Biological Drug ( DrugBank: - )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ5
96クローン病2
97潰瘍性大腸炎1

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05267431
(ClinicalTrials.gov)
June 202214/2/2022Outcomes of Biological Therapy on Rheumatoid ArthritisOutcomes of Different Biological Therapy on Rheumatoid ArthritisRheumatoid ArthritisDrug: Biological DrugSohag UniversityNULLNot yet recruiting18 YearsN/AAll200Egypt
2NCT04470453
(ClinicalTrials.gov)
October 8, 20209/7/2020Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological DrugAssociation Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological DrugRheumatoid ArthritisBiological: Blood sample;Diagnostic Test: CRQCentre Hospitalier Universitaire de Saint EtienneNULLRecruiting18 YearsN/AAll60Phase 4France
3EUCTR2019-003700-12-FR
(EUCTR)
13/03/202004/06/2020Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patientsAssociation between methotrexate erythrocyte polyglutamate concentration and biological drug concentration and clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate and a first biological drug rheumatoid arthritis
MedDRA version: 21.0;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Methotrexate
Product Code: MTX
Other descriptive name: METHOTREXATE DISODIUM
Product Code: bDMARD
INN or Proposed INN: INFLIXIMAB
INN or Proposed INN: ETANERCEPT
INN or Proposed INN: ADALIMUMAB
INN or Proposed INN: CERTOLIZUMAB PEGOL
INN or Proposed INN: GOLIMUMAB
CHU Saint-EtienneNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 4France
4EUCTR2009-012041-35-FR
(EUCTR)
27/11/200916/10/2009A phase II, randomized, partially double blind, controlled study to evaluate the immunogenicity, safety, and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis (RA) who have relapsed despite use of an anti-TNFa biological drug, due to anti-drug antibodiesA phase II, randomized, partially double blind, controlled study to evaluate the immunogenicity, safety, and clinical efficacy of three doses of Neovacs’ TNF-Kinoid in adult patients with rheumatoid arthritis (RA) who have relapsed despite use of an anti-TNFa biological drug, due to anti-drug antibodies Rheumatoid arthritis
MedDRA version: 12.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: TNF-Kinoid
Product Code: TNF-K
Neovacs SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2Bulgaria;France
5NCT03496831
(ClinicalTrials.gov)
January 1, 20065/4/2018Predicting Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological DrugsDevelopment of a Prediction Model for the Risk of Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological DrugsRheumatoid Arthritis;Spondyloarthritis;Psoriatic ArthritisDrug: Biologic AgentsSimon KrabbeUniversity of Aarhus;Zealand University Hospital;University of Southern DenmarkCompleted18 YearsN/AAll7500NULL

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05169593
(ClinicalTrials.gov)
September 8, 20228/11/2021Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological TherapyPrevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy: a Randomized, Multicentre, Parallel Group Pragmatic Non-inferiority Trial in Crohn DiseaseCrohn DiseaseDrug: Biological DrugUniversitaire Ziekenhuizen KU LeuvenNULLRecruiting18 Years80 YearsAll292Phase 4Belgium;Italy
2EUCTR2016-000522-18-IT
(EUCTR)
24/02/201708/06/2021Comparison of the effectiveness of treatment with an immunosuppressant medication over another or with respect to a biological drug in the maintenance of remission in children suffering from Crohn's Disease.Risk-stratified randomized controlled trial in paediatric Crohn¿s Disease: Methotrexate versus Azathioprine or Adalimumab for mantaining remission in patients at low or at high risk for aggressive disease course, respectively ¿ a treatment strategy - REDUCE-RISKincd-PBID-TRIAL Crohn Disease
MedDRA version: 20.0;Level: LLT;Classification code 10042759;Term: Symptoms involving digestive system;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: METHOTREXATE - 20 MG/0.8 ML SOLUZIONE INIETTABILE 4 SIRINGHE PRERIEMPITE MONOUSO DA 1.25 ML
Product Name: Methotrexate
Product Code: N.A
Trade Name: HUMIRA - 40MG/0.8ML SOLUZ. INIETTABILE- USO SOTTOCUTANEO-FLACONCINO(VETRO) 0.8ML 2 ASTUCCI:1 FLACONCINO+1SIRINGA+1AGO+1ADATT.STERILE-2TAMPONI IMBEVUTI ALCOOL
Product Name: Humira
Product Code: N.A
Trade Name: AZATIOPRINA ASPEN - 50 COMPRESSE
Product Name: Azatioprina
Product Code: N.A
Trade Name: PURINETHOL - 50 MG COMPRESSE25 COMPRESSE
Product Name: Purinethol
UMBERTO I - POLICLINICO DI ROMANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
312Phase 4France;Czechia;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy

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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04818788
(ClinicalTrials.gov)
April 1, 202120/3/2021Hematological Indices and Fecal Calprotectin Predict Histological Remission in Ulcerative ColitisHematological Indices and Fecal Calprotectin as Predictors of Histological Remission in Ulcerative Colitis Patients Receiving Biological TherapyUlcerative ColitisDrug: Biological DrugAssiut UniversityNULLNot yet recruiting18 Years55 YearsAll24NULL