Disease details

臨床試験数 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241

46 trials found

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	EUCTR2020-001205-23-SE (EUCTR)	08/02/2022	06/12/2021	Ocrelizumab VErsus Rituximab off-Label at the Onset of Relapsing MS Disease	Ocrelizumab VErsus Rituximab off-Label at the Onset of RelapsingMS Disease (OVERLORD-MS) - OVERLORD-MS	Remitting Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus Product Name: Ocrelizumab Trade Name: Rituximab Product Name: Rituximab	Helse Bergen HF, Haukeland University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	211	Phase 3	Sweden
2	NCT05049161 (ClinicalTrials.gov)	August 27, 2021	31/8/2021	A Long-term Extension of Study GNC-401	A Long-term Extension of Study GNC-401 With Temelimab in Patients With Relapsing Forms of Multiple Sclerosis (RMS) Under Treatment With Rituximab	Multiple Sclerosis	Drug: Temelimab 18 mg/kg;Drug: Temelimab 36mg/kg;Drug: Temelimab 54 mg/kg	GeNeuro Innovation SAS	NULL	Recruiting	18 Years	55 Years	All	40	Phase 2	Sweden
3	EUCTR2021-001973-21-SE (EUCTR)	09/07/2021	04/06/2021	Extension of Study GNC-401 with temelimab in patients with Multiple Sclerosis under treatment with rituximab	A long-term extension of Study GNC-401 with temelimab in patients with Relapsing forms of Multiple Sclerosis (RMS) under treatment with rituximab - ProTEct-MS Extension	Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: TEMELIMAB Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: TEMELIMAB Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: TEMELIMAB	GeNeuro Innovation SAS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	Sweden
4	NCT04688788 (ClinicalTrials.gov)	April 28, 2021	22/12/2020	Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis	Danish Non-inferiority Study of Ocrelizumab and Rituximab in MS (DanNORMS): A Randomized Study Comparing the Efficacy of Ocrelizumab and Rituximab in Active Multiple Sclerosis	Relapsing Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple Sclerosis	Drug: Rituximab;Drug: Ocrelizumab;Drug: Fexofenadine;Drug: Paracetamol;Drug: Methylprednisolone	Rigshospitalet, Denmark	Odense University Hospital;Aarhus University Hospital;Aalborg University Hospital;Herlev Hospital;Hillerod Hospital, Denmark;Zealand University Hospital;Kolding Sygehus;Regional Hospital Holstebro;Hvidovre University Hospital;Hospital of South West Jutland, Esbjerg, Denmark;GCP unit, Copenhagen University Hospital;GCP-unit at Aarhus University Hospital, Aarhus, Denmark;Hospital of Southern Jutland, Sønderborg, Denmark;Hospital of Central Denmark Region, Viborg, Denmark;Danske Regioner	Recruiting	18 Years	65 Years	All	594	Phase 3	Denmark
5	ChiCTR2100043013	2021-01-31	2021-02-04	Efficacy difference between low dose rituximab and mycophenolate mofetil in preventing recurrence of NMOSD	Efficacy difference between low dose rituximab and mycophenolate mofetil in preventing recurrence of NMOSD	Neuromyelitis optica spectrum diseases	low dose rituximab group: low dose rituximab ;mycophenolate mofetil group:mycophenolate mofetil ;	Shandong University Qilu Hospital	NULL	Pending			Both	low dose rituximab group:30;mycophenolate mofetil group:30;	Phase 4	China
6	NCT04640818 (ClinicalTrials.gov)	December 17, 2020	18/11/2020	Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy	Safety and Efficacy of a Therapy With Cladribine Following a Treatment With Anti CD20 Compounds in Relapsing Multiple Sclerosis Patients: a Pilot Study	Multiple Sclerosis	Drug: Cladribine Oral Tablet;Drug: Rituximab;Drug: Ocrelizumab	Claudio Gobbi	Merck AG Switzerland	Recruiting	18 Years	80 Years	All	45		Switzerland
7	EUCTR2020-002981-15-DK (EUCTR)	15/12/2020	13/07/2020	Non-inferiority study of ocrelizumab and rituximab in active multiple sclerosis.	Danish non-inferiority study of ocrelizumab and rituximab in MS (DanNORMS): A randomized study comparing the efficacy of ocrelizumab and rituximab in active multiple sclerosis. - DanNORMS	Multiple sclerosis. MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Ocrevus INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ruxience INN or Proposed INN: RITUXIMAB	Danish Multiple Sclerosis Center, Rigshospitalet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	594	Phase 3	Denmark
8	NCT04578639 (ClinicalTrials.gov)	November 2, 2020	22/9/2020	Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS Disease	Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing	Relapsing Remitting Multiple Sclerosis	Drug: Rituximab;Drug: Ocrelizumab	Haukeland University Hospital	University Hospital, Akershus;Oslo University Hospital;Helse Stavanger HF;St. Olavs Hospital;University Hospital of North Norway	Recruiting	18 Years	60 Years	All	211	Phase 3	Norway
9	NCT04480307 (ClinicalTrials.gov)	June 17, 2020	10/7/2020	Clinical Trial Assessing Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis	A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients With Relapsing Forms of Multiple Sclerosis (RMS)	Multiple Sclerosis	Drug: temelimab 18 mg/kg;Drug: temelimab 36 mg/kg;Drug: temelimab 54 mg/kg;Drug: Placebo	GeNeuro Innovation SAS	NULL	Active, not recruiting	18 Years	55 Years	All	41	Phase 2	Sweden
10	EUCTR2019-004822-15-SE (EUCTR)	18/05/2020	17/01/2020	A Clinical Trial Examining the Effects of Temelimab Following Rituximab Treatment in Patients with Multiple Sclerosis	A Randomized, Double-Blind, Placebo Controlled Trial, Examining the Safety, Tolerability, Pharmacodynamic Effects and Pharmacokinetics of Temelimab Following Rituximab Treatment in Patients with Relapsing Forms of Multiple Sclerosis (RMS) - ProTEct-MS	Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab Product Name: Temelimab Product Code: GNbAC1 INN or Proposed INN: temelimab	GeNeuro Innovation SAS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	40	Phase 2	Sweden
11	NCT03829566 (ClinicalTrials.gov)	November 2019	1/2/2019	Autologous Transplant To End NMO Spectrum Disorder	Autologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD)	Neuromyelitis Optica;Devic's Disease;NMO Spectrum Disorder	Drug: Rituximab;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem Cells	Northwestern University	NULL	Withdrawn	18 Years	65 Years	All	0	Phase 2/Phase 3	United States
12	NCT04121403 (ClinicalTrials.gov)	October 16, 2019	23/9/2019	Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)	Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS) A Prospective Randomized Open-label Blinded Endpoint (PROBE) Multicenter Non-inferiority Study	Relapsing Multiple Sclerosis;Multiple Sclerosis	Biological: Rituximab;Drug: Cladribine	Oslo University Hospital	University of Oslo;Göteborg University;Sykehuset Ostfold;Sykehuset Telemark;Vestre Viken Hospital Trust;Sorlandet Hospital HF;Helse Stavanger HF;Sykehuset Innlandet HF;Sykehuset i Vestfold HF;Helse Forde;University Hospital of North Norway;St. Olavs Hospital	Recruiting	18 Years	65 Years	All	264	Phase 3	Norway
13	ChiCTR1900025744	2019-09-01	2019-09-07	Clinical effectiveness and safety of Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trial	Clinical effectiveness and safety Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trial	neuromyelitis optica spectrum disorder (NMOSD)	1:Intravenous 200mg Rituximab, 1/week*2, if the proportion of CD19+ B lymphocytes in peripheral blood is above 1% then repeat administration (200mg);2:Oral azathioprine (2.5-3 mg/kg bodyweight/day) or mycophenolate mofetil (750~3000mg/day);	The Ophthalmology Department of the Chinese Peoples Liberation Army Hospital	NULL	Recruiting	18	70	Both	1:30;2:30;	Phase 4	China
14	EUCTR2019-001505-24-NO (EUCTR)	25/07/2019	28/05/2019	A Clinical Study Comparing Rituximab and Cladribine for Relapsing Multiple Sclerosis	Norwegian study of Oral cladribine versus Rituximab in Multiple Sclerosis (NOR-MS). A prospective randomized open-label blinded endpoint (PROBE) multicenter non-inferiority study. - NOR-MS	Relapsing Multiple Sclerosis (RMS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Rituximab konsentrat til infusjonsvaeske oppløsning 10 mg/ml Product Name: Rituximab Trade Name: Mavenclad tabletter 10 mg Product Name: Cladribine	Department of Neurology, Division of Clinical Neuroscience, Oslo University Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	264	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Norway
15	NCT03979456 (ClinicalTrials.gov)	July 4, 2018	3/6/2019	RItuximab Long-Term DOSE Trial in Multiple Sclerosis - RIDOSE-MS	RItuximab Long-Term DOSE Trial in Multiple Sclerosis - RIDOSE-MS. A Randomized Trial of Long-term Dosage of Rituximab in Multiple Sclerosis	Multiple Sclerosis, Relapsing-Remitting	Drug: Rituximab	Karolinska Institutet	NULL	Active, not recruiting	20 Years	52 Years	All	200	Phase 3	Sweden
16	EUCTR2018-000721-31-SE (EUCTR)	04/07/2018	24/04/2018	A clincial study comparing the effectiveness of two doses of the drug Rituximab during long-term treatment of the neurological disease Multiple Sclerosis.	RItuximab Long-Term DOSE Trial in Multiple Sclerosis – RIDOSE-MSA randomized trial of long-term dosage of rituximab in multiple sclerosisThe RIDOSE-MS trial is a multi-centre trial of long-term treatment with rituximab in MS, randomised between two different dosing regimens. Population: Patients with RRMS that has completed the RIFUND-MS trial in either the rituximab or DMF arm. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.Intervention: Treatment with rituximab (Mabthera®) 500 mg every six months. Both the previous rituximab and DMF arms from the RIFUND trial will be treated with rituximab in the RIDOSE trial.Control: After one year of treatment in RIDOSE-MS, patients will be randomised 1:1 to either continue with 500 mg every 6 months or 500 mg every 12 months and continue on this treatment schedule for another 3 years.Outcome: Primary outcome will be the proportion of patients remaining with no evidence of disease activity (NEDA) -3 over the randomised period of 3 years. As secondary endpoints progression of disability, brain atrophy, cognitive function and level of serum Neurofilament-Light will be evaluated. In addition, Patient-related outcome scales measuring fatigue, work ability and treatment satisfaction will be analysed. - RIDOSE-MS	Patients with multiple sclerosis (MS), 20 - 52 years of age, that have completed the RIFUND-MS trial (EudraCT 2015-004116-38) will be offered to continue in this extension trial, RODOSE-MS. In addition, patients will be recruited that has not participated in the RIFUND trial but has been treated with rituximab with the same protocol as in the RIFUND trial as part of clinical practice.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB	Department of Clinical Sciences, Karolinska Institutet Danderyd Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 2	Sweden
17	EUCTR2017-000426-35-AT (EUCTR)	17/04/2018	12/03/2018	The efficacy of treatment of patients with multiple sclerosis, a chronic, inflammatory, autoimmune, disease that leads to neurologic deficits and aggravates with flairs, with low doses of rituximab, an antibody directed against the CD20 epitope on B Lymphocytes, specific cells of the immune system contributing to the progression of the disease - a pilot trial	Efficacy of Rituximab at low doses in Multiple Sclerosis – A prospective, randomized, double-blind, active controlled, pilo trial - Low-dose Rituximab in MS	Relapse Remitting Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;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: Mabthera or biosimilar rituximab product Product Name: Rituximab Product Code: Rituximab INN or Proposed INN: RITUXIMAB Trade Name: Mabthera or biosimilar rituximab product Product Name: Rituximab Product Code: Rituximab INN or Proposed INN: RITUXIMAB	Medical University of Vienna - Department of Neurology	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 2	Austria
18	NCT03315923 (ClinicalTrials.gov)	December 1, 2017	17/10/2017	Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients	Comparison of Expanded Disability Status Scale, Gad-enhanced Brain Lesions, Annualized Relapse Rate, and Side Effects Between Active Secondary Progressive Multiple Sclerosis Patients on Rituximab and Glatiramer Acetate	Secondary Progressive Multiple Sclerosis	Drug: Rituximab;Drug: Glatiramer Acetate	Isfahan University of Medical Sciences	NULL	Completed	18 Years	55 Years	All	84	Phase 2/Phase 3	Iran, Islamic Republic of
19	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
20	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
21	NCT03193866 (ClinicalTrials.gov)	February 1, 2017	20/4/2017	COMparison Between All immunoTherapies for Multiple Sclerosis.	COMparison Between All immunoTherapies for Multiple Sclerosis. An Observational Long-term Prospective Cohort Study of Safety, Efficacy and Patient's Satisfaction of MS Disease Modulatory Treatments in Relapsing-remitting Multiple Sclerosis	Relapsing-remitting Multiple Sclerosis	Drug: Rituximab	Karolinska Institutet	Patient-Centered Outcomes Research Institute;Kaiser Foundation Research Institute	Active, not recruiting	18 Years	N/A	All	3526		Sweden
22	NCT02980042 (ClinicalTrials.gov)	January 1, 2017	9/11/2016	Tolerability and Safety of Switching From Rituximab to Ocrelizumab in Patients With Relapsing Forms of Multiple Sclerosis	Evaluating the Tolerability and Safety Profile of Switching From Rituximab to Ocrelizumab: A Real World Evaluation of Patients With Relapsing Forms of Multiple Sclerosis	Multiple Sclerosis	Drug: Ocrelizumab;Drug: Rituximab	University of Colorado, Denver	NULL	Completed	18 Years	65 Years	All	200	Phase 3	United States
23	NCT02746744 (ClinicalTrials.gov)	May 2016	18/4/2016	RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.	RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis. A Randomized Phase 3 Study Comparing Rituximab With Dimethyl Fumarate in Early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.	Multiple Sclerosis, Relapsing-Remitting	Drug: Rituximab;Drug: Dimethyl fumarate;Drug: Sodium Chloride solution	Anders Svenningsson	NULL	Completed	18 Years	50 Years	All	200	Phase 3	Sweden
24	EUCTR2015-004116-38-SE (EUCTR)	18/12/2015	20/10/2015	A clincial study comparing the effectiveness of two drugs, named Rituximab and Dimethyl Fumarate (Tecfidera®), for the neurological disease Multiple Sclerosis.	RItuximab versus FUmarate in Newly Diagnosed Multiple Sclerosis – RIFUND-MSA randomized phase 3 study comparing Rituximab with Dimethyl Fumarate in early Relapsing-Remitting Multiple SclerosisObjective: To compare the efficacy of rituximab on the ability to prevent relapses in early RRMS and CIS compared with dimethyl fumarate (DMF), which is an approved first-line medication for RRMS today, using a phase 3 design.Population: Patients with newly diagnosed RRMS or CIS with no more than 10 years disease duration (since diagnosis), 18 – 50 years of age and previously not treated with immunomodulating drugs OR treated with first-line injectables. Patients should display protocol-defined clinical or radiological disease activity during the preceding year before screening for inclusion.Intervention: Treatment with rituximab (Mabthera®) with an initial dose of 1000 mg intravenously (iv) followed by 500 mg iv every six months.Control: Treatment with DMF (Tecfidera®) 240 mg twice daily. The two treatments are randomised in a 1:1 proportion.Outcome: Primary outcome is the relative risk of experiencing a relapse during the two–year period for either compound. As secondary endpoints worsening on neurological disability, magnetic-resonance imaging-defined disease activity and effect on cerebrospinal fluid biomarkers will be analysed. In addition, health-economic evaluations of using rituximab as first-line treatment for RRMS will be performed.	Patients with multiple sclerosis (MS) or patients presenting with symptoms highly suspicious of MS while not completely fulfilling diagnostic criteria, 18 - 50 years of age and no more than 10 years of disease duration (from diagnosis). Patients treated with immunomodulatory drugs or treated with first-line injectable therapies (eg interferons or glatiramer acetate) may be included.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Tecfidera INN or Proposed INN: DIMETHYL FUMARATE Other descriptive name: DIMETHYL FUMARATE	Department of Clinical Sciences, Danderyd Hospital	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	Sweden
25	NCT02545959 (ClinicalTrials.gov)	November 30, 2015	7/9/2015	Intrathecal Rituximab in Progressive Multiple Sclerosis	Intrathecal Rituximab in Progressive Multiple Sclerosis	Multiple Sclerosis, Chronic Progressive;Nervous System Diseases	Drug: Rituximab IT;Drug: methylprednisolone IV;Drug: Rituximab IV	Centre Hospitalier de PAU	University Hospital, Bordeaux	Completed	45 Years	N/A	All	10	Phase 2	France
26	NCT03002038 (ClinicalTrials.gov)	September 2015	21/12/2016	Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients	Comparison of Annual Relapse Rate, Expanded Disability Status Scale, and Side Effects Between Azathioprine and Rituximab in Patients With Neuromyelitis Optica Spectrum Disorders	Neuromyelitis Optica Spectrum Disorder	Drug: Azathioprine;Drug: Rituximab	Isfahan University of Medical Sciences	NULL	Completed	18 Years	50 Years	All	86	Phase 2/Phase 3	Iran, Islamic Republic of
27	EUCTR2014-005493-11-FR (EUCTR)	31/08/2015	15/03/2018	Study the action of a single dose of intrathecally-infused rituximab upon cerebro-spinal fluid (CSF) biological targets, assuming that a definitive action upon CSF biological targets would be strongly predictive of a delayed clinical action in patients with Progressive Multiple Sclerosis.	Intrathecal Rituximab in Progressive Multiple Sclerosis - EFFRITE	Patients included in our study suffer from a progressive form of Multiple sclerosis and will be treated by intravenous and intrathecal rituximab, with intravenous methylprednisolone.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Méthylprednisolone Mylan Product Name: méthylprednisolone Trade Name: Mabthera Product Name: rituximab Trade Name: Mabthera Product Name: rituximab	Centre Hospitalier de Pau	NULL	Not Recruiting			Female: yes Male: yes	12	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France
28	JPRN-UMIN000017217	2015/04/21	21/04/2015	An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica	An open-label extension study following the RIN-1 study to investigate the efficacy of rituximab against a relapse of neuromyelitis optica - RIN-2	Neuromyelitis optica	Rituximab intravenous infusion	Clinical Research Center, Utano National Hospital, National Hospital Organization	Zenyaku Kogyo Co., Ltd.	Complete: follow-up complete	16years-old	80years-old	Male and Female	40	Phase 2,3	Japan
29	EUCTR2013-002378-26-SE (EUCTR)	13/11/2014	15/08/2013	Switch To RItuXimab in MS extensionAn extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytes	Switch To RItuXimab in MS extensionAn extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSext	The original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate. This extension study involves the same patients, those that consent to participate in this extension trial. MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: Mabthera ® Product Name: Mabthera	Västerbottens Läns Landsting	NULL	Not Recruiting			Female: yes Male: yes	74	Phase 2	Sweden
30	NCT02253264 (ClinicalTrials.gov)	November 2014	29/9/2014	A Phase 1 Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients	A Phase 1 Open-label Trial of Intrathecal Rituximab for Progressive Multiple Sclerosis Patients With Magnetic Resonance Imaging Evidence of Leptomeningeal Enhancement	Primary Progressive Multiple Sclerosis;Secondary Progressive Multiple Sclerosis	Drug: Rituximab	Johns Hopkins University	NULL	Completed	18 Years	N/A	All	8	Phase 1	United States
31	ChiCTR-ICR-15007177	2014-08-30	2014-05-30	A Prospective Study on the Efficacy andSafety of Rituximab in Treatment for Neuromyelitis Optica associated Optic Neuritis	A Prospective Study on the Efficacy andSafety of Rituximab in Treatment for Neuromyelitis Optica associated Optic Neuritis	Neuromyelitis Optica associated Optic Neuritis	1:Intravenous 100mg Rituximab, 1/week*4 ;2:Oral azathioprine (2.5-3 mg/kg bodyweight/day) or mycophenolate mofetil (1000-1500mg/day);	The Ophthalmology Department of the Chinese Peoples Liberation Army Hospital	NULL	Recruiting	18	70	Both	1:30;2:30;		China
32	JPRN-UMIN000013453	2014/05/10	18/03/2014	A multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibody	A multi-center, randomized, double-blind, placebo-controlled trial to determine the efficacy of rituximab against a relapse of neuromyelitis optica spectrum disorders with anti-aquaporin 4 antibody - RIN-1	Neuromyelitis optica	Rituximab intravenous infusion Placebo	Clinical Research Center, NHO Utano National Hospital	Zenyaku Kogyo Co., Ltd.	Complete: follow-up complete	16years-old	80years-old	Male and Female	40	Phase 2,3	Japan
33	NCT04256252 (ClinicalTrials.gov)	April 2014	2/2/2020	Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE)	Rituximab at Low dosE for neuromyelitiS optiCa spectrUm disordEr (RESCUE): a Prospective, Multicenter, Open-label, Follow-up Clinical Trial	Neuromyelitis Optica Spectrum Disorder	Drug: Rituximab	Tang-Du Hospital	NULL	Completed	16 Years	75 Years	All	108	Phase 4	NULL
34	EUCTR2012-004436-36-DK (EUCTR)	19/04/2013	22/04/2013	Effect of rituximab in secondary progressive multiple sclerosis	A prospective pilotstudy of immunological and radiological effects of intrathecal rituximab in patients with secondary progressive multiple sclerosis	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: MabThera (Rituximab) Product Name: MabThera INN or Proposed INN: RITUXIMAB	Odense University Hospital	NULL	Not Recruiting			Female: yes Male: yes	15	Phase 2	Denmark
35	NCT02040116 (ClinicalTrials.gov)	February 2013	14/1/2014	Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases	Study Evaluating Rapid Infusion Rituximab in Patients With Autoimmune Diseases	Multiple Sclerosis	Drug: Rituximab Infusion	Wake Forest University Health Sciences	NULL	Completed	18 Years	80 Years	All	19	Phase 4	United States
36	EUCTR2012-000721-53-SE (EUCTR)	07/12/2012	16/10/2012	An extension trial of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis	ITT-PMS ExtensionAn extension study of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis - ITT-PMS Ext	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: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB	Dept of Neurology, Umeå University Hospital, Umeå, Sweden	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Sweden
37	JPRN-UMIN000009421	2012/06/28	28/11/2012	Efficacy and safety of rituximab for intractable immunogenic neurological disorder in children		neuromyelitis optica (NMO), opsoclonus-myoclonus syndrome (OMS)	administration of rituximab	Department of Pediatrics, Kobe Universtiy Graduate School of Medicine	NULL	Recruiting	Not applicable	18years-old	Male and Female	10	Not applicable	Japan
38	NCT01569451 (ClinicalTrials.gov)	February 2012	30/3/2012	Comparison of Rituximab Induction Therapy Followed by Glatiramer Acetate	A Double Blinded, Randomized Study Comparing Rituximab Induction Therapy Followed by Glatiramer Acetate Therapy to Glatiramer Acetate Monotherapy in Patients With Relapsing Forms of Multiple Sclerosis	Multiple Sclerosis	Drug: Rituximab;Drug: Glatiramer Acetate;Other: Placebo	University of Colorado, Denver	Rocky Mountain MS Research Group, LLC	Completed	18 Years	55 Years	All	53	Phase 2	United States
39	EUCTR2010-023021-38-SE (EUCTR)	23/02/2011	26/11/2010	Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS	Switch To RItuXimab in MSA phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MS	Relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis	Trade Name: Mabthera INN or Proposed INN: RITUXIMAB	Västerbottens läns landsting	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Sweden
40	NCT01212094 (ClinicalTrials.gov)	September 2010	29/9/2010	Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)	Double Blind Combination of Rituximab by Intravenous and Intrathecal Injection Versus Placebo in Patients With Low-Inflammatory Secondary Progressive Multiple Sclerosis (RIVITaLISe)	Multiple Sclerosis	Drug: Rituximab;Other: normal saline	National Institute of Neurological Disorders and Stroke (NINDS)	NULL	Terminated	18 Years	65 Years	All	44	Phase 1/Phase 2	United States
41	NCT01719159 (ClinicalTrials.gov)	November 2009	25/10/2012	Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis	Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis	Progressive Multiple Sclerosis	Drug: Rituximab	Anders Svenningsson	Västerbotten County Council, Sweden	Completed	18 Years	65 Years	Both	23	Phase 2	Sweden
42	EUCTR2008-002626-11-SE (EUCTR)	02/07/2009	24/04/2009	Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis	Intrathecal therapy with monoclonal antibodies in severe progressive multiple sclerosis - PMSIT	Severe progressive multiple sclerosis in which there is no other documented treatment avalilable or allready tested. It is estimated that the prognosis for these patients are poor without any effective treatment MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders	Trade Name: Mabthera Other descriptive name: RITUXIMAB	Dept of Neurology	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Sweden
43	NCT00097188 (ClinicalTrials.gov)	December 2004	18/11/2004	A Study to Evaluate Rituximab in Adults With Relapsing Remitting Multiple Sclerosis	A Phase II, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab (Mabthera/Rituxan) in Adults With Relapsing Remitting Multiple Sclerosis	Multiple Sclerosis	Drug: rituximab	Genentech, Inc.	NULL	Completed	18 Years	55 Years	Both	104	Phase 2	United States
44	NCT00087529 (ClinicalTrials.gov)	June 2004	9/7/2004	A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis	A Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis	Multiple Sclerosis	Drug: placebo;Drug: rituximab	Genentech, Inc.	NULL	Completed	18 Years	65 Years	All	439	Phase 2/Phase 3	Canada;United States
45	NCT00501748 (ClinicalTrials.gov)	January 2004	12/7/2007	Safety and Tolerability of Rituximab in Neuromyelitis Optica	Open Label Study of Safety and Tolerability of Rituximab in Neuromyelitis Optica, Recurrent Transverse Myelitis and Recurrent Bilateral Simultaneous Optic Neuritis	Neuromyelitis Optica	Drug: Rituximab	University of California, San Francisco	Genentech, Inc.	Completed	12 Years	86 Years	Both	20	Phase 1	United States
46	EUCTR2008-005773-35-IT (EUCTR)		15/01/2013	AUTOLOUGUS STEM CELLS TRANSPLANTATION AFTER LINFOCYTE DEPLETION AS A NEW THERAPY FOR THE AGGRESSIVE AND DRUG RESISTANT FORMS OF MULTIPLE SLEROSIS IN THE ADULTS AND CHILDREN. - AUTOLOUGUS STEM CELLS TRANSPLANTATION IN SM	AUTOLOUGUS STEM CELLS TRANSPLANTATION AFTER LINFOCYTE DEPLETION AS A NEW THERAPY FOR THE AGGRESSIVE AND DRUG RESISTANT FORMS OF MULTIPLE SLEROSIS IN THE ADULTS AND CHILDREN. - AUTOLOUGUS STEM CELLS TRANSPLANTATION IN SM	MULTIPLE SCLEROSIS MedDRA version: 15.1;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: ENDOXAN BAXTER INN or Proposed INN: Cyclophosphamide Trade Name: FLUDARA INN or Proposed INN: Fludarabine Trade Name: THYMOGLOBULINE INN or Proposed INN: Antithymocyte immunoglobulin (rabbit) Trade Name: MABTHERA INN or Proposed INN: Rituximab	AZIENDA OSPEDALIERA DI PADOVA	NULL	NA			Female: yes Male: yes		Phase 1	Italy

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