Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
SponsorNovartis Pharmaceuticals

About this trial

This is an observational study to evaluate the effectiveness and safety of secukinumab in participants with AS who have never used TNFi, JAKi, or IL-17i drugs before.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects diagnosed with ankylosing spondylitis (AS), as defined by the modified 1984 New York criteria

Subjects who have symptoms of active disease at screening and baseline, as evidenced by BASDAI score of ≥ 4

Subjects who have never used TNFi, JAKi, or IL-17i drugs before

Patients suitable for secukinumab treatment within the scope of labeling by the Ministry of Food and Drug Safety

Disqualifiers

Subjects who are in a medical or psychological condition which may prevent them from participating in the study for the study period(28±4 weeks)

Subjects who have congenital/traumatic spinal deformities

Subjects currently enrolled in other clinical studies

Subjects who have any contraindications to secukinumab treatment

Trial population

The subjects are biologic-naive AS patients who are \<40 years old and have a time of less than 5 years since AS diagnosis.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Secukinumab

    Drug

    This is a prospective observational study. There is no treatment allocation. The decision to initiate treatment will be based solely on clinical judgement.

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: group 11 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

The BASDAI consists of 6 questions to measure the participant's symptoms and disease activity, and each question is evaluated using a numeric rating scale from 0 to 10 or a 10 cm Visual Analog Scale (VAS) with 0 being no problem and 10 being the worst problem

Time frame
Baseline and 28 weeks

Secondary outcomes

1

Change from baseline in C-Reactive Protein (CRP)

CRP is a blood test that indicates levels of inflammation * CRP\< 5mg/L: Normal * CRP\>=5 mg/L: High

Time frame
Baseline, 16 and 28 weeks
2

Change from baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS-CRP

ASDAS-CRP is the score for participant's evaluation of low back pain, peripheral pain/swelling, duration of morning stiffness, disease activity, and the disease activity score of ankylosing spondylitis calculated from CRP levels. Ranges for Disease activity status are defined as follows: * Disease activity status \<1.3: Inactive disease * Disease activity status 1.3-2.1: Low disease activity * Disease activity status 2.1-3.5: High disease activity * Disease activity status \>3.5 (No maximum limit): Very high disease activity

Time frame
Baseline, 16 and 28 week
3

Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) stratified by specific variables

The BASDAI consists of 6 questions to measure the participant's symptoms and disease activity, and each question is evaluated using a numeric rating scale from 0 to 10 or a 10 cm Visual Analog Scale (VAS) with 0 being no problem and 10 being the worst problem. Stratified by different baseline variables

Time frame
Baseline, 16 and 28 weeks
4

Adverse events and Serious Adverse events

Incidence of Adverse events and Serious Adverse events

Time frame
From baseline up to 28 weeks

Other outcomes

Sponsors and contacts

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