Patients with rheumatoid arthritis and synovitis treated with ultrasound guided intraarticular or intramuscular glucocorticoid injection - A randomised, double-blind, controlled study (Panguian)

Phase 1

• Conditions: Treatment of synovitis among rheumatoid arthritis patients; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; MedDRA version: 21.0Level: PTClassification code 10042868Term: SynovitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2017-003425-15-DK
• Lead Sponsor: Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-12
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Treatment demanding synovitis in up to 4 joints, defined as clinical assessed swollen joint and US grey scale og Doppler score =1, in following joints: interphalangeal(IP)-, proximal interphalangeal (PIP)-, metacarpophalangeal(MCP)-, wrist- (radiocarpal-intercarpal and/or ulnacarpal), ankle- and metatarsophalangeal(MTP).

Rheumatoid arthritis according to ACR/EULAR 2010 criteria

Above 18 years of age

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 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Start of Disease-modifying anti-rheumatic drugs (DMARDs) / biological treatment within the last 12 weeks
Change of DMARDs treatment within the last 6 weeks.
Change of glucocorticoid treatment within the last 6 weeks.
Start of Non-Steroidal Anti-Inflammatory Drugs (NSAID) treatment within the last 10 days.
Chronic synovitis in the same IP-, PIP-, MCP-, wrist-, ankle- and MTP 2-5 joints, is defined as either severe destructive erosions, assessed by previously x-rays or persistent synovitis (6 months) despite >1 local joint injection with glucocorticoid according to DANBIO or journal registrations.
Treatment demanding synovitis in more than 4 joints, defined as clinical assessed swollen using a 44 joint assessment.
Lack of ability to understand the information given about the study.
Recent operation in hands or feet (12 month).
Allergy to betamethasone.
Systemic fungal infection
Positive urine HCG among women in the age of fertility.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Explore whether ultrasound-guided intra-articular glucocorticoid injection in the joint has better effect than intramuscularly glucocorticoid injection among patients with synovitis, assessed by US examination, clinical evaluation and patients reported outcomes<br>;Secondary Objective: Not applicable;Primary end point(s): The primary outcome was the proportion of subjects in each group (A and B) achieving US synovitis remission, defined as US synovitis GS score = 1 and Doppler score = 0, at week 4. ;Timepoint(s) of evaluation of this end point: After the last visit of the last subject