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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 January 2021 |
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Main ID: |
NCT03701789 |
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Date of registration:
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04/10/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Baricitinib Treatment on Peripheral Bone in RA
BAREBONE |
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Scientific title:
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Evaluation of Bone Quality in Patients With Rheumatoid Arthritis Treated With Baricitinib: Single Centre, Mode of Action Study (BARE BONE) |
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Date of first enrolment:
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September 11, 2018 |
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Target sample size:
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15 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03701789 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Germany
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Contacts
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Name:
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Arnd Kleyer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Internal Medicine 3, Rheumatology and Immunology Universital Hospital Erlangen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Main inclusion criteria:
Patients eligible for inclusion in this study have to fulfil all of the following criteria:
- Subject must be able to understand and communicate with the investigator and comply
with the requirements of the study, must give a written and signed and dated informed
consent before any study assessment is performed
- Male or non-pregnant, non-lactating female subjects aged between 18 - 74
- Women of childbearing potential must oblige to use a highly effective method of birth
control until at least 4 weeks after the last IMP administration
- Diagnosis of RA according to the ACR/EULAR criteria and with symptoms for at least 3
months with moderate to severe RA
- pathologic volumetric bone density, microstructure or presence of erosions detected by
HR-pQCT and or MRI measurement
- Previous treatment with at least one DMARD (e.g. methotrexate) without sufficient
clinical response or stopped due to toxicities
- Fulfil criteria for baricitinib treatment according to its SmPC
Exclusion Criteria:
- Ongoing pregnancy status or breast-feeding
- Chest X-ray or chest MRI with evidence of ongoing infectious or malignant
process, obtained within 3 months or according to local guidelines, prior to
screening and evaluated by a qualified physician
- Contraindication for baricitinib treatment according to its SmPC
- Current treatment with bDMARDs or other JAK-inhibitors
- Creatinine clearance < 60ml/min (calculated analogue MDRD)
- Current treatment with OAT3 inhibitors
- History or evidence of ongoing alcohol or drug abuse, within the last six months
before inclusion
- Participation in an interventional clinical trial with an IMP within the last 4
weeks
Age minimum:
18 Years
Age maximum:
74 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Finger Joints
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Bone Density
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Baricitinib
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Primary Outcome(s)
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Change in volumetric bone mineral density (vBMD) in metacarpal and radial bone between baseline and week 52 in patients with rheumatoid arthritis treated with baricitinib as determined by HR-pQCT
[Time Frame: 52 weeks]
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Secondary ID(s)
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BAREBONE2018
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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