Evaluation of bone mineral density and bone metabolism during treatment with januskinaseinhibitors baricitinib or tofacintib in patients with rheumatoid arthritis

• Conditions: M05.80; M06.00

• Registration Number: DRKS00020780
• Lead Sponsor: Campus Kerckhoff der Justus Liebig Universität Giessen, Abteiliung für Rheumatologie, Immunologie, Osteologie und Physikalische Medizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Patients > 18 years with moderate to severe active rheumatoid arthritis who are going to receive treatment with tofacitinib or baricitinib. The indication for treatment with either one of the JAKi needs to be given by the treating rheumatologist. Only patients with RA fulfilling the ACR/EULAR classification criteria are eligible.

Exclusion Criteria

Contraindications to treatment with tofacitinib or baricitinib.
Incompatible language barriers
Missing consent
During study: inadherence to pharmacological treatment

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change of bone mineral density (BMD) using DEXA measurement (peripheral and axial skeleton) at baseline (0 month) and after 24 months under treatment with baricitinib or tofacitinib

Secondary Outcome Measures

Name	Time	Method
To evaluate secondary objectives secondary endpoints will assess the change between baseline (0 months) and<br>i) 12 months follow-up<br>ii) 24 months follow-up<br><br>• biochemical markers of bone metabolism: ALP, TRAP5b, BALP, CTX-1, osteocalcin, ß-crossLaps, RANKL/OPG quotient<br>• molecular parameters of inflammation: CRP and ESR<br>• patient global assessment and pain level (VAS, NRS) of the last 7 days<br>• PROs (Patient Reported Outcomes) on functional impairment (FFbH, HAQ)<br>• disease activity (DAS28, cDAI, sDAI)