitting Multiple Sclerosis (RRMS)	Drug: BG00002 (natalizumab)	Biogen	Elan Pharmaceuticals	Completed	18 Years	60 Years	All	224	Phase 4	Belgium;Mexico;Poland;Romania;Saudi Arabia;Ukraine;Venezuela
74	NCT00884481 (ClinicalTrials.gov)	March 23, 2009	17/4/2009	Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMS	A Multi-centre and Prospective Trial to Evaluate the Effects on Multiple Sclerosis Related Fatigue During Treatment With Tysabri in Patients With Relapsing Remitting Multiple Sclerosis Over the Course of 12 Months	Relapsing-Remitting Multiple Sclerosis;Fatigue	Other: Natalizumab	Biogen	NULL	Completed	18 Years	65 Years	All	195		Austria;Denmark;Norway;Sweden;United States
75	EUCTR2008-008065-35-SE (EUCTR)	13/03/2009	17/12/2008		A multi-centre and prospective trial to evaluate the effects on mul-tiple sclerosis related fatigue during treatment with Tysabri® in patients with relapsing remitting multiple sclerosis over the course of 12 months - TYNERGY	Mutiple sclerosis related fatigue in subjects with relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1;Classification code 10016256;Term: Fatigue	Trade Name: Tysabri	BiogenIdec A/S	NULL	Not Recruiting			Female: yes Male: yes	200		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	NCT00818038 (ClinicalTrials.gov)	March 2009	5/1/2009	A Proof of Concept Study to Evaluate the Effectiveness of Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) Patient Bladder Function	Phase IV, Proof of Concept Study to Evaluate Tysabri Effectiveness in RRMS Patient Bladder Function	Relapsing-Remitting Multiple Sclerosis	Drug: BG0002 (natalizumab)	Biogen Idec	NULL	Completed	18 Years	85 Years	Both	30	Phase 4	United States
77	EUCTR2008-005906-38-FR (EUCTR)	09/02/2009	19/03/2009	Détermination de biomarqueurs associés à la réponse au Natalizumab dans la Sclérose en plaques	Détermination de biomarqueurs associés à la réponse au Natalizumab dans la Sclérose en plaques	sclérose en plaques MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis	Trade Name: Tysabri Product Name: Tysabri	CHU de Toulouse	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	300		France
78	NCT00771043 (ClinicalTrials.gov)	November 2008	7/10/2008	A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a	Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a	Relapsing-Remitting Multiple Sclerosis	Drug: TYSABRI and AVONEX	Biogen Idec	NULL	Withdrawn	18 Years	55 Years	Both	50	Phase 4	United States
79	NCT00744679 (ClinicalTrials.gov)	November 2008	29/8/2008	A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State	An Assessment of the Steady-State Pharmacokinetic and Pharmacodynamic Profile of Tysabri 300 mg Following at Least 12 Monthly Infusions	Multiple Sclerosis	Drug: Natalizumab	Biogen Idec	Elan Pharmaceuticals	Completed	18 Years	55 Years	Both	20	Phase 4	United States
80	EUCTR2007-007394-22-GB (EUCTR)	22/05/2008	11/04/2008	The role of white and grey matter and meningeal inflammation in multiple sclerosis (MS) and clinically isolated syndromes (CIS) as quantified using [(11)C](R)-PK11195 positron emission tomography (PET) scanning	The role of white and grey matter and meningeal inflammation in multiple sclerosis (MS) and clinically isolated syndromes (CIS) as quantified using [(11)C](R)-PK11195 positron emission tomography (PET) scanning	Multiple Sclerosis MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive	Trade Name: Tysabri Product Name: Tysabri	Imperial College London	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 4	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
81	NCT00536120 (ClinicalTrials.gov)	January 2008	25/9/2007	The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis	A Randomized, Open-Label Study to Assess the Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis	Multiple Sclerosis	Biological: BG00002 (natalizumab);Biological: keyhole limpet hemocyanin (KLH);Biological: tetanus diphtheria toxoid vaccine (Td)	Biogen	NULL	Completed	18 Years	60 Years	All	60	Phase 4	United States
82	NCT00937677 (ClinicalTrials.gov)	November 2007	9/7/2009	Effect of Tysabri in Patients With Relapsing-Remitting Multiple Sclerosis: A Follow-up Magnetization Transfer Imaging (MTI) Study	Effect of Natalizumab (Tysabri®) on Remyelination in Patients With Relapsing-remitting Multiple Sclerosis. A Follow-up Voxel-wise Magnetization Transfer Imaging Study.	Multiple Sclerosis	Drug: Tysabri	University at Buffalo	Biogen Idec	Completed	18 Years	65 Years	Both	85	N/A	United States
83	NCT00493298 (ClinicalTrials.gov)	June 29, 2007	27/6/2007	Tysabri Observational Program	TOP: Tysabri® Observational Program	Relapsing-Remitting Multiple Sclerosis	Drug: natalizumab	Biogen	NULL	Active, not recruiting	18 Years	65 Years	All	6620		Argentina;Australia;Belgium;Brazil;Canada;Czechia;Finland;France;Germany;Greece;Italy;Mexico;Netherlands;Norway;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Denmark;Switzerland
84	EUCTR2005-004061-41-SE (EUCTR)	29/06/2007	15/12/2005	TYSABRI Long Term Re-Dosing Study	An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA	Multiple sclerosis (MS) 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: TYSABRI ® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	521		Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
85	EUCTR2005-004061-41-HU (EUCTR)	22/11/2006	20/12/2005	TYSABRI Long Term Re-Dosing Study	An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA	Multiple sclerosis (MS) MedDRA version: 16.0;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: TYSABRI ® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	458		Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;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
86	EUCTR2005-004061-41-GR (EUCTR)	31/10/2006	28/07/2006	An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA	An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA	Multiple sclerosis (MS) MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis	Trade Name: TYSABRI ® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody	BIOGEN IDEC LTD	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900		Finland;Czech Republic;Germany;United Kingdom;Denmark;Spain;Ireland;Italy;Greece;Austria;Sweden
87	EUCTR2005-004061-41-BE (EUCTR)	17/07/2006	29/11/2005	TYSABRI Long Term Re-Dosing Study	An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA	Multiple sclerosis (MS) 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: TYSABRI ® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	521	Phase 3	Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
88	EUCTR2005-004061-41-DK (EUCTR)	19/06/2006	09/01/2006	TYSABRI Long Term Re-Dosing Study	An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA	Multiple sclerosis (MS) 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: TYSABRI ® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	458		Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;New Zealand;Sweden
89	EUCTR2005-004061-41-GB (EUCTR)	01/06/2006	25/10/2005	TYSABRI Long Term Re-Dosing Study	An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA	Multiple sclerosis (MS) 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]		BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	458	Phase 3	Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;New Zealand;Sweden
90	EUCTR2005-004061-41-DE (EUCTR)	18/05/2006	14/12/2005	TYSABRI Long Term Re-Dosing Study	An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA	Multiple sclerosis (MS) 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: TYSABRI ® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	521		Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;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
91	NCT00297232 (ClinicalTrials.gov)	March 2006	27/2/2006	Natalizumab (Tysabri) Re-Initiation of Dosing	An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, C-1803, or C-1808 and a Dosing Suspension Safety Evaluation	Relapsing-Remitting Multiple Sclerosis	Drug: Natalizumab	Biogen	NULL	Terminated	18 Years	N/A	All	1094	Phase 3	Australia;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;New Zealand;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Austria
92	EUCTR2005-004061-41-IT (EUCTR)	24/02/2006	21/04/2006	Extension study with Natalizumab for pts already pertecipated in studies C-1801 e 1802 to evaluate safety of treatment	An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA	sclerosi multipla 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: Tysabri INN or Proposed INN: Natalizumab	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	700		Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Australia;Germany;New Zealand;Sweden
93	EUCTR2005-004061-41-FI (EUCTR)	10/02/2006	01/12/2005	TYSABRI Long Term Re-Dosing Study	An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA	Multiple sclerosis (MS) 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: TYSABRI ® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	458		Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
94	EUCTR2005-004061-41-CZ (EUCTR)	26/01/2006	11/01/2006	TYSABRI Long Term Re-Dosing Study	An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA	Multiple sclerosis (MS) MedDRA version: 16.1;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: TYSABRI ® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	458		Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
95	EUCTR2005-004061-41-IE (EUCTR)	20/01/2006	08/12/2005	TYSABRI Long Term Re-Dosing Study	An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA	Multiple sclerosis (MS) 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: TYSABRI ® Product Name: NATALIZUMAB Product Code: BG00002 INN or Proposed INN: Natalizumab Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody	BIOGEN IDEC LTD	NULL	Not Recruiting			Female: yes Male: yes	458		Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;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

NCT04565431
(ClinicalTrials.gov)

October 2020

25/8/2020

Examining Effects of Tysabri on Cognitive Fatigue Using fMRI

Biomarker for Cognitive Fatigue Using Functional Imaging in Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Drug: Tysabri

Kessler Foundation

St. Barnabas Medical Center

Not yet recruiting

18 Years

64 Years

All

United States

NCT04115488
(ClinicalTrials.gov)

October 1, 2019

10/9/2019

Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®

Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

Relapsing-Remitting Multiple Sclerosis (RRMS)

Biological: Intravenous (IV) infusions

Polpharma Biologics S.A.

NULL

Active, not recruiting

18 Years

60 Years

All

260

Phase 3

Belarus;Croatia;Georgia;Moldova, Republic of;Poland;Serbia;Ukraine

EUCTR2018-004751-20-HR
(EUCTR)

18/09/2019

02/12/2019

A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple Sclerosis

Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope

Relapsing-Remitting Multiple Sclerosis (RRMS)
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]

Product Code: PB006
INN or Proposed INN: NATALIZUMAB
Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: NATALIZUMAB

Polpharma Biologics S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 3

Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of

EUCTR2018-004751-20-PL
(EUCTR)

22/07/2019

25/04/2019

A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple Sclerosis

Antelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope

Product Code: PB006
INN or Proposed INN: NATALIZUMAB
Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: NATALIZUMAB

Polpharma Biologics S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 3

Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of

EUCTR2018-002145-11-GB
(EUCTR)

21/03/2019

11/10/2018

A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab Administration

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration - BIIB 101MS329

Relapsing-remitting multiple sclerosis (RRMS)
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: TYSABRI
Product Name: TYSABRI
INN or Proposed INN: NATALIZUMAB
Trade Name: TYSABRI
Product Name: TYSABRI
INN or Proposed INN: NATALIZUMAB
Other descriptive name: BG00002

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

480

Phase 3

United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;New Zealand;Italy;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

EUCTR2018-002145-11-NL
(EUCTR)

14/03/2019

05/11/2018

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration

Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: BG00002

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

480

Phase 3

United States;France;Canada;Spain;Belgium;Australia;Israel;Germany;Netherlands;United Kingdom;New Zealand;Italy

EUCTR2018-002145-11-DE
(EUCTR)

15/02/2019

17/10/2018

A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab Administration

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration

Biogen Idec Research Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

480

Phase 3

United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;New Zealand;Italy

NCT03399981
(ClinicalTrials.gov)

January 24, 2018

9/1/2018

Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries

An Observational Study Utilising Data From the US Tysabri TOUCH Programme and Select EU MS Registries to Estimate the Risk of Progressive Multifocal Leukoencephalopathy (PML) and Other Serious Opportunistic Infections Among Patients Who Were Exposed to an MS Disease Modifying Treatment Prior to Treatment With Tysabri

Progressive Multifocal Leukoencephalopathy

Biological: Tysabri

Biogen

NULL

Active, not recruiting

N/A

All

72600

United States

EUCTR2017-002634-24-SE
(EUCTR)

29/09/2017

06/07/2017

MultipleMS – a study with the aim to accelerate personalised medicine in multiple sclerosis.

MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMS

Newly diagnosed patients with Clinically Isolated Syndrome (CIS) and multiple sclerosis (MS) -both relapsing remitting and primary progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Gilenya
INN or Proposed INN: FINGOLIMOD
Other descriptive name: FINGOLIMOD
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA -1B
Other descriptive name: INTERFERON BETA -1B
Trade Name: Extavia
INN or Proposed INN: INTERFERON BETA -1B
Other descriptive name: INTERFERON BETA -1B
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: INTERFERON BETA -1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name:

Karolinska Institutet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 4

Sweden

EUCTR2016-003587-39-SE
(EUCTR)

22/05/2017

23/03/2017

This is a long-term study of the safety, efficacy and patient satisfaction of the drug rituximab in comparison with other immunomodulatory treatments for multiple sclerosis. The study will use a national registry for both retrospective and prospective data retrieval.

COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)A prospective long-term cohort study of safety, efficacy and patient’s satisfaction of MS disease modulatory treatments in relapsing-remitting multiple sclerosis - COMparison Between All immunoTherapies for Multiple Sclerosis (COMBAT-MS)

Relapsing-remitting multiple sclerosis (RRMS) that has started on their first or second immunomodulatory drug at the earliest 2011-01-01 and at the latest 2018-06-30. The clinical course and response to treatment is thereafter followed until 2021-06-30;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Karolinska Institutet

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

3700

Phase 4

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

EUCTR2016-000345-31-NL
(EUCTR)

30/09/2016

11/04/2016

Reduce the number of natalizumab infusions in patients with multiple sclerosis

Towards personalized dosing of natalizumab in multiple sclerosis - Personalised Dosing of Natalizumab in Multiple Sclerosis (The PDNMS trial)

multiple sclerosis
MedDRA version: 18.1;Level: LLT;Classification code 10070425;Term: Multiple sclerosis exacerbation;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: tysabri
Product Name: natalizumab
INN or Proposed INN: NATALIZUMAB

VU medical center

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 4

Netherlands

EUCTR2013-004622-29-DE
(EUCTR)

23/02/2015

11/11/2014

Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects

A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects

Multiple Sclerosis (MS)
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: Tysabri ®
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: Gilenya
Product Name: Fingolimod
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 4

France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden

EUCTR2013-005586-39-DE
(EUCTR)

29/01/2015

02/09/2014

Natalizumab (BG00002) as an Efficacy Switch in Subjects with Relapsing Multiple Sclerosis (MS) after Failure on Other Therapies

A Phase 4 Multicenter, Open-Label, Single Arm Study toEvaluate Switching from BRACET/Gilenya® to Natalizumabin Subjects with Relapsing Forms of Multiple Sclerosis (MS)

