Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting Biological Therapy

Ultrasonography Clinical Trial

— ULSPABIT  

Official title:

Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting First Time or Switching to a New Biological Therapy; the ULSpABiT Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219257
• Other study ID #: 011110
• Status: Completed
• Start date: September 2011
• Est. completion date: January 2016

Study information

• Verified date: August 2022
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Spondylarthritis
• Spondylitis
• Spondyloarthritis
• Ultrasonography

Intervention

Biological:
• Anti-TNF alpha therapy
All medical treatment will be standardizes following good medical practice

Locations

Country	Name	City	State
Norway	Department of Rheumatology, Diakonhjemmet Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the sensitivity to change of US pathology in joints and entheses in SpA patients starting biological treatment.	The joints will be assessed according to a US atlas by use of a semi-quantitative (0-3) scoring system and the entheses will be evaluated according to internationally accepted scoring methods.	Including patients for about 1.5 years
Secondary	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.		2.5 years
Secondary	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.		2.5 years
Secondary	3. Explore potential differences of US detected pathology in joints and entheses between subgroups of spondylarthritis patients.		2.5 years
Secondary	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.		2.5 years
Secondary	5. Explore the association between the US findings (BM and/or PD) and the patient's experience of pain and fatigue.		2.5 years
Secondary	6. Explore the associations between calprotectin and US detected inflammation in joints and/or entheses as well as traditional assessments of disease activity.	Calprotectin, a major granulocyte protein, is assessed by use of ELISA in plasma. Plasma samples will be frozen at all visits, and the calprotectin assessments will be performed when all patients have finished the study.	2.5 years
Secondary	7. Explore whether baseline calprotectin or other biomarkers in blood may predict response to biological medication.	Plasma and serum will be frozen at each visit, and the S100 proteins calprotectin as well as A12 will be assessed. In addition, other relevant biomarkers may be analyzed after 2.5 years.	2.5 years