51. 全身性強皮症 Scleroderma Clinical trials / Disease details
臨床試験数 : 523 / 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215
| 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 | NCT04325217 (ClinicalTrials.gov) | April 15, 2020 | 26/3/2020 | Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan | Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan | Lung Diseases, Interstitial | Drug: Nintedanib | Boehringer Ingelheim | NULL | Recruiting | N/A | N/A | All | 600 | Japan | |
| 2 | NCT03675581 (ClinicalTrials.gov) | November 8, 2018 | 17/9/2018 | A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD) | A Phase I Trial to Investigate the Effect of Nintedanib on the Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Female Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD) | Scleroderma, Systemic | Drug: Microgynon;Drug: Nintedanib | Boehringer Ingelheim | NULL | Completed | 18 Years | N/A | Female | 17 | Phase 1 | Belgium;France;Germany;Netherlands;Portugal;Spain |
| 3 | EUCTR2016-003403-66-SE (EUCTR) | 15/10/2018 | 14/05/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 4 | EUCTR2016-003403-66-IT (EUCTR) | 28/09/2018 | 14/06/2021 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS(TM)- ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: [BIBF 1120] INN or Proposed INN: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: [BIBF 1120] INN or Proposed INN: NINTEDANIB | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 5 | EUCTR2016-003403-66-GR (EUCTR) | 21/09/2018 | 14/05/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim B.V | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 6 | EUCTR2016-003403-66-FI (EUCTR) | 17/07/2018 | 29/06/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R) -ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Fnland Ky | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 7 | EUCTR2016-003403-66-CZ (EUCTR) | 20/06/2018 | 12/04/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden | ||
| 8 | EUCTR2016-003403-66-AT (EUCTR) | 17/04/2018 | 28/02/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 9 | EUCTR2016-003403-66-BE (EUCTR) | 12/04/2018 | 12/02/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM) Extension | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | SCS Boehringer Ingelheim Comm. V | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 10 | EUCTR2016-003403-66-DK (EUCTR) | 05/04/2018 | 02/02/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS(R)-on | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer-Ingelheim Pharma GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 11 | EUCTR2016-003403-66-FR (EUCTR) | 04/04/2018 | 01/02/2018 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer-Ingelheim France | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 12 | EUCTR2016-003403-66-PT (EUCTR) | 23/02/2018 | 13/12/2017 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Unilfarma - União Internacional de Lab. Farmacêuticos, Lda. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Norway;Japan;Sweden;United States;Portugal;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany | ||
| 13 | EUCTR2016-003403-66-GB (EUCTR) | 07/02/2018 | 09/01/2018 | A trial to evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden | ||
| 14 | EUCTR2016-003403-66-ES (EUCTR) | 19/01/2018 | 22/11/2017 | A trial to evaluate the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) - SENSCIS (TM)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer-Ingelheim España, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 15 | NCT03313180 (ClinicalTrials.gov) | November 27, 2017 | 13/10/2017 | A Trial to Evaluate the Safety of Long Term Treatment With Nintedanib in Patients With Scleroderma Related Lung Fibrosis | An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD) | Lung Diseases, Interstitial | Drug: Nintedanib | Boehringer Ingelheim | NULL | Active, not recruiting | 18 Years | N/A | All | 444 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;China;Czechia;Denmark;Finland;France;Germany;Greece;India;Israel;Italy;Japan;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland;Thailand;United Kingdom;Ireland |
| 16 | EUCTR2016-003403-66-NL (EUCTR) | 06/11/2017 | 27/09/2017 | A trial to evaluate the safety of long term treatment withnintedanib in patients with scleroderma related lung fibrosis. | An open-label extension trial to assess the long term safety ofnintedanib in patients with ‘Systemic Sclerosis associatedInterstitial Lung Disease’ (SSc-ILD) - SENSCIS (R)-ON | Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim bv | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 17 | EUCTR2015-000392-28-CZ (EUCTR) | 27/06/2017 | 27/04/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 18 | EUCTR2015-000392-28-HU (EUCTR) | 08/06/2017 | 26/04/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 19 | EUCTR2015-000392-28-NO (EUCTR) | 02/06/2017 | 15/02/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Norway KS | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Norway;Germany;Japan;Sweden | ||
| 20 | EUCTR2015-000392-28-AT (EUCTR) | 12/05/2017 | 31/03/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim RCV GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Belgium;Norway;Germany;Japan;Sweden;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia | ||
| 21 | EUCTR2015-000392-28-SE (EUCTR) | 08/05/2017 | 24/02/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim AB | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden;Switzerland;Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel | ||
| 22 | EUCTR2015-000392-28-FI (EUCTR) | 21/02/2017 | 10/02/2017 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Finland Ky | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 23 | EUCTR2015-000392-28-IE (EUCTR) | 27/06/2016 | 13/04/2016 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 24 | EUCTR2015-000392-28-PL (EUCTR) | 09/03/2016 | 21/01/2016 | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer-Ingelheim RCV GmbH&Co KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 25 | EUCTR2015-000392-28-PT (EUCTR) | 08/01/2016 | 14/09/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Unilfarma - União Internacional de Lab. Farmacêuticos, Lda | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 26 | EUCTR2015-000392-28-IT (EUCTR) | 23/12/2015 | 08/06/2021 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - SENSCIS¿ | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 21.0;Level: LLT;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 21.0;Classification code 10042953;Term: Systemic sclerosis;Classification code 10012977;Term: Diffuse systemic sclerosis;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib | BOEHRINGER-INGELHEIM ITALIA S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Greece;Spain;Thailand;Ireland;Israel;Chile;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Norway;Japan;Sweden | ||
| 27 | EUCTR2015-000392-28-FR (EUCTR) | 11/12/2015 | 14/12/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 18.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 18.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 28 | EUCTR2015-000392-28-BE (EUCTR) | 08/12/2015 | 25/09/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | SCS Boehringer Ingelheim Comm. V | NULL | Not Recruiting | Female: yes Male: yes | 520 | Phase 3 | Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Norway;Japan;Sweden;United States;Portugal;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Netherlands;China | ||
| 29 | EUCTR2015-000392-28-ES (EUCTR) | 19/11/2015 | 05/10/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 18.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 30 | EUCTR2015-000392-28-GR (EUCTR) | 18/11/2015 | 22/10/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Ellas SA | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | United States;Portugal;Greece;Spain;Ireland;Israel;Switzerland;Italy;India;France;Denmark;Australia;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Germany;Norway;Japan;Sweden | ||
| 31 | NCT02597933 (ClinicalTrials.gov) | November 12, 2015 | 8/10/2015 | A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis | A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD) | Scleroderma, Systemic | Drug: Nintedanib;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 18 Years | N/A | All | 580 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;China;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Japan;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Spain;Sweden;Switzerland;Thailand;United Kingdom |
| 32 | EUCTR2015-000392-28-DE (EUCTR) | 11/11/2015 | 25/08/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 33 | EUCTR2015-000392-28-GB (EUCTR) | 10/11/2015 | 01/09/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 34 | EUCTR2015-000392-28-NL (EUCTR) | 02/11/2015 | 24/08/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 19.1;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.1;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden | ||
| 35 | EUCTR2015-000392-28-DK (EUCTR) | 22/09/2015 | 22/09/2015 | A trial to compare nintedanib with placebo for patients with scleroderma related lung fibrosis | A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD) - Nintedanib in SSc-ILD | Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 MedDRA version: 20.0;Classification code 10036814;Term: Progressive systemic sclerosis;Level: PT;Classification code 10042954;Term: Systemic sclerosis pulmonary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10025109;Term: Lung involvement in systemic sclerosis;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB Trade Name: Ofev Product Name: Nintedanib Product Code: BIBF 1120 INN or Proposed INN: Nintedanib Other descriptive name: NINTEDANIB | Boehringer-Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 750 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Greece;Thailand;Spain;Ireland;Chile;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;China;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Norway;Germany;Japan;Sweden |