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 | 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 | ||
| 2 | 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 | ||||
| 3 | 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 | |||
| 4 | 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 | |||
| 5 | 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 | |||
| 6 | 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 | |||
| 7 | 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 | |||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | |||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | |||
| 14 | 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 | ||
| 15 | 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 | |||
| 16 | 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 | |||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 |
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | 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 | ||
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | 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 |
| 37 | 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 |