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Adalimumab in Alleviating Inflammation in Patients With Axial Spondyloarthritis (PETSPA)

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ClinicalTrials.gov Identifier: NCT02634541
Recruitment Status : Unknown
Verified February 2017 by Tuomo Nieminen, Helsinki University.
Recruitment status was:  Recruiting
First Posted : December 18, 2015
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Tuomo Nieminen, Helsinki University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Ankylosing Spondyloarthritis Drug: Adalimumab Other: PET/CT imaging Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Active Comparator: DMARD-naive
Sulfasalazine will be given as the initial therapy.
Other: PET/CT imaging
PET/CT imaging

Experimental: Post-sulfasalazine
Sulfasalazine contraindicated or not efficient, adalimumab will be given as the initial therapy.
Drug: Adalimumab
Biologic drug

Other: PET/CT imaging
PET/CT imaging




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. PET signals between groups [ Time Frame: 16 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Axial spondyloarthritis (ASAS criteria) and radiologic sacroiliitis as detected either by MRI or X-ray.

Exclusion Criteria:

  • 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
  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT02634541


Contacts
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Contact: Tuomo Nieminen, PhD, MD +358 50 910 5150 tuomo.vm.nieminen@helsinki.fi
Contact: Anne Kerola, BMS +358 50 360 0550 anne.kerola@helsinki.fi

Locations
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Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland
Contact: Tuomo Nieminen       tuomo.vm.nieminen@helsinki.fi   
Päijät-Häme Central Hospital Recruiting
Lahti, Finland
Contact: Anne Kerola       anne.kerola@helsinki.fi   
Sponsors and Collaborators
Helsinki University
AbbVie

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Responsible Party: Tuomo Nieminen, Professor of Internal Medicine, Helsinki University
ClinicalTrials.gov Identifier: NCT02634541     History of Changes
Other Study ID Numbers: PETSPA
2015-000752-20 ( EudraCT Number )
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Inflammation
Spondylarthritis
Spondylitis, Ankylosing
Pathologic Processes
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Spondylarthropathies
Ankylosis
Adalimumab
Sulfasalazine
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents