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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

625 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-15

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Arthritis, Rheumatoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Pre-Rheumatoid arthritis

Patients with joint pain, but no swelling and Anti-CCP 3 times above the upper limit.

No interventions assigned to this group

Healthy Subjects

Healthy age- and sex-matched Individuals are recruited, as a control group.

No interventions assigned to this group

Eligibility Criteria

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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.

* 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.

* 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 active malignant disease.
* Hypo- or hyperthyroidism.
* Hypocalcaemia.
* Impaired renal function (eGFR \<35ml/min).

* 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.

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No