97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,527 / 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05242484 (ClinicalTrials.gov) | May 20, 2022 | 15/2/2022 | A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2b Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Guselkumab;Biological: Golimumab;Biological: JNJ-78934804 | Janssen Research & Development, LLC | NULL | Not yet recruiting | 18 Years | 65 Years | All | 500 | Phase 2 | United States |
| 2 | EUCTR2021-002211-65-ES (EUCTR) | 13/08/2021 | 11/06/2021 | EFFECT OF TOFACITINIB ON COAGULATION | EFFECT OF TOFACITINIB ON COAGULATION AND PLATELET FUNCTION, AND ITS ROLE IN THROMBOEMBOLIC EVENTS | ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Level: PT;Classification code 10009790;Term: Coagulation time;System Organ Class: 10022891 - Investigations MedDRA version: 21.0;Classification code 10061684;Term: Platelet function test;System Organ Class: 10022891 - Investigations;Therapeutic area: Body processes [G] - Biological Phenomena [G16] | 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: Tofacitinib INN or Proposed INN: TOFACITINIB | Fundación Española de Gastroenterología | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 4 | Spain | ||
| 3 | NCT04156984 (ClinicalTrials.gov) | May 2020 | 24/10/2019 | Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis | Exposure-response of Golimumab During Maintenance in Ulcerative Colitis: An Exploratory Pharmacokinetics/Pharmacodynamics Comparison of Different Dose Regimens | Ulcerative Colitis | Drug: Golimumab Prefilled Syringe | David Drobne | NULL | Not yet recruiting | 18 Years | 65 Years | All | 30 | Phase 4 | Slovenia |
| 4 | EUCTR2019-003987-37-SI (EUCTR) | 26/02/2020 | 27/11/2019 | Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis | Exposure-response of golimumab during maintenance in ulcerative colitis: An exploratory Pharmacokinetics/Pharmacodynamics comparison of different dose regimens | Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Simponi Product Code: CNTO-148 | University Medical Centre Ljubljana, Department of gastroenterology | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Slovenia | ||
| 5 | EUCTR2017-004496-31-NL (EUCTR) | 20/09/2019 | 27/09/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Poland;Belgium;Brazil;Israel;Netherlands;Italy;Korea, Republic of | ||
| 6 | NCT03885713 (ClinicalTrials.gov) | September 10, 2019 | 4/3/2019 | Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease | Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | NULL | Recruiting | 18 Years | N/A | All | 180 | Phase 4 | Spain |
| 7 | EUCTR2018-001510-15-DE (EUCTR) | 02/05/2019 | 19/11/2018 | A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: Simponi® Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Mexico;Argentina;Poland;Brazil;Ukraine;Australia;Russian Federation;Germany | ||
| 8 | EUCTR2018-001510-15-PL (EUCTR) | 01/03/2019 | 04/02/2019 | A Proof-of-concept Study of the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis - VEGA | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: TREMFYA® Product Name: Guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Trade Name: Simponi® Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | United States;Mexico;Argentina;Brazil;Poland;Ukraine;Australia;Russian Federation;Germany | ||
| 9 | NCT03773445 (ClinicalTrials.gov) | March 1, 2019 | 25/11/2018 | Golimumab Trough Levels in Patients With Ulcerative Colitis | Association of Golimumab Trough Levels With Endoscopic and Histologic Healing in Patients With Ulcerative Colitis | Ulcerative Colitis | Diagnostic Test: Golimumab trough levels;Diagnostic Test: Antibodies to golimumab;Diagnostic Test: Histology;Diagnostic Test: Colonoscopy | Hospital San Carlos, Madrid | Hospital Universitario La Fe;Hospital Universitario 12 de Octubre;Hospital Universitario Ramon y Cajal;Gregorio Marañón Hospital;Complejo Hospitalario de Navarra;Hospital Universitario Fundación Alcorcón;Hospital Infanta Sofia;Hospital Clínico Universitario de Valencia;Puerta de Hierro University Hospital;Hospital Universitario La Paz;Hospital Universitario de Fuenlabrada;Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 100 | Spain | |
| 10 | EUCTR2017-004496-31-IT (EUCTR) | 18/02/2019 | 17/06/2021 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Trade Name: SIMPONI Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Other descriptive name: D.3.6.2.1 - valore: 45 / 0.45 mg/ml Trade Name: Simponi Product Name: Golimumab Product Code: [CNTO148] INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: [CNTO312] INN or Proposed INN: INFLIXIMAB Other descriptive name: D.3.6.2.1 - valore: 5 o 10 mg/kg | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 3 | France;United States;Taiwan;Spain;Poland;Belgium;Brazil;Israel;Netherlands;Italy;Korea, Republic of | ||
| 11 | EUCTR2017-004496-31-PL (EUCTR) | 30/01/2019 | 06/12/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Belgium;Brazil;Poland;Israel;Netherlands;Italy;Korea, Republic of | ||
| 12 | EUCTR2018-002925-47-ES (EUCTR) | 28/12/2018 | 16/11/2018 | prediction of response to therapy in inflammatory bowel disease | Identification 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 Princesa | NULL | Authorised-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): yes | Spain | ||
| 13 | EUCTR2017-004496-31-FR (EUCTR) | 17/12/2018 | 14/09/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of | ||
| 14 | NCT03662542 (ClinicalTrials.gov) | November 20, 2018 | 6/9/2018 | A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Golimumab Dose 1;Drug: Golimumab Dose 2;Drug: Placebo | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 65 Years | All | 214 | Phase 2 | United States;Argentina;Australia;Brazil;Germany;Mexico;Poland;Russian Federation;Ukraine |
| 15 | EUCTR2017-004496-31-BE (EUCTR) | 07/11/2018 | 25/07/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab Product Code: CNTO312 INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | France;United States;Taiwan;Spain;Poland;Brazil;Belgium;Israel;Netherlands;Italy;Korea, Republic of | ||
| 16 | NCT03596645 (ClinicalTrials.gov) | October 29, 2018 | 13/7/2018 | A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab;Drug: Infliximab | Janssen Research & Development, LLC | NULL | Recruiting | 2 Years | 17 Years | All | 100 | Phase 3 | United States;Belgium;Brazil;France;Israel;Italy;Korea, Republic of;Netherlands;Poland;Spain;Taiwan |
| 17 | EUCTR2017-004496-31-ES (EUCTR) | 15/10/2018 | 28/08/2018 | A Study of the Efficacy and Safety of Golimumab in Pediatric Participantswith Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFaMonoclonal Antibody, Administered Subcutaneously in PediatricParticipants with Moderately to Severely Active Ulcerative Colitis - PURSUIT 2 | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Remicade Product Name: Infliximab INN or Proposed INN: INFLIXIMAB | Janssen Biologics BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 125 | Phase 3 | France;United States;Taiwan;Poland;Brazil;Belgium;Spain;Israel;Netherlands;Italy;Korea, Republic of | ||
| 18 | NCT03669029 (ClinicalTrials.gov) | October 1, 2018 | 4/7/2018 | Optimization of Golimumab Treatment in Ulcerative Colitis | Optimization of Golimumab Treatment in Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg;Drug: Golimumab treatment optimization. | Hospital de Manises | Valencia University General Hospital;Hospital Clínico Universitario de Valencia;Hospital de Sagunto;Hospital Universitario La Fe;Hospital General Universitario de Alicante;Hospital Universitario Doctor Peset;Hospital Arnau de Vilanova;Hospital Provincial de Castellon;Merck Sharp & Dohme Corp. | Unknown status | 18 Years | 80 Years | All | 50 | Phase 4 | Spain |
| 19 | NCT03394586 (ClinicalTrials.gov) | January 1, 2018 | 28/12/2017 | Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab | Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab | Ulcerative Colitis;Flare Up, Symptom | Drug: Exposure to golimumab | University of Zurich | NULL | Unknown status | N/A | N/A | All | 100 | Switzerland | |
| 20 | NCT03182166 (ClinicalTrials.gov) | November 21, 2017 | 29/5/2017 | Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization | Pharmacokinetic and Pharmacodynamic Study of Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization | Ulcerative Colitis | Drug: Golimumab (Optimization);Diagnostic Test: Rectosigmoidoscopy;Biological: Blood samples | Centre Hospitalier Universitaire de Saint Etienne | Merck Sharp & Dohme Corp. | Completed | 18 Years | N/A | All | 51 | Phase 2 | France |
| 21 | NCT03124121 (ClinicalTrials.gov) | September 5, 2017 | 4/4/2017 | Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels | Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels | Ulcerative Colitis | Drug: Golimumab | Guy's and St Thomas' NHS Foundation Trust | Merck Sharp & Dohme Corp. | Completed | 18 Years | N/A | All | 112 | Phase 4 | United Kingdom |
| 22 | EUCTR2017-001374-42-GB (EUCTR) | 21/07/2017 | 19/07/2017 | Measuring levels of golimumab to improve the understanding of differences in its effectiveness amongst patients with ulcerative colitis | Study of the Golimumab Exposure-Response Relationship using Serum Trough Levels - GO-LEVEL | Ulcerative Colitis (UC);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Golimumab | Guy's and St Thomas' NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 112 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 23 | EUCTR2016-001409-18-NO (EUCTR) | 06/12/2016 | 09/05/2016 | A study to evaluate the safety of stopping versus continuing anti TNF therapy in ulcerative colitis patients in remission, and to evaluate the safety and efficacy of restarting anti TNF therapy in patients with disease recurrence | A prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop study | Ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: 1.Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Helse More og Romsdal Hospital Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Norway | |||
| 24 | NCT02425865 (ClinicalTrials.gov) | December 2016 | 21/4/2015 | Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET | Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis- In-TARGET | ULCERATIVE COLITIS | Drug: GOLIMUMAB | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Active, not recruiting | 18 Years | 75 Years | All | 202 | Phase 4 | Belgium;France |
| 25 | NCT03018925 (ClinicalTrials.gov) | October 2016 | 13/12/2016 | Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis | Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis: Pilot Study | Ulcerative Colitis | Drug: Golimumab | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | NULL | Recruiting | 18 Years | N/A | All | 15 | N/A | Spain |
| 26 | NCT02687724 (ClinicalTrials.gov) | June 2016 | 16/2/2016 | Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in Colitis | GLM Dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC). A Nationwide Multi-centred Randomised Controlled Trial (RCT) Investigating the Use of GLM Dose Adjustment in Ulcerative Colitis (UC). | Colitis | Drug: Golimumab (GLM) | University College Dublin | NULL | Unknown status | 18 Years | N/A | All | 136 | Phase 4 | Ireland |
| 27 | EUCTR2015-004724-62-IE (EUCTR) | 22/12/2015 | 05/11/2015 | Golimumab dose variation to achieve response in Colitis | Golimumab (GLM) dose Optimisation to Adequate Levels to Achieve Response in Colitis. (GOAL-ARC) | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Simponi INN or Proposed INN: GOLIMUMAB INN or Proposed INN: GOLIMUMAB | UCD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 4 | Ireland | ||
| 28 | EUCTR2014-002579-27-IT (EUCTR) | 03/03/2015 | 19/01/2015 | Pilot study on the efficacy of golimumab in normalizing the symptoms and lesions of the colon-rectum in patients with ulcerative colitis who only respond to therapy with cortisone | Pilot study on the efficacy of golimumab in the induction and maintenance of clinical and endoscopic remission in patients with steroid-dependent ulcerative colitis. - UC-GOL | active steroid-dependent ulcerative colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: SIMPONI Product Name: SIMPONI Product Code: NA INN or Proposed INN: GOLIMUMAB | Istituto Clinico Humanitas | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Italy | ||
| 29 | NCT02412085 (ClinicalTrials.gov) | March 2015 | 26/3/2015 | Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission | Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab | Istituto Clinico Humanitas | NULL | Recruiting | 18 Years | 65 Years | Both | 100 | Phase 4 | Italy |
| 30 | NCT02318667 (ClinicalTrials.gov) | February 27, 2015 | 12/12/2014 | Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022). | An Open Label, Single Group Assignment Design Study to Correlate Soluble ST2 With Clinical, Endoscopic and Histological Activity in Moderate to Severe Ulcerative Colitis Patients Under Golimumab. | Colitis, Ulcerative | Biological: Golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | 65 Years | All | 38 | Phase 4 | Portugal |
| 31 | EUCTR2013-002042-36-FR (EUCTR) | 04/02/2015 | 22/06/2015 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;United States | ||
| 32 | EUCTR2014-003262-25-PT (EUCTR) | 12/12/2014 | 20/11/2014 | Study to correlate a new biomarker (ST2) with clinical activity in Ulcerative Colitis patients under golimumab | An open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab - EVOLUTION | Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi INN or Proposed INN: GOLIMUMAB | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 37 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Portugal | ||
| 33 | EUCTR2013-002042-36-NL (EUCTR) | 24/09/2014 | 13/06/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Netherlands;Germany | ||
| 34 | EUCTR2013-002042-36-BG (EUCTR) | 11/09/2014 | 30/04/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 35 | EUCTR2013-002042-36-DE (EUCTR) | 31/07/2014 | 27/05/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 36 | EUCTR2013-002042-36-BE (EUCTR) | 10/07/2014 | 20/02/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 37 | NCT02155335 (ClinicalTrials.gov) | July 1, 2014 | 2/6/2014 | Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027) | Preference for a Prefilled Syringe or Smartject™ Device for Delivering SIMPONI (Golimumab) in Patients Suffering From Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Prefilled Syringe delivery of Golimumab;Drug: Smartject Device delivery of Golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 100 | Phase 4 | Belgium |
| 38 | EUCTR2014-000656-29-BE (EUCTR) | 13/06/2014 | 05/03/2014 | Study to evaluate delivery preference of Simponi (golimumab) by Ulcerative Colitis patients: delivery using a prefilled syringe or the Smartject™ device | Preference for a prefilled syringe or Smartject™ device for delivering SIMPONI (golimumab) in patients suffering from moderate to severe ulcerative colitis - SMART | Ulcerative Colitis MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Simponi® (Golimumab) Product Name: Simponi (Golimumab) Product Code: MK-8259 INN or Proposed INN: GOLIMUMAB Other descriptive name: Simponi Trade Name: Simponi® (Golimumab) Product Name: Simponi (Golimumab) Product Code: MK-8259 INN or Proposed INN: GOLIMUMAB Other descriptive name: Simponi | MSD Belgium BVBA/SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 39 | EUCTR2013-002042-36-PL (EUCTR) | 09/06/2014 | 06/05/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Germany;Netherlands | ||
| 40 | EUCTR2013-002042-36-CZ (EUCTR) | 04/06/2014 | 21/03/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands | ||
| 41 | NCT02186886 (ClinicalTrials.gov) | June 2014 | 1/7/2014 | Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab | Personalised Medicine: a Break Through Approach for Early Determination of Anti Tumor Necrosis Factor (TNF) Responders and Non Responders Among Patients With Ulcerative Colitis in a Prospective Study With Golimumab (Simponi) | Ulcerative Colitis | Drug: Golimumab | Kliniken im Naturpark Altmuehltal | NULL | Recruiting | 18 Years | N/A | Both | 50 | Phase 4 | Germany |
