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 | 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 | |
| 2 | NCT02749396 (ClinicalTrials.gov) | May 2, 2016 | 20/4/2016 | EPID Multiple Sclerosis Pregnancy Study | Pregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon ß - a Register-based Study in the Nordic Countries | Multiple Sclerosis | Drug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG;Drug: Extavia (interferon beta-1b), Novartis Pharma AG;Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd;Drug: Plegridy (peginterferon beta-1a), Biogen Idec Ltd;Drug: Avonex (interferon beta-1a), Biogen Idec Ltd;Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046);Other: No MSDMDs therapy (control) | Bayer | EPID Research;Biogen;Merck Serono Europe Ltd;Novartis Pharmaceuticals | Completed | N/A | N/A | Female | 2089 | Finland | |
| 3 | NCT02652091 (ClinicalTrials.gov) | February 5, 2016 | 5/1/2016 | Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction | Impact of the BETACONNECT Auto-injector on BETASERON Therapy Adherence and Patient Satisfaction | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta-1b (Betaseron, BAY86-5046);Device: BETACONNECT device | Bayer | NULL | Completed | 18 Years | N/A | All | 146 | United States | |
| 4 | NCT02121444 (ClinicalTrials.gov) | June 23, 2014 | 22/4/2014 | BAY86-5046 (Betaseron), Non Interventional Studies | BETAEVAL - The New BETACONNECT® Auto-injector: Adherence and EVALuation of MS Patients Treated With Betaferon® | Multiple Sclerosis | Drug: Interferon beta-1b (Betaferon, BAY 86-5046);Device: BETACONNECT auto-injector. | Bayer | NULL | Completed | 18 Years | N/A | All | 151 | N/A | Germany |
| 5 | NCT01706055 (ClinicalTrials.gov) | September 2012 | 7/9/2012 | Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE) | Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon® | Multiple Sclerosis | Biological: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | All | 629 | N/A | Poland |
| 6 | NCT01491100 (ClinicalTrials.gov) | April 30, 2012 | 12/12/2011 | Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis | Study Assessing Cognitive Performance Plus Physical Activity in Patients With Relapsing-Remitting MS Under Treatment With Betaferon® | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 12 Years | 70 Years | All | 1085 | Albania;Algeria;Argentina;Belgium;Czechia;Egypt;France;Germany;Greece;Hungary;Israel;Kazakhstan;Netherlands;Portugal;Saudi Arabia;Tunisia;Turkey;Bosnia and Herzegovina;Czech Republic;Jordan;Lebanon;Mexico;Poland;Syrian Arab Republic | |
| 7 | NCT01436838 (ClinicalTrials.gov) | March 2012 | 19/9/2011 | China Betaferon Adherence, Coping and Nurse Support Study | Prospective Study of Betaferon in Adherence, Coping and Nurse Support in Patients of Chinese Origin With Multiple Sclerosis | Multiple Sclerosis, Chronic Progressive | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 75 Years | Both | 110 | N/A | China |
| 8 | NCT01076595 (ClinicalTrials.gov) | May 2010 | 25/2/2010 | Prospective, Multicenter Non Interventional Study to Evaluate Adherence to Betaferon Over a 2 Years Period | Prospective Multicenter, Non Interventional Study to Evaluate the Patient's Characteristics Associated With Adherence to Treatment Regimen by Betaferon in the BetaPlus Program | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 73 | N/A | France |
| 9 | NCT01031459 (ClinicalTrials.gov) | January 2010 | 8/12/2009 | Telephone Interview of Patients That Participated in the the Pivotal Betaferon MS Trial. | An Observational 20-year, Cross-sectional, Long-term Follow up of the Patient Cohort Enrolled in the Pivotal Study of Betaseron® (Interferon Beta-1b) in Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Betaseron (Interferon beta-1b, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 176 | N/A | United States;Canada |
| 10 | NCT00963833 (ClinicalTrials.gov) | December 17, 2009 | 21/8/2009 | Study Evaluating Betaferons Safety and Tolerability In Pediatric Patients With Multiple Sclerosis | Study Evaluating Betaferons® Safety and Tolerability In Pediatric Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 12 Years | 16 Years | All | 68 | N/A | Austria;Belgium;Finland;Germany;Israel;United Kingdom;Italy;Portugal |
| 11 | NCT01049451 (ClinicalTrials.gov) | November 2009 | 13/1/2010 | Pulse ACTH vs. MP for MS | Comparison of Monthly Pulse ACTH (Acthar Gel) Therapy With Methylprednisolone (MP, Solumedrol) for Long-Term Treatment of Multiple Sclerosis (MS) as an Add on Therapy to Beta-interferons (Avonex, Betaseron or Rebif) | Multiple Sclerosis | Drug: ACTH;Drug: Methylprednisolone | University of Southern California | NULL | Completed | 18 Years | 65 Years | All | 23 | Phase 1 | United States |
| 12 | NCT00902135 (ClinicalTrials.gov) | May 2009 | 13/5/2009 | Injection Management With Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH) | Betaferon® Injection Management: Non-interventional Study on Personal Digital Assistant (PDA)Supported Effects on Adherence to a Long-term Injection Therapy (BETAPATH) | Relapsing-Remitting Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 702 | N/A | Germany |
| 13 | NCT03408093 (ClinicalTrials.gov) | February 3, 2009 | 8/1/2018 | Study of Betaferon Adherence in Patients With Multiple Sclerosis Treated With Interferon Beta-1b | Cross-sectional Retrospective Study of Therapeutic Compliance in Patients With Multiple Sclerosis Treated With Interferon Beta-1b | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 100 Years | All | 120 | NULL | |
| 14 | NCT01184833 (ClinicalTrials.gov) | September 2008 | 18/8/2010 | Evaluation of Risk Factors for Early Termination of Injection Treatment With Betaferon in Patients Suffering From Multiple Sclerosis | Evaluation of Risk Factors for Premature Discontinuation of Injection Treatment With Betaferon in Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 852 | N/A | Poland |
| 15 | NCT03577977 (ClinicalTrials.gov) | June 1, 2008 | 25/6/2018 | Betaferon Use in Children and Adolescents With Multiple Sclerosis | Retrospective Data Collection on Betaferon Use in Children and Adolescents With Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, Betaferon, BAY86-5046) | Bayer | NULL | Completed | N/A | 18 Years | All | 70 | Russian Federation | |
| 16 | NCT00787657 (ClinicalTrials.gov) | June 2008 | 6/11/2008 | Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment | Betaferon Prospective Study on Adherence, Coping and Nursing Support | Relapsing Remitting Multiple Sclerosis (RRMS) | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 12 Years | N/A | Both | 1723 | N/A | Argentina;Bahrain;Belgium;Bosnia and Herzegovina;Canada;China;Colombia;Czech Republic;Egypt;Estonia;France;Germany;Iran, Islamic Republic of;Israel;Italy;Jordan;Korea, Republic of;Kuwait;Lebanon;Libyan Arab Jamahiriya;Mexico;Netherlands;New Zealand;Norway;Pakistan;Portugal;Saudi Arabia;Singapore;Slovakia;Slovenia;Sweden;Syrian Arab Republic;Taiwan;United Arab Emirates;United Kingdom;Venezuela |
| 17 | NCT01414816 (ClinicalTrials.gov) | April 2008 | 13/7/2011 | Betaferon® Regulatory Post-Marketing Surveillance | Betaferon® Regulatory Post-Marketing Surveillance | Multiple Sclerosis;Clinically Isolated System | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 12 Years | N/A | Both | 355 | N/A | Korea, Republic of |
| 18 | NCT00873340 (ClinicalTrials.gov) | October 2007 | 31/3/2009 | Physical Disability in Patients Treated With Betaferon | Physical Disability Observational Study in Patients Treated With Betaferon in Daily Practice | Multiple Sclerosis | Drug: Interferon-1beta (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 83 | N/A | Colombia |
| 19 | NCT00544037 (ClinicalTrials.gov) | September 2007 | 15/10/2007 | BENEFIT Extension Study | Extension Study of the BENEFIT (304747) and BENEFIT Follow-up (305207) Studies to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 23 Years | 50 Years | Both | 283 | N/A | Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Slovenia;Spain;Sweden;Switzerland;Portugal;United Kingdom |
| 20 | NCT01235455 (ClinicalTrials.gov) | August 2007 | 4/11/2010 | Portuguese Observational Survey to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon by Using Elements of the BetaPlus Program - Nurse Support, Auto-injectors | Portuguese BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis (MS) After Conversion to Betaferon by Using Elements of the BetaPlus Program | Relapsing Remitting Multiple Sclerosis (RRMS);Secondary Progressive Multiple Sclerosis (SPMS) | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 10 | N/A | Portugal |
| 21 | EUCTR2006-005270-47-GR (EUCTR) | 03/07/2007 | 18/06/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 22 | NCT01158183 (ClinicalTrials.gov) | July 2007 | 7/7/2010 | Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis | Real-World Betaseron® Outcomes Study (ROBUST): A Twelve-month, US Prospective, Observational, Open-label, Single-arm, Multi-center Outcomes Study of Interferon ß-1b (Betaseron®) Given Every Other Day for Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: BAY86-5046_Interferon-beta-1b | Bayer | NULL | Completed | 18 Years | 65 Years | Both | 226 | N/A | United States |
| 23 | EUCTR2006-005270-47-IT (EUCTR) | 28/06/2007 | 19/07/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other- day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind betaseron/Betaferon 250 ?g or 500 ?g or open-label Betaseron/Betaferon 250 ?g and (Phase B) open-label Betaseron/Betaferon 500 ?g - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other- day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind betaseron/Betaferon 250 ?g or 500 ?g or open-label Betaseron/Betaferon 250 ?g and (Phase B) open-label Betaseron/Betaferon 500 ?g - Beyond Follow-up | Relapsing multiple sclerosis MedDRA version: 6.1;Level: PT;Classification code 10028245 | Trade Name: BETAFERON 250 mcg INN or Proposed INN: interferon beta-1b Product Name: BETAFERON 500 mcg Product Code: ZK 157046 INN or Proposed INN: interferon beta-1b | SCHERING | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 24 | EUCTR2006-005270-47-FR (EUCTR) | 22/05/2007 | 23/01/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 25 | EUCTR2006-005270-47-SI (EUCTR) | 16/05/2007 | 04/04/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 26 | EUCTR2006-005270-47-LV (EUCTR) | 02/05/2007 | 03/04/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 27 | NCT00928967 (ClinicalTrials.gov) | May 2007 | 23/6/2009 | Open, Multicentric, Prospective, Quality of Life Study in Multiple Sclerosis Patients | Prospective Multicenter, Non-interventional Study to Evaluate the Impact of the Introduction of Interferon Beta-1 b Treatment on Daily Life Activities in Patients at High Risk of Developing Multiple Sclerosis After a First Clinical Demyelinating Event or Having Received a Confirmed Diagnosis of RRMS | Multiple Sclerosis | Drug: Interferon beta-1b, (Betaseron BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 67 | N/A | France |
| 28 | NCT00461396 (ClinicalTrials.gov) | May 2007 | 17/4/2007 | Success of Titration, Analgesics, and B.E.T.A Nurse Support on Acceptance Rates in Early Multiple Sclerosis (MS) Treatment With Betaseron | Open-Label, Multicenter, Observational, Phase IV Study to Evaluate the Adherence to Treatment With 250mcg (8MIU) IFNB-1b (Betaseron®) Given Subcutaneous Every Other Day Over a Period of up to 12 Months in Patients With a First Clinical Demyelinating Event Suggestive of Multiple Sclerosis and Patients With Onset of Relapsing-Remitting Multiple Sclerosis (RRMS) Within the Past 12 Months | Multiple Sclerosis;Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon-1beta (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 50 Years | Both | 104 | Phase 4 | United States |
| 29 | NCT00459667 (ClinicalTrials.gov) | May 2007 | 11/4/2007 | BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose | International, Multicenter, Phase IIIb Study of Subcutaneous Every-other-day Treatment of Patients With Relapsing Multiple Sclerosis With (Phase A): Double-blind Betaseron/Betaferon 250µg or 500µg or Open-label Betaseron/Betaferon 250µg and (Phase B): Open-label Betaseron/Betaferon 500µg | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 55 Years | All | 1420 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Slovenia;Spain;Sweden;Switzerland;Ukraine |
| 30 | EUCTR2006-005270-47-FI (EUCTR) | 23/04/2007 | 19/12/2006 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 31 | EUCTR2006-005270-47-HU (EUCTR) | 16/04/2007 | 09/03/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 32 | EUCTR2006-005270-47-BE (EUCTR) | 12/04/2007 | 22/12/2006 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 33 | EUCTR2006-005270-47-ES (EUCTR) | 08/04/2007 | 05/02/2007 | Estudio internacional, multicéntrico, de fase IIIb, sobre el tratamiento en días alternos de pacientes con Esclerosis Múltiple Recidivante con: (Fase A) Betaseron/Betaferon 250 µg ó 500 µg de forma doble ciego o Betaferon 250 µg en régimen abierto (Fase B) Betaseron/Betaferon 500 µg en régimen abierto International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A)double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - BEYOND Follow up | Estudio internacional, multicéntrico, de fase IIIb, sobre el tratamiento en días alternos de pacientes con Esclerosis Múltiple Recidivante con: (Fase A) Betaseron/Betaferon 250 µg ó 500 µg de forma doble ciego o Betaferon 250 µg en régimen abierto (Fase B) Betaseron/Betaferon 500 µg en régimen abierto International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A)double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - BEYOND Follow up | Esclerosis Múltiple Recidivante | Trade Name: Betaferon 250 microgramos INN or Proposed INN: Interferon beta 1b Product Name: Betaferon 500 µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta 1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 34 | EUCTR2006-005270-47-NL (EUCTR) | 02/04/2007 | 18/04/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 35 | 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 | |
| 36 | EUCTR2006-005270-47-SE (EUCTR) | 28/02/2007 | 02/02/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer AB, Bayer Health Care, Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | ||
| 37 | EUCTR2006-005270-47-AT (EUCTR) | 22/02/2007 | 31/01/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Germany;Latvia;Netherlands;Sweden | ||
| 38 | EUCTR2006-005270-47-IE (EUCTR) | 16/02/2007 | 10/01/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B)open-label Betaseron/Betaferon 500 µg - Beyond Follow-up | Relapsing Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Betaferon 250mcg Product Name: Betaferon 500mcg Product Code: ZK 157046 | Schering AG | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;France;Hungary;Belgium;Germany;Latvia;Netherlands;Sweden | ||
| 39 | NCT00428584 (ClinicalTrials.gov) | December 2006 | 29/1/2007 | RNF and Betaseron® Tolerability Study | A Randomized, Multicenter, Two Arm, Open Label, Twelve Week Phase IIIb Study to Evaluate the Tolerability of Rebif (New Formulation) (IFN Beta-1a) and Betaseron (IFN Beta-1b) in IFN-naive Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Followed by a Single Arm, Eighty-two Week Minimum, Rebif (New Formulation) Only Safety Extension | Relapsing Remitting Multiple Sclerosis (RRMS) | Drug: New Formulation of rebif - human interferon beta-1a;Drug: Interferon beta -1b | EMD Serono | Pfizer | Completed | 18 Years | 60 Years | All | 129 | Phase 3 | United States |
| 40 | NCT00370071 (ClinicalTrials.gov) | November 2006 | 29/8/2006 | Open Label Study to Evaluate Effect, Safety and Tolerability of Betaferon Standard Dose of 250µg in Patients of Chinese Origin With Multiple Sclerosis | Open Label Study to Evaluate the Effect, Safety and Tolerability of 250µg (8 MIU) Interferon Beta 1b (Betaferon) Given Subcutaneously Every Other Day (for 24 Weeks) in Patients of Chinese Origin With Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 16 Years | 55 Years | All | 39 | Phase 3 | China |
| 41 | NCT00882453 (ClinicalTrials.gov) | August 2006 | 15/4/2009 | Physical Activity and Fatigue in Early Multiple Sclerosis (MS) | Betaferon Treatment and Exercise Data Gathering IN Early MS | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 1739 | N/A | Australia;Austria;Bahrain;Belgium;Canada;Colombia;Czech Republic;Denmark;Egypt;France;Germany;Greece;Indonesia;Israel;Italy;Jordan;Kazakhstan;Korea, Republic of;Kuwait;Lebanon;Mexico;Netherlands;Norway;Oman;Portugal;Slovenia;Spain;Sweden;Switzerland;Taiwan;Thailand;United Arab Emirates;United Kingdom |
| 42 | NCT00206635 (ClinicalTrials.gov) | January 2005 | 9/9/2005 | Betaseron 16-Year Long-Term Follow-Up (LTF) in Patients With Relapsing-Remitting Multiple Sclerosis | A Long-term Follow up of Patients Enrolled in the Pivotal Study of Betaseron® (Interferon Beta 1b) in Relapsing-remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 33 Years | N/A | Both | 432 | N/A | United States;Canada;United Kingdom |
| 43 | NCT00202995 (ClinicalTrials.gov) | July 2004 | 13/9/2005 | Randomized Study Designed to Look at Disease Progression Using 2 Currently FDA Approved Drugs for the Treatment of RRMS | A Multi-Center, Randomized, Single-Blind, Parallel Group Study to Compare the Efficacy, Tolerability and Safety, of Copaxone® to That of High Dose Interferon (Betaseron® or Rebif®) in the Treatment of Relapsing Multiple Sclerosis Patients | Relapsing Remitting Multiple Sclerosis | Drug: Glatiramer Acetate;Drug: Betaseron;Drug: Rebif | Teva Pharmaceutical Industries | NULL | Terminated | 18 Years | 50 Years | Both | 91 | Phase 4 | United States;Canada |
| 44 | NCT01233245 (ClinicalTrials.gov) | April 2004 | 14/10/2010 | BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program | BetaPlus Survey - Observational Study to Assess Drug Adherence in Patients With Multiple Sclerosis After Conversion to Betaferon® by Using Elements of the BetaPlus Program | Relapsing Remitting MS (RRMS);Secondary Progressive MS (SPMS) | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | N/A | Both | 1077 | N/A | Czech Republic;France;Germany;Iran, Islamic Republic of;Israel;Italy;Jordan;Korea, Republic of;Lebanon;Netherlands;Portugal;Saudi Arabia;Spain;Taiwan;Turkey |
| 45 | NCT00099502 (ClinicalTrials.gov) | November 2003 | 15/12/2004 | BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose in Multiple Sclerosis (MS) Patients | International, Randomized, Multicenter, Phase IIIb Study in Patients With Relapsing-Remitting Multiple Sclerosis Comparing Over a Treatment Period of at Least 104 Weeks: 1. Double-Blinded Safety, Tolerability, and Efficacy of Betaseron/ Betaferon 250 µg (8 MIU) and Betaseron/-Betaferon 500 µg (16 MIU), Both Given Subcutaneously Every Other Day, and 2. Rater-Blinded Safety, Tolerability, and Efficacy of Betaseron/-Betaferon s.c. Every Other Day With Copaxone 20 mg s.c. Once Daily. | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046);Drug: Copaxone | Bayer | NULL | Completed | 18 Years | 55 Years | Both | 2244 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Slovenia;Spain;Sweden;Switzerland;Ukraine |
| 46 | NCT00235989 (ClinicalTrials.gov) | June 2003 | 10/10/2005 | Extension of Prior Study Evaluating Safety and Tolerability of Two Doses of Betaseron® to Treat Relapsing-remitting Multiple Sclerosis | An Open-label Extension Study of the Double-blind, Randomized, Parallel Group, Multicenter Phase 2 Study 307000A to Further Evaluate the Safety and Tolerability of Betaseron® 500 mcg Subcutaneously Every Other Day and Betaseron® 250 mcg Subcutaneously Every Other Day in Patients With Relapsing-remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta 1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 55 Years | All | 63 | Phase 2 | United States |
| 47 | NCT00206648 (ClinicalTrials.gov) | March 2003 | 13/9/2005 | An Efficacy and Safety Comparison Study of Two Marketed Drugs in Patients With Relapsing-remitting MS | A Randomized, Rater-blinded, Multicenter, Parallel-group Study Comparing the Efficacy and Safety of Betaseron 250 µg Subcutaneously Every Other Day With Avonex 30 µg Intramuscularly Once Per Week in Relapsing-remitting Multiple Sclerosis Patients Previously Treated With Avonex | Multiple Sclerosis, Relapsing-Remitting | Drug: Betaferon/Betaseron | Bayer | NULL | Completed | 18 Years | 60 Years | Both | 271 | Phase 4 | United States;Canada |
| 48 | NCT00298662 (ClinicalTrials.gov) | February 2003 | 2/3/2006 | Combination Therapy of Betaseron-Prograf in Multiple Sclerosis | A Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying Agents | Multiple Sclerosis | Drug: Interferon beta-1b and Tacrolimus | Clinique de sclérose en plaques et neuromusculaire de l'Outaouais | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 30 | Phase 2 | Canada |
| 49 | NCT00176592 (ClinicalTrials.gov) | January 2003 | 13/9/2005 | Phase IV Study, Betaseron Versus Copaxone for Relapsing Remitting or CIS Forms of MS Using Triple Dose Gad 3 T MRI | Phase IV, Rater-blinded, Randomized Study, Comparing 250 mg of Betaseron With 20 mg of Copaxone in Patients With the Relapsing-remitting(RR) or CIS Forms of ms Using 3 Tesla(3T) Magnetic Resonance Imaging (MRI) With Triple-dose Gadolinium | Multiple Sclerosis | Drug: Betaseron;Drug: Copaxone | Stuart D Cook MD | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 93 | Phase 4 | United States |
| 50 | NCT00893217 (ClinicalTrials.gov) | November 2002 | 4/5/2009 | BEYOND Pilot Study | Double-blind, Randomized, Parallel Group, Multicenter Study of the Safety and Tolerability of Betaseron 500 Mcg Subcutaneously Every Other Day and Betaseron 250 Mcg Subcutaneously Every Other Day for at Least 12 Weeks in Patients With RRMS | Multiple Sclerosis;Relapsing-Remitting | Drug: Betaseron (Interferon beta-1b, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 55 Years | Both | 71 | Phase 2 | United States |
| 51 | NCT00185211 (ClinicalTrials.gov) | August 2002 | 9/9/2005 | BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) and BENEFIT Follow-up Study | Open-label, Multi-center Phase III Extension of the Double-blind, Placebo-controlled BENEFIT Study (no. 92012/304747) to Obtain Long-term Follow-up Data of Patients With Clinically Definite Multiple Sclerosis (MS) and Patients With a First Demyelinating Event Suggestive of MS Treated With 8 MIU (250 µg) Interferon Beta-1b (Betaferon® / Betaseron®) Given Subcutaneously Every Other Day for at Least 36 Months. | Multiple Sclerosis | Drug: Interferon beta-1b (Betaseron, BAY86-5046) | Bayer | NULL | Completed | 18 Years | 48 Years | All | 468 | Phase 3 | Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom |
| 52 | EUCTR2006-005270-47-DE (EUCTR) | 09/02/2007 | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | International, multicenter, Phase IIIb study of subcutaneous every-other-day treatment of patients with relapsing multiple sclerosis with (Phase A) double-blind Betaseron/Betaferon 250 µg or 500 µg or open-label Betaseron/Betaferon 250 µg and (Phase B) open-label Betaseron/Betaferon 500 µg version: final internal approved - Beyond Follow-up | relapsing multiple sclerosis | Trade Name: Betaferon 250µg INN or Proposed INN: Interferon beta-1b Product Name: Betaferon 500µg Product Code: ZK 157046 INN or Proposed INN: Interferon beta-1b | Bayer Schering Pharma | NULL | Not Recruiting | Female: yes Male: yes | 1880 | Phase 3 | Hungary;Germany;Netherlands;France;Ireland;Italy;Latvia;Austria;Sweden;Finland;Slovenia;Spain;Greece | |||
| 53 | EUCTR2014-004613-93-Outside-EU/EEA (EUCTR) | 12/01/2015 | Open label study to evaluate effect, safety and tolerability of Betaferon standard dose of 250µg in patients of Chinese origin with multiple sclerosis | Open label study to evaluate the effect, safety and tolerability of 250µg (8 MIU) interferon beta 1b (Betaferon) given subcutaneously every other day (for 24 weeks) in patients of Chinese origin with multiple sclerosis | Multiple sclerosis 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: Betaseron Product Code: BAY86-5046 INN or Proposed INN: INTERFERON BETA-1B | Bayer HealthCare AG | NULL | NA | Female: yes Male: yes | 35 | China |