Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray (RACTX)
12 janvier 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Description détaillée
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)
Type d'étude
Observationnel
Inscription (Anticipé)
625
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
Aarhus, Danemark, 8000
- Department of Rheumatology, Aarhus University Hospital
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
N/A
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Erosion changes by HR-pQCT
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Radiographic erosion score
Délai: One year
|
Change in Sharp/van der Heijde (SvH) score from baseline to one-year follow-up, in the three groups.
|
One year
|
|
CTX
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: one year
|
Changes from baseline to one-year follow-up in Osteoprotegerin (OPG) in pg/mL, in the three groups.
|
one year
|
|
BGLAP
Délai: one year
|
Changes from baseline to one-year follow-up in Osteocalcin (BGLAP) in pg/mL, in the three groups.
|
one year
|
|
SCL
Délai: one year
|
Changes from baseline to one-year follow-up in Sclerostin(SCL) in pg/mL, in the three groups.
|
one year
|
|
Dkk-1
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: one year
|
Disease Activity Score (DAS28-CRP) [2.0-10.0]
|
one year
|
|
Health Assessment Questionnaire
Délai: one year
|
Health Assessment Questionnaire (HAQ) [0-3 HAQ Total Score]
|
one year
|
|
VAS for pain
Délai: one year
|
Visual Analog Scale(VAS) for pain [0-100mm]
|
one year
|
|
VAS for fatigue
Délai: one year
|
Visual Analog Scale(VAS) for fatigue [0-100mm]
|
one year
|
|
VAS for quality of life
Délai: one year
|
Visual Analog Scale(VAS) for quality of life [0-100mm]
|
one year
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
areal bone mineral density (aBMD)
Délai: one year
|
aBMD in the lumbar spine, and the left hip by DXA, in RA patients
|
one year
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Ellen-Margrethe Hauge, MD, PhD, Department of Rheumatology - Aarhus University Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
15 février 2018
Achèvement primaire (Anticipé)
1 février 2022
Achèvement de l'étude (Anticipé)
31 décembre 2026
Dates d'inscription aux études
Première soumission
24 janvier 2018
Première soumission répondant aux critères de contrôle qualité
5 février 2018
Première publication (Réel)
12 février 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 janvier 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 janvier 2021
Dernière vérification
1 janvier 2021
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RACTX
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Indécis
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .