Clinical trial NCT03258814: A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis (axSpA)
Official title: Treat and Train - A Post-Marketing-Observational Study (PMOS) to Determine the Effectiveness of Combined Adalimumab Treatment and Active Supervised Training in Patients With Axial Spondyloarthritis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Axial Spondyloarthritis
Keywords: axial spondyloarthritis
active supervised training
physical training
adalimumab
spinal mobility
physiotherapy
physical function
health-related quality of life
pain
disease activity
psychosocial risk factors
workability
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-08-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with axial spondyloarthritis who received Humira® per local product label at rheumatology centers in Germany.

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 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.

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 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 6
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline and Month 3
measure: Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI)
timeFrame: Baseline and Month 3
measure: Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline and Month 3
measure: Percentage of Participants Achieving a BASDAI 50 Response
timeFrame: Month 3
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
timeFrame: Baseline and Month 3
measure: Percentage of Participants With ASDAS Inactive Disease
timeFrame: Month 3
measure: Percentage of Participants With ASDAS Low Disease Activity
timeFrame: Month 3
measure: Percentage of Participants With ASDAS Moderate Disease Activity
timeFrame: Month 3
measure: Percentage of Participants With ASDAS High Disease Activity
timeFrame: Month 3
measure: Percentage of Participants With ASDAS Very High Disease Activity
timeFrame: Month 3
measure: Percentage of Participants Achieving ASDAS Major Improvement
timeFrame: Baseline and Month 3
measure: Percentage of Participants Achieving ASDAS Clinically Important Improvement
timeFrame: Baseline and Month 3
measure: Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 Response
timeFrame: Baseline and Month 3
measure: Percentage of Participants Achieving an ASAS 40 Response
timeFrame: Baseline and Month 3
measure: Percentage of Participants Achieving ASAS Partial Remission
timeFrame: Month 3
measure: Change From Baseline in Patient's Global Assessment of Pain
timeFrame: Baseline and Month 3
measure: Change From Baseline in Patient's Assessment of Total Back Pain
timeFrame: Baseline and Month 3
measure: Change From Baseline in Patient's Assessment of Nocturnal Back Pain
timeFrame: Baseline and Month 3
measure: Change From Baseline in Modified Work Ability Index (WAI)
timeFrame: Baseline and Month 3
measure: Change From Baseline in Fatigue
timeFrame: Baseline and Month 3
measure: Change From Baseline in Severity and Duration of Morning Stiffness
timeFrame: Baseline and Month 3
measure: Change From Baseline in Fear-Avoidance Belief Questionnaire Score (FABQ)
timeFrame: Baseline and Month 3
Other outcomes:
Locations:
city: Potsdam
country: Germany
facility: Rheumahaus Studien GbR, Potsdam, DE /ID# 164494
state: Brandenburg
city: Berlin
country: Germany
facility: MVZ Wittenbergplatz PP Orthos /ID# 204802
city: Halle
country: Germany
facility: Rheumapraxis /ID# 164461
city: Hamburg
country: Germany
facility: Praxis Ortho DE /ID# 204149
city: Leipzig
country: Germany
facility: Praxis internistische Rheumato /ID# 164463
city: Wuppertal
country: Germany
facility: Krankenhaus St. Josef /ID# 164501
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: