Jnj-40346527 (DrugBank: JNJ-40346527)
2 diseasesID | Disease name (Link within this page) | Number of trials |
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46 | Malignant rheumatoid arthritis | 5 |
96 | Crohn disease | 6 |
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 |
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1 | EUCTR2011-004529-28-CZ (EUCTR) | 25/07/2012 | 03/04/2012 | A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis | A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available | Rheumatoid Arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: JNJ-40346527-AAC - capsule - 50 mg Product Code: JNJ-40346527 INN or Proposed INN: Not assigned Other descriptive name: Not assigned | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2a | Hungary;Czech Republic;Argentina;Poland;Malaysia;Bulgaria;Chile;Russian Federation;Korea, Republic of | ||
2 | NCT01597739 (ClinicalTrials.gov) | July 2012 | 10/5/2012 | A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy | A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy | Arthritis, Rheumatoid | Drug: JNJ-40346527;Drug: Placebo | Janssen Research & Development, LLC | NULL | Completed | 18 Years | 80 Years | Both | 96 | Phase 2 | Argentina;Bulgaria;Chile;Czech Republic;Hungary;Korea, Republic of;Poland;Russian Federation;Singapore;Ukraine |
3 | EUCTR2011-004529-28-BG (EUCTR) | 01/06/2012 | 07/05/2012 | A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis | A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available | 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] - Immune System Diseases [C20] | Product Name: JNJ-40346527-AAC - capsule - 50 mg Product Code: JNJ-40346527 INN or Proposed INN: Not assigned Other descriptive name: Not assigned | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2a | Hungary;Poland;Bulgaria | ||
4 | EUCTR2011-004529-28-PL (EUCTR) | 14/05/2012 | 28/03/2012 | A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis | A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available | 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] - Immune System Diseases [C20] | Product Name: JNJ-40346527-AAC - capsule - 50 mg Product Code: JNJ-40346527 INN or Proposed INN: Not assigned Other descriptive name: Not assigned | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2a | Hungary;Poland;Bulgaria | ||
5 | EUCTR2011-004529-28-HU (EUCTR) | 18/04/2012 | 01/03/2012 | A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis | A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy - not available | 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] - Immune System Diseases [C20] | Product Name: JNJ-40346527-AAC - capsule - 50 mg Product Code: JNJ-40346527 INN or Proposed INN: Not assigned Other descriptive name: Not assigned | Janssen-Cilag International NV | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2a | Czech Republic;Hungary;Argentina;Poland;Ukraine;Singapore;Chile;Bulgaria;Russian Federation;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 |
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1 | EUCTR2017-003017-25-PL (EUCTR) | 23/03/2018 | 19/12/2017 | Clinical Study to Evaluate the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) | Moderately to Severely Active Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: JNJ-40346527-AAC Product Code: PRV-6527 (JNJ-40346527) Other descriptive name: JNJ-40346527-AAC | Provention Bio, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Spain;Poland;Ukraine;Austria;Russian Federation;Germany | ||
2 | EUCTR2017-003017-25-DE (EUCTR) | 20/03/2018 | 22/02/2018 | Clinical Study to Evaluation the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) | Moderately to severely Active Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Provention Bio, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany | |||
3 | NCT03854305 (ClinicalTrials.gov) | March 20, 2018 | 23/2/2019 | Phase 2a Study of PRV-6527 in Subjects With Moderately to Severely Active Crohn's Disease | Phase 2a Multicenter Randomized Double-Blind Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of CSF-1 Receptor, in Subjects With Moderately to Severely Active Crohn's | Crohn's Disease | Drug: PRV-6527;Drug: Placebo | Provention Bio, Inc. | NULL | Active, not recruiting | 18 Years | 75 Years | All | 93 | Phase 2 | Austria;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine |
4 | EUCTR2017-003017-25-ES (EUCTR) | 14/03/2018 | 15/12/2017 | Clinical Study to Evaluate the Efficacy and Safety of PRV-6527, an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) | Moderately to severely Active Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Provention Bio, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany | |||
5 | EUCTR2017-003017-25-AT (EUCTR) | 06/02/2018 | 11/12/2017 | Clinical Study to Evaluation the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) | Moderately to severely Active Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Provention Bio, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;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 |
6 | EUCTR2017-003017-25-HU (EUCTR) | 08/01/2018 | 13/11/2017 | Clinical Study to Evaluation the Efficacy and Safety of PRV-6527 an Inhibitor of Colony Stimulating Factor-1 Receptor, in patients with Moderately to Severely Active Crohn’s Disease | A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of Oral PRV-6527 (JNJ-40346527), an Inhibitor of Colony Stimulating Factor-1 Receptor, in Subjects with Moderately to Severely Active Crohn’s Disease - PRovention INvestigation in Crohn’s DiseasE (PRINCE) | Moderately to severely Active Crohn's Disease MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10011403;Term: Crohn's disease aggravated;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Provention Bio, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Poland;Spain;Ukraine;Austria;Russian Federation;Germany |