Status:
ENROLLING_BY_INVITATION
Progression of Bone Erosions in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray
Lead Sponsor:
Aarhus University Hospital
Collaborating Sponsors:
University of Aarhus
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
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 conventio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
625 Patients enrolled
Trial Details
Trial ID
NCT03429426
Start Date
February 15 2018
End Date
December 31 2026
Last Update
January 13 2021
Active Locations (1)
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1
Department of Rheumatology, Aarhus University Hospital
Aarhus, Denmark, 8000