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

NCT ID: NCT03258814

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-08
• Study Completion Date: 2018-09-14

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).

Conditions

Axial Spondyloarthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Active Supervised Training (AST)

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).

Active Supervised Training (AST)

Intervention Type: BEHAVIORAL

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.

Standard of Care (SOC) Physiotherapy

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.

Standard of Care (SOC) Physiotherapy

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

Rheumahaus Studien GbR, Potsdam, DE /ID# 164494

Potsdam, Brandenburg, Germany

MVZ Wittenbergplatz PP Orthos /ID# 204802

Berlin, , Germany

Rheumapraxis /ID# 164461

Halle, , Germany

Praxis Ortho DE /ID# 204149

Hamburg, , Germany

Praxis internistische Rheumato /ID# 164463

Leipzig, , Germany

Krankenhaus St. Josef /ID# 164501

Wuppertal, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.rxabbvie.com/

Related Info

Other Identifiers

P15-710

Identifier Type: -

Identifier Source: org_study_id