Clinical trial NCT01219257: Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting Biological Therapy
Official title: Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting First Time or Switching to a New Biological Therapy; the ULSpABiT Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondyloarthritis
Ultrasonography
Keywords: SpA
Anti-TNF alpha treatment
Ultrasonography
Synovitis
Enthesitis
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SpA patients with high disease activity

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess the sensitivity to change of US pathology in joints and entheses in SpA patients starting biological treatment.
timeFrame: Including patients for about 1.5 years
Secondary outcomes:
measure: 1. Explore whether the US (B-mode and power Doppler) scores at baseline or after 3 months predict patients responding to biological treatment after 6 and 12 months.
timeFrame: 2.5 years
measure: 2. Explore whether the sensitivity for change is higher for US (B-mode and/or power Doppler) than for the traditional assessments for inflammatory activity.
timeFrame: 2.5 years
measure: 3. Explore potential differences of US detected pathology in joints and entheses between subgroups of spondylarthritis patients.
timeFrame: 2.5 years
measure: 4. Explore whether the different subgroups of spondylarthritis patients have different US response (B-mode synovitis and power Doppler in joints and entheses) to biological treatment.
timeFrame: 2.5 years
measure: 5. Explore the association between the US findings (BM and/or PD) and the patient's experience of pain and fatigue.
timeFrame: 2.5 years
measure: 6. Explore the associations between calprotectin and US detected inflammation in joints and/or entheses as well as traditional assessments of disease activity.
timeFrame: 2.5 years
measure: 7. Explore whether baseline calprotectin or other biomarkers in blood may predict response to biological medication.
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of Rheumatology, Diakonhjemmet Hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Hilde B Hammer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: