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

12. Januar 2021 aktualisiert von: 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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Detaillierte Beschreibung

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)

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

625

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

N/A

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Kohorte
  • Zeitperspektiven: Interessent

Kohorten und Interventionen

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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Erosion changes by HR-pQCT
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Radiographic erosion score
Zeitfenster: One year
Change in Sharp/van der Heijde (SvH) score from baseline to one-year follow-up, in the three groups.
One year
CTX
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: one year
Changes from baseline to one-year follow-up in Osteoprotegerin (OPG) in pg/mL, in the three groups.
one year
BGLAP
Zeitfenster: one year
Changes from baseline to one-year follow-up in Osteocalcin (BGLAP) in pg/mL, in the three groups.
one year
SCL
Zeitfenster: one year
Changes from baseline to one-year follow-up in Sclerostin(SCL) in pg/mL, in the three groups.
one year
Dkk-1
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: one year
Disease Activity Score (DAS28-CRP) [2.0-10.0]
one year
Health Assessment Questionnaire
Zeitfenster: one year
Health Assessment Questionnaire (HAQ) [0-3 HAQ Total Score]
one year
VAS for pain
Zeitfenster: one year
Visual Analog Scale(VAS) for pain [0-100mm]
one year
VAS for fatigue
Zeitfenster: one year
Visual Analog Scale(VAS) for fatigue [0-100mm]
one year
VAS for quality of life
Zeitfenster: one year
Visual Analog Scale(VAS) for quality of life [0-100mm]
one year

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
areal bone mineral density (aBMD)
Zeitfenster: one year
aBMD in the lumbar spine, and the left hip by DXA, in RA patients
one year

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Aarhus University Hospital

Mitarbeiter

University of Aarhus

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Februar 2018

Primärer Abschluss (Voraussichtlich)

1. Februar 2022

Studienabschluss (Voraussichtlich)

31. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

24. Januar 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Februar 2018

Zuerst gepostet (Tatsächlich)

12. Februar 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Januar 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Januar 2021

Zuletzt verifiziert

1. Januar 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RACTX

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

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