NCT03429426

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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
625

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Feb 2018Dec 2026

First Submitted

Initial submission to the registry

January 24, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

February 15, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

4 years

First QC Date

January 24, 2018

Last Update Submit

January 12, 2021

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid ArthritisHigh-resolution peripheral quantitative computed tomographyRadiography

Outcome Measures

Primary Outcomes (4)

  • Erosion changes by HR-pQCT

    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

    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

    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

    Changes in bone erosions depth in mm by HR-pQCT-imaging from baseline to one-year follow-up, in the three groups.

    One year

Secondary Outcomes (26)

  • Radiographic erosion score

    One year

  • CTX

    one year

  • P1NP

    one year

  • BAP

    one year

  • TNF-α

    one year

  • +21 more secondary outcomes

Other Outcomes (1)

  • areal bone mineral density (aBMD)

    one year

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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.
  • 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.
  • Age over 18 years.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rheumatology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (3)

  • Therkildsen J, Klose-Jensen R, Langdahl B, Bruel A, Thomsen JS, Moger C, Stilling M, Keller KK, Hauge EM. Mapping the bare area and transcortical pores in finger joints: co-location with bone erosions in rheumatoid arthritis. RMD Open. 2026 Jan 22;12(1):e006371. doi: 10.1136/rmdopen-2025-006371.

    PMID: 41571324DERIVED

  • Therkildsen J, Klose-Jensen R, Hanel M, Langdahl BL, Thomsen JS, Manske SL, Keller KK, Hauge EM. Detecting new erosions in rheumatoid arthritis over one year - Radiography and high-resolution computed tomography of finger joints. Joint Bone Spine. 2025 Jan;92(1):105812. doi: 10.1016/j.jbspin.2024.105812. Epub 2024 Nov 14.

    PMID: 39547428DERIVED

  • Klose-Jensen R, Therkildsen J, Blavnsfeldt AG, Langdahl BL, Zejden A, Thygesen J, Keller KK, Hauge EM. Diagnostic accuracy of high-resolution peripheral quantitative computed tomography and X-ray for classifying erosive rheumatoid arthritis. Rheumatology (Oxford). 2022 Mar 2;61(3):963-973. doi: 10.1093/rheumatology/keab446.

    PMID: 34015091DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

A research biobank for blood samples will be established for the project.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Ellen-Margrethe Hauge, MD, PhD

    Department of Rheumatology - Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD Student

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 12, 2018

Study Start

February 15, 2018

Primary Completion

February 1, 2022

Study Completion (Estimated)

December 31, 2026

Last Updated

January 13, 2021

Record last verified: 2021-01

Locations

DK(1)