Ankylosing SpondyloarthritisPhase 4PETSPANCT02634541
Adalimumab in Alleviating Inflammation in Patients With Axial Spondyloarthritis
A Phase 4 study testing Adalimumab and PET/CT imaging in people with Ankylosing Spondyloarthritis, run by University of Helsinki at 2 sites in Finland.
Trial summary
Axial spondyloarthritis is an inflammatory rheumatic disease mainly affecting joints in the spine and the sacroiliac joints. Inflammatory pathways are likely the central link from axial spondyloarthritis to the known increased risk of atherosclerotic morbidity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ankylosing Spondyloarthritis
- What is being tested?
- Adalimumab and PET/CT imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFinland
- Study dates
- Jan 2016to Dec 2017
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Axial spondyloarthritis (ASAS criteria) and radiologic sacroiliitis as detected either by MRI or X-ray.
Who cannot join
- Psoriasis or psoriasis arthropathy
- Inflammatory bowel disease
- Unwillingness to participate in the study with additional imaging protocols
- Expected life-span less than <1 year
- Diabetes (to improve the PET imaging quality)
- Probable noncompliance
Show all 11Show fewer
- Pregnancy
- Age <18 years or >75 years
- Contraindication for adalimumab
- Methotrexate used within the previous 6 months
- A biologic medicine used within the previous 6 months
Trial locations and contacts
2 sites in 1 country.
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Central Hospital
Helsinki
Tuomo Nieminen, tuomo.vm.nieminen@helsinki.fi
- Recruiting
Päijät-Häme Central Hospital
Lahti
Anne Kerola, anne.kerola@helsinki.fi
About this study
Official title: The Efficacy of Adalimumab and Conventional Antirheumatic Drugs in Alleviating Axial and Aortic Inflammation Detected in PET/CT in Patients With Axial Spondyloarthritis
Axial spondyloarthritis is an inflammatory rheumatic disease mainly affecting joints in the spine and the sacroiliac joints. Inflammatory pathways are likely the central link from axial spondyloarthritis to the known increased risk of atherosclerotic morbidity. Positron emission tomography (PET) is the most sensitive method to detect inflammatory foci in clinical practice. A few small studies have demonstrated that PET imaging together with computed tomography (PET/CT) detects inflamed tissues in relevant patient groups. One study suggested that antirheumatic treatment diminishes the inflammation detected in PET/CT. No study so far has disclosed whether aortic inflammation is present in patients with spondyloarthritis, and whether the inflammation would wane with efficient antirheumatic treatment. The current study is aimed to grade the articular and aortic inflammatory signals in the PET/CT imaging before and after antirheumatic treatment of clinically active axial spondyloarthritis.
Sixty patients aged 18-75 years with axial spondyloarthritis and radiologic sacroiliitis as detected either by MRI or X-ray will be recruited. Twenty of those are DMARD-naive, and 40 patients have axial spondyloarthritis resistant to sulfasalazine or other conventional antirheumatic drug. In addition, approximately 30 patients without spondyloarthritis but with stable coronary heart disease and approximately 20 healthy controls will be taken as historical controls. All the axial spondyloarthritis patients are PET/CT scanned after inclusion in the study. The DMARD-naive patients (n=20) are started sulfasalazine-based regimen for 12 weeks, which is the time point for a second PET scan for this subgroup. Adalimumab will be commenced for those without remission at 12 weeks. After another 16 weeks, those with adalimumab will be scanned with PET/CT for the third time. The subgroup with active disease in spite of prior conventional treatment (n=40) is also scanned with PET/CT right after the enrolment and after 16-week treatment with adalimumab. The first 15 patients form a pilot group, which is used to check the validity of the power calculation.
The project will give essential new information on PET-detectable inflammation in the patients with axial spondyloarthritis. The results will be published in international publication series. The publications will form the basis for a doctoral thesis. Funding for the project comes from Abbvie Ltd.
- Conditions
- Ankylosing Spondyloarthritis
- Being tested
- Adalimumab, PET/CT imaging
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Biologic drug
PET/CT imagingOther
PET/CT imaging
| Study group | Role | What they receive |
|---|---|---|
| DMARD-naive | Active comparator | Sulfasalazine will be given as the initial therapy. Receives: Other: PET/CT imaging |
| Post-sulfasalazine | Experimental | Sulfasalazine contraindicated or not efficient, adalimumab will be given as the initial therapy. Receives: Drug: Adalimumab; Other: PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET signals within groups
Decrease in PET signal levels both in major CV tissues (mean TBR in the whole aorta) and musculoskeletal tissues (lumbar spine and articular enthesitis as well as arthritis) after antirheumatic treatment. Thus the variables of most interest reflect intraindividual changes.
Measured: 16 weeks
Secondary outcomes (1)
PET signals between groups
Comparison of the pre-treatment PET signals between the three groups: those with axial spondyloarthritis, historical healthy controls and the patients with coronary heart disease.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, Tuomo Nieminen, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634541
- Sponsor's protocol ID
- PETSPA
- Other IDs
- 2015-000752-20, 2015
- Acronym
- PETSPA
- Status last verified
- Feb 2017
- First submitted
- 16 Dec 2015
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Adalimumab and Conventional Antirheumatic Drugs in Alleviating Axial and Aortic Inflammation Detected in PET/CT in Patients With Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT02634541
- Acronym / sponsor ID
- PETSPA / PETSPA
- Conditions
- Ankylosing Spondyloarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Dec 2015 (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.
Axial spondyloarthritis is an inflammatory rheumatic disease mainly affecting joints in the spine and the sacroiliac joints. Inflammatory pathways are likely the central link from axial spondyloarthritis to the known increased risk of atherosclerotic morbidity. Positron emission tomography (PET) is the most sensitive method to detect inflammatory foci in clinical practice. A few small studies have demonstrated that PET imaging together with computed tomography (PET/CT) detects inflamed tissues in relevant patient groups. One study suggested that antirheumatic treatment diminishes the inflammation detected in PET/CT. No study so far has disclosed whether aortic inflammation is present in patients with spondyloarthritis, and whether the inflammation would wane with efficient antirheumatic treatment. The current study is aimed to grade the articular and aortic inflammatory signals in the PET/CT imaging before and after antirheumatic treatment of clinically active axial spondyloarthritis.
Sixty patients aged 18-75 years with axial spondyloarthritis and radiologic sacroiliitis as detected either by MRI or X-ray will be recruited. Twenty of those are DMARD-naive, and 40 patients have axial spondyloarthritis resistant to sulfasalazine or other conventional antirheumatic drug. In addition, approximately 30 patients without spondyloarthritis but with stable coronary heart disease and approximately 20 healthy controls will be taken as historical controls. All the axial spondyloarthritis patients are PET/CT scanned after inclusion in the study. The DMARD-naive patients (n=20) are started sulfasalazine-based regimen for 12 weeks, which is the time point for a second PET scan for this subgroup. Adalimumab will be commenced for those without remission at 12 weeks. After another 16 weeks, those with adalimumab will be scanned with PET/CT for the third time. The subgroup with active disease in spite of prior conventional treatment (n=40) is also scanned with PET/CT right after the enrolment and after 16-week treatment with adalimumab. The first 15 patients form a pilot group, which is used to check the validity of the power calculation.
The project will give essential new information on PET-detectable inflammation in the patients with axial spondyloarthritis. The results will be published in international publication series. The publications will form the basis for a doctoral thesis. Funding for the project comes from Abbvie Ltd.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMARD-naive | Active comparator | Other: PET/CT imagingSulfasalazine will be given as the initial therapy. |
| Post-sulfasalazine | Experimental | Drug: Adalimumab, Other: PET/CT imagingSulfasalazine contraindicated or not efficient, adalimumab will be given as the initial therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Axial spondyloarthritis (ASAS criteria) and radiologic sacroiliitis as detected either by MRI or X-ray.
Key exclusion criteria (11 listed)
- Psoriasis or psoriasis arthropathy
- Inflammatory bowel disease
- Unwillingness to participate in the study with additional imaging protocols
- Expected life-span less than <1 year
- Diabetes (to improve the PET imaging quality)
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 |
|---|---|---|
| AdalimumabBiologic drug | Drug | Post-sulfasalazine |
| PET/CT imagingPET/CT imaging | Other | DMARD-naive, Post-sulfasalazine |
Primary outcome
PET signals within groups
Time frame: 16 weeks
Decrease in PET signal levels both in major CV tissues (mean TBR in the whole aorta) and musculoskeletal tissues (lumbar spine and articular enthesitis as well as arthritis) after antirheumatic treatment. Thus the variables of most interest reflect intraindividual changes.
1 secondary outcome
PET signals between groups
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab and PET/CT imaging in people with Ankylosing Spondyloarthritis, run by University of Helsinki at 2 sites in Finland.
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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tuomo Nieminen, PhD, MD (+358 50 910 5150, tuomo.vm.nieminen@helsinki.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET signals within groups (time frame: 16 weeks). 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 23 Feb 2017.