Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray (RACTX)
12 januari 2021 uppdaterad 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.
Studieöversikt
Status
Anmälan via inbjudan
Betingelser
Detaljerad beskrivning
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)
Studietyp
Observationell
Inskrivning (Förväntat)
625
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Aarhus, Danmark, 8000
- Department of Rheumatology, Aarhus University Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
N/A
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Erosion changes by HR-pQCT
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Radiographic erosion score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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areal bone mineral density (aBMD)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Ellen-Margrethe Hauge, MD, PhD, Department of Rheumatology - Aarhus University Hospital
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 februari 2018
Primärt slutförande (Förväntat)
1 februari 2022
Avslutad studie (Förväntat)
31 december 2026
Studieregistreringsdatum
Först inskickad
24 januari 2018
Först inskickad som uppfyllde QC-kriterierna
5 februari 2018
Första postat (Faktisk)
12 februari 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 januari 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 januari 2021
Senast verifierad
1 januari 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RACTX
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Kliniska prövningar på Artrit, reumatoid
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Novartis PharmaceuticalsRekryteringRheumatoid artrit (RA) och Sjögrens sjukdom (SJD)Spanien, Frankrike, Tyskland, Singapore