Multiple Sclerosis (MS)
MedDRA version: 17.1;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: Tysabri ®
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

United States;Germany;Italy

EUCTR2013-004622-29-DK
(EUCTR)

29/01/2015

04/12/2014

Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects

Multiple Sclerosis (MS)
MedDRA version: 19.0;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]

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 4

France;United States;Czech Republic;Spain;Australia;Denmark;Germany;Italy;United Kingdom;Sweden

EUCTR2013-004622-29-SE
(EUCTR)

30/12/2014

29/09/2014

Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 4

France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;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

EUCTR2013-004622-29-ES
(EUCTR)

03/12/2014

03/10/2014

Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects

Multiple Sclerosis (MS)
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]

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 4

France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden

EUCTR2013-004622-29-GB
(EUCTR)

20/11/2014

28/08/2014

Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 4

France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden

EUCTR2013-004622-29-IT
(EUCTR)

10/11/2014

05/08/2014

Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

540

France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Italy;Sweden

EUCTR2013-004622-29-CZ
(EUCTR)

31/10/2014

13/08/2014

Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) Subjects

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

540

Phase 4

France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden

EUCTR2014-003669-97-BE
(EUCTR)

27/10/2014

02/09/2014

A safety study for patients with Relapsing Forms of Multiple Sclerosis who participated STRATA.

A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA.

Relapsing Forms of Multiple Sclerosis
MedDRA version: 17.0;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: Tysabri
Product Name: Tysabri
INN or Proposed INN: NATALIZUMAB

Biogen Idec

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Belgium

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

EUCTR2014-003209-14-FR
(EUCTR)

01/09/2014

18/06/2015

ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS

ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS - TYSADIFF

MULTIPLE SCLEROSIS;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: TYSABRI 300 mg solution à diluer pour perfusion
INN or Proposed INN: NATALIZUMAB

Hôpitaux Universitaires de Strasbourg

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

France

NCT02159573
(ClinicalTrials.gov)

July 2014

19/5/2014

Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)

A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate)

Relapsing-Remitting Multiple Sclerosis

Biological: natalizumab;Drug: dimethyl fumarate

Biogen

NULL

Completed

18 Years

N/A

Both

530

N/A

United States

EUCTR2013-004616-21-DE
(EUCTR)

13/03/2014

04/02/2014

A study to assess immune function and typical disease characteristics in patients with multiple sclerosis, when switching from the medication Natalizumab to the medication Gilenya.

A 32-week, monocentric, exploratory, single arm study to assess immune function and MRI disease activity in patients with relapsing remitting multiple sclerosis (RRMS) transferred from previous treatment with Natalizumab to Gilenya® (Fingolimod) - ToFingo Successor

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: Gilenya
Product Name: Fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB

Universitätsklinikum Münster

NULL

Not Recruiting

Female: yes
Male: yes

Germany

NCT02137109
(ClinicalTrials.gov)

March 2014

1/5/2014

Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

Meta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple Sclerosis

Multiple Sclerosis

Drug: natalizumab

Biogen

NULL

Completed

N/A

18 Years

Both

400

N/A

NULL

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

EUCTR2012-004165-41-GB
(EUCTR)

04/11/2013

19/09/2013

Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study

Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - Hematopoietic Stem Cell Therapy for Inflammatory MS

Inflammatory Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: natalizumab
Trade Name: Fingolimod
Product Name: Gilenya
INN or Proposed INN: Fingolimod
Trade Name: Tecfidera
Product Name: Tecfidera
Product Code: BG-12 120
INN or Proposed INN: dimethyl fumarate

Northwestern University

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 2

United States;United Kingdom

NCT03133403
(ClinicalTrials.gov)

November 2013

21/4/2016

Hematopoietic Stem Cell Therapy for Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy

Hematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study

Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting

Drug: Tecfidera (BG12);Drug: Gilenya;Drug: Tysabri ®;Drug: Avonex /Betaseron/Copaxone/Rebif;Procedure: Hematopoietic stem cell transplantation (HSCT)

Sheffield Teaching Hospitals NHS Foundation Trust

NULL

Recruiting

18 Years

55 Years

All

Phase 2;Phase 3

United Kingdom

EUCTR2012-005082-13-IT
(EUCTR)

02/04/2013

18/02/2013

A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple Sclerosis

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: TYSABRI
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1

Italy

EUCTR2011-001437-16-DE
(EUCTR)

19/09/2012

09/02/2012

A 3 year study to determine if optical coherence tomography can be used to measure disease progression in patients with multiple sclerosis

A 3-year, multi-center study to evaluate optical coherence tomography as an outcome measure in patients with multiple sclerosis -

multiple sclerosis
MedDRA version: 15.0;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: Gilenya
INN or Proposed INN: Fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Extavia
INN or Proposed INN: Interferon beta -1b
Other descriptive name: INTERFERON BETA -1B
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Avonex
INN or Proposed INN: Interferon beta -1a
Other descriptive name: INTERFERON BETA -1A

Novartis Pharma Services AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

420

Germany;Switzerland;Netherlands;France;Italy;Austria;Australia;Czech Republic;United Kingdom;Canada;Denmark;Spain;United States;Poland

EUCTR2010-021978-11-IE
(EUCTR)

06/07/2012

14/05/2012

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis

Secondary Progressive Multiple Sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

Phase 3

United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;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

NCT02142205
(ClinicalTrials.gov)

May 2012

16/5/2014

Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

A Prospective, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety and Efficacy in RUSsian RRMS Patients on One Year Treatment With Natalizumab (TYSabri®).

Relapsing-Remitting Multiple Sclerosis

Biological: BG00002

Biogen Idec

Biogen Idec International GmbH

Completed

18 Years

60 Years

Both

100

Phase 4

Russian Federation

NCT01591551
(ClinicalTrials.gov)

March 2012

22/4/2012

NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or Sleepiness

NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Relapsing Forms of Multiple Sclerosis Experiencing Fatigue or Sleepiness

Multiple Sclerosis, Relapsing-Remitting

Drug: Natalizumab (Tysabri)

Cornerstone Health Care, PA

Biogen Idec

Completed

18 Years

65 Years

Both

Phase 4

United States

NCT01485003
(ClinicalTrials.gov)

February 7, 2012

1/12/2011

Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants

A Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative Patients

Relapsing-Remitting Multiple Sclerosis

Biological: natalizumab

Biogen

NULL

Completed

18 Years

65 Years

All

231

United States

EUCTR2010-021978-11-BE
(EUCTR)

03/02/2012

20/09/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis

Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Sweden

EUCTR2010-021978-11-IT
(EUCTR)

14/12/2011

02/03/2012

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis - 101MS326

Multiple Sclerosis
MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: TYSABRI *IV 1FL 300MG 15ML
INN or Proposed INN: NA
Other descriptive name: NA

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

856

United States;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Belgium;Poland;Denmark;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

EUCTR2010-021978-11-PL
(EUCTR)

07/12/2011

28/10/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

Secondary Progressive Multiple Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden

EUCTR2010-021978-11-CZ
(EUCTR)

02/12/2011

22/08/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

Secondary Progressive Multiple Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

Phase 3

United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden

NCT01943526
(ClinicalTrials.gov)

November 30, 2011

12/9/2013

Ireland Natalizumab (TYSABRI) Observational Program

Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)

Relapsing-Remitting Multiple Sclerosis

Biological: natalizumab

Biogen

NULL

Completed

N/A

All

191

Ireland

EUCTR2010-021978-11-ES
(EUCTR)

21/11/2011

26/09/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis

Secondary Progressive Multiple Sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

Phase 3

United States;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden

EUCTR2010-024000-10-IT
(EUCTR)

26/10/2011

27/12/2011

A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: TYSABRI *IV 1FL 300MG 15ML
Trade Name: TYSABRI *IV 1FL 300MG 15ML

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Spain;Belgium;Germany;Italy

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

EUCTR2010-021978-11-FI
(EUCTR)

28/09/2011

15/08/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

Secondary Progressive Multiple Sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden

EUCTR2010-021978-11-DK
(EUCTR)

19/09/2011

23/08/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

Phase 3

United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden

EUCTR2010-021978-11-DE
(EUCTR)

19/08/2011

04/04/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

United States;Finland;Spain;Ireland;Russian Federation;Israel;United Kingdom;Iraq;Italy;France;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden

EUCTR2010-024000-10-ES
(EUCTR)

08/08/2011

26/05/2011

A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple Sclerosis

A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE

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: TYSABRI
Product Name: Natalizumab for IV Infusion
Product Code: AN100226; BG00002
INN or Proposed INN: NATALIZUMAB
Product Name: Natalizumab for Subcutaneous Injection
Product Code: AN100226; BG00002
INN or Proposed INN: NATALIZUMAB

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Belgium;Spain;Germany;Italy

EUCTR2010-024000-10-DE
(EUCTR)

19/07/2011

21/04/2011

A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple Sclerosis

A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE

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]

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Spain;Belgium;Germany;Italy

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

EUCTR2010-024000-10-BE
(EUCTR)

28/06/2011

08/04/2011

A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple Sclerosis

A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Spain;Belgium;Germany;Italy

EUCTR2010-021978-11-SE
(EUCTR)

04/05/2011

30/03/2011

A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMS

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis

Secondary Progressive Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

856

United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden

EUCTR2010-023560-40-SE
(EUCTR)

23/03/2011

21/12/2010

Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed.

Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST

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: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Sendoxan
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE
Trade Name: Thymoglobuline
Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN
Trade Name: Neupogen
Trade Name: Solu-Medrol

Uppsala l?ns landsting

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

United States;Canada;Brazil;Sweden

NCT01455220
(ClinicalTrials.gov)

January 2011

10/10/2011

The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis

Multiple Sclerosis

Drug: Tysabri ® (Natalizumab)

University of South Florida

NULL

Completed

18 Years

60 Years

All

N/A

United States

EUCTR2009-015556-15-AT
(EUCTR)

19/11/2010

07/06/2010

A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA -1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA -1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

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

NCT01440101
(ClinicalTrials.gov)

November 2010

14/4/2011

Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)

Multicenter Study of BG00002 in Japanese Subjects With RRMS, Consisting of a Multiple-Dose, Open-Label Evaluation of Its Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Part A) and a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Evaluation of Safety and Efficacy (Part B)

Multiple Sclerosis

Drug: Natalizumab (BG00002);Drug: Placebo

Biogen

NULL

Completed

18 Years

65 Years

All

106

Phase 2;Phase 3

Japan;China

EUCTR2009-015556-15-GB
(EUCTR)

02/09/2010

17/03/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

EUCTR2009-015556-15-DK
(EUCTR)

25/08/2010

17/06/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden

EUCTR2009-015556-15-DE
(EUCTR)

20/08/2010

19/03/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

EUCTR2009-015556-15-NL
(EUCTR)

13/08/2010

08/04/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms solution for injection in pre-filled syringe
Other descriptive name: INTERFERON BETA -1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA -1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

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

EUCTR2009-009503-19-BE
(EUCTR)

20/07/2010

12/05/2009

A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMER

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

Trade Name: Tysabri
INN or Proposed INN: Natalizumab

Biogen Idec International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 4

Belgium

EUCTR2009-015556-15-HU
(EUCTR)

14/07/2010

07/04/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Hungary;Portugal;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

EUCTR2009-015556-15-GR
(EUCTR)

13/07/2010

14/12/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

EUCTR2009-015556-15-PT
(EUCTR)

02/07/2010

30/03/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden

EUCTR2009-015556-15-LV
(EUCTR)

11/06/2010

13/04/2010

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

A Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS

Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;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

EUCTR2009-015556-15-CZ
(EUCTR)

10/06/2010

29/03/2010

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Germany;Netherlands;Latvia;Sweden

EUCTR2009-015556-15-IT
(EUCTR)

07/06/2010

A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND

Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399

Trade Name: TYSABRI
INN or Proposed INN: Natalizumab
Trade Name: COPAXONE
INN or Proposed INN: Glatiramer acetate
Trade Name: REBIF
INN or Proposed INN: Interferon beta -1a
Trade Name: REBIF *SC 12SIR 6000000UI 22MCG
INN or Proposed INN: Interferon beta -1a

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

EUCTR2009-015556-15-SI
(EUCTR)

07/06/2010

12/04/2010

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

A Multicenter, Randomized, Open-label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS

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]

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Canada;Denmark;Slovenia;Spain;Greece;United States

EUCTR2009-015556-15-ES
(EUCTR)

24/05/2010

24/03/2010

Estudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS

Esclerosis Múltiple Recidivante-RemitenteRelapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: TYSABRI 300 mg concentrado para solución para perfusión
INN or Proposed INN: NATALIZUMAB
Other descriptive name: NATALIZUMAB
Trade Name: COPAXONE 20 mg/ml solución inyectable en jeringa precargada
INN or Proposed INN: GLATIRAMERO ACETATO
Other descriptive name: GLATIRAMER ACETATE
Trade Name: REBIF 44 microgramos solución inyectable en jeringa precargada
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

EUCTR2009-015556-15-FI
(EUCTR)

07/05/2010

24/02/2010

Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

1800

Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece

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

EUCTR2009-015556-15-SE
(EUCTR)

06/05/2010

09/03/2010

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack.
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available

Biogen Idec Limited

NULL

Not Recruiting

Female: yes
Male: yes

United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Canada;Denmark;Germany;Netherlands;Sweden

EUCTR2009-017490-38-DE
(EUCTR)

03/05/2010

01/02/2010

Randomized Treatment Interruption of Natalizumab - RESTORE

Natalizumab is a highly efficacious therapy used in the treatment of patients with relapsing multiple sclerosis (MS).This is a prospective randomized study in subjects with relapsing forms of MS who have been receiving natalizumab treatment for at least 12 months with no MS relapses during these 12 months.
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: TYSABRI
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: COPAXONE
Trade Name: AVONEX
INN or Proposed INN: INTERFERON BETA -1A
Other descriptive name: AVONEX
Trade Name: Urbason Forte
INN or Proposed INN: METHYLPREDNISOLONE
Other descriptive name: URBASON FORTE

Biogen Idec

NULL

Not Recruiting

Female: yes
Male: yes

200

Germany;Spain

NCT01071512
(ClinicalTrials.gov)

April 2010

17/2/2010

Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis

Multiple Sclerosis

Drug: Tysabri

University of Chicago

Biogen

Completed

18 Years

60 Years

All

N/A

United States

NCT01070823
(ClinicalTrials.gov)

March 2010

17/2/2010

JC-Virus (JCV) Antibody Program

JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1

Multiple Sclerosis

Drug: Tysabri® (natalizumab)

Biogen

United BioSource Corporation;Elan Pharmaceuticals;United BioSource Corporation;Elan Pharmaceuticals

Completed

N/A

Both

1096

N/A

United States

NCT01058005
(ClinicalTrials.gov)

March 2010

26/1/2010

Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis

A Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple Sclerosis

Relapsing Remitting Multiple Sclerosis

Drug: BG00002 (natalizumab);Drug: interferon beta -1a;Drug: glatiramer acetate

Biogen

Elan Pharmaceuticals

Terminated

18 Years

60 Years

All

Phase 3

United States;Australia;Canada;Czech Republic;Finland;France;Hungary;Italy;Latvia;Poland;Slovenia;Spain;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

NCT01070836
(ClinicalTrials.gov)

March 2010

17/2/2010

JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With Natalizumab

JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2

Relapsing Multiple Sclerosis

Drug: natalizumab

Biogen

NULL

Completed

N/A

Both

35895

N/A

United States;Puerto Rico

EUCTR2009-016703-35-DK
(EUCTR)

08/01/2010

27/11/2009

Natalizumabbehandling af progressiv multipel sklerose - NAPMS

Secondary progressive multiple sclerosis and primary progressive multiple sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis
MedDRA version: 12.0;Classification code 10063401;Term: Primary progressive multiple sclerosis

Trade Name: Tysabri
Product Name: Natalizumab
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Tysabri

Dansk Multipel Sclerose Center

NULL

Not Recruiting

Female: yes
Male: yes

Denmark

NCT00871780
(ClinicalTrials.gov)

August 2009

26/3/2009

A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients

A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients TIMER Study

Relapsing Remitting Multiple Sclerosis (RRMS)

Drug: BG00002 (natalizumab)

Biogen

Elan Pharmaceuticals

Completed

18 Years

60 Years

All

224

Phase 4

Belgium;Mexico;Poland;Romania;Saudi Arabia;Ukraine;Venezuela

NCT00884481
(ClinicalTrials.gov)

March 23, 2009

17/4/2009

Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMS

A Multi-centre and Prospective Trial to Evaluate the Effects on Multiple Sclerosis Related Fatigue During Treatment With Tysabri in Patients With Relapsing Remitting Multiple Sclerosis Over the Course of 12 Months

Relapsing-Remitting Multiple Sclerosis;Fatigue

Other: Natalizumab

Biogen

NULL

Completed

18 Years

65 Years

All

195

Austria;Denmark;Norway;Sweden;United States

EUCTR2008-008065-35-SE
(EUCTR)

13/03/2009

17/12/2008

A multi-centre and prospective trial to evaluate the effects on mul-tiple sclerosis related fatigue during treatment with Tysabri® in patients with relapsing remitting multiple sclerosis over the course of 12 months - TYNERGY

Mutiple sclerosis related fatigue in subjects with relapsing remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10016256;Term: Fatigue

Trade Name: Tysabri

BiogenIdec A/S

NULL

Not Recruiting

Female: yes
Male: yes

200

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

NCT00818038
(ClinicalTrials.gov)

March 2009

5/1/2009

A Proof of Concept Study to Evaluate the Effectiveness of Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) Patient Bladder Function

Phase IV, Proof of Concept Study to Evaluate Tysabri Effectiveness in RRMS Patient Bladder Function

Relapsing-Remitting Multiple Sclerosis

Drug: BG0002 (natalizumab)

Biogen Idec

NULL

Completed

18 Years

85 Years

Both

Phase 4

United States

EUCTR2008-005906-38-FR
(EUCTR)

09/02/2009

19/03/2009

Détermination de biomarqueurs associés à la réponse au Natalizumab dans la Sclérose en plaques

sclérose en plaques
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis

Trade Name: Tysabri
Product Name: Tysabri

CHU de Toulouse

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

France

NCT00771043
(ClinicalTrials.gov)

November 2008

7/10/2008

A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a

Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a

Relapsing-Remitting Multiple Sclerosis

Drug: TYSABRI and AVONEX

Biogen Idec

NULL

Withdrawn

18 Years

55 Years

Both

Phase 4

United States

NCT00744679
(ClinicalTrials.gov)

November 2008

29/8/2008

A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady State

An Assessment of the Steady-State Pharmacokinetic and Pharmacodynamic Profile of Tysabri 300 mg Following at Least 12 Monthly Infusions

Multiple Sclerosis

Drug: Natalizumab

Biogen Idec

Elan Pharmaceuticals

Completed

18 Years

55 Years

Both

Phase 4

United States

EUCTR2007-007394-22-GB
(EUCTR)

22/05/2008

11/04/2008

The role of white and grey matter and meningeal inflammation in multiple sclerosis (MS) and clinically isolated syndromes (CIS) as quantified using [(11)C](R)-PK11195 positron emission tomography (PET) scanning

Multiple Sclerosis
MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive

Trade Name: Tysabri
Product Name: Tysabri

Imperial College London

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

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

NCT00536120
(ClinicalTrials.gov)

January 2008

25/9/2007

The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis

A Randomized, Open-Label Study to Assess the Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis

Multiple Sclerosis

Biological: BG00002 (natalizumab);Biological: keyhole limpet hemocyanin (KLH);Biological: tetanus diphtheria toxoid vaccine (Td)

Biogen

NULL

Completed

18 Years

60 Years

All

Phase 4

United States

NCT00937677
(ClinicalTrials.gov)

November 2007

9/7/2009

Effect of Tysabri in Patients With Relapsing-Remitting Multiple Sclerosis: A Follow-up Magnetization Transfer Imaging (MTI) Study

Effect of Natalizumab (Tysabri®) on Remyelination in Patients With Relapsing-remitting Multiple Sclerosis. A Follow-up Voxel-wise Magnetization Transfer Imaging Study.

Multiple Sclerosis

Drug: Tysabri

University at Buffalo

Biogen Idec

Completed

18 Years

65 Years

Both

N/A

United States

NCT00493298
(ClinicalTrials.gov)

June 29, 2007

27/6/2007

Tysabri Observational Program

TOP: Tysabri® Observational Program

Relapsing-Remitting Multiple Sclerosis

Drug: natalizumab

Biogen

NULL

Active, not recruiting

18 Years

65 Years

All

6620

Argentina;Australia;Belgium;Brazil;Canada;Czechia;Finland;France;Germany;Greece;Italy;Mexico;Netherlands;Norway;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Denmark;Switzerland

EUCTR2005-004061-41-SE
(EUCTR)

29/06/2007

15/12/2005

TYSABRI Long Term Re-Dosing Study

An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA

Multiple sclerosis (MS)
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: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

521

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden

EUCTR2005-004061-41-HU
(EUCTR)

22/11/2006

20/12/2005

TYSABRI Long Term Re-Dosing Study

Multiple sclerosis (MS)
MedDRA version: 16.0;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: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

458

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;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

EUCTR2005-004061-41-GR
(EUCTR)

31/10/2006

28/07/2006

Multiple sclerosis (MS)
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis

Trade Name: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Finland;Czech Republic;Germany;United Kingdom;Denmark;Spain;Ireland;Italy;Greece;Austria;Sweden

EUCTR2005-004061-41-BE
(EUCTR)

17/07/2006

29/11/2005

TYSABRI Long Term Re-Dosing Study

Trade Name: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

521

Phase 3

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden

EUCTR2005-004061-41-DK
(EUCTR)

19/06/2006

09/01/2006

TYSABRI Long Term Re-Dosing Study

Trade Name: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

458

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;New Zealand;Sweden

EUCTR2005-004061-41-GB
(EUCTR)

01/06/2006

25/10/2005

TYSABRI Long Term Re-Dosing Study

Multiple sclerosis (MS)
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]

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

458

Phase 3

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;New Zealand;Sweden

EUCTR2005-004061-41-DE
(EUCTR)

18/05/2006

14/12/2005

TYSABRI Long Term Re-Dosing Study

Trade Name: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

521

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;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

NCT00297232
(ClinicalTrials.gov)

March 2006

27/2/2006

Natalizumab (Tysabri) Re-Initiation of Dosing

An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, C-1803, or C-1808 and a Dosing Suspension Safety Evaluation

Relapsing-Remitting Multiple Sclerosis

Drug: Natalizumab

Biogen

NULL

Terminated

18 Years

N/A

All

1094

Phase 3

Australia;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;New Zealand;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Austria

EUCTR2005-004061-41-IT
(EUCTR)

24/02/2006

21/04/2006

Extension study with Natalizumab for pts already pertecipated in studies C-1801 e 1802 to evaluate safety of treatment

sclerosi multipla
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: Tysabri
INN or Proposed INN: Natalizumab

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

700

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Australia;Germany;New Zealand;Sweden

EUCTR2005-004061-41-FI
(EUCTR)

10/02/2006

01/12/2005

TYSABRI Long Term Re-Dosing Study

Trade Name: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

458

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden

EUCTR2005-004061-41-CZ
(EUCTR)

26/01/2006

11/01/2006

TYSABRI Long Term Re-Dosing Study

Multiple sclerosis (MS)
MedDRA version: 16.1;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: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

458

Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden

EUCTR2005-004061-41-IE
(EUCTR)

20/01/2006

08/12/2005

TYSABRI Long Term Re-Dosing Study

Trade Name: TYSABRI ®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody

BIOGEN IDEC LTD

NULL

Not Recruiting

Female: yes
Male: yes

458

Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden