Working... Menu
Trial record 72 of 559 for:    Cachectin OR Tumor Necrosis Factor-alpha

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01219257
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
Hilde Berner Hammer, Diakonhjemmet Hospital

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.

Condition or disease Intervention/treatment
Spondyloarthritis Ultrasonography Biological: Anti-TNF alpha therapy

Layout table for study information
Study Type : Observational
Actual Enrollment : 50 participants
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.
Study Start Date : September 2011
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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)

Primary Outcome Measures :
  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 Outcome Measures :
  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.

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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
SpA patients with high disease activity

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01219257

Layout table for location information
Department of Rheumatology, Diakonhjemmet Hospital
Oslo, Norway, 0319
Sponsors and Collaborators
Diakonhjemmet Hospital
Layout table for investigator information
Principal Investigator: Hilde B Hammer, MD, PhD Diakonhjemmet Hospital

Layout table for additonal information
Responsible Party: Hilde Berner Hammer, Senior consultant, PhD, Diakonhjemmet Hospital Identifier: NCT01219257     History of Changes
Other Study ID Numbers: 011110
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Keywords provided by Hilde Berner Hammer, Diakonhjemmet Hospital:
Anti-TNF alpha treatment

Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Joint Diseases