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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 14 March 2016
Main ID:  EUCTR2013-003486-34-DK
Date of registration: 04/11/2013
Prospective Registration: Yes
Primary sponsor: Knowledge Centre for Rheumatology and Back Diseases
Public title: Treatment of Tenosynovitis among rheumatoid arthritis patients
Scientific title: Systemic versus ultrasound-guided local glucocorticoid treatment, among rheumatoid arthritis patients with tenosynovitis - a randomized double blind study - SULTAN
Date of first enrolment: 04/11/2013
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003486-34
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: CS inj. in the synovial sheath and NaCL Solvens IM vs CS IM and NaCL Solvens inj.in synovial sheath Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Denmark
Contacts
Name: Mads Ammitzbøll Danielsen   
Address:  Nordre Ringvej 57 2600 Glostrup Denmark
Telephone:
Email: mads.ammitzboell.danielsen@regionh.dk
Affiliation:  Knowledge Centre for Rheumatology and Back Diseases
Name: Mads Ammitzbøll Danielsen   
Address:  Nordre Ringvej 57 2600 Glostrup Denmark
Telephone:
Email: mads.ammitzboell.danielsen@regionh.dk
Affiliation:  Knowledge Centre for Rheumatology and Back Diseases
Key inclusion & exclusion 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:
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.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied

MedDRA version: 16.0 Level: LLT Classification code 10042869 Term: Synovitis and tenosynovitis System Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Intervention(s)

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: Binyrebarkhormon
Concentration unit: mg/l milligram(s)/litre
Concentration type: range
Concentration number: 3,5-14

Trade Name: Natriumklorid 9mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SODIUM CHLORIDE
Current Sponsor code: Natriumklorid
Other descriptive name: SODIUM CHLORIDE
Concentration unit: mg/l milligram(s)/litre
Concentration type: range
Concentration number: 4,5-18

Primary Outcome(s)
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.
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.
Secondary Objective: Not applicable
Timepoint(s) of evaluation of this end point: After the last visit of the last subject.
Secondary Outcome(s)
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
Secondary ID(s)
39132
Source(s) of Monetary Support
Knowledge Centre for Rheumatology and Back Diseases, Glostrup
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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