Comparative Study of Gastrointestinal Safety Between IL-17 and TNF Inhibitors in Patients with Ankylosing Spondylitis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0011960

Enrollment

Registered

2026-05-11

Start date

2026-07-31

Completion date

Unknown

Last updated

2026-05-18

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

Conditions

None listed

Interventions

Drug : 1. TNF inhibitor (Yuflyma Pen) (1) Ingredient: Adalimumab (2) Appearance: A colorless to pale brown, clear to slightly opalescent solution, contained in a pre-filled syringe mounted inside a co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 19–79 years with active AS (diagnosed by Modified New York Criteria, MRI, or bone SPECT) who are starting treatment with IL-17 or TNF inhibitors

Exclusion criteria

Exclusion criteria: 1. Patients with a known history of Inflammatory Bowel Disease. 2. Patients with a history of or current gastrointestinal adverse events. 3. Patients with fecal calprotectin levels exceeding 250 µg/g at screening. 4. Patients diagnosed with Inflammatory Bowel Disease during screening endoscopy. 5. Patients aged under 19 years or 80 years and older. 6. Women who are pregnant or breastfeeding.

Design outcomes

Primary

Measure	Time frame
Incidence of gastrointestinal symptoms (abdominal pain, diarrhea, hematochezia, etc.)	—

Secondary

Measure	Time frame
Identification of endoscopic findings and histological (microstructural) abnormalities; Incidence of endoscopic findings (inflammation, ulcers, mucosal damage, etc.) via colonoscopy (or sigmoidoscopy);Fecal calprotectin levels	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Eun Kim

Asan Medical Center

tph00066@naver.com+82-2-3010-0263

Outcome results