Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting Biological Therapy

NCT ID: NCT01219257

Last Updated: 2022-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-01-31

Brief Summary

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Patients with spondylarthritis (SpA) (including ankylosing spondylitis, psoriatic arthritis, arthritis as part of inflammatory bowel disease and reactive arthritis) have axial involvement (the spine) as well as peripheral inflammation in joints and entheses (where the tendons and ligaments are anchored to the bone). Patients with high disease activity of SpA may need biological treatment (anti-TNF alpha), which are very expensive medications. Thus it is necessary to have a sensitive method for assessing the response to treatment. Ultrasonography (US) is a validated and reliable method for assessing disease activity in joints and tendons, and may be used to follow the treatment response.

The present study will include patients with SpA starting on anti-TNF alpha treatment (as first biologic medication or when switching to a new biologic treatment). The study is an extension of the ongoing NORDMARD study (Norwegian longitudinal observational study of arthritic patients starting disease-modifying treatment). The patients will be examined by use of US of 38 joints and 14 entheses at baseline and after 3, 6 and 12 months.

The objectives are to explore US as a method to assess peripheral inflammatory activity for evaluation of response to medication as well as to compare the US pathology with clinical and laboratory findings.

Detailed Description

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Conditions

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Spondyloarthritis Ultrasonography

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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SpA patients

The patients may be included when their rheumatologist has decided that the patient are going to start biological medication.

Anti-TNF alpha therapy

Intervention Type BIOLOGICAL

All medical treatment will be standardizes following good medical practice

Interventions

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Anti-TNF alpha therapy

All medical treatment will be standardizes following good medical practice

Intervention Type BIOLOGICAL

Other Intervention Names

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Adalimumab (HumiraR) Etanercept (EnbrelR) Infliximab (RemicadeR) Golimumab (SimponiR)

Eligibility Criteria

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Inclusion Criteria

* SpA
* Planning to start anti-TNF alpha treatment

Exclusion Criteria

* Patients not being able to communicate in Norwegian or not being able to fill in questionnaires
* Surgery in more than 5 of the joints/entheses to be examined by US
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diakonhjemmet Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hilde Berner Hammer

Senior consultant, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hilde B Hammer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Diakonhjemmet Hospital

Locations

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Department of Rheumatology, Diakonhjemmet Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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011110

Identifier Type: -

Identifier Source: org_study_id

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