13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| 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 | NCT04079088 (ClinicalTrials.gov) | June 30, 2021 | 3/9/2019 | Study to Evaluate Oral BIIB061 Added to Interferon-beta1 (IFN-ß1) or Glatiramer Acetate in Relapsing Multiple Sclerosis (RMS) | A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Placebo;Drug: BIIB061;Biological: Interferon-beta1;Drug: Glatiramer acetate | Biogen | NULL | Not yet recruiting | 18 Years | 55 Years | All | 300 | Phase 2 | NULL |
| 2 | NCT04356339 (ClinicalTrials.gov) | November 24, 2020 | 19/4/2020 | US PROmyBETAapp2.0: A Study to Learn More About the Medication Usage and Patient Reported Outcomes Via the myBETAapp in Medical Care of Patients With Multiple Sclerosis Treated With BETASERON Using BETACONNECT Autoinjector | US PROmyBETAapp2.0: Ascertaining Medication Usage and Patient-reported Outcomes (PROs) Via the myBETAapp™ in Patients With Multiple Sclerosis Treated With BETASERON® Using BETACONNECT™ Autoinjector | Multiple Sclerosis | Drug: Interferon-beta-1b (BETASERON, BAY 86-5046) | Bayer | NULL | Completed | 18 Years | N/A | All | 100 | United States | |
| 3 | NCT02903537 (ClinicalTrials.gov) | July 6, 2017 | 21/7/2016 | Tolerogenic Dendritic Cells as a Therapeutic Strategy for the Treatment of Multiple Sclerosis Patients (TOLERVIT-MS) | Tolerance-Induction With Dendritic Cells Treated With Vitamin-D3 and Loaded With Myelin Peptides, in Multiple Sclerosis Patients (TOLERVIT-MS) | Multiple Sclerosis, Relapsing-Remitting;Multiple Sclerosis, Chronic Progressive | Drug: Autologous VitD3 tolerogenic monocyte-derived dendritic cells loaded with a pool of myelin peptides (tolDC-VitD3);Drug: Interferon-beta | Fundació Institut Germans Trias i Pujol | Clinica Universidad de Navarra, Universidad de Navarra | Recruiting | 18 Years | 60 Years | All | 16 | Phase 1 | Spain |
| 4 | EUCTR2014-003145-99-GB (EUCTR) | 19/03/2015 | 19/01/2015 | A trial to determine bexarotene's safety and tolerability and it's ability to promote brain repair in patients with multiple sclerosis. | A randomised placebo-controlled study of the safety and tolerability of a retinoid-X receptor agonist's ability to promote remyelination in people with relapsing-remitting multiple sclerosis already on interferon-beta therapy: a phase 2a trial - CCMR One | Relapsing-remitting multiple sclerosis already on interferon-beta therapy MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Targretin Product Name: Bexarotene INN or Proposed INN: Bexarotene | Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United Kingdom | ||
| 5 | EUCTR2012-005450-30-SE (EUCTR) | 27/01/2014 | 10/12/2013 | Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk of immunization in multiple sclerosis patients on interferon-beta treatment | Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk of immunization in multiple sclerosis patients on interferon-beta treatment - ABIRISK | Development of neutralising antibodies against Interferon-beta in the treatment of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex Trade Name: Rebif Trade Name: Betaferon Trade Name: Extavia | Medizinische Universität Innsbruck | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Austria;Sweden | |||
| 6 | EUCTR2012-005450-30-AT (EUCTR) | 08/01/2014 | 11/11/2013 | Investigation of neutralising antibodies against interferon-beta in patients with multiple sclerosis, in order to find markers to predict the development of these antibodies and minimize the risk of ineffective therapy | Anti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk of immunization in multiple sclerosis patients on interferon-beta treatment - ABIRISK | Development of neutralising antibodies against Interferon-beta in the treatment of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | 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: INTERFERON BETA-1A 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: Rebif 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: INTERFERON BETA-1A | Medizinische Universität Innsbruck | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Austria;Sweden | ||
| 7 | EUCTR2012-004040-30-AT (EUCTR) | 24/05/2013 | 12/03/2013 | Natalizumab de-escalation to interferon-beta-1b in patients withrelapsing-remitting multiple sclerosis: A multicenter study | Natalizumab de-escalation to interferon-beta-1b in patients withrelapsing-remitting multiple sclerosis: A multicenter study | relapse-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BETAFERON® (interferon beta-1b) Product Name: Betaferon INN or Proposed INN: Betaferon Other descriptive name: INTERFERON BETA-1B | Ospedale Regionale di Lugano | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Austria;Switzerland | |||
| 8 | NCT01701856 (ClinicalTrials.gov) | September 2012 | 18/9/2012 | Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis | Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis: A Swiss Multicenter Study Prospective, Controlled, Single-arm, Open-label, Multi-centre, Phase IV Study | Relapsing-remitting Multiple Sclerosis | Drug: Interferon beta-1b | Claudio Gobbi | Bayer | Terminated | 18 Years | 70 Years | Both | 5 | Phase 4 | Switzerland |
| 9 | EUCTR2010-023172-12-LT (EUCTR) | 12/06/2012 | 13/04/2012 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Sweden | |||
| 10 | NCT01404117 (ClinicalTrials.gov) | March 2012 | 26/7/2011 | A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability | Relapsing Multiple Sclerosis | Drug: Laquinimod 0.6;Drug: Laquinimod 1.2;Other: Glatiramer Acetate or interferon-beta+ Placebo | Teva Pharmaceutical Industries | NULL | Withdrawn | 18 Years | 55 Years | Both | 0 | Phase 2 | NULL | |
| 11 | EUCTR2010-023023-19-DE (EUCTR) | 04/01/2012 | 18/11/2011 | Studyto compare the efficacy and safety of fingolimod and interferon-beta-1b in patients with mutliple sclerosis | A 18-month, open-label, rater-blinded, randomized, multicenter, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod in comparison to interferon beta 1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy | treating of cognitive symptoms in 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: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Extavia Other descriptive name: INTERFERON BETA-1B Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Extavia Product Name: Extavia Product Code: NVF233 Other descriptive name: INTERFERON BETA-1B | Novartis Farma S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | Germany;Italy | ||||
| 12 | NCT04289675 (ClinicalTrials.gov) | January 1, 2012 | 27/12/2019 | Multiple Sclerosis: Chi3L1 and Treatment Efficacy | Chi3L1: A Marker of Efficacy of Platform Treatments in Relapsing-onset Multiple Sclerosis: A Prognostic Study on Existing Clinical Data and Biological Samples | Multiple Sclerosis | Drug: Interferon-Beta | Central Hospital, Nancy, France | NULL | Completed | 18 Years | 55 Years | All | 63 | NULL | |
| 13 | EUCTR2010-023172-12-AT (EUCTR) | 26/05/2011 | 06/04/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden | |||
| 14 | EUCTR2010-023172-12-PT (EUCTR) | 30/03/2011 | 01/02/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 15 | EUCTR2010-023172-12-DK (EUCTR) | 23/03/2011 | 26/04/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 16 | EUCTR2010-023677-19-IT (EUCTR) | 23/03/2011 | 10/06/2011 | Bio-molecular effects of interferon-beta and d-vitamin association - VITAD-2010 | Bio-molecular effects of interferon-beta and d-vitamin association - VITAD-2010 | PATIENT WITH RRMS AND SPMS MedDRA version: 13.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive;System Organ Class: 10029205 - Nervous system disorders | Trade Name: BETAFERON*15CONFEZ 0,25MG/ML+ INN or Proposed INN: Interferon beta-1b Trade Name: EXTAVIA*SC 15FL 250MCG/ML+15SI INN or Proposed INN: Interferon beta-1b Trade Name: DIBASE INN or Proposed INN: Colecalciferol | AZIENDA OSPEDALIERA S. LUIGI GONZAGA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 17 | EUCTR2010-023172-12-GR (EUCTR) | 15/03/2011 | 27/01/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Other descriptive name: NA Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis group | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 18 | EUCTR2010-023172-12-GB (EUCTR) | 14/03/2011 | 20/12/2010 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 19 | EUCTR2010-023172-12-FI (EUCTR) | 02/03/2011 | 10/01/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden | |||
| 20 | EUCTR2010-023172-12-DE (EUCTR) | 25/02/2011 | 05/01/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Sweden | |||
| 21 | EUCTR2010-023172-12-SE (EUCTR) | 18/02/2011 | 07/12/2010 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden | |||
| 22 | EUCTR2010-023172-12-NL (EUCTR) | 15/02/2011 | 17/11/2010 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Sweden | |||
| 23 | EUCTR2010-023172-12-ES (EUCTR) | 14/02/2011 | 23/12/2010 | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y seguridad de la teriflunomida en pacientes con esclerosis múltiple recurrente que están en tratamiento con interferón-beta____________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y seguridad de la teriflunomida en pacientes con esclerosis múltiple recurrente que están en tratamiento con interferón-beta____________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Esclerosis múltiple_______Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 24 | EUCTR2010-023172-12-BE (EUCTR) | 08/02/2011 | 29/11/2010 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 25 | EUCTR2010-023172-12-SK (EUCTR) | 26/01/2011 | 20/12/2010 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 26 | EUCTR2010-023172-12-NO (EUCTR) | 25/01/2011 | 03/01/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Norway;Germany;Sweden | |||
| 27 | EUCTR2010-023172-12-IT (EUCTR) | 13/01/2011 | 08/02/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta - ND | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta - ND | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245 | Product Name: teriflunomide Product Code: HMR1726 INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726 INN or Proposed INN: teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 28 | EUCTR2010-023172-12-EE (EUCTR) | 12/01/2011 | 14/12/2010 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden;United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation | |||
