EUCTR2017-003425-15-DK
Active, Not Recruiting
Phase 1
Patients with rheumatoid arthritis and synovitis treated with ultrasound guided intraarticular or intramuscular glucocorticoid injection - A randomised, double-blind, controlled study (Panguian)
Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet0 sites100 target enrollmentSeptember 12, 2017
ConditionsTreatment of synovitis among rheumatoid arthritis patientsMedDRA version: 21.0Level: PTClassification code 10042868Term: SynovitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsDiprofos Depot
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Treatment of synovitis among rheumatoid arthritis patients
- Sponsor
- Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet
- Enrollment
- 100
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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