Benlysta ( DrugBank: - )
5 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 43 | 顕微鏡的多発血管炎 | 10 |
| 49 | 全身性エリテマトーデス | 48 |
| 53 | シェーグレン症候群 | 8 |
| 66 | IgA腎症 | 1 |
| 222 | 一次性ネフローゼ症候群 | 6 |
43. 顕微鏡的多発血管炎
臨床試験数 : 88 / 薬物数 : 81 - (DrugBank : 21) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 90
| 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 | EUCTR2011-004569-33-PL (EUCTR) | 12/09/2013 | 01/07/2013 | Belimumab in Remission of Vasculitis | A Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluatethe Efficacy and Safety of Belimumab (HGS1006) in Combination withAzathioprine for the Maintenance of Remission in Wegener'sGranulomatosis and Microscopic Polyangiitis - BREVAS | Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis MedDRA version: 18.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 18.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Peru;Australia;Germany;Sweden | ||
| 2 | EUCTR2011-004569-33-SE (EUCTR) | 03/04/2013 | 07/12/2012 | Belimumab in Remission of Vasculitis | A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS | Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis MedDRA version: 16.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 16.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Italy;Switzerland;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Peru;Germany;Sweden | ||
| 3 | EUCTR2011-004569-33-DE (EUCTR) | 11/03/2013 | 15/11/2012 | Belimumab in Remission of Vasculitis | A Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS | Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis MedDRA version: 18.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 18.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Peru;Australia;Germany;Sweden | ||
| 4 | EUCTR2011-004569-33-IT (EUCTR) | 15/02/2013 | 14/01/2013 | Belimumab in Remission of Vasculitis | A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis - BREVAS | Wegener's granulomatosis (WG) Microscopic polyangiitis (MPA) Vasculitis MedDRA version: 15.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 15.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400mg polvere per concentrato per soluzione per infusione INN or Proposed INN: BELIMUMAB | HUMAN GENOME SCIENCES INC | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;India;Hungary;Czech Republic;Mexico;European Union;Canada;Poland;Belgium;Peru;Australia;Germany;Sweden | ||
| 5 | EUCTR2011-004569-33-CZ (EUCTR) | 14/02/2013 | 21/11/2012 | Belimumab in Remission of Vasculitis | A Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS | Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis MedDRA version: 18.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 18.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Peru;Australia;Germany;Sweden | ||
| 6 | EUCTR2011-004569-33-HU (EUCTR) | 11/02/2013 | 18/12/2012 | Belimumab in Remission of Vasculitis | A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS | Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis MedDRA version: 16.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 16.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Italy;Switzerland;India;France;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Australia;Peru;Germany;Sweden | ||
| 7 | EUCTR2011-004569-33-IE (EUCTR) | 25/01/2013 | 29/11/2012 | Belimumab in Remission of Vasculitis | A Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS | Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis MedDRA version: 18.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 18.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Peru;Australia;Germany;Sweden | ||
| 8 | EUCTR2011-004569-33-BE (EUCTR) | 23/01/2013 | 21/11/2012 | Belimumab in Remission of Vasculitis | A Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS | Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis MedDRA version: 18.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 18.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Peru;Australia;Germany;Sweden | ||
| 9 | EUCTR2011-004569-33-ES (EUCTR) | 23/01/2013 | 26/11/2012 | Belimumab in Remission of Vasculitis | A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis. - BREVAS | Wegener's granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis MedDRA version: 14.1;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.1;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Peru;Australia;Germany;Sweden | ||
| 10 | EUCTR2011-004569-33-GB (EUCTR) | 20/12/2012 | 08/11/2012 | Belimumab in Remission of Vasculitis | A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS | Wegener’s granulomatosis (WG) Microscopic polyangiitis (MPA) Vasculitis MedDRA version: 16.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 16.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Finland;Spain;Ireland;Austria;Russian Federation;Italy;United Kingdom;Switzerland;India;France;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Australia;Peru;Germany;Sweden |
49. 全身性エリテマトーデス
臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
| 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 | EUCTR2021-001802-30-DE (EUCTR) | 28/10/2021 | 02/09/2021 | Efficacy of the drug Benlysta (active ingredient: belimumab) to improve cardiac abnormalities in patients with systemic lupus erythematosus (BeCarma) | Efficacy of belimumab to improve subclinical cardiovascular abnormalitiesusing imaging endpoints with cardiac magnetic resonance in patients withsystemic lupus erythematosus (BeCarma) - BeCarma | Efficacy of belimumab to improve subclinical cardiovascular abnormalities using imaging endpoints with cardiac magnetic resonance in patients with systemic lupus erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta® | Fraunhofer Institut für Translationale Medizin und Pharmakologie (ITMP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | Phase 4 | Germany | ||
| 2 | JPRN-jRCTs021210042 | 14/10/2021 | 14/10/2021 | Randomized , double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of belimumab for early systemic lupus erythematosus | Randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of belimumab for early systemic lupus erythematosus - BEFORE-S | Systemic Lupus Erythematosus : SLE Systemic Lupus Erythematosus, SLE;D008180 | Group A to which the test drug is administered and Group B to which the placebo is administered will be set. Group A: In addition to the usual treatment, belimumab (GlaxoSmithKline Co., Ltd., trade name Benlysta) will be administered subcutaneously once a week at 200 mg. Administration will be continued for 24 weeks. Group B: Placebo will be administered and standard of care will be performed. Both groups will receive a combination of hydroxychloroquine unless there is a reason not to use hydroxychloroquine as usual treatment. If the attending physician determines that it is not appropriate to administer the study drug, the attending physician will not administer the study drug during the week and will record the reason | Ishii Tomonori | NULL | Recruiting | >= 20age old | < 80age old | Both | 30 | N/A | Japan |
| 3 | NCT04447053 (ClinicalTrials.gov) | September 2020 | 23/6/2020 | Sequential Belimumab and T-cell Based Therapy in SLE | Sequential Belimumab Followed by T-cell Based Therapy in the Treatment of Systemic Lupus Erythematosus (SUBTLE) - a Preliminary Proof-of-concept Mechanistic Study | Systemic Lupus Erythematosus | Drug: Belimumab Injection [Benlysta] | National University Hospital, Singapore | GlaxoSmithKline | Not yet recruiting | 21 Years | 70 Years | All | 80 | Phase 4 | Singapore |
| 4 | EUCTR2018-004645-16-NL (EUCTR) | 29/01/2020 | 29/10/2019 | A study of belimumab in children with lupus | A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE | Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA® | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Mexico;Argentina;Spain;Germany;Netherlands;Japan | ||
| 5 | EUCTR2018-004645-16-DE (EUCTR) | 27/12/2019 | 18/09/2019 | A study of belimumab in children with lupus | A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE | Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA® | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan | ||
| 6 | EUCTR2018-004645-16-ES (EUCTR) | 16/12/2019 | 11/11/2019 | A study of belimumab in children with lupus | A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE) - Ph 2,Benlysta, PLUTO-SC, PK-PD study in pediatric patients with SLE | Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Other descriptive name: LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA® | GlaxoSmithKline, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan | ||
| 7 | EUCTR2018-001392-21-NL (EUCTR) | 25/09/2018 | 25/09/2018 | Synergetic B-cell immunomodulation in SLE – 2nd study | A randomized trial to investigate the reset of humoral autoimmunity by combining belimumab with rituximab in severe systemic lupus erythematosus | systemic lupus erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10029142;Term: Nephritis systemic lupus erythematosus;System Organ Class: 100000004857 MedDRA version: 21.1;Classification code 10042948;Term: Systemic lupus erythematosus syndrome aggravated;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: belimumab or benlysta Trade Name: anti-CD20 B cell depletion with Truxima Product Name: truxima | Leiden University Medical Center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2;Phase 3 | Netherlands | ||
| 8 | EUCTR2016-003050-32-NL (EUCTR) | 16/02/2018 | 24/10/2017 | A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) – BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Germany;Netherlands;Korea, Republic of | ||
