SpondyloarthritisULSPABITNCT01219257
Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting Biological Therapy
An observational study of Spondyloarthritis and Ultrasonography, run by Diakonhjemmet Hospital at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Spondyloarthritis, Ultrasonography
- What is being tested?
- Anti-TNF alpha therapy
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2011to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SpA patients with high disease activity
Who may be able to join
- SpA
- Planning to start anti-TNF alpha treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Spondyloarthritis, Ultrasonography
- Being tested
- Anti-TNF alpha therapy
- Keywords
- SpA, Anti-TNF alpha treatment, Ultrasonography, Synovitis, Enthesitis
- Medical subject headings
- Spondylarthritis, Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-TNF alpha therapyBiological
Also called Adalimumab (HumiraR), Etanercept (EnbrelR), Infliximab (RemicadeR), Golimumab (SimponiR)
All medical treatment will be standardizes following good medical practice
| Study group | Role | What they receive |
|---|---|---|
| SpA patients | The patients may be included when their rheumatologist has decided that the patient are going to start biological medication. Receives: Biological: Anti-TNF alpha therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Including patients for about 1.5 years
Secondary outcomes (7)
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.
Measured: 2.5 years
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.
Measured: 2.5 years
3. Explore potential differences of US detected pathology in joints and entheses between subgroups of spondylarthritis patients.
Measured: 2.5 years
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.
Measured: 2.5 years
5. Explore the association between the US findings (BM and/or PD) and the patient's experience of pain and fatigue.
Measured: 2.5 years
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.
Measured: 2.5 years
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.
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startSep 2011
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilde Berner Hammer, Diakonhjemmet Hospital
- Investigators
- Hilde B Hammer, MD, PhD, Principal investigator, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219257
- Sponsor's protocol ID
- 011110
- Acronym
- ULSPABIT
- Status last verified
- Aug 2022
- First submitted
- 15 Sep 2010
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting First Time or Switching to a New Biological Therapy; the ULSpABiT Study.
- ClinicalTrials.gov ID
- NCT01219257
- Acronym / sponsor ID
- ULSPABIT / 011110
- Conditions
- Spondyloarthritis, Ultrasonography
- Keywords
- SpA, Anti-TNF alpha treatment, Ultrasonography, Synovitis, Enthesitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SpA patients | – | Biological: Anti-TNF alpha therapyThe patients may be included when their rheumatologist has decided that the patient are going to start biological medication. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SpA patients with high disease activity
Key inclusion criteria (2 listed)
- SpA
- Planning to start anti-TNF alpha treatment
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-TNF alpha therapyAlso: Adalimumab (HumiraR), Etanercept (EnbrelR), Infliximab (RemicadeR), Golimumab (SimponiR)All medical treatment will be standardizes following good medical practice | Biological | SpA patients |
Primary outcome
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.
7 secondary outcomes
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. 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. Explore potential differences of US detected pathology in joints and entheses between subgroups of spondylarthritis patients.
Time frame: 2.5 years
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. 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. 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
7. Explore whether baseline calprotectin or other biomarkers in blood may predict response to biological medication.
Time frame: 2.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilde B Hammer, MD, PhD principal investigator
Diakonhjemmet Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthritis and Ultrasonography, run by Diakonhjemmet Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.