96. クローン病 Crohn disease Clinical trials / Disease details


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 168 - 標的パスウェイ数 : 214

  
171 trials found
No.TrialIDDate_
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PhaseCountries
1NCT05242458
(ClinicalTrials.gov)
March 2, 202215/2/2022A Study of Ustekinumab Treatment in Children With Crohn's DiseaseReal-world Evidence for the Effectiveness and Safety of Ustekinumab Treatment in Children With Crohn's Disease: A Retrospective Cohort Study Using the ImproveCareNow Registry DataCrohn's DiseaseDrug: UstekinumabJanssen Research & Development, LLCImproveCareNow (ICN);Children's Hospital Medical Center, CincinnatiNot yet recruiting2 Years25 YearsAll662United States
2NCT04779762
(ClinicalTrials.gov)
January 202228/2/2021Stelara and Diet Trial for Crohns DiseaseStelara and CDED Diet Trial for Crohns DiseaseCrohn DiseaseOther: Crohn's disease exclusion diet (CDED);Drug: Ustekinumab Injection [Stelara]Wolfson Medical CenterSheba Medical Center, IsraelNot yet recruiting18 Years65 YearsAll40N/AIsrael
3EUCTR2020-004527-16-IT
(EUCTR)
21/12/202129/09/2021A study to test whether BI 706321 combined with ustekinumab helps people with Crohn’s DiseaseA Phase IIa, randomised, double-blind, placebo-controlled trial to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BI 706321 orally administered for 12 weeks in patients with Crohn`s Disease (CD) receiving ustekinumab induction treatment - InCharge Crohn`s Disease (CD)
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Stelara 130mg / 26mL concentrate for solution for infusion
Product Name: Stelara 130mg / 26mL concentrate for solution for infusion
Product Code: [Stelara 130mg / 26mL concentrate for solution for
INN or Proposed INN: USTEKINUMAB
Product Name: BI 706321
Product Code: [BI 706321]
Product Name: BI 706321
Product Code: [BI 706321]
Product Name: BI 706321
Product Code: [BI 706321]
Trade Name: STELARA - 90 MG - SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA(VETRO) 1 ML(90MG/ML) 1 SIRINGA PRERIEMPITA DA 1 ML
Product Name: Stelara 90mg/1ml solution for injection in pre-filled syringe (PFS)
Product Code: [Stelara 90mg/1ml solution for injecti
BOEHRINGER INGELHEIM INTERNATIONAL GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2France;United States;Czechia;Spain;Poland;Belgium;Italy
4NCT05029921
(ClinicalTrials.gov)
December 10, 202130/8/2021A Study of Ustekinumab (STELARA) in Chinese Participants With Moderately to Severely Active Crohn's DiseaseA Phase 4, Single Arm, Open-Label, 52-Week, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab (STELARA), an Anti-Interleukin-12/23 Monoclonal Antibody, in Chinese Participants With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: UstekinumabJanssen Research & Development, LLCNULLRecruiting18 YearsN/AAll180Phase 4China
5NCT04629196
(ClinicalTrials.gov)
November 202110/11/2020Induction Optimization With Stelara for Crohn's DiseaseInduction Optimization With Stelara for Crohn's DiseaseCrohn DiseaseDrug: UstekinumabNYU Langone HealthNULLNot yet recruiting18 Years70 YearsAll113Phase 4United States
6EUCTR2020-004457-76-PL
(EUCTR)
28/10/202115/09/2021A Long-term Extension Study of Ustekinumab in Pediatric Participants with different medical conditions.A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) - UNITED Paediatric conditions in - Moderately to Severely Active Crohn's Disease - Moderately to Severely Active Ulcerative Colitis - Juvenile Psoriatic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3France;United States;Argentina;Poland;Turkey;Russian Federation;Japan
7NCT05092269
(ClinicalTrials.gov)
October 18, 202113/10/2021A Long-term Extension Study of Ustekinumab in Pediatric ParticipantsA Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age)Crohn Disease;Colitis, Ulcerative;Arthritis, PsoriaticDrug: UstekinumabJanssen Research & Development, LLCNULLRecruiting2 Years17 YearsAll151Phase 3United States;Belgium;France;Hungary;Poland
8NCT04978493
(ClinicalTrials.gov)
October 4, 202126/7/2021A Study to Test Whether BI 706321 Combined With Ustekinumab Helps People With Crohn's DiseaseA Phase IIa, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BI 706321 Orally Administered for 12 Weeks in Patients With Crohn's Disease (CD) Receiving Ustekinumab Induction TreatmentCrohn DiseaseDrug: BI 706321;Drug: ustekinumab;Drug: PlaceboBoehringer IngelheimNULLRecruiting18 Years75 YearsAll50Phase 2United States;Poland
9NCT03712826
(ClinicalTrials.gov)
October 202116/8/2018Identification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's DiseaseIdentification by Cytometry by Mass of Predictive Immunological Profiles of Answer to Treatmentby Biotherapics for Patients With Crohn's DiseaseCrohn DiseaseDrug: Anti-TNF Drug;Drug: UstekinumabHospices Civils de LyonNULLNot yet recruiting18 YearsN/AAll60N/AFrance
10JPRN-jRCT2031200345
11/08/202105/02/2021A Study of Ustekinumab in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's Disease Crohn Disease-Ustekinumab
Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.
Open- Label UstekinumabIntravenous (IV): Induction Period
UstekinumabSubcutaneous (SC) Every8 Weeks (q8w): Maintenance Period
Ustekinumab SC Every12 Weeks (q12w): Maintenance Period

-Placebo
Matching placebo will be administered as SC injection.
UstekinumabSubcutaneous (SC) Every8 Weeks (q8w): Maintenance Period
Ustekinumab SC Every12 Weeks (q12w): Maintenance Period
Nishikawa KazukoNULLRecruiting>= 2age old< 18age oldBoth90Phase 3United States Of America;Belgium;Germany;Hungary;Poland;Russian Federation;United Kingdom Of Great Britain And Northern Irela;Japan
11NCT04372108
(ClinicalTrials.gov)
June 24, 202130/4/2020A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative ColitisAn Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records DatabaseCrohn Disease;Colitis, UlcerativeDrug: Ustekinumab;Drug: Other Biologic TherapiesJanssen Scientific Affairs, LLCNULLRecruiting18 YearsN/AAll1056United States
12EUCTR2020-002674-26-DE
(EUCTR)
19/05/202117/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
13EUCTR2018-002629-51-CZ
(EUCTR)
12/05/202102/03/2021A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Czechia;Czech Republic;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
14NCT04673357
(ClinicalTrials.gov)
April 6, 202114/12/2020A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: Ustekinumab;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting2 Years17 YearsAll90Phase 3United States;Belgium;Germany;Hungary;Japan;Poland;Russian Federation;United Kingdom
15JPRN-jRCT2031200406
27/03/202110/03/2021A Study of JNJ-64304500 as Add-on Therapy in Participants with Active Crohn's DiseaseA Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy with Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants with Active Crohn's Disease - DUET Crohn DiseaseGroup 1- Standard of Care (SOC) Biological Therapy: Adalimumab: Participants will receive JNJ-64304500 Dose 1 or matching placebo subcutaneous (SC) injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to adalimumab or its biosimilar as SOC therapy.

Group 2: SOC Biological Therapy: Ustekinumab: Participants will receive JNJ-64304500 Dose 1 or matching placebo SC injection as induction dose (Week 0) followed by JNJ-64304500 Dose 2 or matching placebo SC injection from Week 2 through Week 10 as maintenance dose in addition to ustekinumab as SOC therapy.
Numaguchi HirotakaNULLNot Recruiting>= 18age old<= 65age oldBoth70Phase 2Canada;France;Germany;Italy;Spain;United States Of America;Japan
16EUCTR2019-004225-24-DE
(EUCTR)
17/03/202117/11/2020A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan
17NCT04655807
(ClinicalTrials.gov)
March 3, 202130/11/2020A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's DiseaseA Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate the Safety and Efficacy of JNJ-64304500 as Add-on Therapy to Standard of Care Biologic Therapy With Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants With Active Crohn's DiseaseCrohn DiseaseDrug: JNJ-64304500;Drug: Placebo;Drug: Adalimumab;Drug: UstekinumabJanssen Research & Development, LLCNULLWithdrawn18 Years65 YearsAll0Phase 2United States;Canada;France;Germany;Italy;Japan;Spain;Sweden
18EUCTR2019-004225-24-BE
(EUCTR)
08/02/202125/11/2020A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3United States;Hungary;Poland;Belgium;Russian Federation;Germany;United Kingdom;Japan
19EUCTR2020-002674-26-SK
(EUCTR)
14/01/202120/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
20EUCTR2020-002674-26-CZ
(EUCTR)
13/01/202118/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
21EUCTR2020-002674-26-HU
(EUCTR)
06/01/202120/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
22EUCTR2019-004225-24-HU
(EUCTR)
05/01/202120/11/2020A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 3Russian Federation;Germany;United Kingdom;Japan;Poland;Belgium;United States;Hungary
23EUCTR2020-002674-26-IT
(EUCTR)
10/12/202021/05/2021A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. - NA Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: [ABBV-066]
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: [ABBV-066]
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: [Ustekinumab]
INN or Proposed INN: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: [Ustekinumab]
INN or Proposed INN: USTEKINUMAB
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
24EUCTR2020-002674-26-GB
(EUCTR)
02/12/202026/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
25EUCTR2020-002674-26-AT
(EUCTR)
23/11/202018/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden;United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada
26EUCTR2020-002674-26-SE
(EUCTR)
19/11/202013/11/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
27NCT04496063
(ClinicalTrials.gov)
November 16, 202029/6/2020USTekinumab in Fistulising Perianal Crohn's Disease (USTAP)USTekinumab in Fistulising Perianal Crohn's Disease (CD): The USTAP CD StudyCrohn's DiseaseDrug: Ustekinumab;Drug: PlaceboGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesJanssen, LPRecruiting18 YearsN/AAll146Phase 4France
28EUCTR2020-002674-26-NL
(EUCTR)
29/10/202015/09/2020A Study to compare the efficacy of Risankizumab and Utsekinumab in Subjects with Moderately to Severe Active Crohns Disease.A phase 3, multicenter, Randomized, Efficacy Assessor-Blinded study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn’s Disease who have failed anti-TNF therapy. Crohns Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Trade Name: Stelara 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
508Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;Italy;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
29NCT04524611
(ClinicalTrials.gov)
September 30, 202020/8/2020Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)A Phase 3, Multicenter, Randomized, Efficacy Assessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Have Failed Anti-TNF TherapyCrohn's Disease (CD)Drug: Risankizumab;Drug: UstekinumabAbbVieNULLRecruiting18 Years80 YearsAll508Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom
30EUCTR2018-004614-18-DK
(EUCTR)
08/09/202005/08/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
31EUCTR2018-004614-18-HR
(EUCTR)
24/08/202023/11/2020Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
32EUCTR2018-004614-18-LT
(EUCTR)
20/05/202025/11/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
33EUCTR2019-001337-13-FR
(EUCTR)
18/03/202002/03/2020USTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD studyUSTekinumab in fistulising Perianal Crohn’s Disease: The USTAP CD study - USTAP patient with moderate to severe Crohn’s diseasewith at least one active perianal fistula track;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: STELARA
Trade Name: STELARA 90 mg solution for injection in pre-filled syringe
GETAIDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
146Phase 4France
34EUCTR2018-002629-51-GB
(EUCTR)
16/03/202008/01/2020A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Spain;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
35EUCTR2018-004614-18-LV
(EUCTR)
19/02/202012/12/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
36NCT04245215
(ClinicalTrials.gov)
February 13, 202023/1/2020Loss of RESponse to Ustekinumab Treated by Dose EscalationLoss of RESponse to Ustekinumab Treated by Dose EscalationCrohn DiseaseDrug: UstekinumabBelgian Inflammatory Bowel Disease Research and Development (BIRD) VZWJanssen Cilag N.V./S.A.Recruiting18 YearsN/AAll108Phase 3Belgium
37EUCTR2018-002629-51-AT
(EUCTR)
12/11/201927/06/2019A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Spain;Austria;Netherlands;Germany;United Kingdom;Sweden
38EUCTR2018-004614-18-NL
(EUCTR)
21/10/201927/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden
39EUCTR2018-004614-18-DE
(EUCTR)
15/10/201925/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
40EUCTR2018-004614-18-IT
(EUCTR)
09/10/201930/07/2021Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: [LY3074828]
INN or Proposed INN: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: [LY3074828]
INN or Proposed INN: Mirikizumab
Trade Name: STELARA 130 mg concentrate for solution for infusion
Product Name: Ustekinumab
Product Code: [Ustekinumab]
INN or Proposed INN: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Product Name: Ustekinumab
Product Code: [Ustekinumab]
INN or Proposed INN: USTEKINUMAB
Product Name: MIRIKIZUMAB
Product Code: [
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden
41JPRN-jRCT1031190056
30/09/201917/07/2019E6011-CS1 studyResearch for medicinal predictive marker on Crohn's disease - E6011-CS1 study Crohn's disease
Crohn's disease;D003424
Study1:Evaluate the disease activity and collect the blood according to the schedule as below. Amount of blood collection should be about 15mL at screening test, after the beginning of the study, about 12.5mL per visit.

1.Adalimumab:At the beginning of the study, after that, 2, 4, 12, 24, 52 weeks after or at the termination
2.Infliximab:At the beginning of the study,after that, 2, 6, 14, 22, 54 weeks after or at the termination
3. Ustekinumab:At the beginning of the study,after that, 2, 8, 20, 32, 56weeks after or at the termination

Study2:None.
Mikami YoheiEA Pharma Co.,Ltd.(Utilize AMED's funds)Not Recruiting>= 16age oldNot applicableBoth32N/AJapan
42EUCTR2018-002629-51-IT
(EUCTR)
26/09/201915/06/2021A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA - 90 MG SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) 1.0 ML (90 MG/ML) 1 FLACONCINO
Product Name: Ustekinumab
Product Code: [CNTO1275]
INN or Proposed INN: USTEKINUMAB
Other descriptive name: ustekinumab
Trade Name: STELARA - 45 MG SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) 0.5 ML (90 MG/ML) 1 FLACONCINO
Product Name: USTEKINUMAB
Product Code: [CNTO1275]
INN or Proposed INN: USTEKINUMAB
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Czech Republic;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
43EUCTR2018-004614-18-GB
(EUCTR)
16/09/201920/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3Russian Federation;United States;Serbia;Taiwan;Spain;Ukraine;Israel;Switzerland;Italy;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden;India;Slovakia
44EUCTR2018-004614-18-ES
(EUCTR)
12/09/201904/07/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 Moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Lilly S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
45EUCTR2018-004614-18-FR
(EUCTR)
11/09/201920/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
46NCT03885713
(ClinicalTrials.gov)
September 10, 20194/3/2019Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel DiseaseIdentification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry ApproachesInflammatory Bowel Diseases;Crohn Disease;Ulcerative ColitisBiological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumabFundación de Investigación Biomédica - Hospital Universitario de La PrincesaNULLRecruiting18 YearsN/AAll180Phase 4Spain
47EUCTR2018-004614-18-PL
(EUCTR)
03/09/201909/07/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1150Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Germany;Japan;Sweden
48EUCTR2018-002629-51-FR
(EUCTR)
31/07/201924/04/2019A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Spain;Netherlands;Germany;Sweden
49EUCTR2018-004614-18-HU
(EUCTR)
25/07/201911/06/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
50NCT03926130
(ClinicalTrials.gov)
July 23, 201923/4/2019A Study of Mirikizumab (LY3074828) in Participants With Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Mirikizumab;Drug: Ustekinumab;Drug: PlaceboEli Lilly and CompanyNULLRecruiting15 Years80 YearsAll1150Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Sweden
51EUCTR2018-004614-18-AT
(EUCTR)
10/07/201928/05/2019Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Active Crohn's DiseaseA Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Crohn's Disease - VIVID-1 moderately to severely active Crohn’s disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: MIRIKIZUMAB
Product Code: LY3074828
INN or Proposed INN: Mirikizumab
Other descriptive name: MIRIKIZUMAB
Trade Name: STELARA 130 mg concentrate for solution for infusion
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Stelara 90 mg solution for injection in pre-filled syringe
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Product Name: MIRIKIZUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3Serbia;United States;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden
52EUCTR2019-002038-35-BE
(EUCTR)
27/06/201907/06/2019A study meausring ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patientsA prospective study investigating ustekinumab concentrations through dried blood spot sampling in Crohn’s disease patients - DUST Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Stelara
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
UZ LeuvenNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Belgium
53EUCTR2017-002195-13-GB
(EUCTR)
05/06/201928/02/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand
54EUCTR2018-002629-51-SE
(EUCTR)
23/04/201929/01/2019A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3United States;Czechia;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Germany;Netherlands;Sweden;Korea, Republic of
55NCT03942120
(ClinicalTrials.gov)
April 8, 20197/5/2019Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)Post-Marketing Surveillance for Crohn's Disease Patients Treated With STELARACrohn DiseaseDrug: UstekinumabJanssen Korea, Ltd., KoreaNULLRecruiting18 YearsN/AAll70Korea, Republic of
56EUCTR2017-002195-13-PT
(EUCTR)
18/03/201923/07/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Serbia;United States;Portugal;Belarus;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
57EUCTR2016-000634-21-FR
(EUCTR)
28/01/201908/11/2018A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: JNJ-64304500
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
693Phase 2United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of
58EUCTR2018-002629-51-NL
(EUCTR)
08/01/201912/11/2018A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3France;United States;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
59EUCTR2018-002925-47-ES
(EUCTR)
28/12/201816/11/2018prediction of response to therapy in inflammatory bowel diseaseIdentification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches Inflammatory bowel disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Trade Name: Infliximab
INN or Proposed INN: INFLIXIMAB
Trade Name: Golimumab
INN or Proposed INN: GOLIMUMAB
Trade Name: Ustekinumab
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Vedolizumab
INN or Proposed INN: VEDOLIZUMAB
Other descriptive name: VEDOLIZUMAB
Fundación de Investigación Biomédica del Hospital Universitario de La PrincesaNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSpain
60NCT03782376
(ClinicalTrials.gov)
December 20, 201811/12/2018A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's DiseaseA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: Ustekinumab approximately 6 mg/kg (IV);Drug: Placebo (SC);Drug: Placebo (IV);Drug: Ustekinumab 90 mg (SC) Group 1;Drug: Ustekinumab 90 mg (SC) Group 2Janssen-Cilag Ltd.NULLRecruiting18 YearsN/AAll200Phase 3United States;Austria;Czechia;France;Germany;Italy;Korea, Republic of;Netherlands;Russian Federation;Spain;Sweden;United Kingdom
61EUCTR2018-002629-51-ES
(EUCTR)
12/12/201816/11/2018A Clinical Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Chronic Inflammatory Bowel Disease That Affects the Lining of the Digestive TractA Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn’s Disease - Patient Optimization With ustekinumab Re-induction (POWER) Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Spain;Netherlands;Germany;Sweden
62EUCTR2017-002195-13-IT
(EUCTR)
05/11/201822/01/2021A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: [CNTO1959]
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: [CNTO1959]
INN or Proposed INN: Guselkumab
Product Name: Ustekinumab
Product Code: [CNTO1275]
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: [CNTO1275]
INN or Proposed INN: USTEKINUMAB
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand
63EUCTR2017-005151-83-DE
(EUCTR)
