96. クローン病
［臨床試験数：2,209，薬物数：1,276（DrugBank：240），標的遺伝子数：166，標的パスウェイ数：210］
Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | NCT04163016 (ClinicalTrials.gov) | June 19, 2020 | 24/10/2019 | A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol) | A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol) | Rheumatoid Arthritis;Psoriatic Arthritis;Crohn's Disease;Axial Spondyloarthritis;Plaque Psoriasis | Drug: Pharmacokinetics of certolizumab pegol | UCB Biopharma S.P.R.L. | NULL | Recruiting | 18 Years | N/A | Female | 20 | Phase 1 | United States;Canada;Switzerland |
| 2 | NCT02154425 (ClinicalTrials.gov) | September 2014 | 30/5/2014 | A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers | A Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol) | Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid Arthritis | Procedure: Breast milk sampling;Biological: Certolizumab Pegol | UCB BIOSCIENCES, Inc. | PPD;Parexel | Completed | 18 Years | N/A | Female | 17 | Phase 1 | United States;Netherlands;Switzerland;France |
| 3 | NCT02019602 (ClinicalTrials.gov) | January 2014 | 18/12/2013 | A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta | A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol) | Axial Spondyloarthritis (AxSpA);Non-radiographic Evidence-AxSpA;Ankylosing Spondylitis;Crohn's Disease;Psoriatic Arthritis;Rheumatoid Arthritis | Procedure: Blood sampling from mother;Procedure: Blood sampling from infant;Procedure: Blood sampling from umbilical cord;Biological: Certolizumab Pegol | UCB BIOSCIENCES, Inc. | PPD;Parexel | Completed | 18 Years | N/A | All | 37 | Phase 1 | United States;France;Netherlands;Switzerland |
| 4 | NCT01817972 (ClinicalTrials.gov) | March 2013 | 19/3/2013 | Cimzia Versus Cimzia Plus Azathioprine in the Treatment of Active Crohn's Disease | A Phase III, Randomized, Double-blind Trial in the Comparison of Cimzia Versus Cimzia Plus Azathioprine in the Change in Mean SES-CD (Simple Endoscopic Scores-Crohn's Disease) Scores in the Treatment of Active, Moderate to Severe Crohn's Disease | Crohn's Disease | Biological: Certolizumab pegol;Drug: Azathioprine | Gastroenterology Research of America | UCB Pharma | Not yet recruiting | 18 Years | 70 Years | Both | 65 | Phase 3 | United States |
| 5 | NCT01696942 (ClinicalTrials.gov) | February 2013 | 25/9/2012 | Cimzia Versus Mesalamine for Crohn's Recurrence | Use of Certolizumab Following Ileocolectomy Lowers Endoscopic and Histological Recurrence Rates for Crohn's Disease at One Year Compared to Mesalamine | Crohn's Disease | Drug: Cimzia;Drug: Mesalamine | Milton S. Hershey Medical Center | UCB Pharma | Terminated | 18 Years | N/A | All | 10 | Phase 4 | United States |
| 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 |
| 6 | NCT01053559 (ClinicalTrials.gov) | January 2010 | 19/1/2010 | Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy | Open Label Investigator Initiated, Single Site Study of Mucosal Healing in Patients With Small Bowel Crohn's Disease Treated With Certolizumab Pegol (Cimzia) Assessed by Wireless Capsule Endoscopy | Crohn's Disease | Drug: certolizumab pegol | Shafran Gastroenterology Center | UCB Pharma | Completed | 18 Years | 70 Years | Both | 15 | N/A | United States |
| 7 | NCT01024647 (ClinicalTrials.gov) | December 2009 | 2/12/2009 | Optimizing Cimzia in Crohn's Patients | Optimizing Response in Crohn's Disease Patients Who Have Insufficient Initial Response or Who Have Loss of Successful Response to Certolizumab Pegol (Cimzia) Induction Therapy | Crohn's Disease | Biological: certolizumab pegol | Atlanta Gastroenterology Associates | UCB Pharma | Recruiting | 18 Years | N/A | Both | 50 | Phase 4 | United States |
| 8 | NCT00844285 (ClinicalTrials.gov) | January 2009 | 13/2/2009 | SECURE, the Cimzia ® Crohn's Disease Post-Marketing Registry | A Non-Interventional Long-term Post-Marketing Registry of Patients Treated With Certolizumab Pegol (Cimzia ®) for Crohn's Disease | Crohn's Disease | Drug: Cimzia | UCB Pharma | NULL | Completed | 18 Years | N/A | All | 3045 | United States | |
| 9 | NCT00552344 (ClinicalTrials.gov) | May 2008 | 31/10/2007 | A Study to Evaluate Safety of Long Term Therapy of Certolizumab Pegol Patients With Crohn's Disease | A Phase IIIb, Multinational, Open-label, follow-on Trial to C87085 Designed to Assess the Long-term Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-TNF-alpha Monoclonal Antibody, Administered at Weeks 0, 2 and 4, and Then Every 4 Weeks Thereafter, in Subjects With Moderately to Severely Active Crohn's Disease Who Have Participated in Study C87085 | Crohn Disease | Biological: Cimzia | UCB BIOSCIENCES GmbH | PPD | Completed | 18 Years | 75 Years | All | 403 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;Estonia;Germany;Hungary;Israel;Italy;Latvia;New Zealand;Poland;Romania;Russian Federation;Ukraine;Chile;Czech Republic;Finland |
| 10 | EUCTR2014-004381-24-Outside-EU/EEA (EUCTR) | 02/03/2015 | The Use of Certolizumab Pegol for Treatment of Active Crohn's Disease in Children and Adolescents | A Phase 2, Open-label, Multicenter Study to Assess the Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease (NURTURE Study) - NURTURE | Crohn’s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Cimzia Product Name: Certolizumab Pegol /Cimzia Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Other descriptive name: Certolizumab Pegol | UCB Celltech | NULL | NA | Female: yes Male: yes | 100 | Phase 2 | United States;Australia;Canada;New Zealand | |||
| 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 |
| 11 | EUCTR2014-004399-42-Outside-EU/EEA (EUCTR) | 05/03/2015 | Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease | A Phase II, Multi-center, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study to Assess the Safety and Efficacy of CDP870/Certolizumab Pegol, Dosed Subcutaneously in Patients With Active Crohn's Disease | Crohn’s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Cimzia Product Name: Certolizumab Pegol /Cimzia Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Other descriptive name: CERTOLIZUMAB PEGOL | UCB Japan Co., Ltd. | NULL | NA | Female: yes Male: yes | 100 | Phase 2 | Japan | |||
| 12 | EUCTR2014-004354-34-Outside-EU/EEA (EUCTR) | 27/02/2015 | Maintenance Study of Certolizumab Pegol (CZP) in Crohn’s Disease | A 26-week, multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn’s disease patients, who showed clinical efficacy in a remission induction study (Study C87037), at Week 26 after subcutaneous administration of CDP870 400 mg from Week 8 until Week 24 at 4-week intervals | Crohn’s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Cimzia Product Name: Certolizumab Pegol /Cimzia Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Other descriptive name: CERTOLIZUMAB PEGOL | UCB Japan Co., Ltd. | NULL | NA | Female: yes Male: yes | 35 | Japan | ||||
| 13 | EUCTR2014-004400-30-Outside-EU/EEA (EUCTR) | 27/02/2015 | Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (2014-004399-42) | A multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn’s Disease patients, who showed no clinical efficacy in a remission induction study (Study C87037) but showed clinical efficacy after additional remission induction therapy was applied, at Week 26 after subcutaneous administration of CDP870 400 mg from Week 8 until Week 24 at 4-week intervals | Crohn’s Disease MedDRA version: 17.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Cimzia Product Name: Certolizumab Pegol /Cimzia Product Code: CDP870 INN or Proposed INN: CERTOLIZUMAB PEGOL Other descriptive name: CERTOLIZUMAB PEGOL | UCB Japan Co., Ltd. | NULL | NA | Female: yes Male: yes | 46 | Japan |