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 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
| 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 | EUCTR2017-001176-31-PT (EUCTR) | 12/03/2018 | 01/03/2018 | A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Norway;Sweden | ||
| 2 | EUCTR2017-001176-31-FR (EUCTR) | 07/12/2017 | 16/01/2018 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | ||
| 3 | EUCTR2017-001176-31-CZ (EUCTR) | 07/12/2017 | 03/08/2017 | A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | ||
| 4 | EUCTR2017-001176-31-GB (EUCTR) | 06/11/2017 | 21/07/2017 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | ||
| 5 | EUCTR2017-001176-31-DK (EUCTR) | 25/10/2017 | 14/08/2017 | A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | ||
| 6 | EUCTR2017-001176-31-ES (EUCTR) | 20/09/2017 | 12/07/2017 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden;Portugal;Slovenia | ||
| 7 | EUCTR2017-001176-31-FI (EUCTR) | 14/09/2017 | 10/08/2017 | A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | ||
| 8 | EUCTR2017-001176-31-AT (EUCTR) | 07/09/2017 | 26/07/2017 | A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron® | BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies | Clinically-isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B Other descriptive name: RECOMBINANT INTERFERON BETA-1B | Bayer AG | ,NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden | ||
| 9 | EUCTR2016-000434-21-PT (EUCTR) | 14/11/2016 | 14/09/2016 | PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™) | PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™) | Relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Plegridy 125 micrograms INN or Proposed INN: Peginterferon beta-1a Other descriptive name: PEGINTERFERON BETA-1A Trade Name: Rebif 22 micrograms INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A Trade Name: Rebif 44 micrograms INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A Trade Name: Betaferon 250 microgram/ml INN or Proposed INN: Recombinant Interferon Beta-1b Other descriptive name: RECOMBINANT INTERFERON BETA-1B Trade Name: Extavia 250 micrograms/ml INN or Proposed INN: Recombinant Interferon Beta-1b Other descriptive name: RECOMBINANT INTERFERON BETA-1B Trade Name: Plegridy 63 micrograms INN or Proposed INN: Peginterferon beta-1a Other descriptive name: PEGINTERFERON BETA-1A | Biogen Portugal | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 4 | Portugal | ||
| 10 | EUCTR2012-005086-12-PL (EUCTR) | 07/01/2015 | 16/09/2014 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Serbia;Hungary;Poland;Ukraine;Austria;Russian Federation;Bulgaria;Germany | ||
| 11 | EUCTR2012-005086-12-BG (EUCTR) | 14/11/2013 | 19/08/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 234 | Phase 3 | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 12 | EUCTR2012-005086-12-DE (EUCTR) | 12/11/2013 | 01/07/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3 | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 13 | EUCTR2012-005262-35-GB (EUCTR) | 14/08/2013 | 11/06/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: Recombinant interferon beta-1b | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 468 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 14 | EUCTR2012-005262-35-IT (EUCTR) | 14/08/2013 | 25/06/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection Product Name: Betaferon Product Code: BAY86-5046 INN or Proposed INN: Recombinant interferon beta-1b | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 468 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 15 | EUCTR2012-005086-12-HU (EUCTR) | 31/07/2013 | 18/06/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3 | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 16 | EUCTR2012-005262-35-AT (EUCTR) | 19/07/2013 | 02/04/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection INN or Proposed INN: Recombinant interferon beta-1b | Bayer HealthCare AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 468 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 17 | EUCTR2012-005262-35-SI (EUCTR) | 10/07/2013 | 10/07/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection INN or Proposed INN: Recombinant interferon beta-1b | Bayer HealthCare AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 468 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 18 | EUCTR2012-005086-12-AT (EUCTR) | 05/07/2013 | 08/05/2013 | Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulin | Active-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial | relapsing multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Octagam 50 mg/ml INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G Trade Name: Copaxone 20 mg/ml INN or Proposed INN: glatiramer acetate Other descriptive name: GLATIRAMER ACETATE Trade Name: Rebif 44 micrograms Product Name: Rebif 44 micrograms INN or Proposed INN: INTERFERON BETA-1a Trade Name: Betaferon 250 microgram/ml Product Name: Betaferon 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1b Trade Name: Extavia 250 microgram/ml Product Name: Extavia 250 microgram/ml INN or Proposed INN: INTERFERON BETA-1a | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 216 | Phase 3 | Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany | ||
| 19 | EUCTR2012-005262-35-ES (EUCTR) | 28/06/2013 | 13/06/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/mL, powder and solvent for solution for injection. Product Name: Betaferon INN or Proposed INN: Recombinant interferon beta-1b | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 468 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 20 | EUCTR2012-005262-35-FI (EUCTR) | 18/06/2013 | 25/04/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection INN or Proposed INN: Recombinant interferon beta-1b | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 468 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | |||
| 21 | EUCTR2012-005262-35-CZ (EUCTR) | 13/06/2013 | 26/03/2013 | A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron® | BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 | Clinically isolated syndrome (CIS) and multiple sclerosis (MS) MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection INN or Proposed INN: Recombinant interferon beta-1b | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 468 | Phase 4 | Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden |