Patients with axial spondyloarthritis and high disease activity treating with systemic glucocorticoids: a double-blinded randomised controlled trial

Phase 3

Conditions: axial spondylarthritis
Bechterew's disease
10023213

Registration Number: NL-OMON52017

Lead Sponsor: Franciscus Gasthuis & Vlietland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 38

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the change in ASDAS between baseline and week 6. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Addition:<br /><br>The primary endpoint is the change in ASDAS between baseline and week 3.<br /><br>Secondary endpoints are change in ASDAS between baseline and week 6 or week 12;<br /><br>number of patients achieving clinically relevant change, complete remission of<br /><br>low disease activity (respectively (ASDAS >=1.1, ASDAS <1.3, ASDAS <2.1)showing<br /><br>clinically important improvement (ASDAS >=1.1); change in CRP, BASDAI, BASFI,<br /><br>patient global assessment and NRS between baseline and week 3, 6 or 12. </p><br>