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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Oslo, Norge, 0319
- Department of Rheumatology, Diakonhjemmet Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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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
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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To assess the sensitivity to change of US pathology in joints and entheses in SpA patients starting biological treatment.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Hilde B Hammer, MD, PhD, Diakonhjemmet Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Infeksjoner
- Leddsykdommer
- Muskel- og skjelettsykdommer
- Leddgikt
- Spinal sykdommer
- Beinsykdommer
- Beinsykdommer, smittsomme
- Spondylitt
- Spondylartritt
- Fysiologiske effekter av legemidler
- Agenter fra det perifere nervesystemet
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirevmatiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Gastrointestinale midler
- Dermatologiske midler
- Tumornekrosefaktorhemmere
- Etanercept
- Adalimumab
- Infliximab
- Golimumab
Andre studie-ID-numre
- 011110
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