Skip to main content
OpenTrials
Completed

NCT Number: NCT01219257

Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting Biological Therapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spondyloarthritis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylitis Synovitis Ultrasonography

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Rheumatology, Diakonhjemmet Hospital

Oslo, 0319, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-TNF alpha therapy

Biological

All medical treatment will be standardizes following good medical practice

Other names: Adalimumab (HumiraR), Etanercept (EnbrelR), Infliximab (RemicadeR), Golimumab (SimponiR)

Primary outcomes

  1. To assess the sensitivity to change of US pathology in joints and entheses in SpA patients starting biological treatment.

    Time frame: Including patients for about 1.5 years

    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.

Secondary outcomes

  1. 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.

    Time frame: 2.5 years

  2. 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.

    Time frame: 2.5 years

  3. 3. Explore potential differences of US detected pathology in joints and entheses between subgroups of spondylarthritis patients.

    Time frame: 2.5 years

  4. 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.

    Time frame: 2.5 years

  5. 5. Explore the association between the US findings (BM and/or PD) and the patient's experience of pain and fatigue.

    Time frame: 2.5 years

  6. 6. Explore the associations between calprotectin and US detected inflammation in joints and/or entheses as well as traditional assessments of disease activity.

    Time frame: 2.5 years

    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.

  7. 7. Explore whether baseline calprotectin or other biomarkers in blood may predict response to biological medication.

    Time frame: 2.5 years

    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.

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Registry information

Official study title

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

Acronym: ULSPABIT

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Oct 13, 2010
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.