Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray (RACTX)
12. januar 2021 oppdatert av: Rasmus Klose-Jensen, Aarhus University Hospital
An Observational Study of Bone Erosion Determination and Progression in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray
Today, regular X-ray examination is not sufficiently sensitive for detecting progression of bone destruction in rheumatoid arthritis, but a new type of high-resolution CT scanner, the High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT) can detect very early and minor joint injuries.
The purpose of this study is to use HR-pQCT techniques to look at the damage and disease activity progression in the hand and wrist joints of patients with rheumatoid arthritis.
Studieoversikt
Status
Påmelding etter invitasjon
Forhold
Detaljert beskrivelse
The design of the trial is an observational study with three distinct groups. At the start of the trial period and at one-year of follow-up, the trial subject will have their hand X-rayed by conventional radiography, and their metacarpophalangeal (MCP) joint and wrist scanned by HR-pQCT-Imaging. The 28-joint Disease Activity Score(DAS28-CRP), Health Assessment Questionnaire (HAQ), Visual analogue scale(VAS)-score for pain, fatigue and quality of life are performed to investigate the correlation between radiographic changes and disease activity. Blood samples are collected to investigate serological markers of bone metabolism and inflammation and the radiographic changes. The following groups are investigated:
- Rheumatoid Arthritis(RA): Patients with RA ≥5 years according to the ACR/EULAR 2010 classification criteria or the American Rheumatism Association 1987 revised criteria are recruited from the outpatient clinic at the Department of Rheumatology, Aarhus University Hospital. Treatment will be adjusted according to the patient's need and according to national guidelines. (n=450)
- Pre-RA patients: Patients with pre-RA, (joint pain, but no swelling and Anti-CCP 3 times above the upper limit) are recruited from the outpatient clinic at the Department of Rheumatology, Aarhus University Hospital. (n=75)
- Healthy subjects: Healthy age- and sex-matched Individuals are recruited, as a control group, by posting at libraries in Aarhus, Aarhus University, Aarhus University Hospital and postings on the websites www.forsøgsperson.dk and www.Sundhed.dk. (N=100)
Studietype
Observasjonsmessig
Registrering (Forventet)
625
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Aarhus, Danmark, 8000
- Department of Rheumatology, Aarhus University Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
N/A
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Rheumatoid arthritis patients and pre-rheumatoid patients are recruited from the outpatient clinic at the Department of Rheumatology, Aarhus University Hospital.
Healthy age- and sex-matched Individuals are recruited, as a control group, by posting at libraries in Aarhus, Aarhus University, Aarhus University Hospital and postings on the websites www.forsøgsperson.dk and www.Sundhed.dk.
Beskrivelse
Rheumatoid arthritis patients Inclusion criteria
- Patients (> 18 years) with rheumatoid arthritis ≥5 years according to the ACR/EULAR (2010) classification criteria or American Rheumatism Association 1987 revised criteria for the patients who were diagnosed before 2010.
- Patients who are receiving treatment on an outpatient basis.
- Ability and willingness to give written informed consent and to meet the requirements of the trial protocol.
Exclusion criteria
- Patients who have previously suffered trauma in the form of fracture or luxation of the hand are excluded.
- Evidence of active malignant disease.
- Hypo- or hyperthyroidism.
- Hypocalcaemia.
- Impaired renal function (eGFR <35ml/min).
- Pregnancy. Pre-rheumatoid arthritis patients Inclusion criteria
- Age over 18 years.
- Anti-CCP 3 times the upper limit of the reference interval.
- Arthralgia.
- Ability and willingness to give written informed consent and to meet the requirements of the trial protocol.
Exclusion criteria
- Pregnancy.
- Swelling of joints. Verified by clinical ultrasound.
- Patients who have previously suffered trauma in the form of fracture or luxation of the hand are excluded.
- Evidence of malignant disease.
- Hypo- or hyperthyroidism.
- Hypocalcaemia. Healthy subjects Inclusion criteria
- Age over 18 years.
- No joint complaints.
- Ability and willingness to give written informed consent and to meet the requirements of the trial protocol.
Exclusion criteria
- Patients who have previously suffered trauma in the form of fracture or luxation of the hand are excluded.
- Evidence of malignant disease.
- Hypo- or hyperthyroidism.
- Hypocalcaemia.
- Impaired renal function (eGFR <35ml/min).
- Earlier or present rheumatological disease or bone metabolic disease.
- Positive anti-CCP.
- Pregnancy.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
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Rheumatoid arthritis
Patients with Rheumatoid arthritis ≥5 years according to the ACR/EULAR 2010 classification criteria or the American Rheumatism Association 1987 revised criteria. ICD-10: M059 Seropositive rheumatoid arthritis UNS, M060 Seronegative rheumatoid arthritis, M069 Rheumatoid arthritis UNS. |
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Pre-Rheumatoid arthritis
Patients with joint pain, but no swelling and Anti-CCP 3 times above the upper limit.
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Healthy Subjects
Healthy age- and sex-matched Individuals are recruited, as a control group.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Erosion changes by HR-pQCT
Tidsramme: One year
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Changes in bone erosions volume in mm3 by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
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One year
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Volumetric bone mineral density(vBMD) changes by HR-pQCT
Tidsramme: One year
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Changes in volumetric bone mineral density(vBMD) in mgHA/cm3 by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
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One year
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Erosion changes by HR-pQCT
Tidsramme: One year
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Changes in bone erosions width in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
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One year
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Erosion changes by HR-pQCT
Tidsramme: One year
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Changes in bone erosions depth in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
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One year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Radiographic erosion score
Tidsramme: One year
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Change in Sharp/van der Heijde (SvH) score from baseline to one-year follow-up, in the three groups.
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One year
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CTX
Tidsramme: one year
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Changes from baseline to one-year follow-up in C-terminal telopeptide (CTX) in pg/mL, in the three groups.
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one year
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P1NP
Tidsramme: one year
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Changes from baseline to one-year follow-up in Procollagen type 1 N-terminal propeptide (P1NP) in pg/mL, in the three groups.
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one year
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BAP
Tidsramme: one year
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Changes from baseline to one-year follow-up in Bone-specific alkaline phosphatase (BAP) in pg/mL, in the three groups.
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one year
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TNF-α
Tidsramme: one year
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Changes from baseline to one-year follow-up in the Tumor necrosis factor-alfa (TNF-α) in pg/mL, in the three groups.
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one year
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RANK-L
Tidsramme: one year
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Changes from baseline to one-year follow-up in RANK-Ligand (RANK-L) in pg/mL, in the three groups.
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one year
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OPG
Tidsramme: one year
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Changes from baseline to one-year follow-up in Osteoprotegerin (OPG) in pg/mL, in the three groups.
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one year
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BGLAP
Tidsramme: one year
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Changes from baseline to one-year follow-up in Osteocalcin (BGLAP) in pg/mL, in the three groups.
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one year
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SCL
Tidsramme: one year
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Changes from baseline to one-year follow-up in Sclerostin(SCL) in pg/mL, in the three groups.
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one year
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Dkk-1
Tidsramme: one year
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Changes from baseline to one-year follow-up in Dickkopf-related protein 1 (Dkk-1) in pg/mL, in the three groups.
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one year
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IL-1
Tidsramme: one year
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Changes from baseline to one-year follow-up in Interleukins 1 (IL-1) in pg/mL, in the three groups.
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one year
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IL-6
Tidsramme: one year
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Changes from baseline to one-year follow-up in Interleukins 6 (IL-6) in pg/mL, in the three groups.
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one year
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IL-15
Tidsramme: one year
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Changes from baseline to one-year follow-up in Interleukins 15 (IL-15) in pg/mL, in the three groups.
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one year
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IL-16
Tidsramme: one year
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Changes from baseline to one-year follow-up in Interleukins 16 (IL-16) in pg/mL, in the three groups.
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one year
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IL-17
Tidsramme: one year
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Changes from baseline to one-year follow-up in Interleukins 17 (IL-17) in pg/mL, in the three groups.
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one year
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IL-22
Tidsramme: one year
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Changes from baseline to one-year follow-up in Interleukins 22 (IL-22) in pg/mL, in the three groups.
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one year
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IL-33
Tidsramme: one year
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Changes from baseline to one-year follow-up in Interleukins 33 (IL-33) in pg/mL, in the three groups.
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one year
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CCL11
Tidsramme: one year
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Changes from baseline to one-year follow-up in Chemokine ligand 11 (CCL11) in pg/mL, in the three groups.
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one year
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CXCL13
Tidsramme: one year
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Changes from baseline to one-year follow-up in Chemokine (C-X-C) motif ligand (CXCL13) in pg/mL, in the three groups.
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one year
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TRACP 5b
Tidsramme: one year
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Changes from baseline to one-year follow-up in Tartrate-resistant acid phosphatase 5b (TRACP 5b) in pg/mL, in the three groups.
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one year
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CRP
Tidsramme: one year
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Changes from baseline to one-year follow-up in C-reactive protein (CRP) in mg/L, in the three groups.
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one year
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Disease Activity Score
Tidsramme: one year
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Disease Activity Score (DAS28-CRP) [2.0-10.0]
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one year
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Health Assessment Questionnaire
Tidsramme: one year
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Health Assessment Questionnaire (HAQ) [0-3 HAQ Total Score]
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one year
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VAS for pain
Tidsramme: one year
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Visual Analog Scale(VAS) for pain [0-100mm]
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one year
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VAS for fatigue
Tidsramme: one year
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Visual Analog Scale(VAS) for fatigue [0-100mm]
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one year
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VAS for quality of life
Tidsramme: one year
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Visual Analog Scale(VAS) for quality of life [0-100mm]
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one year
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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areal bone mineral density (aBMD)
Tidsramme: one year
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aBMD in the lumbar spine, and the left hip by DXA, in RA patients
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one year
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Ellen-Margrethe Hauge, MD, PhD, Department of Rheumatology - Aarhus University Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. februar 2018
Primær fullføring (Forventet)
1. februar 2022
Studiet fullført (Forventet)
31. desember 2026
Datoer for studieregistrering
Først innsendt
24. januar 2018
Først innsendt som oppfylte QC-kriteriene
5. februar 2018
Først lagt ut (Faktiske)
12. februar 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. januar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. januar 2021
Sist bekreftet
1. januar 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RACTX
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