MedDRA version: 16.0 Level: LLT Classification code 10042869 Term: Synovitis and tenosynovitis System Organ Class: 100000004859
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: Glucocorticoid
Other descriptive name: B
Sponsors
Knowledge Centre for Rheumatology and Back Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ultrasonic signs of treatment demanding tenosynovitis in flexor or extensor tendons in the hand (1st - 6th compatment) or flexor- , extensor-, or peroneus tendons in the ankle. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Lack of ability to understand the information given about the study. Recent operation in hands or feet. Start of Disease-modifying anti-rheumatic drugs (DMARDs) / biological treatment within the last 12 weeks Change of DMARD / biological or glucocorticoid treatment within the last 6 weeks. Allergy to betamethasone. Start of Non-Steroidal Anti-Inflammatory Drugs (NSAID) treatment within the last 10 days. 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 glucocorticoid injection in the synovial sheath has better effect than intramuscularly glucocorticoid injection among patients with tenosynovitis, assessed by US examination, pain VAS-score and clinical evaluation. ;Secondary Objective: Not applicable;Primary end point(s): Differences in the scoring of tenosynovitis evaluated by US, between treatment arm A and B (US-tenosynovitis scoring = 1 4 weeks after the injektion), assessed by the Mann-Whitney U test.;Timepoint(s) of evaluation of this end point: After the last visit of the last subject. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in the patient parameters (Clinical and US-sound assessment, as well as the participant’s own reporting and visual Analog Scale for tenosynovitis) assessed by Wilcoxon Pratt test after 2, 4 and 12 weeks. Correlation between findings (Clinical and US-sound assessment, as well as the participant’s own reporting and visual Analog Scale for tenosynovitis) , assessed by Spearman's correlation analysis after 2, 4 and 12 weeks. Differences in the scoring of tenosynovitis evaluated by US, between treatment arm A and B (US-tenosynovitis scoring = 1 12 weeks after the injektion), assessed by the Mann-Whitney U test. ;Timepoint(s) of evaluation of this end point: After the last visit of the last subject | — |
Countries
Denmark
Contacts
Public ContactMads Ammitzbøll Danielsen
Knowledge Centre for Rheumatology and Back Diseases
Outcome results
None listed