Metabolic adverse events before and after glucocorticoid pulse therapy in rheumatoid arthritis
- Conditions
- Patients with rheumatoid arthritis, who suffer from a exacerbation of disease can be included in this study. Exacerbation is defined as a Disease Activity Score of 5.1 or higher.Patients will be excluded if they suffer from diabetes (irrespective of medication) or if they have a contra-indication for dexamethason use.MedDRA version: 12.0Level: LLTClassification code 10060732Term: Rheumatoid arthritis flare up
- Registration Number
- EUCTR2009-017051-10-NL
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Rheumatoid arthritis exacerbation, defined by Disease Activity Score of 5.1 or higher.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-Clinical contra-indication for glucocorticoid pulse therapy.
-Pre-existent diabetes (irrespective of medication).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Standardized reporting of occurrence of metabolic adverse events after treatment with glucocorticoid pulse therapy in chronic rheumatoid arthritis patients (who have exacerbation of disease).;Secondary Objective: -Determing if adverse events due to glucocorticoid pulse therapy are transient or persistent.<br>-Investigate whether non-responders to glucocorticoid pulse therapy suffer from less metabolic adverse events than responders.;Primary end point(s): Metabolic disturbances<br>-Physical examination: weight, blood pressure<br>-Laboratory examination: fasting lab with a.o. an Oral Glucose Tolerance Test and lipid profile.
- Secondary Outcome Measures
Name Time Method