Effects of IL-23 inhibition in patients with very early axial spondyloarthritis – evidence for a true disease modification?

Conditions

AXIAL SPONDYLOARTHRITIS

Brief summary

Proportion of patients in low disease activity, defined as ASDAS status of <2.1 after 28 weeks of treatment (primary endpoint), assessed 4 weeks after the last injection (week 32 of the study), Proportion of patients who stay in low disease activity for at least 6 months after treatment withdrawal

Detailed description

Improvement of patient´s global assessment after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study), Proportion of patients in inactive disease, defined as ASDAS status of <1.3 at week 32 and at week 56, Improvement in MRI-related inflammatory lesions (quantified by Berlin score for spine and sacroiliac joints) at week 32 and week 56, Proportion of patients with good overall clinical function (ASAS Health Index (HI) ≤ 5) at week 32 and at week 56, Proportion of patients with a major clinical response, defined as a 50% improvement of the initial BASDAI (BASDAI 50) after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study), Change from baseline in BASMI and BASFI after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study)

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Interventions

DRUGSkyrizi 150 mg solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Proportion of patients in low disease activity, defined as ASDAS status of <2.1 after 28 weeks of treatment (primary endpoint), assessed 4 weeks after the last injection (week 32 of the study), Proportion of patients who stay in low disease activity for at least 6 months after treatment withdrawal	—

Secondary

Measure	Time frame
Improvement of patient´s global assessment after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study), Proportion of patients in inactive disease, defined as ASDAS status of <1.3 at week 32 and at week 56, Improvement in MRI-related inflammatory lesions (quantified by Berlin score for spine and sacroiliac joints) at week 32 and week 56, Proportion of patients with good overall clinical function (ASAS Health Index (HI) ≤ 5) at week 32 and at week 56, Proportion of patients with a major clinical response, defined as a 50% improvement of the initial BASDAI (BASDAI 50) after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study), Change from baseline in BASMI and BASFI after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study)	—

Measure

Time frame

Improvement of patient´s global assessment after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study), Proportion of patients in inactive disease, defined as ASDAS status of <1.3 at week 32 and at week 56, Improvement in MRI-related inflammatory lesions (quantified by Berlin score for spine and sacroiliac joints) at week 32 and week 56, Proportion of patients with good overall clinical function (ASAS Health Index (HI) ≤ 5) at week 32 and at week 56, Proportion of patients with a major clinical response, defined as a 50% improvement of the initial BASDAI (BASDAI 50) after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study), Change from baseline in BASMI and BASFI after 28 weeks of treatment, assessed 4 weeks after the last injection (week 32 of the study)

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Countries

Germany

Outcome results

None listed