CELLCEPT® ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
35天疱瘡6

35. 天疱瘡


臨床試験数 : 99 薬物数 : 124 - (DrugBank : 36) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 169
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02993133
(ClinicalTrials.gov)
December 201612/12/2016Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.Pharmacokinetics Study of Mycophenolic Acid in Patients With an Autoimmune Bullous Dermatose, Pemphigus or Cicatricial Pemphigoid.Autoimmune Bullous DermatoseDrug: Cellcept® in autoimmune bullous dermatosesUniversity Hospital, LimogesNULLCompleted18 YearsN/AAll53Phase 3France
2EUCTR2014-000382-41-FR
(EUCTR)
02/04/201524/06/2015A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus VulgarisA randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX Pemphigus Vulgaris (PV)
MedDRA version: 18.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: MABTHERA®
Product Name: Rituximab
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB
Trade Name: CELLCEPT®
Product Name: Mycophenolate mofetil
Product Code: RO1061443/F02
INN or Proposed INN: Mycophenolate mofetil
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
124 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
3EUCTR2014-000382-41-IT
(EUCTR)
12/03/201502/02/2015A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus VulgarisA randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX Pemphigus Vulgaris (PV)
MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: MABTHERA®
Product Name: Rituximab
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB
Trade Name: CELLCEPT®
Product Name: Mycophenolate mofetil
Product Code: RO1061443/F02
INN or Proposed INN: Mycophenolate mofetil
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
124Phase 3United States;France;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
4EUCTR2014-000382-41-ES
(EUCTR)
09/03/201522/12/2014A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus VulgarisA randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX Pemphigus Vulgaris (PV)
MedDRA version: 17.1;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: MABTHERA®
Product Name: Rituximab
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB
Trade Name: CELLCEPT®
Product Name: Mycophenolate mofetil
Product Code: RO1061443/F02
INN or Proposed INN: Mycophenolate mofetil
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
124 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
5EUCTR2014-000382-41-DE
(EUCTR)
06/03/201509/12/2014A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Patients With Pemphigus VulgarisA randomized, double-blind, double-dummy active-comparator, multicenter study to evaluate the efficacy and safety of rituximab versus MMF in patients with pemphigus vulgaris - PEMPHIX Pemphigus Vulgaris (PV)
MedDRA version: 20.0;Level: LLT;Classification code 10052802;Term: Pemphigus vulgaris;System Organ Class: 100000004858 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Trade Name: MABTHERA®
Product Name: Rituximab
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB
Trade Name: CELLCEPT®
Product Name: Mycophenolate mofetil
Product Code: RO1061443/F02
INN or Proposed INN: Mycophenolate mofetil
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
132 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Argentina;Spain;Ukraine;Turkey;Australia;Israel;Germany;Italy
6EUCTR2004-000526-75-ES
(EUCTR)
06/02/200612/12/2005Estudio multicéntrico, prospectivo, aleatorizado, con doble enmascaramiento, controlado con placebo, de grupos paralelos y 52 semanas de duración para evaluar la eficacia y la seguridad del micofenolato mofetilo (MMF) como tratamiento complementario para conseguir remisión con una dosis reducida de corticosteroides en pacientes con pénfigo vulgar - Seguridad y Eficacia de micofenolato mofetilo en Pemphigus VulgarisEstudio multicéntrico, prospectivo, aleatorizado, con doble enmascaramiento, controlado con placebo, de grupos paralelos y 52 semanas de duración para evaluar la eficacia y la seguridad del micofenolato mofetilo (MMF) como tratamiento complementario para conseguir remisión con una dosis reducida de corticosteroides en pacientes con pénfigo vulgar - Seguridad y Eficacia de micofenolato mofetilo en Pemphigus Vulgaris Pénfigo vulgar
MedDRA version: 8.1;Level: LLT;Classification code 10052802
Trade Name: CellCept®500 mg comprimidos
Product Name: CellCept 500 mg comprimidos recubiertos
INN or Proposed INN: micofenolato mofetilo
Aspreva pharmaceuticals CorporationNULLNot RecruitingFemale: yes
Male: yes
72Phase 3Spain