Belimumab for IV

( DrugBank: Belimumab / KEGG DRUG: Belimumab )

1 disease

告示番号	疾患名（ページ内リンク）	臨床試験数
49	全身性エリテマトーデス	47

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

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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 pat ...	Efficacy of belimumabto improve subclinical cardiovascular abnormalitiesusing imaging endpoints with ...	Efficacy of belimumabto improve subclinical cardiovascular abnormalities using imaging endpoints wit ...	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-jRCTs011190011 (jRCTs011190011)	13/03/2020	13/03/2020	Steroid-Independent protocol using BELImumab fordisease flare in patients with systemic lupUS erythe ...	Steroid-Independent protocol using BELImumab fordisease flare in patients with systemic lupUS erythe ...	Systemic lupus erythematosus Systemic lupus erhythematosus;D008180	Subjects who have met the entry criteria will be randomly to one of the two treatment groups based o ... a maximum of 2 weeks followed by steroid tapering schedule according to the ACR Ad hoc working group on steroid-sparing criteria in Lupus and The British Society for Rheumatology guideline for the management of SLE in adults. All subjects will start treatment with MMF oral 1g/day In both groups, if subjects are not on treatment with HCQ, their drug will be started at a dose individually adjusted on basis of the patient's height (from 200 to 400mg/day). In the BEL group, the baseline dose of CS	Atsumi Tatsuya	NULL	Recruiting	>= 18age old	Not applicable	Both	48	Phase 4	Japan
3	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 S ...	Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythem ...	Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Oth ...	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
4	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 S ...	Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythem ...	Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Oth ...	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
5	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 S ...	Lupus - SLE MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythem ...	Trade Name: Benlysta Product Name: Belimumab Product Code: GSK1550188 INN or Proposed INN: BELIMUMAB Oth ...	GlaxoSmithKline, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	24	Phase 2	United States;Mexico;Argentina;Spain;Netherlands;Germany;Japan
6	NCT04136145 (ClinicalTrials.gov)	October 28, 2019	21/10/2019	Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab200 Milligrams (mg ...	An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate the PK and Safety of Bel ...	Systemic Lupus Erythematosus	Drug: Belimumab for IV;Drug: Belimumab for SC	GlaxoSmithKline	NULL	Completed	18 Years	45 Years	All	36	Phase 1	China
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 belimumabwith ritux ...	systemic lupus erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Syst ...	Trade Name: belimumabor benlysta Trade Name: anti-CD20 B cell depletion with Truxima Product Name: tru ...	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 Rit ...	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate th ...	Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 21.1;Level: PT;Classification code 10042 ...	Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trad ...	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, Rep ...
9	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 Rit ...	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate th ...	Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 21.1;Level: PT;Classification code 10042 ...	Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trad ...	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, Rep ...
10	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 Rit ...	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate th ...	Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 20.0;Level: PT;Classification code 10042 ...	Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trad ...	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;Germa ...

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