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

Arthritis, Rheumatoid Clinical Trial

— RACTX  

Official title:

An Observational Study of Bone Erosion Determination and Progression in Rheumatoid Arthritis Assessed by HR-pQCT and Conventional X-ray

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03429426
• Other study ID #: RACTX
• Status: Enrolling by invitation
• Start date: February 15, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2021
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 625
• Est. completion date: December 31, 2026
• Est. primary completion date: February 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Locations

Country	Name	City	State
Denmark	Department of Rheumatology, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital	University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	areal bone mineral density (aBMD)	aBMD in the lumbar spine, and the left hip by DXA, in RA patients	one year
Primary	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
Primary	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
Primary	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
Primary	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	Radiographic erosion score	Change in Sharp/van der Heijde (SvH) score from baseline to one-year follow-up, in the three groups.	One year
Secondary	CTX	Changes from baseline to one-year follow-up in C-terminal telopeptide (CTX) in pg/mL, in the three groups.	one year
Secondary	P1NP	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
Secondary	BAP	Changes from baseline to one-year follow-up in Bone-specific alkaline phosphatase (BAP) in pg/mL, in the three groups.	one year
Secondary	TNF-a	Changes from baseline to one-year follow-up in the Tumor necrosis factor-alfa (TNF-a) in pg/mL, in the three groups.	one year
Secondary	RANK-L	Changes from baseline to one-year follow-up in RANK-Ligand (RANK-L) in pg/mL, in the three groups.	one year
Secondary	OPG	Changes from baseline to one-year follow-up in Osteoprotegerin (OPG) in pg/mL, in the three groups.	one year
Secondary	BGLAP	Changes from baseline to one-year follow-up in Osteocalcin (BGLAP) in pg/mL, in the three groups.	one year
Secondary	SCL	Changes from baseline to one-year follow-up in Sclerostin(SCL) in pg/mL, in the three groups.	one year
Secondary	Dkk-1	Changes from baseline to one-year follow-up in Dickkopf-related protein 1 (Dkk-1) in pg/mL, in the three groups.	one year
Secondary	IL-1	Changes from baseline to one-year follow-up in Interleukins 1 (IL-1) in pg/mL, in the three groups.	one year
Secondary	IL-6	Changes from baseline to one-year follow-up in Interleukins 6 (IL-6) in pg/mL, in the three groups.	one year
Secondary	IL-15	Changes from baseline to one-year follow-up in Interleukins 15 (IL-15) in pg/mL, in the three groups.	one year
Secondary	IL-16	Changes from baseline to one-year follow-up in Interleukins 16 (IL-16) in pg/mL, in the three groups.	one year
Secondary	IL-17	Changes from baseline to one-year follow-up in Interleukins 17 (IL-17) in pg/mL, in the three groups.	one year
Secondary	IL-22	Changes from baseline to one-year follow-up in Interleukins 22 (IL-22) in pg/mL, in the three groups.	one year
Secondary	IL-33	Changes from baseline to one-year follow-up in Interleukins 33 (IL-33) in pg/mL, in the three groups.	one year
Secondary	CCL11	Changes from baseline to one-year follow-up in Chemokine ligand 11 (CCL11) in pg/mL, in the three groups.	one year
Secondary	CXCL13	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
Secondary	TRACP 5b	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
Secondary	CRP	Changes from baseline to one-year follow-up in C-reactive protein (CRP) in mg/L, in the three groups.	one year
Secondary	Disease Activity Score	Disease Activity Score (DAS28-CRP) [2.0-10.0]	one year
Secondary	Health Assessment Questionnaire	Health Assessment Questionnaire (HAQ) [0-3 HAQ Total Score]	one year
Secondary	VAS for pain	Visual Analog Scale(VAS) for pain [0-100mm]	one year
Secondary	VAS for fatigue	Visual Analog Scale(VAS) for fatigue [0-100mm]	one year
Secondary	VAS for quality of life	Visual Analog Scale(VAS) for quality of life [0-100mm]	one year