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 | Terminated Results

• 1 other identifier: P15-710
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 6

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.

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)

Outcome Measures

Primary Outcomes (1)

• Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 6

  BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. The total BASMI score ranges from 0 to 10 reflecting mild to moderate disease activity and functional ability in the spinal column. The higher the BASMI score the more severe the patient's limitation of movement due to their ankylosing spondylitis

  Baseline and Month 6

Secondary Outcomes (23)

• Change Form Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Month 3

  Baseline and Month 3

• Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

  Baseline and Month 3

• Change From Baseline in Assessment of Spondyloarthritis International Society (ASAS) Health Index (HI)

  Baseline and Month 3

• Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  Baseline and Month 3

• Percentage of Participants Achieving a BASDAI 50 Response

  Month 3

Study Arms (2)

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).

Behavioral: Active Supervised Training (AST)

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.

Behavioral: Standard of Care (SOC) Physiotherapy

Interventions

Active Supervised Training (AST) 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.

Active Supervised Training (AST)

Standard of Care (SOC) Physiotherapy BEHAVIORAL

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

Standard of Care (SOC) Physiotherapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with axial spondyloarthritis who received Humira® per local product label at rheumatology centers in Germany.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (6)

Rheumahaus Studien GbR, Potsdam, DE /ID# 164494

Potsdam, Brandenburg, 14467, Germany

Location

MVZ Wittenbergplatz PP Orthos /ID# 204802

Berlin, 10787, Germany

Location

Rheumapraxis /ID# 164461

Halle, 06128, Germany

Location

Praxis Ortho DE /ID# 204149

Hamburg, 22415, Germany

Location

Praxis internistische Rheumato /ID# 164463

Leipzig, 04129, Germany

Location

Krankenhaus St. Josef /ID# 164501

Wuppertal, 42105, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Axial Spondyloarthritis; Pain

Interventions

Standard of Care; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Rehabilitation

Limitations and Caveats

Due to early termination of the study, no interpretations or conclusions can be made based on the results.

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 23, 2017
• Study Start: December 8, 2017
• Primary Completion: September 14, 2018
• Study Completion: September 14, 2018
• Last Updated: October 2, 2019
• Results First Posted: October 2, 2019

Record last verified: 2019-08

Locations

DE (6)