M06.00 M05.80
Conditions
Interventions
Group 1: Patient with rheumatoid arthritis under treatment with baricitinib
Group 2: Patient with rheumatoid arthritis under treatment with tofacitinib
Group 3: historical control group of patients w
Sponsors
Campus Kerckhoff der Justus Liebig Universität Giessen, Abteiliung für Rheumatologie, Immunologie, Osteologie und Physikalische Medizin
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 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
Exclusion criteria: Contraindications to treatment with tofacitinib or baricitinib. 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 baricitinib or tofacitinib | — |
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) | — |
Countries
Germany
Contacts
Public ContactPhilipp Klemm
Campus Kerckhoff der Justus Liebig Universität Giessen, Abteiliung für Rheumatologie, Immunologie, Osteologie und Physikalische Medizin
Outcome results
None listed