Interferon-beta-1 ( DrugBank: Interferon-beta )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 34 |
13. 多発性硬化症／視神経脊髄炎
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 | EUCTR2012-004040-30-AT (EUCTR) | 24/05/2013 | 12/03/2013 | Natalizumab de-escalation to interferon-beta-1b in patients withrelapsing-remitting multiple sclerosis: A multicenter study | Natalizumab de-escalation to interferon-beta-1b in patients withrelapsing-remitting multiple sclerosis: A multicenter study | relapse-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: BETAFERON® (interferon beta-1b) Product Name: Betaferon INN or Proposed INN: Betaferon Other descriptive name: INTERFERON BETA-1B | Ospedale Regionale di Lugano | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Austria;Switzerland | |||
| 3 | NCT01701856 (ClinicalTrials.gov) | September 2012 | 18/9/2012 | Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis | Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis: A Swiss Multicenter Study Prospective, Controlled, Single-arm, Open-label, Multi-centre, Phase IV Study | Relapsing-remitting Multiple Sclerosis | Drug: Interferon beta-1b | Claudio Gobbi | Bayer | Terminated | 18 Years | 70 Years | Both | 5 | Phase 4 | Switzerland |
| 4 | EUCTR2010-023023-19-DE (EUCTR) | 04/01/2012 | 18/11/2011 | Studyto compare the efficacy and safety of fingolimod and interferon-beta-1b in patients with mutliple sclerosis | A 18-month, open-label, rater-blinded, randomized, multicenter, active-controlled, parallel-group pilot study to assess efficacy and safety of fingolimod in comparison to interferon beta 1b in treating the cognitive symptoms associated to relapsing-remitting multiple sclerosis and to assess possible relationship of these effects to regional brain atrophy | treating of cognitive symptoms in relapsing-remitting multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Extavia Other descriptive name: INTERFERON BETA-1B Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Gilenya Product Name: Fingolimod Product Code: FTY720 Other descriptive name: FINGOLIMOD HYDROCHLORIDE Trade Name: Extavia Product Name: Extavia Product Code: NVF233 Other descriptive name: INTERFERON BETA-1B | Novartis Farma S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | Germany;Italy | ||||
| 5 | NCT01144052 (ClinicalTrials.gov) | June 2010 | 11/6/2010 | Natalizumab De-escalation With Interferon Beta-1b | De-escalation After Natalizumab Treatment With Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: interferon beta-1b;Drug: Natalizumab | Claudio Gobbi | Ospedale Civico, Lugano | Completed | 18 Years | 60 Years | All | 19 | Phase 4 | Switzerland |
| 6 | NCT01432704 (ClinicalTrials.gov) | March 2008 | 16/8/2011 | Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis (MS) | Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS | Multiple Sclerosis | Drug: colecalciferol | University of Turku | Bayer | Completed | 18 Years | 50 Years | Both | 70 | Phase 2/Phase 3 | NULL |
| 7 | NCT01339676 (ClinicalTrials.gov) | March 2008 | 19/4/2011 | Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatment of Multiple Sclerosis (MS) | Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS | Multiple Sclerosis | Drug: Colecalciferol;Drug: Placebo capsules | University of Turku | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 70 | Phase 4 | Finland |
| 8 | EUCTR2007-001958-99-FI (EUCTR) | 18/12/2007 | 07/12/2007 | Collecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MS | Collecalciferol as an Add-on Treatment to Subcutaneously-Administred Interferon-beta-1b for Treatment MS | Patients with relapsing remitting MS according to the revised Mc Donald's criteria who meet all criteria for inclusion and none criteria of exclusion. MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: Dekristol 20000 IE Product Name: Dekristol INN or Proposed INN: INN COLECALCIFEROL Product Name: Placebo Dekristol SGC 20000 | Merja Soilu Häninen | NULL | Not Recruiting | Female: yes Male: yes | Finland | ||||
| 9 | NCT01111656 (ClinicalTrials.gov) | March 2007 | 15/3/2010 | Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b | SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study (SWABIMS Follow Up-study) | Relapsing-remitting Multiple Sclerosis | Drug: Interferon beta-1b group;Drug: Interferon beta-1b/Atorvastatin group | University Hospital Inselspital, Berne | Viollier AG, Basel, Switzerland;PharmaPart GmbH, Thalwil, Switzerland | Completed | 18 Years | 67 Years | Both | 28 | Phase 2 | Switzerland |
| 10 | NCT00441103 (ClinicalTrials.gov) | December 2006 | 26/2/2007 | A Study to Evaluate Rebif® New Formulation (Interferon-beta-1a) in Relapsing Remitting Multiple Sclerosis | A Two-arm, Randomized, Double-blind, Control Group-compared, Multicenter, Phase IIIb Study With Monthly MRI and Biomarker Assessments to Evaluate the Efficacy, Safety, and Tolerability of Rebif® New Formulation (IFN Beta-1a) in Subjects With Relapsing Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Rebif® New Formulation (IFN-beta-1a, RNF);Drug: Placebo | Merck KGaA | NULL | Completed | 18 Years | 60 Years | All | 180 | Phase 3 | Canada;Germany;Italy;Russian Federation;Spain;Switzerland |
| 11 | EUCTR2006-000606-23-ES (EUCTR) | 23/11/2006 | 15/03/2012 | ?Post-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phase | Post-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phase - PASS-PD del escalado de dosis de Rebif | Not applicalbe MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif 22 y 44 mcg Product Name: Interferon-beta-1a Other descriptive name: INTERFERON BETA-1A | Merck, S.L. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Spain | ||
| 12 | EUCTR2004-001286-17-PT (EUCTR) | 08/09/2006 | 23/03/2006 | Exploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosis | Exploratory trial to evaluate the risk-benefit ratio of the use of mitoxantrone in patients under treatment with high dose interferon-beta-1a for relapsing-remitting or relapsing secondary progresive multiple sclerosis with high activity. - Mitoxantrone in high activity multiple sclerosis | Relapsing-remitting or relapsing secondary progressive multiple sclerosis with high activity MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Mitoxantrone Product Code: N/A | Fundación Española de Esclerosis Múltiple (FEDEM) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Portugal | |||
| 13 | EUCTR2005-005751-18-GB (EUCTR) | 07/09/2006 | 17/02/2006 | A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study | A multi-centre randomised study to evaluate the efficacy of Betaferon-interferon-beta-1b (IFNB-1B) 500 mcg therapy in the induction of tolerance to IFNB in MS patients with neutralising antibodies (NAbs) to IFNB-1a (Rebif) - Betaferon NaB Anergy Study | Multiple sclerosis (MS) is an inflammatory demyelinating disease of the central nervous system of unknown aetiology. It is the commonest cause of disability in young adults. The prevalence in the UK is approximately 125/100,000 of the population with an annual incidence of 6/100,000. Approximately 80,000 individuals are affected with MS in the UK. | Trade Name: Rebif 44 Product Name: Rebif 44 Product Code: Interferon beta 1a INN or Proposed INN: Interferon beta 1a Trade Name: Rebif 22 Product Name: Rebif 22 Product Code: Interferon beta 1a INN or Proposed INN: Interferon beta 1a Product Name: Betaferon 500mcg Product Code: Betaferon 500mcg INN or Proposed INN: Interferon beta 1b | UCL Biomedicine R&D Unit | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom | |||
| 14 | NCT01134627 (ClinicalTrials.gov) | February 2006 | 28/5/2010 | Minocycline as add-on to Interferon Beta-1a [IFN Beta-1a] (Rebif®) in Relapsing-Remitting Multiple Sclerosis [RRMS] | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline Versus Placebo as Add-on Therapy in Patients Who Are on Treatment With Interferon-beta-1a 44 Mcg Tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Minocycline;Drug: Placebo | Merck KGaA | NULL | Terminated | 18 Years | 55 Years | All | 305 | Phase 2 | Denmark |
| 15 | NCT00492765 (ClinicalTrials.gov) | February 2006 | 25/6/2007 | Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment IM Administered Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Interferon-beta-1a;Drug: Simvastatin;Drug: Placebo | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 380 | Phase 4 | Denmark |
| 16 | EUCTR2005-004289-18-FI (EUCTR) | 26/01/2006 | 07/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Sweden | |||
| 17 | EUCTR2005-003930-16-SE (EUCTR) | 19/01/2006 | 21/11/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Sweden | |||
| 18 | EUCTR2005-003930-16-FI (EUCTR) | 05/01/2006 | 29/11/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who have been prescribed treatment with Avonex. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Trade Name: Simvastatin Alternova Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Sweden | |||
| 19 | EUCTR2005-004289-18-SE (EUCTR) | 04/01/2006 | 10/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Sweden | |||
| 20 | EUCTR2005-004289-18-DK (EUCTR) | 19/12/2005 | 28/11/2005 | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | A Multi-centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Minocycline versus placebo as add-on therapy in patients who are on treatment with Interferon-beta-1a 44mcg tiw (Rebif®) for the Treatment of Relapsing-Remitting Multiple Sclerosis - Minocycline as add-on to Interferon-beta-1a (Rebif®) in RRMS (Recycline) | Relapse Remitting Multiple Sclerosis MedDRA version: 8.0;Level: PT;Classification code 10063399 | Product Name: Minocycline 100 mg Film-coated Tablets INN or Proposed INN: Minocycline Hydrochloride | E. Merck AB | NULL | Not Recruiting | Female: yes Male: yes | 320 | Finland;Denmark;Sweden | |||
| 21 | EUCTR2005-003930-16-DK (EUCTR) | 09/12/2005 | 05/12/2005 | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | A Multi-centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Study Investigating Simvastatin as an Add-on Treatment to Interferon-beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis - SIMCOMBIN | Patients with definite relapsing-remitting multiple sclerosis who have never received treatment with interferons or glatiramer acetate, who meet all the criteria for inclusion and none of the exclusion criteria. Patients will be recruited from the outpatient clinics of the participating neurological departments among patients who are eligible for treatment with interferon-beta-1a. MedDRA version: 7.0;Level: PT;Classification code 10028425 | Product Name: Simvastatin Alternova INN or Proposed INN: Simvastatin | Biogen Idec A/S | NULL | Not Recruiting | Female: yes Male: yes | 380 | Finland;Denmark;Sweden | |||
| 22 | NCT00942591 (ClinicalTrials.gov) | May 2005 | 17/7/2009 | Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b | Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b.SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis. | Multiple Sclerosis | Drug: Interferon beta 1b;Drug: Atorvastatin | University Hospital Inselspital, Berne | CRO: PharmaPart AG, Bahnhofstrasse 20, P.O. Box 173, CH-8800 Thalwil;Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 Basel | Completed | 18 Years | 55 Years | Both | 77 | Phase 2 | Switzerland |
| 23 | EUCTR2004-003799-13-GB (EUCTR) | 16/03/2005 | 18/07/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | ||
| 24 | EUCTR2004-003799-13-LT (EUCTR) | 08/03/2005 | 27/12/2004 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | United Kingdom;Spain;Ireland;Sweden;Lithuania | ||
| 25 | EUCTR2004-003799-13-DK (EUCTR) | 24/02/2005 | 18/01/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | ||
| 26 | EUCTR2004-003799-13-ES (EUCTR) | 17/02/2005 | 04/11/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Trade Name: Rebif Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden | ||
| 27 | EUCTR2004-003799-13-SE (EUCTR) | 03/02/2005 | 23/12/2004 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | United Kingdom;Spain;Ireland;Lithuania;Sweden | ||
| 28 | NCT00110396 (ClinicalTrials.gov) | January 2005 | 6/5/2005 | Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis | A Multicentre, Single Arm, Open-Label, Phase IIIB Study to Evaluate the Safety and Antigenicity of Rebif® (Interferon-beta-1a) in Subjects With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Biological: Interferon-beta-1a FBS-free/HSA-free | EMD Serono | Pfizer | Completed | 18 Years | 60 Years | All | 260 | Phase 3 | United States |
| 29 | NCT00493077 (ClinicalTrials.gov) | May 2004 | 25/6/2007 | Safety of Avonex Treatment in Multiple Sclerosis Patients With Neutralizing Antibodies to Interferon Beta Therapy | A Swedish Multi-Centre, Prospective, Open Label Study: Safety of Avonex Treatment in Multiple Sclerosis Patients Who Are NAB Positive on Previous s.c Interferon Beta Therapy | Multiple Sclerosis | Drug: low immunogenic interferon-beta-1a | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 3 | Phase 4 | Sweden |
| 30 | NCT00493116 (ClinicalTrials.gov) | October 2003 | 25/6/2007 | Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta | A Multi-Centre, Open Label Study to Investigate the Recovery of IFN-beta Efficacy in Relapsing-Remitting Multiple Sclerosis Patients With Neutralising IFN-beta Antibodies and Reduced Bioavailability | Relapsing-Remitting Multiple Sclerosis | Drug: Interferon-beta-1a;Drug: methylprednisolone | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 20 | Phase 4 | Australia;New Zealand |
| 31 | NCT00492466 (ClinicalTrials.gov) | March 2003 | 25/6/2007 | Investigating if Interferon-Beta Can be Used in Patients With MS After They Have Developed Neutralizing Antibodies | A Multicentre, Open Label, Non-Comparative Trial Investigating the Recovering of INF-Beta Efficacy in Breakthrough Relapsing-Remitting Multiple Sclerosis Patients With Neutralizing Interferon-Beta Antibodies | Relapsing-Remitting Multiple Sclerosis | Drug: Interferon-beta-1a;Drug: methylprednisolone | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 14 | Phase 4 | Finland |
| 32 | NCT00168766 (ClinicalTrials.gov) | January 2003 | 13/9/2005 | Avonex (Interferon-beta-1a) and Avonex Plus Methylprednisolone for the Treatment of Relapsing-remitting MS | A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-beta-1a for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis | Drug: Interferon-beta-1a (Avonex) plus methylprednisolone | Biogen Idec | NULL | Completed | 18 Years | 55 Years | Both | 345 | Phase 4 | Belgium;Denmark;Finland;Netherlands;Norway;Sweden;Switzerland;United Kingdom |
| 33 | 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 |
| 34 | EUCTR2004-003799-13-IE (EUCTR) | 13/01/2005 | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | A multicentre, single arm, open-label, phase IIIb study to evaluate the safety and antigenicity of Rebif® (IFN-beta-1a) in subjects with relapsing forms of multiple sclerosis. - Rebif® New Formulation in RMS | Relapsing form of MS ; diagnosis of MS is in accordance with the McDonald criteria MedDRA version: 7.0;Level: PT;Classification code 10028245 | Product Name: Interferon-beta-1a FBS-free/HSA free, RNF Product Code: Not applicable INN or Proposed INN: Interferon-beta-1a Other descriptive name: G2-SFM (IFN-beta-1a from clone 484-39,FBS-free process) | Serono International SA | NULL | Not Recruiting | Female: yes Male: yes | 230 | Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): | Spain;Ireland;Lithuania;Denmark;United Kingdom;Sweden |