| 29 | EUCTR2010-023172-12-HU (EUCTR) | 11/01/2011 | 23/11/2010 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Phase 3 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Sweden | ||
| 30 | NCT01252355 (ClinicalTrials.gov) | January 2011 | 30/11/2010 | Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta | A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis Who Are Treated With Interferon-beta | Multiple Sclerosis Relapse | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-beta (IFN-beta) | Sanofi | NULL | Terminated | 18 Years | 55 Years | All | 534 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;Colombia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;Italy;Korea, Republic of;Lithuania;Netherlands;Norway;Portugal;Russian Federation;Slovakia;Spain;Sweden;Tunisia;United Kingdom;Turkey |
| 31 | NCT01171209 (ClinicalTrials.gov) | July 2010 | 8/7/2010 | REsPonse to Interferon-Alpha in InterfeRon-ß Neutralizing Antibody Positive Multiple Sclerosis Patients | REsPonse to Interferon-Alpha in InterfeRon-ß Neutralizing Antibody Positive Multiple Sclerosis Patients | Multiple Sclerosis | Drug: Interferon-beta and human leukocyte Interferon-a | Melinda Magyari | University of Copenhagen | Completed | 18 Years | 55 Years | Both | 10 | Phase 2 | Denmark |
| 32 | NCT01144052 (ClinicalTrials.gov) | June 2010 | 11/6/2010 | Natalizumab De-escalation With Interferon Beta-1b | De-escalation After Natalizumab Treatment With Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: interferon beta-1b;Drug: Natalizumab | Claudio Gobbi | Ospedale Civico, Lugano | Completed | 18 Years | 60 Years | All | 19 | Phase 4 | Switzerland |
| 33 | EUCTR2009-017003-28-IT (EUCTR) | 12/04/2010 | 08/04/2010 | Relationship between IL-6 and TNF-α polymorphism and flu-like syndrome development in multiple sclerosis patients treated with Interferon-beta 1a i.m. Open label multicentre study - Flu-like Symdrome | Relationship between IL-6 and TNF-α polymorphism and flu-like syndrome development in multiple sclerosis patients treated with Interferon-beta 1a i.m. Open label multicentre study - Flu-like Symdrome | multiple sclerosis MedDRA version: 9.1;Level: SOC;Classification code 10029205 MedDRA version: 9.1;Level: HLGT;Classification code 10012303 MedDRA version: 9.1;Level: HLT;Classification code 10052785 MedDRA version: 9.1;Level: LLT;Classification code 10063399 | Trade Name: AVONEX INN or Proposed INN: Interferon beta-1a | BIOGEN-DOMPE` SRL | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 34 | EUCTR2008-004954-34-AT (EUCTR) | 21/01/2010 | 09/12/2008 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | |||
| 35 | EUCTR2009-013284-19-AT (EUCTR) | 10/12/2009 | 23/11/2009 | Immune tolerance induction in MS patients with neutralizing antibodies against interferon-beta - HINABS | Immune tolerance induction in MS patients with neutralizing antibodies against interferon-beta - HINABS | multiple sclerosis patients with neutralizing antibodies against interferon-beta | Trade Name: Betaferon Other descriptive name: INTERFERON BETA-1B | Medical University Innsbruck | NULL | Not Recruiting | Female: yes Male: yes | Austria | ||||
| 36 | EUCTR2008-004954-34-PL (EUCTR) | 09/09/2009 | 05/06/2009 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 14.0;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: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 37 | EUCTR2008-004954-34-BG (EUCTR) | 28/05/2009 | 29/05/2009 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | |||
| 38 | EUCTR2008-004954-34-GR (EUCTR) | 19/05/2009 | 06/03/2009 | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono International, a branch of Laboratoires Serono SA an affiliate of Merck KGaA, Darmstadt | NULL | Not Recruiting | Female: yes Male: yes | 492 | Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia | |||
| 39 | EUCTR2008-004954-34-DE (EUCTR) | 05/05/2009 | 15/01/2009 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 40 | EUCTR2008-004954-34-FR (EUCTR) | 08/04/2009 | 17/03/2009 | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A.- Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia | ||
| 41 | EUCTR2007-004452-36-GB (EUCTR) | 24/03/2009 | 01/02/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis using interferon-beta 1a (Rebif®) as an open-label rater-blind calibrator | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis using interferon-beta 1a (Rebif®) as an open-label rater-blind calibrator | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | Phase 3 | Belarus;United States;Philippines;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Chile;France;Australia;Netherlands;Tunisia;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Germany;Sweden | ||
| 42 | EUCTR2008-004954-34-LV (EUCTR) | 12/03/2009 | 27/02/2009 | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Latvia;Germany | |||
| 43 | EUCTR2008-004954-34-BE (EUCTR) | 09/03/2009 | 23/01/2009 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Germany | ||
| 44 | EUCTR2008-004954-34-SK (EUCTR) | 05/03/2009 | 09/09/2009 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | ||
| 45 | EUCTR2008-004954-34-EE (EUCTR) | 13/02/2009 | 08/01/2009 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Portugal;Serbia;Estonia;Morocco;Slovakia;Greece;Spain;Lebanon;Israel;Russian Federation;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | |||
