Treatment of synovitis among rheumatoid arthritis patients MedDRA version: 21.0 Level: PT Classification code 10042868 Term: Synovitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Diprofos Depot
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BETAMETHASONE ACIBUTATE
CAS Number: 5534-05-4
Current Sponsor code: Glucococorticoid
Other descriptive name:
Sponsors
Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 12. The proportion of subjects in each group (A and B) achieving an acceptable response from the injected joint(s) (binary) at week 4 and 12 weeks. The proportion of subjects in each group (A and B) achieving clinical joint remission, defined as treated joints with no swollenness and painfulness, at week 4 and 12 weeks. Differences in the response of synovitis US scores, between treatment arm A and B, at week 4 and 12. Differences in the response of synovitis US scores ((grey scale, colour Doppler), between treatment arm A and B, at week 4 and 12. Differences in the response of patient reported Visuel Analog Skala (VAS) local joint pain, for treated joints, between treatment arm A and B, at week 4 and 12. ;Timepoint(s) of evaluation of this end point: After the last visit of the last subject | — |
Countries
Denmark
Contacts
Public ContactIndgang 5, stuen
Videncenter for Reumatologi og Rygsygdomme, Rigshospitalet
Outcome results
None listed