Romosozumab    (DrugBank: Romosozumab)

2 diseases
IDDisease name (Link within this page)Number of trials
46Malignant rheumatoid arthritis1
274Osteogenesis Imperfecta2

46. Malignant rheumatoid arthritis    [ 4,183 clinical trials,   2,538 drugs,   (DrugBank: 401 drugs),   183 drug target genes,   219 drug target pathways]
Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 4,183 trial found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
Inclusion_
agemax
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PhaseCountries
1JPRN-jRCT1041190127
10/03/202010/03/2020Romosozumab Against GLucocorticoid-induced Osteoporosis in Rheumatoid arthritis despite bisphosphonate over a YearRandomized controlled trial of romosozumab and denosumab for glucocorticoid-induced osteoporosis with inadequate response to bisphosphonate in rheumatoid arthritis patients Rheumatoid arthritis, Glucocoluticoid-induced osteoporosis
Rheumatoid arthritis, Glucocoluticoid-induced osteoporosis
arm Romosozumab-denosumab: romosozumab 210mg s.c. once monthly for 12months, after that, denosumab 60mg s.c. once every 6months for 12months
arm Denosumab: denosumab 60mg s.c. once every 6months for 12months after that romosozumab 210mg s.c. once monthly for 12months
Arm denosumab, in case denosumab has enough response, based on physician's dicision, denosumab can be continued.
all patients: eldecalcitol 0.75microg ram p.o. once a day (Dose reduced to 0.5microg ram once a d
ay depending on symptoms)
KOJIMA TOSHIHISANULLPendingNot applicableNot applicableFemale100N/AJapan

274. Osteogenesis Imperfecta    [ 78 clinical trials,   87 drugs,   (DrugBank: 19 drugs),   14 drug target genes,   74 drug target pathways]
Searched query = "Osteogenesis Imperfecta"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 78 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04545554
(ClinicalTrials.gov)
November 16, 20204/9/2020Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis ImperfectaAn Open-label, Ascending Multiple-dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: Romosozumab;Dietary Supplement: Calcium;Dietary Supplement: Vitamin DAmgenNULLNot yet recruiting5 Years17 YearsAll16Phase 1NULL
2EUCTR2017-004972-74-HU
(EUCTR)
15/09/202010/07/2020An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents with Osteogenesis ImperfectaAn Open-label, Ascending Multiple dose Study to Evaluate Safety,Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta Osteogenesis imperfecta (OI) is a group of genetic skeletal disorderscharacterized by increased bone fragility, low bone mass , and increasedbone turnover contributing to osteoporosis, fractures, and otherconditions. OI is the most common form of primary osteoporosis inchildren with an estimated incidence of 1 per 25,000 live births.
MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
Product Name: Romosozumab
Product Code: AMG 785
INN or Proposed INN: ROMOSOZUMAB
Other descriptive name: AMG 785
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 1France;Hungary;Greece;Spain;Turkey;Germany;Italy