26/10/201809/07/2018Treatment of Crohn's disease with Ustekinumab in clinical practiceINDUCTION AND MAINTENANCE OF MUCOSAL HEALING IN CROHN’S DISEASE WITH USTEKINUMAB IN CLINICAL PRACTICE - MUCUS Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: STELARA
Product Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA
Product Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Charité Universitätsmedizin BerlinNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 4Germany
64EUCTR2017-004209-41-BE
(EUCTR)
25/10/201821/08/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of
65EUCTR2017-004209-41-DE
(EUCTR)
16/10/201821/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
66EUCTR2017-004209-41-NL
(EUCTR)
01/10/201827/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
67NCT03606499
(ClinicalTrials.gov)
September 26, 201820/7/2018Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory DiseasesEffectiveness of Ustekinumab in Patients Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases in a Real-world SettingCrohn Disease;Colitis, UlcerativeDrug: UstekinumabJanssen Cilag S.A.S.NULLRecruiting18 YearsN/AAll214France
68EUCTR2017-004209-41-BG
(EUCTR)
26/09/201819/07/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one year Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
69JPRN-JapicCTI-183950
20/9/201807/05/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallelgroup, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease Crohn's DiseaseIntervention name : Guselkumab
INN of the intervention : Guselkumab
Dosage And administration of the intervention : Phase 2 (GALAXI 1): Group 1 (Guselkumab) Guselkumab will be administered by IV infusion. Phase 2 (GALAXI 1): Group 1 and Group 2 (Guselkumab) Guselkumab will be administered by SC injection. Phase 2 (GALAXI 1): Group 2 (Guselkumab) Guselkumab will be administered by IV infusion. Phase 2 (GALAXI 1): Group 3 (Guselkumab) Guselkumab will be administered by IV infusion and SC injection. Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab) Guselkumab will be administered by IV infusion and SC injection
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Phase 2 (GALA XI 1): Group 5(Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 3 (Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Ustekinumab will be administered by IV infusion and SC injection. Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Placebo will be administered as IV infusion.
Control intervention name : Ustekinumab
INN of the control intervention : Ustekinumab
Dosage And administration of the control intervention : Phase 2 (GALAXI 1): Group 4 (Ustekinumab) Phase 2 (GALA XI 1): Group 5(Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 3 (Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Ustekinumab will be administered by IV infusion and SC injection. Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab) Phase 3 (GALAXI 2 and 3):Group 4 (Placebo/Ustekinumab) Placebo will be administered as IV infusion.
Janssen Pharmaceutical K.K.NULLrecruiting18BOTH2000Phase 2-3Japan, North America
70EUCTR2017-002195-13-NL
(EUCTR)
10/09/201830/04/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Latvia;Netherlands;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand
71EUCTR2017-002195-13-HR
(EUCTR)
07/09/201816/05/2019A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand
72EUCTR2017-004209-41-IT
(EUCTR)
31/08/201817/06/2021A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: [CNTO1275]
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: [CNTO1275]
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: Humira®
Product Name: Adalimumab
Product Code: [Adalimumab]
INN or Proposed INN: ADALIMUMAB
Other descriptive name: ADALIMUMAB
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
73EUCTR2017-004209-41-CZ
(EUCTR)
27/08/201813/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Serbia;United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
74EUCTR2017-004209-41-GB
(EUCTR)
24/08/201822/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Serbia;United States;Czechia;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
75EUCTR2017-002195-13-PL
(EUCTR)
13/08/201825/05/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Portugal;United States;Belarus;Serbia;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Switzerland;Italy;India;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden
76EUCTR2017-002195-13-LV
(EUCTR)
10/08/201821/05/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand
77EUCTR2017-004209-41-PL
(EUCTR)
03/08/201820/06/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Korea, Republic of;Germany;Netherlands;Bulgaria;Australia;Belgium;Brazil;Poland;Canada;Hungary;Czech Republic;France;Italy;United Kingdom;Russian Federation;Spain;Czechia;United States;Serbia
78EUCTR2017-004209-41-FR
(EUCTR)
30/07/201814/06/2018A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3United States;Serbia;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Brazil;Poland;Australia;Bulgaria;Germany;Netherlands;Korea, Republic of
79EUCTR2017-002195-13-ES
(EUCTR)
30/07/201821/05/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Serbia;Portugal;Belarus;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
80EUCTR2017-002195-13-GR
(EUCTR)
27/07/201817/07/2018A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Portugal;Serbia;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;North Macedonia;Israel;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;New Zealand;Japan
81EUCTR2017-002195-13-DE
(EUCTR)
03/07/201801/03/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3United States;Serbia;Portugal;Belarus;Taiwan;Saudi Arabia;Slovakia;Greece;Spain;Ukraine;Lebanon;Russian Federation;Israel;North Macedonia;Colombia;Italy;France;Jordan;Australia;South Africa;Tunisia;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;New Zealand;Japan
82EUCTR2017-002195-13-LT
(EUCTR)
28/06/201820/04/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand
83EUCTR2017-004209-41-ES
(EUCTR)
21/06/201821/05/2018A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With BiologicA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to that of Adalimumab in the Treatment of Biologic Naïve Subjects with Moderately-to-Severely Active Crohn’s Disease - SEAVUE: Safety and Efficacy of Adalimumab Versus Ustekinumab for one yEar Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: Humira®
Product Name: Adalimumab
INN or Proposed INN: ADALIMUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Serbia;United States;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany;Korea, Republic of
84EUCTR2017-002195-13-CZ
(EUCTR)
19/06/201820/04/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand
85EUCTR2017-002195-13-SK
(EUCTR)
18/06/201826/04/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
INN or Proposed INN: ustekinumab
Trade Name: STELARA
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Portugal;United States;Belarus;Serbia;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Switzerland;Italy;India;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Bosnia and Herzegovina;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Norway;Germany;Japan;New Zealand;Sweden
86EUCTR2017-002195-13-BE
(EUCTR)
15/06/201830/03/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Georgia;Germany;Japan;New Zealand
87EUCTR2017-002195-13-AT
(EUCTR)
28/05/201818/04/2018A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Crohn's Disease - GALAXI Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2000Phase 2;Phase 3Portugal;Belarus;Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Lebanon;Israel;North Macedonia;Russian Federation;Colombia;Italy;France;Jordan;Australia;South Africa;Netherlands;Latvia;Tunisia;China;Korea, Republic of;Bosnia and Herzegovina;Czechia;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Georgia;Germany;Japan;New Zealand
88EUCTR2016-002918-43-DK
(EUCTR)
03/05/201815/02/2018Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
650Phase 3Portugal;France;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
89NCT03466411
(ClinicalTrials.gov)
April 13, 20188/3/2018A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's DiseaseA Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Guselkumab Dose 3;Drug: Guselkumab Dose 4;Drug: Guselkumab Dose 5;Drug: Guselkumab;Drug: Ustekinumab;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting18 YearsN/AAll2000Phase 2/Phase 3United States;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;France;Georgia;Germany;Greece;Hungary;India;Israel;Italy;Japan;Jordan;Korea, Republic of;Latvia;Lebanon;Lithuania;Malaysia;Netherlands;New Zealand;North Macedonia;Poland;Portugal;Puerto Rico;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Taiwan;Tunisia;Turkey;Ukraine;United Kingdom;Ireland;Macedonia, The Former Yugoslav Republic of;Slovenia;South Africa
90NCT03464136
(ClinicalTrials.gov)
March 29, 20187/3/2018Safety and Efficacy of Adalimumab Versus Ustekinumab for One YearA Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's DiseaseCrohn DiseaseBiological: Placebo for Ustekinumab;Biological: Placebo for Adalimumab;Biological: Ustekinumab (6 mg/kg);Biological: Ustekinumab (90 mg);Biological: Adalimumab (40 mg)Janssen Scientific Affairs, LLCNULLCompleted18 YearsN/AAll386Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Korea, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;United Kingdom
91EUCTR2016-002918-43-SK
(EUCTR)
16/03/201815/02/2018Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
650Phase 3Portugal;France;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
92JPRN-jRCTs021200013
28/02/201831/07/2020A comparison between combination therapy of Ustekinumab boosted by Budesonide and monotherapy of Ustekinumab for Crohn's disease.A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial. - BUUST Crohn's disease
Crohn's disease;D003424
Ustekinumab monotherapy for 32 weeks.Moroi RintaoNULLRecruiting>= 18age old<= 75age oldBoth80Phase 3Japan
93JPRN-UMIN000030884
2018/02/2720/02/2018A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial. Crohn's diseaseUstekinumab monotherapy for 32 weeks.
Combination of Budesonide and Ustekinumab for 32 weeks.
Tohoku University Hospital, Division of GastroenterologyNULLRecruiting18years-old75years-oldMale and Female80Phase 3Japan
94NCT03351647
(ClinicalTrials.gov)
February 14, 201830/10/2017Predictive Factors of Clinical Response to Ustekinumab in Active Crohn's DiseaseIdentification of Biological Predictive Factors of Clinical Response to Ustekinumab in Patients With Anti-Tumor Necrosis Factor (TNF) Antagonists Refractory Crohn's Disease: Interest of Dosage of C Reactive Protein (CRP), Calprotectin, Ustekinumab Through Levels and AntibodiesCrohn DiseaseBiological: Evaluation of biological predictive factors of clinical response to ustekinumabHospices Civils de LyonNULLUnknown status18 Years18 YearsAll50France
95NCT03358706
(ClinicalTrials.gov)
February 2, 201827/11/2017A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative ColitisA Phase 1, Open-label, Drug Interaction Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis.Crohn Disease;Ulcerative ColitisDrug: Ustekinumab IV Infusion;Drug: Ustekinumab SC Injection;Drug: Midazolam 2 mg;Drug: Warfarin 10 mg;Drug: Vitamin K 10 mg;Drug: Omeprazole 20 mg;Drug: Dextromethorphan 30 mg;Drug: Caffeine 100 mgJanssen Research & Development, LLCNULLRecruiting18 Years75 YearsAll57Phase 1United States;Belgium;Germany;United Kingdom;Austria;Denmark;Sweden
96NCT03362736
(ClinicalTrials.gov)
November 27, 201730/11/2017An Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's DiseaseAn Early Access Program for Ustekinumab in Patients With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: UstekinumabJanssen Research & Development, LLCNULLNo longer available18 YearsN/AAllBrazil
97NCT03167437
(ClinicalTrials.gov)
October 30, 201724/5/2017An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With UstekinumabAn Open-Label, Proof of Concept Study of Vorinostat for the Treatment of Moderate-to-Severe Crohn's Disease and Maintenance Therapy With UstekinumabCrohn's DiseaseDrug: Vorinostat;Drug: UstekinumabNational Institute of Allergy and Infectious Diseases (NIAID)NULLRecruiting18 Years65 YearsAll35Phase 1/Phase 2United States
98NCT03495973
(ClinicalTrials.gov)
October 25, 201728/3/2018Prospective Observational Study on Ustekinumab (Stelara) Assessing Efficacy and Healthcare Resource Utilization in Crohn's DiseaseProspective Observational Study on Stelara Assessing Efficacy and Healthcare Resource Utilization in Crohn's Disease (PROSE)Crohn DiseaseDrug: UstekinumabJanssen-Cilag Ltd.NULLCompleted18 YearsN/AAll114Sweden
99EUCTR2016-002918-43-PT
(EUCTR)
09/10/201711/08/2017Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
650Phase 3France;Portugal;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
100JPRN-UMIN000028139
2017/07/0407/07/2017Therapeutic reactivity of Ustekinumab in moderate to severe active stage Crohn's disease Crohn's diseaseTreatment with UstekinumabGraduate School of Medical Sciences, Kyushu UniversityNULLRecruiting20years-oldNot applicableMale and Female50Not selectedJapan
101EUCTR2016-001956-22-DE
(EUCTR)
04/07/201728/10/2016A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's DiseaseA Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 1France;United States;Canada;Poland;Belgium;Germany
102EUCTR2016-002918-43-DE
(EUCTR)
03/07/201713/02/2017Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
650Phase 3Portugal;France;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
103EUCTR2016-002918-43-NL
(EUCTR)
14/06/201702/03/2017Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
650Phase 3Portugal;France;Slovakia;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
104EUCTR2016-002918-43-FR
(EUCTR)
16/05/201716/05/2017Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
650Phase 3Sweden;Italy;United Kingdom;Germany;Netherlands;Denmark;Belgium;Spain;Slovakia;France;Portugal
105NCT03107793
(ClinicalTrials.gov)
April 19, 201728/3/2017Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With UstekinumabCrohn DiseaseDrug: UstekinumabJanssen-Cilag Ltd.NULLCompleted18 YearsN/AAll500Phase 3Belgium;Czechia;Denmark;France;Germany;Italy;Netherlands;Portugal;Slovakia;Spain;Sweden;United Kingdom
106NCT03108326
(ClinicalTrials.gov)
April 15, 201730/3/2017Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s DiseaseReal World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease in Conjunction With Long-term OutcomeCrohn DiseaseBiological: Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, InflectraCed Service GmbHNULLRecruiting18 Years80 YearsAll900Germany
107EUCTR2016-002918-43-BE
(EUCTR)
03/04/201702/02/2017Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
650Phase 3Portugal;France;Slovakia;Spain;Belgium;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
108EUCTR2016-002918-43-IT
(EUCTR)
27/03/201717/06/2021Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn¿s Disease Patients Treated with Ustekinumab - . Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
Trade Name: STELARA
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Other descriptive name: USTEKINUMAB
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3Portugal;France;Slovakia;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
109EUCTR2016-002918-43-ES
(EUCTR)
20/03/201725/01/2017Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.Janssen-Cilag International N.V.Authorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3France;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom;Sweden
110EUCTR2016-002918-43-SE
(EUCTR)
15/03/201719/01/2017Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
650Phase 3Portugal;France;Slovakia;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
111EUCTR2016-002918-43-GB
(EUCTR)
28/02/201710/01/2017Study to compare 2 treatment strategies in Crohn's Disease patients treated with UstekinumabStudy of Treat to Target Versus Routine Care Maintenance Strategies in Crohn’s Disease Patients Treated with Ustekinumab Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3Portugal;Belgium;Spain;Netherlands;Germany;United Kingdom
112EUCTR2016-001956-22-BE
(EUCTR)
25/01/201726/10/2016A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's DiseaseA Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
40Phase 1France;United States;Canada;Poland;Belgium;Germany
113NCT02968108
(ClinicalTrials.gov)
January 18, 201724/10/2016A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's DiseaseA Randomized Double-blind Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: UstekinumabJanssen Research & Development, LLCNULLActive, not recruiting2 Years17 YearsAll45Phase 1United States;Belgium;Canada;France;Germany;Poland
114EUCTR2016-000634-21-PL
(EUCTR)
13/01/201711/10/2016A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: JNJ-64304500
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
654Phase 2United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Korea, Republic of
115EUCTR2016-001956-22-PL
(EUCTR)
12/01/201701/12/2016A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's DiseaseA Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
40Phase 1France;United States;Canada;Belgium;Poland;Germany
116EUCTR2016-000634-21-IT
(EUCTR)
29/12/201622/01/2021A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn¿s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn¿s Disease - - Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: -
Product Code: JNJ-64304500
INN or Proposed INN: -
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA¿
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: -
JANSSEN CILAG INTERNATIONAL NVNULLNot RecruitingFemale: yes
Male: yes
654Phase 2United States;Korea, Democratic People's Republic of;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Korea, Republic of
117EUCTR2016-000634-21-HU
(EUCTR)
11/11/201612/09/2016A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: JNJ-64304500
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
693Phase 2United States;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of
118EUCTR2016-000634-21-GB
(EUCTR)
11/11/201603/08/2016 A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: JNJ-64304500
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Janssen-Cilag International NVNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
654 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of
119EUCTR2016-000634-21-DE
(EUCTR)
08/11/201607/07/2016A double-blind, placebo-controlled Clinical Trial to evaluate the Safety and Efficacy of JNJ-64304500 in patients with Moderately to Severely Active Crohn’s DiseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of JNJ-64304500 in Subjects with Moderately to Severely Active Crohn’s Disease Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: JNJ-64304500
INN or Proposed INN: JNJ-64304500
Other descriptive name: JNJ-64304500-AAA
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
Janssen-Cilag International NVNULLNot RecruitingFemale: yes
Male: yes
654Phase 2United States;Ukraine;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Korea, Republic of
120NCT02877134
(ClinicalTrials.gov)
August 25, 201619/8/2016A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's DiseaseA Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: JNJ-64304500;Drug: Placebo;Drug: UstekinumabJanssen Research & Development, LLCNULLActive, not recruiting18 YearsN/AAll388Phase 2United States;Belgium;Bulgaria;Canada;France;Germany;Hungary;Japan;Korea, Republic of;Poland;Romania;Russian Federation;Ukraine;United Kingdom;Czechia;Italy;Serbia
121NCT02103361
(ClinicalTrials.gov)
November 201313/2/2014Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy ProjectStelara® and Tremfya® Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy ProjectPsoriasis;Pregnancy;Psoriatic Arthritis;Crohn DiseaseDrug: Ustekinumab;Drug: GuselkumabUniversity of California, San DiegoThe Organization of Teratology Information Specialists;Janssen Biotech, Inc.RecruitingN/AN/AFemale200United States
122EUCTR2010-022758-18-BE
(EUCTR)
16/04/201207/06/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
703Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of
123EUCTR2010-022760-12-BE
(EUCTR)
16/04/201207/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1310 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
124EUCTR2010-022760-12-NL
(EUCTR)
04/04/201213/07/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 18.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
1310Phase 3Serbia;United States;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
125EUCTR2010-022759-42-IS
(EUCTR)
22/12/201129/10/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 Moderately to severely active Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Spain;Russian Federation;Israel;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Netherlands;Germany;Iceland;New Zealand;Japan;Korea, Republic of
126EUCTR2010-022760-12-BG
(EUCTR)
14/12/201111/11/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
1310Phase 3Brazil;Serbia;United States;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
127EUCTR2010-022759-42-BG
(EUCTR)
02/12/201111/11/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 Moderately to severely active Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
612Phase 3Korea, Republic of;New Zealand;Japan;Germany;Netherlands;Iceland;South Africa;Bulgaria;Australia;Croatia;Brazil;Canada;European Union;Hungary;United Kingdom;Italy;Russian Federation;Israel;Spain;United States
128EUCTR2010-022759-42-NL
(EUCTR)
01/12/201113/07/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 Moderately to severely active Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
612Phase 3United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Germany;Netherlands;Japan;New Zealand;Korea, Republic of
129EUCTR2010-022759-42-GB
(EUCTR)
21/10/201102/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 Moderately to severely active Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
612 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
130EUCTR2010-022758-18-GB
(EUCTR)
21/10/201102/06/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
703Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of
131EUCTR2010-022760-12-GB
(EUCTR)
21/10/201102/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1310 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;New Zealand;Japan
132EUCTR2010-022760-12-IE
(EUCTR)
17/10/201108/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1310 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Japan;New Zealand;Germany;Iceland;Bulgaria;Croatia;Belgium;Brazil;Canada;European Union;Hungary;Czech Republic;United Kingdom;Austria;Korea, Republic of;Netherlands
133EUCTR2010-022758-18-IE
(EUCTR)
17/10/201108/06/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 15.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
703Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of
134EUCTR2010-022760-12-FR
(EUCTR)
13/10/201123/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1275 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;Japan;New Zealand
135EUCTR2010-022759-42-ES
(EUCTR)
13/09/201127/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn's DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease - UNITI 2 Moderately to severely active Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Spain;Russian Federation;Israel;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
136EUCTR2010-022760-12-DE
(EUCTR)
13/09/201126/05/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1310Phase 3United States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
137NCT01369355
(ClinicalTrials.gov)
September 13, 20117/6/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's DiseaseCrohn's Disease;Colitis;IBD;Inflammatory Bowel DiseaseDrug: Placebo SC;Drug: Placebo IV;Drug: Ustekinumab 90 mg SC q8w;Drug: Ustekinumab 130 mg IV;Drug: Ustekinumab 90 mg SC q12wJanssen Research & Development, LLCNULLCompleted18 Years99 YearsAll1282Phase 3United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;France;Germany;Hungary;Iceland;Ireland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;South Africa;Spain;United Kingdom;Czech Republic
138EUCTR2010-022760-12-ES
(EUCTR)
02/09/201103/11/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn?s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn?s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1275 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;Japan;New Zealand
139EUCTR2010-022758-18-ES
(EUCTR)
01/09/201122/06/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
675Phase 3Hungary;Germany;European Union;Ireland;Italy;Austria;South Africa;Australia;Brazil;Israel;Czech Republic;United Kingdom;New Zealand;Serbia;Canada;Iceland;Denmark;Belgium;Korea, Republic of;Spain;Japan;United States
140EUCTR2010-022759-42-DE
(EUCTR)
29/08/201126/05/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 Moderately to severely active Crohn's disease
MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
612Phase 3United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
141EUCTR2010-022758-18-DE
(EUCTR)
24/08/201126/05/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
703Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of
142EUCTR2010-022758-18-CZ
(EUCTR)
22/08/201108/06/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 16.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
703Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of
143EUCTR2010-022760-12-CZ
(EUCTR)
17/08/201108/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1310 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGermany;New Zealand;Japan;Iceland;Bulgaria;Croatia;Belgium;Brazil;Canada;European Union;Hungary;Czech Republic;United Kingdom;Austria;Korea, Republic of;Netherlands;South Africa;Denmark;Australia;France;Italy;Russian Federation;Israel;Ireland;Spain;Serbia;United States
144EUCTR2010-022758-18-DK
(EUCTR)
15/08/201125/07/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
703Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of
145EUCTR2010-022760-12-DK
(EUCTR)
15/08/201126/08/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1310 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
146EUCTR2010-022759-42-IT
(EUCTR)
09/08/201123/01/2012A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn's DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallelgroup, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Moderately to severely active Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
JANSSEN-CILAG INTERNATIONAL N.V.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Spain;Russian Federation;Israel;United Kingdom;Italy;Hungary;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;New Zealand;Japan;Korea, Republic of
147EUCTR2010-022760-12-IT
(EUCTR)
09/08/201130/03/2012A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 18.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
1310Phase 3Serbia;United States;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
148EUCTR2010-022759-42-HU
(EUCTR)
09/08/201110/08/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - UNITI 2 Moderately to severely active Crohn's disease
MedDRA version: 17.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
612Phase 3United States;Spain;Israel;Russian Federation;Italy;United Kingdom;Hungary;European Union;Canada;Brazil;Croatia;Australia;Bulgaria;South Africa;Iceland;Netherlands;Germany;Japan;New Zealand;Korea, Republic of
149EUCTR2010-022758-18-IT
(EUCTR)
09/08/201122/06/2012Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallelgroup, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy Moderately to severely active Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: USTEKINUMAB
JANSSEN-CILAG INTERNATIONAL N.V.NULLNot RecruitingFemale: yes
Male: yes
675Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Italy;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of
150EUCTR2010-022760-12-HU
(EUCTR)
09/08/201108/07/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1310 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Spain;Ireland;Israel;Russian Federation;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
151EUCTR2010-022758-18-HU
(EUCTR)
02/08/201110/08/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
675Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Czech Republic;Hungary;European Union;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Germany;Iceland;New Zealand;Japan;Korea, Republic of
152EUCTR2010-022760-12-IS
(EUCTR)
02/08/201108/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
1275Phase 3Serbia;United States;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;European Union;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
153EUCTR2010-022760-12-AT
(EUCTR)
28/07/201101/06/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients with Moderately to Severely Active Crohn’s DiseaseA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease - IMUNITI Moderately to severely active Crohn's disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot Recruiting Female: yes
Male: yes
1310 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Spain;Ireland;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Croatia;Bulgaria;Iceland;Germany;New Zealand;Japan
154EUCTR2010-022758-18-AT
(EUCTR)
28/07/201101/06/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Stelara
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
703Phase 3Serbia;United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Brazil;Denmark;Australia;South Africa;Iceland;Germany;New Zealand;Japan;Korea, Republic of
155EUCTR2010-022758-18-IS
(EUCTR)
08/07/201108/06/2011Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist TherapyA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy - UNITI 1 Moderately to severely active Crohn's disease
MedDRA version: 13.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: N/A
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
675Phase 3Hungary;Czech Republic;Spain;Belgium;Ireland;Denmark;Austria;Germany;Iceland;Italy;United Kingdom
156NCT01369329
(ClinicalTrials.gov)
July 20117/6/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)Crohn's Disease;IBD;Colitis;Inflammatory Bowel DiseaseDrug: Group 2 ustekinumab 130 mg;Drug: Group 3: ustekinumab approximately 6 mg/kg;Drug: Group 1: PlaceboJanssen Research & Development, LLCNULLCompleted18 YearsN/AAll769Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Czech Republic;Denmark;France;Germany;Hungary;Iceland;Ireland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Serbia;South Africa;Spain;United Kingdom
157NCT01369342
(ClinicalTrials.gov)
July 20117/6/2011A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2)Crohn's Disease;Inflammatory Bowel Disease;IBD;ColitisDrug: Group 1: Placebo;Drug: Group 2 ustekinumab 130 mg;Drug: Group 3: ustekinumab approximately 6 mg/kgJanssen Research & Development, LLCNULLCompleted18 Years99 YearsAll640Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Canada;Croatia;France;Germany;Hungary;Iceland;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;South Africa;Spain;United Kingdom;Ireland
158EUCTR2008-000649-77-DE
(EUCTR)
11/03/200926/09/2008A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFIA Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
500Phase 2United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria
159EUCTR2008-000649-77-FR
(EUCTR)
16/02/200907/12/2009A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFIA Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
500Phase 2France;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
160EUCTR2008-000649-77-NL
(EUCTR)
06/02/200912/09/2008A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFIA Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
500Phase 2United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria
161EUCTR2008-000649-77-ES
(EUCTR)
27/01/200929/10/2008Estudio de fase IIB, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad del tratamiento conustekinumab en pacientes con enfermedad de Crohn activa de moderada a gravetratados previamente con antagonistas del factor de necrosis tumoral - CERTIFIEstudio de fase IIB, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad del tratamiento conustekinumab en pacientes con enfermedad de Crohn activa de moderada a gravetratados previamente con antagonistas del factor de necrosis tumoral - CERTIFI Enfermedad de Crohn activa de moderada a grave
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
500Phase 2France;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom
162EUCTR2008-000649-77-GB
(EUCTR)
23/01/200903/10/2008A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFIA Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
500Phase 2Germany;United Kingdom;Netherlands;Belgium;France;Spain;Austria
163EUCTR2008-000649-77-BE
(EUCTR)
05/01/200920/10/2008A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFIA Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
500Phase 2United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria
164NCT00771667
(ClinicalTrials.gov)
December 200810/10/2008A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF TherapyA Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist TherapyCrohn's DiseaseDrug: Placebo (IP);Drug: Ustekinumab 1mg/kg (IP);Drug: Ustekinumab 3 mg/kg (IP);Drug: Ustekinumab 6 mg/kg (IP);Drug: Placebo IV - Responder - Placebo SC (MP);Drug: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP);Drug: Ustekinumab IV - Responder - Placebo SC (MP);Drug: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP);Drug: Ustekinumab IV - Nonresponder - Placebo SC (MP);Drug: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)Centocor, Inc.NULLCompleted18 YearsN/AAll526Phase 2United States;Australia;Austria;Belgium;Canada;France;Germany;Israel;Netherlands;New Zealand;Spain;United Kingdom
165EUCTR2008-000649-77-AT
(EUCTR)
20/11/200803/11/2008A Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFIA Phase 2b, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study to Evaluate the Efficacyand Safety of Ustekinumab Therapy in Subjects with Moderatelyto Severely Active Crohn’s Disease Previously Treated with TNFAntagonist Therapy - CERTIFI Moderately to Severely Active Crohn’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Product Name: Ustekinumab
Product Code: CNTO 1275
INN or Proposed INN: Ustekinumab
Other descriptive name: Human Monoclonal Antibody (CNTO 1275) to Interleukin 12p-40; Anti-IL-12; Human Anti-IL-12 Antibody
Centocor BVNULLNot RecruitingFemale: yes
Male: yes
500Phase 2United Kingdom;Germany;Netherlands;Belgium;France;Spain;Austria
166NCT00265122
(ClinicalTrials.gov)
April 200413/12/2005A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's DiseaseA Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects With Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDrug: Ustekinumab 90 mg;Drug: Ustekinumab 4.5 mg/kg;Drug: Placebo SC;Drug: Placebo IVCentocor, Inc.NULLCompleted18 YearsN/AAll131Phase 2United States;Belgium;Canada
167EUCTR2019-004225-24-GB
(EUCTR)
25/11/2020A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLNAFemale: yes
Male: yes
90Phase 3United States;Hungary;Poland;Belgium;Russian Federation;Germany;Japan;United Kingdom
168EUCTR2019-004225-24-PL
(EUCTR)
16/12/2020A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLNAFemale: yes
Male: yes
90Phase 3United States;Hungary;Belgium;Poland;Russian Federation;Germany;United Kingdom;Japan
169EUCTR2019-004225-24-Outside-EU/EEA
(EUCTR)
08/02/2021A Clinical Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Intravenous Induction Treatment Followed by Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn's DiseaseA Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease - UNITI-Jr Moderately to Severely Active Crohn's Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLNAFemale: yes
Male: yes
Phase 3Japan;Russian Federation;United States;Belgium;Germany;Hungary;Poland;United Kingdom
170EUCTR2020-004457-76-FR
(EUCTR)
27/08/2021A Long-term Extension Study of Ustekinumab in Pediatric Participants with different medical conditions.A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study of Ustekinumab in Pediatric Clinical Study Participants (2 to <18 Years of Age) - UNITED Paediatric conditions in - Moderately to Severely Active Crohn's Disease - Moderately to Severely Active Ulcerative Colitis - Juvenile Psoriatic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10076674;Term: Juvenile psoriatic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International NVNULLNAFemale: yes
Male: yes
180Phase 3United States;Spain;Turkey;Russian Federation;Italy;United Kingdom;France;Hungary;Argentina;Belgium;Poland;Germany;Japan
171EUCTR2016-001956-22-FR
(EUCTR)
23/01/2017A Randomized Double-blind study of Ustekinumab in Pediatric Subjects with Crohn's DiseaseA Randomized Double-blind Pharmacokinetic study of Ustekinumab in Pediatric Subjects with Moderately to Severely Active Crohn's Disease Moderately to severely active Crohn's disease
MedDRA version: 19.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: STELARA®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Janssen-Cilag International N.V.NULLNot RecruitingFemale: yes
Male: yes
40Phase 1United States;France;Canada;Poland;Belgium;Germany