| 46 | EUCTR2008-004954-34-PT (EUCTR) | 06/02/2009 | 05/01/2009 | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia | ||
| 47 | EUCTR2008-004954-34-FI (EUCTR) | 26/01/2009 | 17/12/2008 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 48 | EUCTR2008-004954-34-CZ (EUCTR) | 12/12/2008 | 21/11/2008 | Long-term Follow-Up of Patients Who Participated in Study 27025 (REFLEX) | Double-blind extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with Rebif® New Formulation (REFLEXION) - REFLEXION | Subjects of high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis. MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA, Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Serbia;Portugal;Estonia;Slovakia;Morocco;Greece;Spain;Lebanon;Russian Federation;Israel;Italy;France;Latvia;Finland;Turkey;Austria;Czech Republic;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Germany | |||
| 49 | NCT01074346 (ClinicalTrials.gov) | August 2008 | 22/2/2010 | Tolerability of Rebif® (Interferon-beta 1-A) Therapy in Korean Patients With Multiple Sclerosis | A Prospective, Multi-center, Observational Study to Assess the Tolerability of Interferon-beta 1-A (Rebif®) Therapy for Korean Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon-ß-1a | Merck KGaA | NULL | Completed | N/A | N/A | Both | 60 | N/A | Korea, Republic of |
| 50 | EUCTR2007-003997-24-GB (EUCTR) | 08/07/2008 | 20/08/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 51 | EUCTR2007-003997-24-IT (EUCTR) | 05/06/2008 | 13/06/2008 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses - ND | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses - ND | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-Aventis recherche & de'veloppement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 52 | NCT01432704 (ClinicalTrials.gov) | March 2008 | 16/8/2011 | Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS) | Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS | Multiple Sclerosis | Drug: colecalciferol | University of Turku | Bayer | Completed | 18 Years | 50 Years | Both | 70 | Phase 2/Phase 3 | NULL |
| 53 | NCT01339676 (ClinicalTrials.gov) | March 2008 | 19/4/2011 | Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS) | Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS | Multiple Sclerosis | Drug: Colecalciferol;Drug: Placebo capsules | University of Turku | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 70 | Phase 4 | Finland |
| 54 | EUCTR2007-001958-99-FI (EUCTR) | 18/12/2007 | 07/12/2007 | Collecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MS | Collecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MS | Patients with relapsing remitting MS according to the revised Mc Donald's criteria who meet all criteria for inclusion and none criteria of exclusion. MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Dekristol 20000 IE Product Name: Dekristol INN or Proposed INN: INN COLECALCIFEROL Product Name: Placebo Dekristol SGC 20000 | Merja Soilu Häninen | NULL | Not Recruiting | Female: yes Male: yes | Finland | ||||
| 55 | EUCTR2006-002982-38-LT (EUCTR) | 30/11/2007 | 01/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 56 | EUCTR2007-003997-24-ES (EUCTR) | 26/11/2007 | 15/10/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias | Multiple Sclerosis.-----------------------Esclerosis Múltiple. | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 57 | EUCTR2007-003997-24-AT (EUCTR) | 14/10/2007 | 21/09/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Multiple Sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 58 | NCT00811395 (ClinicalTrials.gov) | October 2007 | 18/12/2008 | Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis | Long-term Extension of the Multinational, Double-blind, Placebo Controlled Studies PDY6045 and PDY6046 to Document the Safety of Teriflunomide When Added to Treatment With Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-ß [IFN-ß];Drug: Glatiramer Acetate [GA] | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 182 | Phase 2 | United States;Austria;Canada;Germany;Italy;Spain;United Kingdom |
| 59 | EUCTR2006-003134-14-IT (EUCTR) | 24/09/2007 | 24/07/2007 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis - ND | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis - ND | multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany;Spain;Italy | |||
| 60 | EUCTR2006-003037-32-LT (EUCTR) | 11/09/2007 | 27/11/2006 | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Relapsing remitting Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10063399 | Trade Name: Rebif Product Name: Interferon beta-1a FBS-free/HSA-free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta 1a Other descriptive name: Not applicable | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;Estonia;Spain;Italy;Lithuania | ||
| 61 | EUCTR2006-005972-42-DE (EUCTR) | 20/06/2007 | 15/08/2007 | A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF | A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: NA Product Name: Interferon-beta 1a FBS-free/HSA-free, RNF Product Code: NA INN or Proposed INN: Interferon beta-1a Other descriptive name: recombinant human IFN beta Trade Name: Ibuprofen Sandoz 400 mg Filmtabletten Product Name: Ibuprofen INN or Proposed INN: Ibuprofen | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | Germany;France | ||
| 62 | EUCTR2006-005972-42-FR (EUCTR) | 12/06/2007 | 05/04/2007 | A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF | A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF | Relapsing multiple sclerosis MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: NA Product Name: Interferon-beta 1a FBS-free/HSA-free, RNF Product Code: NA | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;Germany | ||
| 63 | EUCTR2006-003134-14-DE (EUCTR) | 04/06/2007 | 08/02/2007 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis | Multiple sclerosis | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany;Spain;Italy | |||
| 64 | NCT00490906 (ClinicalTrials.gov) | June 2007 | 21/6/2007 | Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis | Comparison of Bone Effects With Copaxone and Interferon in Multiple Sclerosis: A Pilot Study | Multiple Sclerosis;Low Bone Density | Drug: Copaxone;Drug: Interferon-beta 1a;Drug: Interferon-beta 1b | Nancy Hammond, MD | Kansas City Area Life Sciences Institute, Inc. | Completed | 18 Years | N/A | Female | 60 | N/A | United States |
| 65 | EUCTR2006-002982-38-PT (EUCTR) | 29/05/2007 | 22/02/2007 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 66 | EUCTR2006-002982-38-GR (EUCTR) | 08/05/2007 | 29/12/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 67 | NCT00489489 (ClinicalTrials.gov) | May 2007 | 20/6/2007 | Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis | A Randomized, Multinational, Double-Blind, Placebo-Controlled, Parallel-Group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Interferon-beta in Subjects With Multiple Sclerosis. | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for Teriflunomide);Drug: Interferon-ß | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 118 | Phase 2 | United States;Canada;Germany;Italy;Spain;Poland |
| 68 | EUCTR2006-003037-32-DE (EUCTR) | 13/04/2007 | 01/12/2006 | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Relapsing remitting Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10063399 | Trade Name: Rebif Product Name: Interferon beta-1a FBS-free/HSA-free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta 1a Other descriptive name: Not applicable | Merck Serono SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;Estonia;Spain;Italy;Lithuania | ||
| 69 | NCT00468182 (ClinicalTrials.gov) | April 2007 | 30/4/2007 | Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis | Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon-beta 1b (Betaseron) | Rutgers, The State University of New Jersey | Bayer | Completed | 18 Years | 60 Years | Both | 24 | United States | |
| 70 | EUCTR2006-002982-38-DE (EUCTR) | 16/03/2007 | 10/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany | ||
| 71 | EUCTR2006-002982-38-EE (EUCTR) | 15/03/2007 | 31/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 72 | EUCTR2006-003037-32-EE (EUCTR) | 06/03/2007 | 26/01/2007 | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Relapsing remitting Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10063399 | Trade Name: Rebif Product Name: Interferon beta-1a FBS-free/HSA-free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta 1a Other descriptive name: Not applicable | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;Estonia;Spain;Italy;Lithuania | ||
| 73 | NCT01111656 (ClinicalTrials.gov) | March 2007 | 15/3/2010 | Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b | SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study (SWABIMS Follow Up-study) | Relapsing-remitting Multiple Sclerosis | Drug: Interferon beta-1b group;Drug: Interferon beta-1b/Atorvastatin group | University Hospital Inselspital, Berne | Viollier AG, Basel, Switzerland;PharmaPart GmbH, Thalwil, Switzerland | Completed | 18 Years | 67 Years | Both | 28 | Phase 2 | Switzerland |
| 74 | EUCTR2006-003134-14-ES (EUCTR) | 23/02/2007 | 26/10/2009 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis.----------------------------------------------------------------------------------------------------------Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias”. | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis.----------------------------------------------------------------------------------------------------------Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias”. | Multiple sclerosis.Esclerosis Múltiple. | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Spain;Germany;Italy | ||
| 75 | EUCTR2007-000503-15-IT (EUCTR) | 19/02/2007 | 20/04/2007 | Experimental clinical open study, randomized, experimental group vs control group, for the evaluation of tolerability and the effects on magnetic resonance parameters and cognitive functions of memantine in patients at early stage of relapsing- remitting multiple sclerosis treated with interferon-beta. - NEMESI-MS Neuroprotection by Memantine at Early Stage In Multiple Sclerosis | Experimental clinical open study, randomized, experimental group vs control group, for the evaluation of tolerability and the effects on magnetic resonance parameters and cognitive functions of memantine in patients at early stage of relapsing- remitting multiple sclerosis treated with interferon-beta. - NEMESI-MS Neuroprotection by Memantine at Early Stage In Multiple Sclerosis | patients at early stage of relapsing- remitting multiple sclerosis treated with interferon-beta. MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: EBIXA INN or Proposed INN: Memantine | AZ. OSPEDALIERA GARIBALDI, S.LUIGI CURRO , ASCOLI TOMASELLI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 76 | EUCTR2006-003037-32-ES (EUCTR) | 09/02/2007 | 10/03/2010 | Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) | Relapsing remitting Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10063399 | Trade Name: Rebif Product Name: Interferon beta-1a FBS-free/HSA-free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta 1a Other descriptive name: Not applicable | Merck Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Estonia;Spain;Lithuania;Germany;Italy | ||
| 77 | EUCTR2006-002982-38-SK (EUCTR) | 12/01/2007 | 06/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International, a branch of Laboratoires Serono SA An affiliate of Merck KGaA | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany | ||
| 78 | EUCTR2006-002982-38-FR (EUCTR) | 05/01/2007 | 24/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany | ||
| 79 | EUCTR2006-002982-38-DK (EUCTR) | 20/12/2006 | 30/11/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Denmark;Belgium;Estonia;Spain;Greece | ||
| 80 | EUCTR2006-002982-38-FI (EUCTR) | 19/12/2006 | 19/10/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 81 | EUCTR2006-002982-38-AT (EUCTR) | 04/12/2006 | 29/09/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Not Applicable Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 82 | NCT00441103 (ClinicalTrials.gov) | December 2006 | 26/2/2007 | A Study to Evaluate Rebif® New Formulation (Interferon-beta-1a) in Relapsing Remitting Multiple Sclerosis | A Two-arm, Randomized, Double-blind, Control Group-compared, Multicenter, Phase IIIb Study With Monthly MRI and Biomarker Assessments to Evaluate the Efficacy, Safety, and Tolerability of Rebif® New Formulation (IFN Beta-1a) in Subjects With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Rebif® New Formulation (IFN-beta-1a, RNF);Drug: Placebo | Merck KGaA | NULL | Completed | 18 Years | 60 Years | All | 180 | Phase 3 | Canada;Germany;Italy;Russian Federation;Spain;Switzerland |
| 83 | NCT00436826 (ClinicalTrials.gov) | November 30, 2006 | 15/2/2007 | A Phase 2 Study of Cladribine Add-on to Interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD) | A Phase II, Multicenter, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability and Efficacy Study of Add-on Cladribine Tablet Therapy With Interferon-beta (IFN-ß) Treatment in Multiple Sclerosis Subjects With Active Disease | Multiple Sclerosis | Drug: Cladribine;Drug: Placebo;Drug: Interferon-beta (IFN-beta) | EMD Serono Research & Development Institute, Inc. | NULL | Completed | 18 Years | 65 Years | All | 172 | Phase 2 | United States;Italy;Russian Federation;Spain |
| 84 | EUCTR2006-002982-38-BE (EUCTR) | 29/11/2006 | 14/09/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A.-Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Belgium;Denmark;Germany | ||
| 85 | EUCTR2006-000606-23-ES (EUCTR) | 23/11/2006 | 15/03/2012 | ?Post-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phase | Post-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phase - PASS-PD del escalado de dosis de Rebif | Not applicalbe MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif 22 y 44 mcg Product Name: Interferon-beta-1a Other descriptive name: INTERFERON BETA-1A | Merck, S.L. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Spain | ||
| 86 | EUCTR2006-002982-38-CZ (EUCTR) | 03/11/2006 | 15/09/2006 | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis - Rebif FLEXible dosing in early Multiple Sclerosis (REFLEX) | Subjects at high risk of converting to Multiple Sclerosis MedDRA version: 9.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta 1a FBS-free/HSA free, RNF Product Code: Not Applicable INN or Proposed INN: Interferon-beta 1a | Merck Serono S.A. - Geneva, an affiliate of Merck KGaA Darmstadt, Germany | NULL | Not Recruiting | Female: yes Male: yes | 480 | Phase 3 | Portugal;Germany;France;Italy;Austria;Lithuania;Finland;Czech Republic;Belgium;Denmark;Estonia;Spain;Greece | ||
| 87 | EUCTR2004-001286-17-PT (EUCTR) | 08/09/2006 | 23/03/2006 | Exploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosis | Exploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosis | Relapsing-remitting or relapsing secondary progressive multiple sclerosis with high activity MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Mitoxantrone Product Code: N/A | Fundación Española de Esclerosis Múltiple (FEDEM) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Portugal | |||
| 88 | EUCTR2005-005751-18-GB (EUCTR) | 07/09/2006 | 17/02/2006 | A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study | A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study | Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system of unknown aetiology. It is the commonest cause of disability in young adults. The prevalence in the UK is approximately 125/100,000 of the population with an annual incidence of 6/100,000. Approximately 80,000 individuals are affected with MS in the UK. | Trade Name: Rebif 44 Product Name: Rebif 44 Product Code: Interferon beta 1a INN or Proposed INN: Interferon beta 1a Trade Name: Rebif 22 Product Name: Rebif 22 Product Code: Interferon beta 1a INN or Proposed INN: Interferon beta 1a Product Name: Betaferon 500mcg Product Code: Betaferon 500mcg INN or Proposed INN: Interferon beta 1b | UCL Biomedicine R&D Unit | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom | |||
| 89 | NCT00344253 (ClinicalTrials.gov) | March 2006 | 22/6/2006 | Randomized, Controlled Trial to Test the Efficacy of Interferon Beta in the Treatment of Intermediate Uveitis | A Monocentric, Randomized, Controlled Trial to Test the Efficacy of Interferon-beta in the Treatment of Disseminated Encephalomyelitis (ED)-Associated and Primary Intermediate Uveitis in Comparison to Standard Treatment (TEAM) | Uveitis, Intermediate;Macular Edema;Multiple Sclerosis | Drug: Interferon beta;Drug: Methotrexate | Heidelberg University | Serono GmbH | Completed | 18 Years | N/A | Both | 19 | Phase 3 | Germany |
| 90 | EUCTR2004-004403-37-DE (EUCTR) | 27/02/2006 | 28/10/2005 | Eine monozentrische, randomisierte, kontrollierte Studie zur Untersuchung von Interferon-beta zur Behandlung der Multiplen-Sklerose (MS)-assoziierten und primären Uveitis intermedia im Vergleich zur StandardtherapieA monocentric, randomised, controlled trial for the investigation of Interferon-beta in the treatment of multiple-slerosis (MS)-associated and primary uveitis intermedia compared to the standardized treatment - TEAM-Studie | Eine monozentrische, randomisierte, kontrollierte Studie zur Untersuchung von Interferon-beta zur Behandlung der Multiplen-Sklerose (MS)-assoziierten und primären Uveitis intermedia im Vergleich zur StandardtherapieA monocentric, randomised, controlled trial for the investigation of Interferon-beta in the treatment of multiple-slerosis (MS)-associated and primary uveitis intermedia compared to the standardized treatment - TEAM-Studie | Uveitis intermedia with inflammatory macula edema with or without associated Multiple Sclerosis | Product Name: Rebif INN or Proposed INN: Interferon beta-1a Product Name: Rebif INN or Proposed INN: Interferon beta-1a Product Name: Metex INN or Proposed INN: Methotrexat | Universitätsklinikum Heidelberg | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 3 | Germany | ||
| 91 | NCT01134627 (ClinicalTrials.gov) | February 2006 | 28/5/2010 | Minocycline as add-on to Interferon Beta-1a [IFN Beta-1a] (Rebif®) in Relapsing-Remitting Multiple Sclerosis [RRMS] | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline Versus Placebo as Add-on Therapy in Patients Who Are on Treatment With Interferon-beta-1a 44 Mcg Tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Minocycline;Drug: Placebo | Merck KGaA | NULL | Terminated | 18 Years | 55 Years | All | 305 | Phase 2 | Denmark |
| 92 | NCT00492765 (ClinicalTrials.gov) | February 2006 | 25/6/2007 | Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment IM Administered Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon-beta-1a;Drug: Simvastatin;Drug: Placebo | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 380 | Phase 4 | Denmark |
| 93 | EUCTR2005-004289-18-FI (EUCTR) | 26/01/2006 | 07/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Sweden | |||
| 94 | EUCTR2005-003930-16-SE (EUCTR) | 19/01/2006 | 21/11/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Sweden | |||
| 95 | EUCTR2005-003930-16-FI (EUCTR) | 05/01/2006 | 29/11/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who have been prescribed treatment with Avonex. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Trade Name: Simvastatin Alternova Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Sweden | |||
| 96 | EUCTR2005-004289-18-SE (EUCTR) | 04/01/2006 | 10/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Sweden | |||
| 97 | EUCTR2005-004289-18-DK (EUCTR) | 19/12/2005 | 28/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | E. Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Denmark;Sweden | |||
| 98 | EUCTR2005-003930-16-DK (EUCTR) | 09/12/2005 | 05/12/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Denmark;Sweden | |||
| 99 | EUCTR2005-001009-25-IT (EUCTR) | 16/07/2005 | 15/03/2006 | Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with Relapsing-remitting multIple sclerosis in treAtment with INterferoN-betA. - ARIANNA | Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with Relapsing-remitting multIple sclerosis in treAtment with INterferoN-betA. - ARIANNA | Multiple sclerosis treatment MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: TORVAST*10CPR 10MG INN or Proposed INN: Atorvastatin Trade Name: TORVAST*10CPR 10MG INN or Proposed INN: Atorvastatin | DR DIMENSIONE RICERCA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 100 | NCT00942591 (ClinicalTrials.gov) | May 2005 | 17/7/2009 | Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b | Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b.SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis. | Multiple Sclerosis | Drug: Interferon beta 1b;Drug: Atorvastatin | University Hospital Inselspital, Berne | CRO: PharmaPart AG, Bahnhofstrasse 20, P.O. Box 173, CH-8800 Thalwil;Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 Basel | Completed | 18 Years | 55 Years | Both | 77 | Phase 2 | Switzerland |
| 101 | NCT01142453 (ClinicalTrials.gov) | May 2005 | 10/6/2010 | An Observational Study Evaluating Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in Multiple Sclerosis (MS) Patients | Therapy Optimisation Using High-frequency and High-dosage Administration of Interferon-beta (Rebif®) in MS Patients. Case Series for Adjustment of Treatment Strategy and Its Monitoring | Relapsing-Remitting Multiple Sclerosis | Drug: Interferon beta 1a | Merck KGaA | Gesellschaft für Therapieforschung mbH | Completed | N/A | N/A | Both | 231 | N/A | NULL |
| 102 | EUCTR2004-003799-13-GB (EUCTR) | 16/03/2005 | 18/07/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | ||
| 103 | EUCTR2004-003799-13-LT (EUCTR) | 08/03/2005 | 27/12/2004 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | United Kingdom;Spain;Ireland;Sweden;Lithuania | ||
| 104 | EUCTR2004-003799-13-DK (EUCTR) | 24/02/2005 | 18/01/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | ||
| 105 | EUCTR2004-003799-13-ES (EUCTR) | 17/02/2005 | 04/11/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | ||
| 106 | EUCTR2004-003799-13-SE (EUCTR) | 03/02/2005 | 23/12/2004 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | United Kingdom;Spain;Ireland;Lithuania;Sweden | ||
| 107 | NCT00110396 (ClinicalTrials.gov) | January 2005 | 6/5/2005 | Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis | A Multicentre, Single Arm, Open-Label, Phase IIIB Study to Evaluate the Safety and Antigenicity of Rebif® (Interferon-beta-1a) in Subjects With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Biological: Interferon-beta-1a FBS-free/HSA-free | EMD Serono | Pfizer | Completed | 18 Years | 60 Years | All | 260 | Phase 3 | United States |
| 108 | NCT01142557 (ClinicalTrials.gov) | June 2004 | 10/6/2010 | An Observational Study to Document the Effectiveness and Compatibility of Rebif 44 or 22 µg in the Therapy of the Chronic Multiple Sclerosis | Therapy of the Chronic Multiple Sclerosis With Interferon-beta 1a (Rebif®) | Multiple Sclerosis | Drug: Interferon beta-1a (Rebif) | Merck KGaA | Gesellschaft für Therapieforschung mbH | Completed | N/A | N/A | Both | 522 | N/A | Germany |
| 109 | NCT00493077 (ClinicalTrials.gov) | May 2004 | 25/6/2007 | Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy | A Swedish Multi-Centre, Prospective, Open Label Study: Safety of Avonex Treatment in Multiple Sclerosis Patients Who Are NAB Positive on Previous s.c Interferon Beta Therapy | Multiple Sclerosis | Drug: low immunogenic interferon-beta-1a | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 3 | Phase 4 | Sweden |
| 110 | NCT00493116 (ClinicalTrials.gov) | October 2003 | 25/6/2007 | Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta | A Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced Bioavailability | Relapsing-Remitting Multiple Sclerosis | Drug: Interferon-beta-1a;Drug: methylprednisolone | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 20 | Phase 4 | Australia;New Zealand |
| 111 | NCT00492466 (ClinicalTrials.gov) | March 2003 | 25/6/2007 | Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies | A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies | Relapsing-Remitting Multiple Sclerosis | Drug: Interferon-beta-1a;Drug: methylprednisolone | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 14 | Phase 4 | Finland |
| 112 | NCT00168766 (ClinicalTrials.gov) | January 2003 | 13/9/2005 | Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS | A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Interferon-beta-1a (Avonex) plus methylprednisolone | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 345 | Phase 4 | Belgium;Denmark;Finland;Netherlands;Norway;Sweden;Switzerland;United Kingdom |
| 113 | NCT00151801 (ClinicalTrials.gov) | May 2002 | 8/9/2005 | Safety and Tolerability of Interferon-Beta-1a and Estroprogestins Association in MS Patients | Safety and Tolerability of Oral Two-Doses Estroprogestins Associated With Interferon-Beta 1a in Patients With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: estroprogestins;Drug: interferon-beta 1a | S. Andrea Hospital | NULL | Recruiting | 18 Years | 40 Years | Female | 200 | Phase 2 | Italy |
| 114 | NCT00219908 (ClinicalTrials.gov) | July 1999 | 16/9/2005 | Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis | Evaluation of a New Therapeutic Strategy in Early and Active Relapsing-Remitting Multiple Sclerosis: Induction Treatment With Mitoxantrone Followed by Long-Term Treatment With Interferon-beta1b | Relapsing-Remitting Multiple Sclerosis | Drug: Mitoxantrone | Rennes University Hospital | Bayer;Wyeth is now a wholly owned subsidiary of Pfizer;Farmades, Italy | Terminated | 18 Years | 45 Years | Both | 124 | Phase 2 | France;Italy |
| 115 | EUCTR2004-003799-13-IE (EUCTR) | 13/01/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden |