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Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray (RACTX)

12. januar 2021 opdateret af: 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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Detaljeret 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)

Undersøgelsestype

Observationel

Tilmelding (Forventet)

625

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Aarhus, Danmark, 8000
        • Department of Rheumatology, Aarhus University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
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.
Pre-Rheumatoid arthritis
Patients with joint pain, but no swelling and Anti-CCP 3 times above the upper limit.
Healthy Subjects
Healthy age- and sex-matched Individuals are recruited, as a control group.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Erosion changes by HR-pQCT
Tidsramme: One year
Changes in bone erosions volume in mm3 by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
One year
Volumetric bone mineral density(vBMD) changes by HR-pQCT
Tidsramme: One year
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.
One year
Erosion changes by HR-pQCT
Tidsramme: One year
Changes in bone erosions width in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
One year
Erosion changes by HR-pQCT
Tidsramme: One year
Changes in bone erosions depth in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.
One year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Radiographic erosion score
Tidsramme: One year
Change in Sharp/van der Heijde (SvH) score from baseline to one-year follow-up, in the three groups.
One year
CTX
Tidsramme: one year
Changes from baseline to one-year follow-up in C-terminal telopeptide (CTX) in pg/mL, in the three groups.
one year
P1NP
Tidsramme: one year
Changes from baseline to one-year follow-up in Procollagen type 1 N-terminal propeptide (P1NP) in pg/mL, in the three groups.
one year
BAP
Tidsramme: one year
Changes from baseline to one-year follow-up in Bone-specific alkaline phosphatase (BAP) in pg/mL, in the three groups.
one year
TNF-α
Tidsramme: one year
Changes from baseline to one-year follow-up in the Tumor necrosis factor-alfa (TNF-α) in pg/mL, in the three groups.
one year
RANK-L
Tidsramme: one year
Changes from baseline to one-year follow-up in RANK-Ligand (RANK-L) in pg/mL, in the three groups.
one year
OPG
Tidsramme: one year
Changes from baseline to one-year follow-up in Osteoprotegerin (OPG) in pg/mL, in the three groups.
one year
BGLAP
Tidsramme: one year
Changes from baseline to one-year follow-up in Osteocalcin (BGLAP) in pg/mL, in the three groups.
one year
SCL
Tidsramme: one year
Changes from baseline to one-year follow-up in Sclerostin(SCL) in pg/mL, in the three groups.
one year
Dkk-1
Tidsramme: one year
Changes from baseline to one-year follow-up in Dickkopf-related protein 1 (Dkk-1) in pg/mL, in the three groups.
one year
IL-1
Tidsramme: one year
Changes from baseline to one-year follow-up in Interleukins 1 (IL-1) in pg/mL, in the three groups.
one year
IL-6
Tidsramme: one year
Changes from baseline to one-year follow-up in Interleukins 6 (IL-6) in pg/mL, in the three groups.
one year
IL-15
Tidsramme: one year
Changes from baseline to one-year follow-up in Interleukins 15 (IL-15) in pg/mL, in the three groups.
one year
IL-16
Tidsramme: one year
Changes from baseline to one-year follow-up in Interleukins 16 (IL-16) in pg/mL, in the three groups.
one year
IL-17
Tidsramme: one year
Changes from baseline to one-year follow-up in Interleukins 17 (IL-17) in pg/mL, in the three groups.
one year
IL-22
Tidsramme: one year
Changes from baseline to one-year follow-up in Interleukins 22 (IL-22) in pg/mL, in the three groups.
one year
IL-33
Tidsramme: one year
Changes from baseline to one-year follow-up in Interleukins 33 (IL-33) in pg/mL, in the three groups.
one year
CCL11
Tidsramme: one year
Changes from baseline to one-year follow-up in Chemokine ligand 11 (CCL11) in pg/mL, in the three groups.
one year
CXCL13
Tidsramme: one year
Changes from baseline to one-year follow-up in Chemokine (C-X-C) motif ligand (CXCL13) in pg/mL, in the three groups.
one year
TRACP 5b
Tidsramme: one year
Changes from baseline to one-year follow-up in Tartrate-resistant acid phosphatase 5b (TRACP 5b) in pg/mL, in the three groups.
one year
CRP
Tidsramme: one year
Changes from baseline to one-year follow-up in C-reactive protein (CRP) in mg/L, in the three groups.
one year
Disease Activity Score
Tidsramme: one year
Disease Activity Score (DAS28-CRP) [2.0-10.0]
one year
Health Assessment Questionnaire
Tidsramme: one year
Health Assessment Questionnaire (HAQ) [0-3 HAQ Total Score]
one year
VAS for pain
Tidsramme: one year
Visual Analog Scale(VAS) for pain [0-100mm]
one year
VAS for fatigue
Tidsramme: one year
Visual Analog Scale(VAS) for fatigue [0-100mm]
one year
VAS for quality of life
Tidsramme: one year
Visual Analog Scale(VAS) for quality of life [0-100mm]
one year

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
areal bone mineral density (aBMD)
Tidsramme: one year
aBMD in the lumbar spine, and the left hip by DXA, in RA patients
one year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Aarhus University Hospital

Samarbejdspartnere

University of Aarhus

Efterforskere

  • Studieleder: Ellen-Margrethe Hauge, MD, PhD, Department of Rheumatology - Aarhus University Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. februar 2018

Primær færdiggørelse (Forventet)

1. februar 2022

Studieafslutning (Forventet)

31. december 2026

Datoer for studieregistrering

Først indsendt

24. januar 2018

Først indsendt, der opfyldte QC-kriterier

5. februar 2018

Først opslået (Faktiske)

12. februar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RACTX

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