Effect of Baricitinib Treatment on Peripheral Bone in RA (NCT03701789) | Clinical Trial Compass
UnknownPhase 3
Effect of Baricitinib Treatment on Peripheral Bone in RA
Germany15 participantsStarted 2018-09-11
Plain-language summary
Patients with Rheumatoid Arthritis (RA) suffer systemic and peripheral bone loss. In this study we aim to test the efficacy of in-label treatment with Baricitinib on the volumetric bone mineral density in patients with RA over 52 weeks. Inclusion of RA patients comprises pathologic volumetric bone mineral density measured by (High Resolution peripheral quantitative Computed Tomomgraphy) HR-pQCT maging of finger joints.
Who can participate
Age range
18 Years – 74 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
* Cur…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: 52 weeks
Trial details
NCT IDNCT03701789
SponsorUniversity of Erlangen-Nürnberg Medical School