| 9 | NCT03370263 (ClinicalTrials.gov) | January 15, 2018 | 6/12/2017 | BENLYSTA® Special Drug Use Investigation | BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation | Systemic Lupus Erythematosus | Drug: Benlysta | GlaxoSmithKline | NULL | Recruiting | N/A | N/A | All | 600 | Japan | |
| 10 | EUCTR2016-003050-32-DE (EUCTR) | 09/01/2018 | 21/06/2017 | A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) – BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic LupusErythematosus (SLE) | Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 11 | EUCTR2016-003050-32-ES (EUCTR) | 05/12/2017 | 01/12/2017 | A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE). | Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Mexico;Canada;Argentina;Brazil;Spain;South Africa;Russian Federation;Netherlands;Germany;Korea, Republic of | ||
| 12 | EUCTR2011-005667-25-PL (EUCTR) | 22/05/2014 | 07/06/2013 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 4 | United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 13 | EUCTR2014-000488-42-NL (EUCTR) | 12/05/2014 | 09/05/2014 | Synergetic B-cell immunomodulation in SLE | The SYNBioSe Study A proof-of-concept study involving synergetic B-cell imunnomodulation in patients with refractory systemic lupus erythematosus - SynBiose | Systemic lupus erythematosus MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: rituximab Product Name: Rituximab INN or Proposed INN: RITUXIMAB Trade Name: Benlysta Product Name: Belimumab INN or Proposed INN: BELIMUMAB | Leiden University Medical Center | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Netherlands | ||
| 14 | EUCTR2011-005667-25-RO (EUCTR) | 21/06/2013 | 21/07/2014 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 4 | United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Romania;Bulgaria;Norway;New Zealand | ||
| 15 | EUCTR2011-005672-42-GB (EUCTR) | 11/06/2013 | 27/03/2013 | Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) (EMBRACE) | A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE) - EMBRACE | Systemic Lupus Erythematosus (SLE) MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3;Phase 4 | United States;France;Martinique;Brazil;South Africa;Colombia;United Kingdom | ||
| 16 | EUCTR2011-005667-25-LT (EUCTR) | 10/05/2013 | 29/11/2012 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | GlaxoSmithKline, LLC | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 4 | Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 17 | EUCTR2011-005667-25-BG (EUCTR) | 24/04/2013 | 31/01/2013 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | GlaxoSmithKline, LLC | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 4 | Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 18 | EUCTR2011-005667-25-PT (EUCTR) | 05/04/2013 | 17/01/2013 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | GlaxoSmithKline, LLC | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 4 | Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 19 | EUCTR2011-005667-25-SK (EUCTR) | 27/03/2013 | 05/02/2013 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 4 | United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 20 | EUCTR2011-005667-25-IT (EUCTR) | 21/03/2013 | 14/01/2013 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 15.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion INN or Proposed INN: BELIMUMAB | HUMAN GENOME SCIENCES INC | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 4 | Portugal;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Chile;Israel;Russian Federation;Colombia;Italy;Switzerland;India;Malaysia;Australia;Peru;China;Korea, Republic of;Korea, Democratic People's Republic of;Lithuania;Turkey;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;New Zealand | ||
| 21 | NCT01729455 (ClinicalTrials.gov) | February 21, 2013 | 14/11/2012 | Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry | A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without BENLYSTA™ (Belimumab) | Systemic Lupus Erythematosus | Biological: BENLYSTA;Other: SLE treatment | GlaxoSmithKline | NULL | Active, not recruiting | 18 Years | N/A | All | 3138 | United States;Argentina;Austria;Belgium;Canada;France;Germany;Israel;Italy;Portugal;Slovakia;Spain;Sweden | |
| 22 | EUCTR2011-005667-25-ES (EUCTR) | 14/02/2013 | 21/12/2012 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 5000 | Phase 4 | United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 23 | EUCTR2011-000368-88-IT (EUCTR) | 04/02/2013 | 11/12/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patient 5 to 17 years of age. | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE | Systemic lupus erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta (belimumab) INN or Proposed INN: BELIMUMAB | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Mexico;Canada;Argentina;Spain;Brazil;Peru;Netherlands;United Kingdom;Italy | |||
| 24 | EUCTR2011-005667-25-CZ (EUCTR) | 30/01/2013 | 04/12/2012 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | GlaxoSmithKline, LLC | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 4 | Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 25 | EUCTR2011-005667-25-HU (EUCTR) | 22/01/2013 | 22/11/2012 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | GlaxoSmithKline, LLC | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 4 | Portugal;Serbia;United States;Philippines;Estonia;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Czechia;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 26 | EUCTR2011-005667-25-EE (EUCTR) | 08/01/2013 | 12/12/2012 | Belimumab Assessment of Safety in SLE (BASE) | A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab | Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 4000 | Phase 4 | United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand | ||
| 27 | EUCTR2011-000368-88-NL (EUCTR) | 03/12/2012 | 02/07/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Mexico;Canada;Argentina;Poland;Brazil;Spain;Peru;Russian Federation;Netherlands;Italy;United Kingdom | |||
| 28 | EUCTR2011-000368-88-ES (EUCTR) | 27/07/2012 | 21/05/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age. | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA? (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Germany;Netherlands;Italy;Brazil;Russian Federation;United Kingdom;Canada;Peru;Argentina;Mexico;Spain;United States;Poland | |||
| 29 | NCT01532310 (ClinicalTrials.gov) | July 16, 2012 | 2/2/2012 | Belimumab (BENLYSTA®) Pregnancy Registry | WEUKBRE6076: Belimumab (BENLYSTA) Pregnancy Registry Protocol | Systemic Lupus Erythematosus | Drug: belimumab | GlaxoSmithKline | PPD | Completed | N/A | N/A | Female | 77 | United States;Argentina;Austria;Belgium;Canada;France;Germany;Israel;Italy;Portugal;Spain;Sweden;Switzerland | |
| 30 | EUCTR2011-000368-88-GB (EUCTR) | 13/06/2012 | 18/04/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline Research & Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Mexico;Canada;Argentina;Spain;Poland;Brazil;Peru;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 31 | EUCTR2011-003814-18-PL (EUCTR) | 06/06/2012 | 19/06/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, Plc | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 32 | EUCTR2011-003814-18-PT (EUCTR) | 01/06/2012 | 21/02/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, Plc | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 33 | NCT01597492 (ClinicalTrials.gov) | May 31, 2012 | 8/5/2012 | A Study to Evaluate the Effect of Belimumab on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE) | A Phase 4, Multi-Center, Randomized, Open-Label Study to Evaluate the Effect of BENLYSTA™ (Belimumab; HGS1006) on Vaccine Responses in Subjects With Systemic Lupus Erythematosus (SLE) | Systemic Lupus Erythematosus | Biological: Belimumab plus Early Vaccination;Biological: Belimumab plus Late Vaccination | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Completed | 18 Years | N/A | All | 79 | Phase 4 | United States |
| 34 | EUCTR2011-003814-18-BE (EUCTR) | 29/05/2012 | 01/02/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 15.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 35 | EUCTR2011-003814-18-BG (EUCTR) | 22/05/2012 | 21/05/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 17.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 36 | EUCTR2011-003814-18-IT (EUCTR) | 15/05/2012 | 08/06/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab Product Code: NA INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta | HUMAN GENOME SCIENCES INC | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Bulgaria;Germany;Sweden | ||
| 37 | EUCTR2011-003814-18-ES (EUCTR) | 03/05/2012 | 29/02/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 38 | EUCTR2011-003814-18-DE (EUCTR) | 03/05/2012 | 16/12/2011 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 18.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 39 | EUCTR2011-003814-18-GB (EUCTR) | 12/04/2012 | 19/04/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholy owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 40 | EUCTR2011-003814-18-SE (EUCTR) | 28/03/2012 | 31/01/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 41 | EUCTR2011-003814-18-CZ (EUCTR) | 27/03/2012 | 25/01/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 42 | EUCTR2011-003814-18-HU (EUCTR) | 08/03/2012 | 18/01/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 18.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 43 | EUCTR2011-003814-18-DK (EUCTR) | 08/03/2012 | 08/03/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 44 | EUCTR2011-003814-18-AT (EUCTR) | 01/02/2012 | 23/01/2012 | A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC | Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta | Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 816 | Phase 3 | United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 45 | EUCTR2007-007648-85-NL (EUCTR) | 07/04/2009 | 19/12/2008 | A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057 | A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA | Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Benlysta 400 mg powder for concentrate for solution for infusions Product Name: Belimumab Product Code: HGS1006 INN or Proposed INN: Belimumab Other descriptive name: LymphoStat-B; Benlysta | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 1620 | Phase 3 | United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Germany;Netherlands;Sweden;Korea, Republic of | ||
| 46 | EUCTR2007-007648-85-CZ (EUCTR) | 01/04/2009 | 26/01/2009 | A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057 | A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA | Systemic lupus erythematosus (SLE) MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Benlysta® Product Name: Belimumab Product Code: HGS1006 INN or Proposed INN: Belimumab Other descriptive name: LymphoStat-B | Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC) | NULL | Not Recruiting | Female: yes Male: yes | 1620 | Phase 3 | United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 47 | EUCTR2011-000368-88-PL (EUCTR) | 04/06/2012 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with SLE - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Mexico;Canada;Argentina;Brazil;Spain;Poland;Peru;Russian Federation;Netherlands;Italy;United Kingdom | |||
| 48 | EUCTR2011-000368-88-Outside-EU/EEA (EUCTR) | 17/02/2014 | A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age | A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE | Systemic Lupus Erythematosus MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab | GlaxoSmithKline Research & Development Ltd | NULL | NA | Female: yes Male: yes | 100 | Argentina;Brazil;Netherlands;Mexico;Peru;Poland;Russian Federation;Germany;Canada;Italy;Spain;United Kingdom;United States |
53. シェーグレン症候群
臨床試験数 : 305 / 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188
| 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 | EUCTR2015-000400-26-GB (EUCTR) | 17/03/2017 | 14/12/2016 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 19.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 2 | EUCTR2015-000400-26-IT (EUCTR) | 18/01/2016 | 10/11/2020 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren's syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome. - NA | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MABTHERA - 1 FIALA 500 MG 50 ML Product Name: MABTHERA Product Code: [NA] INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: BENLYSTA - 120 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 120 MG 1 FLACONCINO Product Name: BENLYSTA Product Code: [na] INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML Product Name: SOLU-MEDROL Product Code: [na] INN or Proposed INN: METILPREDNISOLONE Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE Product Name: Tachipirina Product Code: [na] INN or Proposed INN: PARACETAMOLO Trade Name: XYZAL - 20 COMPRESSE RI | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 3 | EUCTR2015-000400-26-NO (EUCTR) | 08/01/2016 | 23/09/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 18.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Netherlands;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 4 | EUCTR2015-000400-26-NL (EUCTR) | 28/12/2015 | 08/12/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 18.1;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2015-000400-26-SE (EUCTR) | 15/12/2015 | 08/09/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 6 | EUCTR2015-000400-26-DE (EUCTR) | 03/12/2015 | 01/10/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 7 | EUCTR2015-000400-26-FR (EUCTR) | 01/12/2015 | 24/02/2017 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Netherlands;Germany;United Kingdom;Italy;Sweden;Norway | ||
| 8 | EUCTR2015-000400-26-ES (EUCTR) | 19/11/2015 | 05/10/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren's syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome. | Primary Sjogrens disease MedDRA version: 18.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden |
66. IgA腎症
臨床試験数 : 275 / 薬物数 : 258 - (DrugBank : 82) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 140
| 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 | EUCTR2017-004366-10-GB (EUCTR) | 24/05/2019 | 04/02/2019 | Efficacy and Safety of Belimumab in the Treatment of IgA Nephropathy | A Phase 2 Placebo-controlled Double Blinded Study to Assess the Efficacy and Safety of Belimumab in Subjects with Immunoglobulin A Nephropathy (IgAN) - Efficacy and Safety of Belimumab in the Treatment of IgA Nephropathy | Immunoglobulin A (IgA) nephropathy MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA® (belimumab) Product Name: BENLYSTA® (belimumab) Product Code: GSK1550188 INN or Proposed INN: Belimumab Other descriptive name: GSK1550188; Benlysta | University of Leicester | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 21 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom |
222. 一次性ネフローゼ症候群
臨床試験数 : 310 / 薬物数 : 295 - (DrugBank : 117) / 標的遺伝子数 : 63 - 標的パスウェイ数 : 194
| 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 | EUCTR2011-000242-38-CZ (EUCTR) | 14/02/2013 | 13/11/2012 | A 2 year study to investigate belimumab in membranous nephropathy | BEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy - GSK1550188 in membranous nephropathy | Idiopathic Membranous Nephropathy (IMN) MedDRA version: 14.1;Level: SOC;Classification code 10038359;Term: Renal and urinary disorders;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA® Product Name: BENLYSTA® Product Code: GSK1550188 (Belimumab) INN or Proposed INN: BELIMUMAB | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 94 | United States;France;Czech Republic;Canada;Spain;Australia;Netherlands;Germany;United Kingdom;Italy | |||
| 2 | EUCTR2011-000242-38-DE (EUCTR) | 09/01/2013 | 25/09/2012 | A 2 year study to investigate belimumab in membranous nephropathy | BEL114674: A 2 year study of efficacy and safety ofintravenous belimumab versus placebo in subjects withidiopathic membranous nephropathy - GSK1550188 in membranous nephropathy | Idiopathic Membranous Nephropathy (IMN) MedDRA version: 16.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA® Product Name: BENLYSTA® Product Code: GSK1550188 (Belimumab) INN or Proposed INN: BELIMUMAB | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 94 | France;United States;Czech Republic;Canada;Spain;Australia;Netherlands;Germany;Italy;United Kingdom | |||
| 3 | EUCTR2011-000242-38-ES (EUCTR) | 20/12/2012 | 22/10/2012 | A 2 year study to investigate belimumab in membranous nephropathy | A 2 year study of efficacy and safety ofintravenous belimumab versus placebo in subjects withidiopathic membranous nephropathy - GSK1550188 in membranous nephropathy | Idiopathic Membranous Nephropathy (IMN) MedDRA version: 14.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA® Product Name: BENLYSTA® Product Code: GSK1550188 (Belimumab) INN or Proposed INN: BELIMUMAB | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 94 | United States;France;Czech Republic;Canada;Spain;Netherlands;Germany;United Kingdom;Italy | |||
| 4 | EUCTR2011-000242-38-IT (EUCTR) | 22/11/2012 | 11/12/2012 | A 2 year study to investigate belimumab in membranous nephropathy | A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy | Idiopathic Membranous Nephropathy (IMN) MedDRA version: 14.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA INN or Proposed INN: BELIMUMAB | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 94 | United States;Czech Republic;Canada;Spain;Germany;United Kingdom;Italy | |||
| 5 | EUCTR2011-000242-38-GB (EUCTR) | 01/11/2012 | 03/10/2012 | A 2 year study to investigate belimumab in membranous nephropathy | BEL114674: A 2 year study of efficacy and safety of intravenous belimumab versus placebo in subjects with idiopathic membranous nephropathy - GSK1550188 in membranous nephropathy | Idiopathic Membranous Nephropathy (IMN) MedDRA version: 15.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 10038359 - Renal and urinary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA® Product Name: BENLYSTA® Product Code: GSK1550188 (Belimumab) INN or Proposed INN: BELIMUMAB | GlaxoSmithKline Research & Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 94 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Czech Republic;Canada;Spain;Netherlands;Germany;Italy;United Kingdom | ||
| 6 | EUCTR2012-000385-38-GB (EUCTR) | 18/05/2012 | 02/04/2012 | A study to investigate belimumab in IMGN | BEL116472. A 2 year mechanistic study of belimumab in Idiopathic Membranous Glomerulonephropathy | Idiopathic Membranous Glomerulonephropathy (IMGN) MedDRA version: 16.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: BENLYSTA® (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: Belimumab | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 18 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom |