OPAL

Optical images for monitoring treatment changes in rheumatoid arthritis – a longitudinal study with Rheumascan

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004006-26-DK

Enrollment

Unknown

Registered

2013-12-18

Start date

2013-12-18

Completion date

Unknown

Last updated

2016-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Detection of synovitis and tenosynovitis in the hands of patients with rheumatoid arthritis

Interventions

Trade Name: ICG-Pulsion Pharmaceutical Form: Powder and solvent for solution for injection/infusion INN or Proposed INN: 2-{7-[1,1-dimethyl-3-(4-sulfobutyl)-benz[e]indolin-2-ylidene]-1,3,5-heptatrieny

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria A. – RA-patients. • RA according to ACR/EULAR 2010 criteria (study A & B). • Above 18 years of age (study A & B). • At least one clinical inflamed joint in hands (study A & B). • Clinical indication for escalating treatment (study B). B. – Healthy controls. • No inflammatory joint disease • No chronic pain syndrome. • No current joint symptoms Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: Exclusion criteria • Lack of ability to understand the information given about the study. • Recent operation i the hands (within the last 4 weeks). • Impaired renal function at inclusion (GFR 2 x upper normal limit at time of inclusion). • Previous allergy to contrast agents. • Contraindications to ICG (Iod allergy, untreated hyperthyroidism, allergy to ICG-pulsion) • Contraindications to MRI (pacemaker, claustrofobia, none compatible MRI metal in the body, allergy to Dotarem). • Positive urine HCG among women in the age of fertility.

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore whether there is a difference between findings among RA patients and healthy controls using Rheumascan of wrist, MCP and PIP joints as well as extensor tendon compartments of the wrist. ;Secondary Objective: To evaluate the reproducibility of Rheumascan findings among RA patients and healthy controls To explore the sensitivity to changes of Rheumascan under treatment, among RA patients. To determine sensitivity, specificity and accuracy of Rheumascan and ultrasound for detection of synovitis and tenosynovitis, with magnetic resonance imaging as standard reference. ;Primary end point(s): Study A • Interscan agreement for Rheumascan using Intra-Class-Correlation coefficient and percentage absolute agreement. Study B • Sensitivity-to-change for quantitative evaluation of inflammation (synovitis and tenosynovits) in hands, evaluated after 6 months by Rheumascan, using standardized response mean (SRM.);Timepoint(s) of evaluation of this end point: After the last visit of the last participant.	—

Measure

Time frame

Main Objective: To explore whether there is a difference between findings among RA patients and healthy controls using Rheumascan of wrist, MCP and PIP joints as well as extensor tendon compartments of the wrist. ;Secondary Objective: To evaluate the reproducibility of Rheumascan findings among RA patients and healthy controls To explore the sensitivity to changes of Rheumascan under treatment, among RA patients. To determine sensitivity, specificity and accuracy of Rheumascan and ultrasound for detection of synovitis and tenosynovitis, with magnetic resonance imaging as standard reference. ;Primary end point(s): Study A • Interscan agreement for Rheumascan using Intra-Class-Correlation coefficient and percentage absolute agreement. Study B • Sensitivity-to-change for quantitative evaluation of inflammation (synovitis and tenosynovits) in hands, evaluated after 6 months by Rheumascan, using standardized response mean (SRM.);Timepoint(s) of evaluation of this end point: After the last visit of the last participant.

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Secondary

Measure	Time frame
Secondary end point(s): Study A • Intraobserver and interobserver agreement for Rheumascan assessed by Intra-Class-Correlation coefficient and percentage absolute agreement . • Sensitivity, specificity and accuracy of Rheumascan and ultrasound for assessment of synovitis and tenosynovitis, with magnetic resonance imaging as standard reference. • Difference between findings (synovitis and tenosynovitis) among RA patients and helathy controls using Rheumascan , assessed by Mann-Whitney U test. Study B Secundary endpoints: • Sensitivity-to-change for quantitative evaluation of inflammation (synovitis and tenosynovits) in hands, evaluated after 3 month by Rheumascan, using standardized response mean (SRM.) • Sensitivity-to-change for semi-quantitative scoring of inflammation (synovitis and tenosynovits) in hands using Rheumascan, evaluated after 3 and 6 months by standardized response mean (SRM) • Changes in inflammatory activity evaluated by Rheumascan, ultrasound and magnetic resonance imaging, using Wilcoxon-Pratt test after 3 and 6 months. • Correlation between changes in inflammatory activity evaluated by Rheumascan, ultrasound and magnetic resonance imaging during treatment using Spearman’s correlation after 3 and 6 months. ;Timepoint(s) of evaluation of this end point: After the last visit of the last participant.	—

Measure

Time frame

Secondary end point(s): Study A • Intraobserver and interobserver agreement for Rheumascan assessed by Intra-Class-Correlation coefficient and percentage absolute agreement . • Sensitivity, specificity and accuracy of Rheumascan and ultrasound for assessment of synovitis and tenosynovitis, with magnetic resonance imaging as standard reference. • Difference between findings (synovitis and tenosynovitis) among RA patients and helathy controls using Rheumascan , assessed by Mann-Whitney U test. Study B Secundary endpoints: • Sensitivity-to-change for quantitative evaluation of inflammation (synovitis and tenosynovits) in hands, evaluated after 3 month by Rheumascan, using standardized response mean (SRM.) • Sensitivity-to-change for semi-quantitative scoring of inflammation (synovitis and tenosynovits) in hands using Rheumascan, evaluated after 3 and 6 months by standardized response mean (SRM) • Changes in inflammatory activity evaluated by Rheumascan, ultrasound and magnetic resonance imaging, using Wilcoxon-Pratt test after 3 and 6 months. • Correlation between changes in inflammatory activity evaluated by Rheumascan, ultrasound and magnetic resonance imaging during treatment using Spearman’s correlation after 3 and 6 months. ;Timepoint(s) of evaluation of this end point: After the last visit of the last participant.

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Countries

Denmark

Contacts

Public ContactMikkel Østergaard

Knowledge Centre for Rheumatology

mo@dadlnet.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026