- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03429426
Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray (RACTX)
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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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)
Opintotyyppi
Ilmoittautuminen (Odotettu)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Aarhus, Tanska, 8000
- Department of Rheumatology, Aarhus University Hospital
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
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.
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: Kohortti
- Aikanäkymät: Tulevaisuuden
Kohortit ja interventiot
Ryhmä/Kohortti |
---|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Erosion changes by HR-pQCT
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Radiographic erosion score
Aikaikkuna: One year
|
Change in Sharp/van der Heijde (SvH) score from baseline to one-year follow-up, in the three groups.
|
One year
|
CTX
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: one year
|
Changes from baseline to one-year follow-up in Osteoprotegerin (OPG) in pg/mL, in the three groups.
|
one year
|
BGLAP
Aikaikkuna: one year
|
Changes from baseline to one-year follow-up in Osteocalcin (BGLAP) in pg/mL, in the three groups.
|
one year
|
SCL
Aikaikkuna: one year
|
Changes from baseline to one-year follow-up in Sclerostin(SCL) in pg/mL, in the three groups.
|
one year
|
Dkk-1
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: one year
|
Disease Activity Score (DAS28-CRP) [2.0-10.0]
|
one year
|
Health Assessment Questionnaire
Aikaikkuna: one year
|
Health Assessment Questionnaire (HAQ) [0-3 HAQ Total Score]
|
one year
|
VAS for pain
Aikaikkuna: one year
|
Visual Analog Scale(VAS) for pain [0-100mm]
|
one year
|
VAS for fatigue
Aikaikkuna: one year
|
Visual Analog Scale(VAS) for fatigue [0-100mm]
|
one year
|
VAS for quality of life
Aikaikkuna: one year
|
Visual Analog Scale(VAS) for quality of life [0-100mm]
|
one year
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
areal bone mineral density (aBMD)
Aikaikkuna: one year
|
aBMD in the lumbar spine, and the left hip by DXA, in RA patients
|
one year
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Opintojohtaja: Ellen-Margrethe Hauge, MD, PhD, Department of Rheumatology - Aarhus University Hospital
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- RACTX
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Niveltulehdus, nivelreuma
-
RemeGen Co., Ltd.ValmisKeskivaikea ja vaikea RheumatoId-niveltulehdusKiina