1. Standardized reporting of occurrence of metabolic adverse events after treatment with glucocorticoid pulse therapy in chronic rheumatoid arthritis patients (who have exacerbation of disease).2. Determing if metabolic adverse events due to…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Metabolic disturbances
-Physical examination: weight, blood pressure
-Laboratory examination: fasting lab with a.o. an OGTT and lipid profile
Secondary outcome
Disease activity
-Interview:
oVisual Analogue Scale (VAS)-pain, VAS-well being
-Physical examination:
oTender joint score
oSwollen joint score
-Laboratory examination:
oFasting with a.o. ESR and hemoglobin
Cardiovascular risk factors
-Interview:
Smoking, alcohol use, diabetes (family history), lipid disorder, hypertension,
cardiovascular disease (family history, events), sports/activities (with
questionnaire Short QUestionnaire to ASses Health enhancing physical activity).
-Physical examination:
Waist- en hip circumference, ankle-arm index with Doppler machine.
Background summary
Since the discovery of glucocorticoids and their efficacy by Philip Hench in
1948, this medication is often used in rheumatoid arthritis. Nevertheless, the
balance between risks and benefits is unclear and the exact place for
glucocorticoids in treating rheumatoid arthritis unknown. Most of the adverse
events (risks) seem to be dose-dependant and are not a serious risk in
treatment with low-dose glucocorticoids (below or equal to 7.5 mg prednisone).
In high-dose therapy, such a pulse therapy, we see these adverse events more
often (for example: increase in blood pressure, glycosuria etc.). Nevertheless,
the occurrence of these adverse events is not clearly described until now.
Therefore, we want to study the occurrence of adverse events.
Study objective
1. Standardized reporting of occurrence of metabolic adverse events after
treatment with glucocorticoid pulse therapy in chronic rheumatoid arthritis
patients (who have exacerbation of disease).
2. Determing if metabolic adverse events due to glucocorticoid pulse therapy
are transient or persistent.
3. Investigate whether non-responders to glucocorticoid pulse therapy suffer
from less metabolic adverse events than responders.
Study design
-Longitudinal
-Monitoring: 3 research-visits of 2.5 hours (2 visitis during the hospital stay
(day 1 and 6) and one visit six weeks later.
Procedure:
-Patients are studied in fasting condition (therefore, the measurements are
performed in the morning). A 2-hours oral glucose tolerance test (OGTT) is
performed and blood will be taken for laboratory analyses. In total, 60 mL will
be drawn. Moreover, urine is collected. During the OGTT an interview will be
taken (partly with help of questionnaires) and physical examination will be
performed.
Study burden and risks
The study consists of three visits. Two times patients participate during their
hospital stay. A third time (six weeks later), they visit for the last
measurements. Patients are asked to remain fasting until blood is drawn.
There are no specific risks involved. A hematoma can develop at the location of
the vene used for blood drawing.
Postbus 85500
3508 GA Utrecht
Nederland
Postbus 85500
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Rheumatoid arthritis exacerbation, defined by Disease Activity Score of 5.1 or higher.
Exclusion criteria
Patients with diabetes
Patients with clinical contra-indication for pulse therapy
Patients with DMARD changes during the last month
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-017051-10-NL |
| Other | Na goedkeuring door de METC zal de studie worden geregistreerd in het trialregister. |
| CCMO | NL29727.041.09 |