| 42 | EUCTR2013-002042-36-HU (EUCTR) | 12/05/2014 | 21/02/2014 | A Study to Evaluate the Accuracy of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects with Moderately to Severely Active Ulcerative Colitis - PROgECT | Moderately to Severely Active Ulcerative Colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB Trade Name: Simponi Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: GOLIMUMAB | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Ukraine;Israel;Russian Federation;France;Hungary;Czech Republic;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany | ||
| 43 | NCT02092285 (ClinicalTrials.gov) | May 9, 2014 | 18/3/2014 | Golimumab Utilization and Impact on Ulcerative Colitis (MK-8259-032) | Golimumab: A Phase 4, UK, Open Label, Single Arm Study on Its Utilization and Impact in Ulcerative Colitis | Ulcerative Colitis | Drug: Golimumab | Merck Sharp & Dohme Corp. | NULL | Completed | 18 Years | N/A | All | 205 | Phase 4 | United Kingdom |
| 44 | EUCTR2013-004583-56-GB (EUCTR) | 28/01/2014 | 23/12/2013 | Go-colitis: Golimumab: A Phase 4 UK Study on its Utilisation and Impact in Ulcerative Colitis | Golimumab: A Phase 4, UK Open Label, Single arm Study on its Utilization and Impact in Ulcerative Colitis - Go-colitis | Ulcerative colitis MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Simponi INN or Proposed INN: golimumab | MSD | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United Kingdom | ||
| 45 | EUCTR2012-004366-18-BE (EUCTR) | 08/01/2014 | 27/06/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany | ||
| 46 | EUCTR2012-004366-18-DE (EUCTR) | 17/12/2013 | 29/07/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Canada;Belgium;Poland;Denmark;Austria;Israel;Netherlands;Germany | ||
| 47 | EUCTR2012-004366-18-DK (EUCTR) | 11/12/2013 | 03/12/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Belgium;Poland;Austria;Denmark;Israel;Germany;Netherlands | ||
| 48 | NCT01988961 (ClinicalTrials.gov) | December 2013 | 14/11/2013 | A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-Label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Golimumab | Janssen Research & Development, LLC | NULL | Completed | 18 Years | N/A | All | 103 | Phase 2 | United States;Belgium;Bulgaria;Canada;Czech Republic;France;Germany;Hungary;Netherlands;Poland;Russian Federation;Ukraine |
| 49 | EUCTR2012-004366-18-NL (EUCTR) | 28/11/2013 | 16/08/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | France;United States;Canada;Poland;Belgium;Denmark;Austria;Israel;Germany;Netherlands | ||
| 50 | NCT01900574 (ClinicalTrials.gov) | August 9, 2013 | 12/7/2013 | A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab | Janssen Research & Development, LLC | NULL | Active, not recruiting | 2 Years | 17 Years | All | 35 | Phase 1 | United States;Austria;Belgium;Canada;Denmark;France;Germany;Israel;Netherlands;Poland |
| 51 | EUCTR2012-004366-18-AT (EUCTR) | 30/07/2013 | 12/06/2013 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany | ||
| 52 | NCT01804166 (ClinicalTrials.gov) | March 21, 2013 | 1/2/2013 | A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL) | A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL) | Hepatosplenic T-Cell Lymphoma | Drug: Infliximab;Drug: Golimumab | Janssen Scientific Affairs, LLC | NULL | Completed | N/A | N/A | All | 1 | Phase 4 | United States |
| 53 | NCT01863771 (ClinicalTrials.gov) | March 15, 2013 | 23/5/2013 | A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis. | A Phase 3 Multicenter, Placebo-controlled, Double-blind, Randomized-withdrawal Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab;Other: Placebo | Janssen Pharmaceutical K.K. | NULL | Completed | 18 Years | 70 Years | All | 144 | Phase 3 | Japan |
| 54 | EUCTR2006-003398-28-CZ (EUCTR) | 24/05/2010 | 10/02/2010 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | France;Hungary;Czech Republic;Belgium;Lithuania;Denmark;Austria;Bulgaria;Netherlands;Latvia;Germany;Sweden | ||
| 55 | EUCTR2006-003399-37-CZ (EUCTR) | 24/05/2010 | 10/02/2010 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 56 | JPRN-JapicCTI-090739 | 08/12/2008 | 10/04/2009 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Intervention name : golimumab Dosage And administration of the intervention : SC | JANSSEN PHARMACEUTICAL K.K | NULL | 18 | BOTH | Phase 2-3 | NULL | |||
| 57 | JPRN-JapicCTI-090740 | 08/12/2008 | 10/04/2009 | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Intervention name : golimumab Dosage And administration of the intervention : SC | JANSSEN PHARMACEUTICAL K.K | NULL | 18 | BOTH | Phase 3 | NULL | |||
| 58 | EUCTR2006-003397-94-SE (EUCTR) | 23/10/2008 | 21/12/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden | ||
| 59 | EUCTR2006-003398-28-DK (EUCTR) | 25/09/2008 | 04/12/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Belgium;Denmark;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 60 | EUCTR2006-003399-37-DK (EUCTR) | 25/09/2008 | 10/12/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 61 | EUCTR2006-003398-28-SE (EUCTR) | 26/08/2008 | 21/12/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden | ||
| 62 | EUCTR2006-003399-37-SE (EUCTR) | 26/08/2008 | 21/12/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 63 | EUCTR2006-003398-28-BG (EUCTR) | 10/06/2008 | 30/04/2008 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania | ||
| 64 | EUCTR2006-003399-37-BG (EUCTR) | 30/05/2008 | 30/04/2008 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Israel;Russian Federation;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;New Zealand;Sweden | ||
| 65 | EUCTR2006-003397-94-BG (EUCTR) | 30/05/2008 | 30/04/2008 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania | ||
| 66 | EUCTR2006-003397-94-LT (EUCTR) | 29/01/2008 | 30/08/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 67 | EUCTR2006-003399-37-LT (EUCTR) | 29/01/2008 | 30/08/2007 | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 68 | EUCTR2006-003398-28-LT (EUCTR) | 29/01/2008 | 30/08/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 69 | EUCTR2006-003398-28-NL (EUCTR) | 17/01/2008 | 08/10/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 70 | EUCTR2006-003397-94-NL (EUCTR) | 17/01/2008 | 07/08/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 71 | EUCTR2006-003399-37-NL (EUCTR) | 17/01/2008 | 08/10/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics BV | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 72 | EUCTR2006-003398-28-BE (EUCTR) | 10/12/2007 | 18/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 73 | EUCTR2006-003399-37-DE (EUCTR) | 27/11/2007 | 03/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Serbia;United States;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 74 | EUCTR2006-003398-28-DE (EUCTR) | 15/11/2007 | 03/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 75 | EUCTR2006-003397-94-BE (EUCTR) | 15/11/2007 | 18/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 76 | EUCTR2006-003399-37-BE (EUCTR) | 15/11/2007 | 18/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 77 | EUCTR2006-003397-94-AT (EUCTR) | 15/11/2007 | 16/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 78 | EUCTR2006-003397-94-HU (EUCTR) | 30/10/2007 | 10/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT -Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT -Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 2;Phase 3 | Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden;France;Hungary;Slovakia;Belgium | ||
| 79 | EUCTR2006-003399-37-HU (EUCTR) | 30/10/2007 | 10/07/2007 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | Serbia;Saudi Arabia;Slovakia;Finland;Ukraine;Lithuania;Austria;Israel;Russian Federation;India;France;Czech Republic;Hungary;Poland;Belgium;Romania;Denmark;Australia;Bulgaria;Netherlands;Latvia;Germany;New Zealand;Sweden | ||
| 80 | EUCTR2006-003398-28-HU (EUCTR) | 29/10/2007 | 10/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 81 | EUCTR2006-003398-28-SK (EUCTR) | 04/10/2007 | 23/12/2009 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2;Phase 3 | Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden | ||
| 82 | EUCTR2006-003399-37-SK (EUCTR) | 04/10/2007 | 23/12/2009 | A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics BV | NULL | Not Recruiting | Female: yes Male: yes | 1228 | Phase 3 | Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden | ||
| 83 | EUCTR2006-003397-94-SK (EUCTR) | 04/10/2007 | 16/04/2008 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2;Phase 3 | France;Hungary;Slovakia;Belgium;Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden | ||
| 84 | EUCTR2006-003399-37-AT (EUCTR) | 27/09/2007 | 17/07/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 85 | EUCTR2006-003399-37-FR (EUCTR) | 21/09/2007 | 23/07/2007 | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden | ||
| 86 | EUCTR2006-003397-94-FR (EUCTR) | 21/09/2007 | 23/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2;Phase 3 | France;Hungary;Slovakia;Belgium;Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden | ||
| 87 | EUCTR2006-003398-28-FR (EUCTR) | 21/09/2007 | 23/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2;Phase 3 | Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden | ||
| 88 | EUCTR2006-003398-28-AT (EUCTR) | 06/09/2007 | 17/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 1002 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 89 | EUCTR2006-003397-94-DE (EUCTR) | 05/09/2007 | 03/07/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 90 | EUCTR2006-003398-28-LV (EUCTR) | 03/09/2007 | 04/09/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 91 | EUCTR2006-003399-37-LV (EUCTR) | 03/09/2007 | 04/09/2007 | The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance | Ulcerative Colitis (UC) MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Golimumab Liquid in prefilled syringe Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Janssen Biologics B.V. | NULL | Not Recruiting | Female: yes Male: yes | 1350 | Phase 3 | Germany;France;Bulgaria;Austria;Australia;South Africa;Sweden;Czech Republic;Canada;Serbia;Belgium;United States;Poland;Hungary;Netherlands;Latvia;Lithuania;Israel;India;Russian Federation;Slovakia;Ukraine;Denmark;Romania;Japan | ||
| 92 | EUCTR2006-003397-94-LV (EUCTR) | 03/09/2007 | 04/09/2007 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Golimumab Liquid in Vial Product Code: CNTO 148 INN or Proposed INN: Golimumab Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa | Centocor BV | NULL | Not Recruiting | Female: yes Male: yes | 676 | Phase 2/3 | Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania | ||
| 93 | NCT00488631 (ClinicalTrials.gov) | September 2007 | 18/6/2007 | An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Placebo;Biological: Golimumab 50 mg;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg | Janssen Research & Development, LLC | Merck Sharp & Dohme Corp. | Completed | 18 Years | N/A | All | 1228 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Latvia;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro;Nauru;United Kingdom |
| 94 | NCT00487539 (ClinicalTrials.gov) | August 2007 | 14/6/2007 | An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Placebo;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg;Biological: Golimumab 400 mg;Biological: Golimumab 50 mg | Janssen Research & Development, LLC | Merck Sharp & Dohme Corp. | Completed | 18 Years | N/A | All | 1065 | Phase 2/Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Latvia;United Kingdom |
| 95 | NCT00488774 (ClinicalTrials.gov) | August 2007 | 18/6/2007 | An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Other: Placebo;Drug: Golimumab 1 mg per kg;Drug: Golimumab 2 mg per kg;Drug: Golimumab 4 mg per kg | Janssen Research & Development, LLC | Merck Sharp & Dohme Corp. | Terminated | 18 Years | N/A | All | 291 | Phase 2/Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;France;Germany;Hungary;India;Israel;Latvia;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;Sweden;Ukraine;Former Serbia and Montenegro;United Kingdom |
| 96 | EUCTR2012-004366-18-FR (EUCTR) | 28/09/2015 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 INN or Proposed INN: Golimumab Other descriptive name: Human anti-TNF-alpha monoclonal antibody | Janssen Biologics B.V. | NULL | NA | Female: yes Male: yes | 30 | Phase 1 | United States;France;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany |