Simponi® ( DrugBank: - )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ1
97潰瘍性大腸炎3
271強直性脊椎炎2

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01313858
(ClinicalTrials.gov)
April 201010/3/2011A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing SpondylitisArthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, AnkylosingDrug: Simponi®;Drug: MethotrexateMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll1613N/AGermany

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-001510-15-DE
(EUCTR)
02/05/201919/11/2018A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: TREMFYA®
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: Simponi®
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Mexico;Argentina;Poland;Brazil;Ukraine;Australia;Russian Federation;Germany
2EUCTR2018-001510-15-PL
(EUCTR)
01/03/201904/02/2019A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative ColitisA Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: TREMFYA®
Product Name: Guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: Simponi®
Product Name: Golimumab
Product Code: CNTO148
INN or Proposed INN: GOLIMUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
210Phase 2United States;Mexico;Argentina;Brazil;Poland;Ukraine;Australia;Russian Federation;Germany
3EUCTR2014-000656-29-BE
(EUCTR)
13/06/201405/03/2014Study to evaluate delivery preference of Simponi (golimumab) by Ulcerative Colitis patients: delivery using a prefilled syringe or the Smartject™ devicePreference for a prefilled syringe or Smartject™ device for delivering SIMPONI (golimumab) in patients suffering from moderate to severe ulcerative colitis - SMART Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: Simponi® (Golimumab)
Product Name: Simponi (Golimumab)
Product Code: MK-8259
INN or Proposed INN: GOLIMUMAB
Other descriptive name: Simponi
Trade Name: Simponi® (Golimumab)
Product Name: Simponi (Golimumab)
Product Code: MK-8259
INN or Proposed INN: GOLIMUMAB
Other descriptive name: Simponi
MSD Belgium BVBA/SPRLNULLNot RecruitingFemale: yes
Male: yes
105Phase 4Belgium

271. 強直性脊椎炎


臨床試験数 : 574 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03557853
(ClinicalTrials.gov)
June 20165/6/2018Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With GolimumabA Prospective Observational Study to Evaluate Clinical and Radiological Manifestations of Coxitis in Patients With Ankylosing Spondylitis Treated With Simponi® (Golimumab)Ankylosing Spondylitis;CoxitisDrug: Golimumab InjectionMSD Pharmaceuticals LLCNULLUnknown status18 YearsN/AAll39Russian Federation
2NCT01313858
(ClinicalTrials.gov)
April 201010/3/2011A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing SpondylitisArthritis, Rheumatoid;Arthritis, Psoriatic;Spondylitis, AnkylosingDrug: Simponi®;Drug: MethotrexateMerck Sharp & Dohme Corp.NULLCompleted18 YearsN/AAll1613N/AGermany