Status:
TERMINATED
A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis (axSpA)
Lead Sponsor:
AbbVie
Conditions:
Axial Spondyloarthritis
Eligibility:
All Genders
18-99 years
Brief Summary
This study is a non-interventional, longitudinal and non-confirmatory study to compare an active supervised training (AST) with standard of care (SOC) physiotherapy in patients with axial spondyloarth...
Detailed Description
Treatment of axSpA patients with adalimumab (HUMIRA®) was according to the local adalimumab product label and local standard of care. AxSpA patients who responded to newly initialized adalimumab treat...
Eligibility Criteria
Inclusion
- Participants diagnosed with axial spondyloarthritis (axSpA) (either ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA)), fulfilling the Assessment of Spondyloarthritis International Society (ASAS) classification, aged at least 18 years
- Prescription of Humira® (adalimumab) for treating axSpA according to the local product label
- Eligibility for active physiotherapy according to the rheumatologist and physiotherapist
- Participants must have signed written informed consent before starting any study related assessments or procedures.
Exclusion
- Participants with total spinal ankylosis based on the investigators' assessments of available radiographs
- Participants who are not eligible for active supervised training or active physiotherapy at the discretion of the rheumatologist and/or the physiotherapist
- Participants with poorly controlled medical condition(s), which in the opinion of the investigator, would put the participant at risk by participation in the protocol
- Any prior treatment with a biologic disease-modifying antirheumatic drugs (DMARD) is prohibited.
Key Trial Info
Start Date :
December 8 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 14 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03258814
Start Date
December 8 2017
End Date
September 14 2018
Last Update
October 2 2019
Active Locations (6)
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1
Rheumahaus Studien GbR, Potsdam, DE /ID# 164494
Potsdam, Brandenburg, Germany, 14467
2
MVZ Wittenbergplatz PP Orthos /ID# 204802
Berlin, Germany, 10787
3
Rheumapraxis /ID# 164461
Halle, Germany, 06128
4
Praxis Ortho DE /ID# 204149
Hamburg, Germany, 22415