Evaluation of bone mineral density and bone metabolism during treatment with the januskinaseinhibitor upadacitinib in patients with rheumatoid arthritis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00021182

Enrollment

Registered

2020-03-26

Start date

2020-04-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M06.8 M05.8

Interventions

Group 1: patient with rheumatoid arthritis under treatment with baricitinib Group 2: historical control group of patients with rheumatoid arthritis under treatment with infliximab and tocilizumab (Lan

44:1546–1548

Stracke et al. Akt Rheumatol 2014

39: 364–369 ©

Wettich et al. Akt Rheumatol 2014

39: 370–374)

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Contraindications to treatment with upadacitinib [Rinvoq®]. Incompatible language barriers Missing consent During study: inadherence to pharmacological treatment

Design outcomes

Primary

Measure	Time frame
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

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactPhilipp Klemm

Campus Kerckhoff der Justus Liebig Universität Giessen, Abt. für Rheumatologie, Immunologie, Osteologie und Physikalische Medizin

p.klemm@kerckhoff-klinik.de06032-996-2101

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026