Evaluation of bone mineral density and bone metabolism during treatment with the januskinaseinhibitor upadacitinib in patients with rheumatoid arthritis
Recruiting
- Conditions
- M06.8M05.8Other specified rheumatoid arthritisOther seropositive rheumatoid arthritis
- Registration Number
- DRKS00021182
- Lead Sponsor
- Campus Kerckhoff der Jusuts-Liebig-Universität Gießen, Abteilung für Rheumatologie, Immunologie, Osteologie und Physikalische Medizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Patients > 18 years with moderate to severe active rheumatoid arthritis who are going to receive treatment with upadacitinib [Rinvoq®]. The indication for treatment with upadacitinib 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 upadacitinib [Rinvoq®].
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 upadacitinib
- 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)<br>