Bechterew's disease axial spondyloarthritis
Conditions
Interventions
Not applicableThe study population includes patients receiving bimekizumab for active axSpA (nr-axSpA or r-axSpA) as per clinical routine.
Sponsors
UCB BioPharma SRL
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Patient with a diagnosis of axSpA and active disease assessed by the treating physician • Patient for whom the physician's decision has been made to initiate treatment with bimekizumab for axSpA, in routine clinical practice according to the bimekizumab SmPC • Patient’s age is =18 years • Patient is treatment-naïve to bimekizumab • Patient has the necessary language skills to understand and are willing to complete the patient questionnaires per physician's judgment • Patient has signed and dated the consent
Exclusion criteria
Exclusion criteria: Patient is participating in an ongoing interventional study or non-UCB NIS (participation in a SpA registry is allowed)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement of ASDAS-LDA at 52 weeks of bimekizumab treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Achievement of ASDAS-LDA at 52 weeks of bimekizumab treatmentAt all OP Visits after the Baseline Visit (and including the Baseline Visit for change from Baseline outcomes) where data are collected in routine practice as per schedule: - ASDAS-LDA (at 12, 24, and 36 weeks only) - ASDAS-CII - ASDAS-ID - ASDAS-MI - Change from Baseline in ASDAS - Change from Baseline in BASDAI - BASDAI50 response- Change from Baseline in the number of digits affected by dactylitisAt OP2, OP3, OP4, and OP5 Visits after the Baseline Visit (and including the Baseline Visit [OP1] for change from Baseline outcomes) where data are collected in routine practice as per schedule in patients with PA at the Baseline Visit (ie, TJC or SJC >0): - Change from Baseline in number of TJC - Change from Baseline in number of SJC - Achievement of TJC =0- Achievement of SJC =0 - Achievement of TJC and SJC =0At OP2, OP3, OP4, and OP5 Visits after the Baseline Visit (and including the Baseline Visit [OP1] for Change from Baseline outcomes) where data are collected in routine practice as per schedule in patients with enthesitis at the Baseline Visit: - Change from Baseline in MASES - Change from Baseline in SPARCC - Achievement of enthesitis resolution - Resolution of Achilles tendon enthesitis - Achievement of dactylitis resolutionPatients’ characteristics and disease manifestations at first prescription of bimekizumab (ie, at OP1 [Baseline]): - axSpA history (duration since first axSpA symptoms [defined based on first axial symptoms (ie cervical / thoracic/back/buttock pain or morning stiffness) ], duration since axSpA diagnosis, r-axSpA/nr-axSpA, SI joint MRI positive or negative) - axSpA disease activity and manifestations (ASDAS, BASDAI, TJC, SJC, MASES, SPARCC, dactylitis) - Demographics and anthropometry (country, age, year of birth, gender, weight, height, and BMI) and lifestyle (eg, smoking status) - Ongoing and history of EMMs: IBD, PSO, AAU and ongoing and history of other comorbidities (eg, HS o | — |
Countries
Austria, Belgium, France, Germany, Greece, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom
Contacts
Public ContactAVC Arno
UCBCares
Outcome results
None listed