Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting Biological Therapy (ULSPABIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Diakonhjemmet Hospital
Sponsor:
Information provided by (Responsible Party):
Hilde Berner Hammer, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier:
NCT01219257
First received: September 15, 2010
Last updated: February 15, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention
Spondyloarthritis
Ultrasonography
Biological: Anti-TNF alpha therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting First Time or Switching to a New Biological Therapy; the ULSpABiT Study.

Resource links provided by NLM:


Further study details as provided by Diakonhjemmet Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 3. Explore potential differences of US detected pathology in joints and entheses between subgroups of spondylarthritis patients. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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. Explore whether baseline calprotectin or other biomarkers in blood may predict response to biological medication. [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

At the first visit, one glass with blood will be frozen for later genetical analyzes, all related to questions regarding SpA.


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SpA patients
The patients may be included when their rheumatologist has decided that the patient are going to start biological medication.
Biological: Anti-TNF alpha therapy
All medical treatment will be standardizes following good medical practice
Other Names:
  • Adalimumab (HumiraR)
  • Etanercept (EnbrelR)
  • Infliximab (RemicadeR)
  • Golimumab (SimponiR)

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

SpA patients with high disease activity

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219257

Contacts
Contact: Hilde B Hammer, MD, PhD 004722451748 hbham@online.no
Contact: Tore K Kvien, Prof, MD 004722451500 t.k.kvien@medisin.uio.no

Locations
Norway
Department of Rheumatology, Diakonhjemmet Hospital Recruiting
Oslo, Norway, 0319
Principal Investigator: Hilde B Hammer, MD, PhD         
Sponsors and Collaborators
Diakonhjemmet Hospital
Investigators
Principal Investigator: Hilde B Hammer, MD, PhD Diakonhjemmet Hospital
  More Information

No publications provided

Responsible Party: Hilde Berner Hammer, Senior consultant, PhD, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT01219257     History of Changes
Other Study ID Numbers: 011110
Study First Received: September 15, 2010
Last Updated: February 15, 2015
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Diakonhjemmet Hospital:
SpA
Anti-TNF alpha treatment
Ultrasonography
Synovitis
Enthesitis

Additional relevant MeSH terms:
Spondylarthritis
Arthritis
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylitis

ClinicalTrials.gov processed this record on August 27, 2015