Cdp6038 (DrugBank: -)
2 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 46 | Malignant rheumatoid arthritis | 17 |
| 96 | Crohn disease | 4 |
| 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 | EUCTR2015-005309-35-DE (EUCTR) | 23/05/2017 | 24/01/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1880 | Phase 3 | United States;Belarus;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 2 | EUCTR2015-005309-35-HU (EUCTR) | 16/03/2017 | 02/02/2017 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis | A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1880 | Phase 3 | United States;Belarus;Taiwan;Estonia;Lithuania;Turkey;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Georgia;Latvia;Germany;Korea, Republic of | ||
| 3 | EUCTR2015-005308-27-DE (EUCTR) | 08/11/2016 | 09/05/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Turkey;Russian Federation;Colombia;Germany;Korea, Republic of | ||
| 4 | EUCTR2015-005307-83-PL (EUCTR) | 06/07/2016 | 01/06/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB Trade Name: Humira 40mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira) Product Code: LO4AB04 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 1575 | Phase 3 | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 5 | EUCTR2015-005307-83-HU (EUCTR) | 09/06/2016 | 28/04/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: Adalimumab (Humira®) INN or Proposed INN: ADALIMUMAB | R-Pharm | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1575 | Phase 3 | United States;Taiwan;Estonia;Lithuania;Russian Federation;Colombia;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Romania;Bulgaria;Germany;Latvia;Korea, Republic of | ||
| 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 | EUCTR2015-005308-27-CZ (EUCTR) | 07/06/2016 | 15/04/2016 | Study of the Efficacy and Safety of Olokizumab in Patients with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3 | Moderately to Severely Active Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: (CDP6038; L04041) INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm International LLC | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Germany;Colombia;Korea, Republic of | ||
| 7 | EUCTR2014-004719-36-BG (EUCTR) | 14/05/2016 | 05/04/2016 | Study of the Efficacy and Safety of Olokizumab in Patients withModerately to Severely Active Rheumatoid Arthritis InadequatelyControlled by Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, Placebo Controlled,Multicenter Phase III Study of the Efficacy and Safety of Olokizumab inSubjects with Moderately to Severely Active Rheumatoid ArthritisInadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 1 | Moderately to Severely Active Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olokizumab Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: CDP6038 | R-Pharm | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Belarus;Turkey;Russian Federation;Bulgaria | ||
| 8 | NCT01533714 (ClinicalTrials.gov) | January 2012 | 10/2/2012 | The Long-term Safety and Efficacy of Olokizumab (CDP6038) With Active Rheumatoid Arthritis | Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety and Efficacy of CDP6038 Administered Subcutaneously to Asian Subjects With Active Rheumatoid Arthritis Who Completed Study RA0083 | Rheumatoid Arthritis | Biological: Olokizumab | UCB Pharma | NULL | Completed | 20 Years | N/A | Both | 103 | Phase 2 | Japan;Korea, Republic of;Taiwan |
| 9 | NCT01463059 (ClinicalTrials.gov) | October 2011 | 27/10/2011 | Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy | A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy | Rheumatoid Arthritis | Biological: Placebo;Biological: Olokizumab 60 mg;Biological: Olokizumab 120 mg;Biological: Olokizumab 240 mg | UCB Japan Co. Ltd. | NULL | Completed | 20 Years | N/A | Both | 119 | Phase 2 | Japan;Korea, Republic of;Taiwan |
| 10 | EUCTR2010-022224-77-BE (EUCTR) | 10/05/2011 | 14/01/2011 | Open-label study to assess the safety and efficacy of CDP6038 inpatients who completed RA0056 | A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056 - RA0057 | Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CDP6038 Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: Recombinant human Mab of IgG4 subtype | UCB Biosciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United States;Belgium;United Kingdom | ||
| 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 | EUCTR2010-020839-39-BE (EUCTR) | 10/05/2011 | 25/11/2010 | Efficacy and safety of CDP6038 in patients with rheumatoid arthritis withan unsuccessful response to anti-TNF therapy | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056 | Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CDP6038 Product Code: CDP6038 Other descriptive name: Recombinant human Mab of IgG4 subtype Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: Tocilizumab INN or Proposed INN: RoActemra® Other descriptive name: TOCILIZUMAB | UCB Biosciences, Inc. A Member of the UCB Group of Companies | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Belgium;United Kingdom | ||
| 12 | EUCTR2010-022224-77-GB (EUCTR) | 27/04/2011 | 21/12/2010 | Open-label study to assess the safety and efficacy of CDP6038 in patients who completed RA0056 | A PHASE 2 MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0056 - RA0057 | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CDP6038 Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: Recombinant human Mab of IgG4 subtype | UCB Biosciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | United States;Belgium;United Kingdom | ||
| 13 | NCT01296711 (ClinicalTrials.gov) | March 2011 | 14/2/2011 | Open-label Study to Assess the Safety and Efficacy of CDP6038 in Patients Who Completed RA0056 | A Phase 2, Multicenter, Open-Label, Follow-up Study to Assess the Long-Term Safety and Efficacy of CDP6038 Administered Subcutaneously to Subjects With Active Rheumatoid Arthritis Who Completed Study RA0056 | Rheumatoid Arthritis | Biological: CDP6038 | UCB BIOSCIENCES, Inc. | NULL | Completed | 18 Years | N/A | Both | 190 | Phase 2 | United States;Belgium;United Kingdom |
| 14 | EUCTR2010-020839-39-GB (EUCTR) | 25/02/2011 | 12/10/2010 | Efficacy and safety of CDP6038 in patients with rheumatoid arthritis with an unsuccessful response to anti-TNF therapy | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056 | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Olikizumab Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: Recombinant human Mab of IgG4 subtype Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: Tocilizumab INN or Proposed INN: RoActemra® Other descriptive name: TOCILIZUMAB | UCB Biosciences, Inc | NULL | Not Recruiting | Female: yes Male: yes | 220 | United Kingdom;United States | |||
| 15 | NCT01242488 (ClinicalTrials.gov) | November 2010 | 15/11/2010 | Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy | Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy | Rheumatoid Arthritis | Biological: CDP6038;Biological: Tocilizumab (Actemra or RoActemra);Other: Placebo sc;Other: Placebo iv | UCB Pharma | NULL | Completed | 18 Years | N/A | Both | 221 | Phase 2 | United States;Belgium;United Kingdom |
| 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 |
| 16 | NCT01009242 (ClinicalTrials.gov) | October 2009 | 4/11/2009 | To Evaluate the Blood Levels and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis Using Methotrexate | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Dose Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of IV and Subcutaneous CDP6038 in Subjects With Rheumatoid Arthritis on a Stable Dose of Methotrexate | Arthritis;Rheumatoid Arthritis | Biological: CDP6038;Other: Placebo IV;Other: Placebo SC;Drug: CDP 6038 SC;Drug: Methotrexate | UCB Pharma | NULL | Completed | 18 Years | 75 Years | All | 40 | Phase 1;Phase 2 | United States;Germany |
| 17 | EUCTR2009-010813-57-DE (EUCTR) | 28/08/2009 | 24/06/2009 | A multicenter, randomized, double-blind, placebo-controlled, single dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of intravenous and subcutaneous CDP6038 in male and female subjects with rheumatoid arthritis on a stable dose of methotrexate. | A multicenter, randomized, double-blind, placebo-controlled, single dose study to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of intravenous and subcutaneous CDP6038 in male and female subjects with rheumatoid arthritis on a stable dose of methotrexate. | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: CDP6038 Product Code: CDP6038 Other descriptive name: recombinant human Mab of IgG4 subtype Product Name: CDP6038 Product Code: CDP6038 Other descriptive name: recombinant human Mab of IgG4 subtype | UCB Celltech | NULL | Not Recruiting | Female: yes Male: yes | 72 | Germany |
| 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 | EUCTR2011-002517-11-BG (EUCTR) | 18/07/2012 | 27/06/2012 | The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placebo | A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab | Moderate to severe Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: olokizumab Product Code: CDP6038 INN or Proposed INN: olokizumab | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | France;Serbia;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Netherlands;Germany | ||
| 2 | EUCTR2011-002517-11-CZ (EUCTR) | 23/04/2012 | 25/01/2012 | The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placebo | A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab | Moderate to severe Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: olokizumab Product Code: CDP6038 INN or Proposed INN: olokizumab | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 96 | Serbia;Hungary;Czech Republic;Germany | |||
| 3 | EUCTR2011-002517-11-HU (EUCTR) | 26/03/2012 | 09/01/2012 | The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placebo | A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab | Moderate to severe Crohn’s disease MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: olokizumab Product Code: CDP6038 INN or Proposed INN: olokizumab | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 96 | Serbia;Czech Republic;Hungary;Germany | |||
| 4 | EUCTR2011-002517-11-DE (EUCTR) | 22/02/2012 | 02/11/2011 | The aim of the study is to evaluate the clinical response and the remission in subjects with moderate to severe Crohn’s disease following 8 weeks of treatment with OKZ relative to placebo | A multi-centre, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacokinetic of olokizumab administered subcutaneously to subjects with moderate to severe Crohn’s disease - Olokizumab | Moderate to severe Crohn’s disease MedDRA version: 15.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 15.0;Level: LLT;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: olokizumab Product Code: CDP6038 INN or Proposed INN: olokizumab | UCB BIOSCIENCES GmbH | NULL | Not Recruiting | Female: yes Male: yes | 96 | Serbia;Czech Republic;Hungary;Germany |