- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01219257
Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting Biological Therapy (ULSPABIT)
Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting First Time or Switching to a New Biological Therapy; the ULSpABiT Study.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oslo, Norway, 0319
- Department of Rheumatology, Diakonhjemmet Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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SpA patients
The patients may be included when their rheumatologist has decided that the patient are going to start biological medication.
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All medical treatment will be standardizes following good medical practice
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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Including patients for about 1.5 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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2.5 years
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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
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2.5 years
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3. Explore potential differences of US detected pathology in joints and entheses between subgroups of spondylarthritis patients.
Time Frame: 2.5 years
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2.5 years
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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
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2.5 years
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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
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2.5 years
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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
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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.
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2.5 years
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7. Explore whether baseline calprotectin or other biomarkers in blood may predict response to biological medication.
Time Frame: 2.5 years
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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.
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2.5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hilde B Hammer, MD, PhD, Diakonhjemmet Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Joint Diseases
- Musculoskeletal Diseases
- Arthritis
- Spinal Diseases
- Bone Diseases
- Bone Diseases, Infectious
- Spondylitis
- Spondylarthritis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Dermatologic Agents
- Tumor Necrosis Factor Inhibitors
- Etanercept
- Adalimumab
- Infliximab
- Golimumab
Other Study ID Numbers
- 011110
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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