Metoject ( DrugBank: - )
6 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 41 | 巨細胞性動脈炎 | 1 |
| 46 | 悪性関節リウマチ | 6 |
| 96 | クローン病 | 1 |
| 97 | 潰瘍性大腸炎 | 3 |
| 107 | 若年性特発性関節炎 | 2 |
| 271 | 強直性脊椎炎 | 1 |
41. 巨細胞性動脈炎
臨床試験数 : 131 / 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125
| 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 | EUCTR2018-002826-22-FR (EUCTR) | 07/03/2019 | 21/11/2018 | MEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial - METOGIA | MEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial - METOGIA | MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: METOJECT Trade Name: RoActemra | CHU Dijon Bourgogne | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: no | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France |
46. 悪性関節リウマチ
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| 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 | EUCTR2014-002374-36-SE (EUCTR) | 19/11/2014 | 27/08/2014 | A study with dose de-escalation of coventional or biologic treatments in early rheeumatoid arthritis in patients with low disease activity. | A multicenter, randomized, open-label, blinded-assessor, follow-up, phase 4 study in patients with rheumatoid arthritis who have completed the initial treatment part (active conventional therapy versus three biologic treatments) in the NORD-STAR study and have reached stable low disease activity - CO-STAR | Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra Trade Name: Methotrexate Trade Name: Metoject Trade Name: Azathioprine Trade Name: Leflunomide | The Karolinska Institutet, ClinTRID | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Sweden | ||
| 2 | EUCTR2011-004720-35-FI (EUCTR) | 10/09/2014 | 09/09/2014 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: METHOTREXATE DISODIUM Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Oxiklorin Product Code: 118-42-3 Other descriptive name: HYDROXYCHLOROQUINE SULFATE | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Finland;Denmark;Sweden | |||
| 3 | EUCTR2011-004720-35-DK (EUCTR) | 28/05/2014 | 24/02/2014 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) 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] | Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 4 | Finland;Denmark;Netherlands;Norway;Iceland;Sweden | ||
| 4 | EUCTR2011-004720-35-IS (EUCTR) | 13/12/2013 | 06/12/2013 | NORD-STAR | A multicenter, randomized, single-blinded, phase 4 study in patients with early rheumatoid arthritis to compare 1) active conventional therapy versus three biologic treatments, and 2) two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) 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] | Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra Trade Name: Metoject | The Karolinska Instutute, ClinTRID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Finland;Denmark;Norway;Iceland;Sweden | |||
| 5 | NCT01871961 (ClinicalTrials.gov) | October 2012 | 14/5/2013 | Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient | Evaluation of Rheumatoid Arthritis Patient Performance Using the Metoject® Prefilled Pen (Methotrexate 50 mg/mL, Prefilled Pen) for Subcutaneous Injection and Subsequent Pharmacokinetic Assessment of Drug Delivery | Rheumatoid Arthritis (RA) | Drug: Methotrexate (Metoject® prefilled pen) | medac GmbH | PPD (CRO) | Completed | 16 Years | N/A | Both | 105 | Phase 1 | United States |
| 6 | EUCTR2011-004720-35-SE (EUCTR) | 28/05/2012 | 22/12/2011 | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. | A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR | Rheumatoid arthritis (RA) 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] | Trade Name: Cimzia Trade Name: Orencia Trade Name: RoActemra INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE | The Karolinska Institute, ClinTRID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Sweden |
96. クローン病
臨床試験数 : 2,442 / 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
| 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 | EUCTR2014-002311-41-SE (EUCTR) | 21/08/2015 | 01/07/2015 | A prospective randomized controlled study comparing continuing treatment with an anti-TNF antibody (infliximab) and an antimetabolite to contiuing with a single agent, either with the anti-TNF antibody or the anti-metabolite in Crohn’s disease in patients without clinical sympthoms and without steroids on combination therapy | A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn’s disease patients in sustained steroid-free remission on combination therapy | Crohn´s disease;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Imurel 25 mg Product Name: Imurel INN or Proposed INN: AZATHIOPRINE Other descriptive name: AZATHIOPRINE Trade Name: Puri-Nethol 50 mg Product Name: Puri-Nethol INN or Proposed INN: MERCAPTOPURINE Trade Name: Metoject Product Name: Metotrexat INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM Trade Name: Remsima Product Name: Remsima INN or Proposed INN: INFLIXIMAB | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 225 | Phase 4 | France;Netherlands;Germany;United Kingdom;Sweden |
97. 潰瘍性大腸炎
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-003524-36-NO (EUCTR) | 06/09/2021 | 16/06/2021 | Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa. | Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Trade Name: Metoject Trade Name: Puri-Nethol Trade Name: Remsima Trade Name: Inflectra | UMC Amsterdam location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 124 | Phase 4 | France;Ireland;Netherlands;Norway;United Kingdom | ||
| 2 | EUCTR2018-003524-36-IE (EUCTR) | 25/03/2020 | 05/11/2019 | Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa. | Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: NA Product Code: NA INN or Proposed INN: INFLIXIMAB Trade Name: Metoject INN or Proposed INN: Methotrexate Other descriptive name: METHOTREXATE DISODIUM Trade Name: Puri-Nethol INN or Proposed INN: MERCAPTOPURINE Trade Name: Remsima INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra INN or Proposed INN: INFLIXIMAB Trade Name: Flixabi INN or Proposed INN: INFLIXIMAB | UMC Amsterdam location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 124 | Phase 4 | Ireland;Netherlands | ||
| 3 | EUCTR2018-003524-36-NL (EUCTR) | 25/04/2019 | 19/11/2018 | Randomized, mulitcenter study to investigate how infliximab dosing calculated by a computer compares to the standard dosing during the induction of infliximab in patients with severe colitis ulcerosa. | Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients with Acute Severe Ulcerative Colitis - TITRATE | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Trade Name: Metoject Trade Name: Puri-Nethol | UMC Amsterdam location AMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Netherlands |
107. 若年性特発性関節炎
臨床試験数 : 447 / 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
| 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 | EUCTR2006-006812-31-DE (EUCTR) | 03/12/2008 | 25/06/2008 | Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance study | Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance study | Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects | Other descriptive name: METHOTREXATE DISODIUM Trade Name: metoject | University of Munster | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | Netherlands;Germany | ||
| 2 | EUCTR2006-006812-31-NL (EUCTR) | 04/06/2007 | 27/06/2007 | Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance study | Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects: Psychological Behavioural therapy versus switch to MTX parenteral versus standard of care - MTX tolerance study | Patients with Juvenile Idiopathic Arthritis and Methotrexate related side effects | Other descriptive name: METHOTREXATE DISODIUM Trade Name: metoject | university medical centre utrecht | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | Germany;Netherlands |
271. 強直性脊椎炎
臨床試験数 : 574 / 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
| 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 | EUCTR2012-004939-23-FR (EUCTR) | 16/07/2013 | 28/10/2021 | Effet de la COmbinaison de Méthotrexate et d’Adalimumab sur la Réduction de l’Immunisation au cours de la Spondylarthrite ankylosante | Effet de la COmbinaison de Méthotrexate et d’Adalimumab sur la Réduction de l’Immunisation au cours de la Spondylarthrite ankylosante | Cette étude portera sur une population avec une spondylarthrite ankylosante (SA) active nécessitant un traitement par adalimumab MedDRA version: 20.0;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: METOJECT INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM | CHRU de TOURS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 4 | France |