To investigate the potential role of systemic glucocorticoids in patient with axial spondylarthritis with high disease activity.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the change in ASDAS between baseline and week 6.
Secondary outcome
Addition:
The primary endpoint is the change in ASDAS between baseline and week 3.
Secondary endpoints are change in ASDAS between baseline and week 6 or week 12;
number of patients achieving clinically relevant change, complete remission of
low disease activity (respectively (*ASDAS >=1.1, ASDAS <1.3, ASDAS <2.1)showing
clinically important improvement (*ASDAS >=1.1); change in CRP, BASDAI, BASFI,
patient global assessment and NRS between baseline and week 3, 6 or 12.
Background summary
The use of systemic glucocorticoids with axial spondylarthritis is discouraged
in the ASAS-EULAR recommendations. However, new data suggesting a potential
role for systemic glucocorticoid for patient with axial spondylarthritis.
Study objective
To investigate the potential role of systemic glucocorticoids in patient with
axial spondylarthritis with high disease activity.
Study design
This will be a double-blinded, randomized controlled study in the outpatients
clinics of Franciscus Gasthuis & Vlietland Group. Patients willing to
participate will be randomised into two groups, receiving either corticosteroid
of placebo intramuscular injection. Comparisons in disease activity scores will
be made between the two groups at baseline, week 3, week 6 and week 12.
Intervention
The intervention group will receive a single intramuscular dose of
methylprednisolone 120mg. The control group will receive a single intramuscular
dose of isotonic saline in the same volume, i.e. three millilitres.
Study burden and risks
In daily practice rheumatologists sometimes already use systemic
glucocorticoids for patients with axial spondylarthritis with high disease
activity. Few risks are to be expected because of the single administration and
the low dosage of methylprednisolone. One hospital visit for injection, two
extra blood samples and four telephonic evaluations are needed.
Kleiweg 500
Rotterdam 3045PM
NL
Kleiweg 500
Rotterdam 3045PM
NL
Listed location countries
Age
Inclusion criteria
Meeting the ASAS classification criteria for axial spondylarthritis
Age 18-64 years
ASDAS >=2.1
Failure of standard treatment, meaning
- taking two different NSAIDs in maximum dosage over 4 weeks in total; or
- use of the same biological for at least 12 weeks
Ability to independently answer Dutch questionnaires
Given informed consent
Exclusion criteria
Starting or switching a biological <12 weeks ago
Concomitant disease that requires treatment with systemic GC (e.g. malignancy,
chronic obstructive pulmonary disease)
Absolute contra-indications for corticosteroids (e.g. systemic infection,
peptic ulcer disease)
Allergy to corticosteroids
Diabetes mellitus
Pregnancy or lactating female
Cognitive impairment
Participation in other medical trial
Language barrier
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 | EUCTR2021-001638-20-NL |
| CCMO | NL76576.041.21 |