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

Patients with axial spondyloarthritis and high disease activity treating with systemic glucocorticoids: a double-blinded randomised controlled trial - Intramuscular glucocorticoid for axial spondylarthritis (SPADE study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52017

Enrollment

Registered

2021-11-18

Start date

2023-01-01

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

axial spondylarthritis Bechterew's disease

Interventions

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. th

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria: Starting or switching a biological

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the change in ASDAS between baseline and week 6.	—

Secondary

Measure	Time frame
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 =1.1); change in CRP, BASDAI, BASFI, patient global assessment and NRS between baseline and week 3, 6 or 12.	—

Measure

Time frame

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 =1.1); change in CRP, BASDAI, BASFI, patient global assessment and NRS between baseline and week 3, 6 or 12.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)