Effect of Baricitinib Treatment on Peripheral Bone in RA

• Status: Active, not recruiting
• Trial end date: 2021-10-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Criteria

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