A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis (axSpA) (Treat & Train)

AbbVie

Status: Terminated

Conditions: Axial Spondyloarthritis

Treatments: Behavioral: Standard of Care (SOC) Physiotherapy; Behavioral: Active Supervised Training (AST)

Study type: Observational

Funder types: Industry

Identifiers

NCT03258814

P15-710

Details and patient eligibility

About

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 spondyloarthritis and stable response to adalimumab (HUMIRA®) with respect to health-related outcomes. The primary objective is the improvement in spinal mobility after a 6 month training program.

Full 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 treatment based on physicians' decision, and who were eligible for active physiotherapy were enrolled in the study. Although this was a non-interventional study, participants were randomly assigned to receive either active supervised and standardized training physiotherapy or standard of care physiotherapy in order to provide adequate numbers of participants in each comparison group.

Participants who consented to participate in the study were observed for up to 12 months from Baseline (defined as the Randomization visit where participants were assigned to one of the two physiotherapy options).

Enrollment: 17 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

17 participants in 2 patient groups

Active Supervised Training (AST)

Description:

Participants with axSpA and treated with adalimumab (HUMIRA®) according to the local product label and local standard of care were to receive active supervised and standardized training (AST).

Treatment:

Behavioral: Active Supervised Training (AST)

Standard of Care (SOC) Physiotherapy

Description:

Participants with axSpA and treated with adalimumab (HUMIRA®) according to the local product label and local standard of care were to receive standard of care physiotherapy, according to the physiotherapist discretion.

Treatment:

Behavioral: Standard of Care (SOC) Physiotherapy