OPA

Phase 1

• Conditions: Detection of synovitis and tenosynovitis in the hands of patients with rheumatoid arthritis; Diagnostic performance of optical imaging in comparison with ultrasound and magnetic resonance imaging.; MedDRA version: 16.1Level: LLTClassification code 10067132Term: Synovitis wristSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-004006-26-DK
• Lead Sponsor: Knowledge Centre for Rheumatology and Back Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-18
• Last Update Posted: 26 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
•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 < 90).
•Significant decreased liver function (liver enzymes > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified