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

NCT03258814 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 17

Last updated 2019-10-02

Study results available
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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.

Conditions

  • Axial Spondyloarthritis

Interventions

BEHAVIORAL

Active Supervised Training (AST)

The active supervised and standardized training consisted of 24 units of exercise within 20 weeks performed in certified training centers and was focused on back fitness, core strengthening and patient engagement to treat back pain and functional impairment.

BEHAVIORAL

Standard of Care (SOC) Physiotherapy

Standard of care physiotherapy as used in this study included active as well as passive training and massages according to the physiotherapist discretion.

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-08
Primary Completion
2018-09-14
Completion
2018-09-14

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03258814 on ClinicalTrials.gov