Using Baricitinib to treat intestinal Behçet's Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is a randomized controlled trial comparing the efficacy and safety of Baricitinib and Adalimumab in patients with refractory intestinal Behçet's Syndrome. The goal is to determine if Baricitinib is non-inferior to Adalimumab in controlling inflammation, reducing recurrence, alleviating gastrointestinal symptoms, and promoting intestinal mucosal healing. The trial will utilize both intention-to-treat and per-protocol analyses to assess outcomes, with a focus on establishing non-inferiority first and then superiority if applicable.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Refer to the consensus on the diagnosis and treatment of intestinal Behçet's syndrome in China: Patients who meet the 2013 International Criteria for Behçet's Disease (ICBD) and have typical Behçet's syndrome-related intestinal ulcers confirmed by colonoscopy, or patients diagnosed according to the criteria for Behçet's syndrome established by the Korean Behçet's Disease Collaborative Group in 2009;
2. Patients have a DAIBD score ≥ 40 points or intestinal symptom score ≥ 3 points at baseline;
3. Endoscopic examination conducted within 60 days before inclusion suggests active intestinal ulcers;
4. Patients who have been treated with medium to high-dose steroids (prednisolone equivalent of 0.5-1 mg/kg/day) for more than 1 month continuously, or any immunomodulator/Immunosuppressants for more than 3 months regularly or biologics for more than 2 months, as judged by the doctor to be treatment failure or intolerance;
5. Currently steroid dose ≤ 30 mg prednisolone equivalent, stabilized for ≥ 2 weeks, and/or stabilized immunomodulator dose for ≥ 4 weeks;
6. Understanding the research process, voluntary participation, and signing of informed consent.

Exclusion Criteria:

1. Diagnosis of other diseases such as Crohn's disease, ulcerative colitis, lymphoma, etc.;
2. Other active organ damage related to BS requires intensified immunosuppressive therapy, including aneurysms, uveitis, and substantial involvement of the central nervous system; skin lesions and joint involvement can be included;
3. Severe organ dysfunction including ALT, AST, TBIL levels exceeding twice the upper limit of normal, creatinine levels exceeding 1.5 times the upper limit of normal, white blood cell count \< 3×10\^9/L, ANC \< 2×10\^9/L, hemoglobin \< 80g/L, platelets \< 100×10\^9/L;
4. Active infections such as active tuberculosis, active hepatitis B or C, syphilis, chronic Epstein-Barr virus infection, HIV infection, sustained or severe bacterial or viral infections, and history of severe herpes zoster;
5. Patients with latent tuberculosis must undergo ≥3 weeks of prophylactic anti-tuberculosis treatment before inclusion;
6. Primary immunodeficiency disease;
7. History of cancer, or endoscopic intestinal histopathology indicating intraepithelial neoplasia or malignancy, or presence of other malignancies;
8. Patients who did not respond to infliximab treatment for primary refractory BS (patients with secondary failure, intolerance, or allergy to infliximab should be included);
9. Patients treated with biologics/small molecule targeting therapies within 5 half-lives (including use of tofacitinib within 10 days, etanercept within 4 weeks, infliximab within 8 weeks, golimumab, certolizumab, abatacept, and tocilizumab within 10 weeks, ustekinumab within 6 months);
10. Patients with prior use of baricitinib or ADA;
11. Complications of intestinal BS such as symptomatic stenosis, short bowel syndrome, intestinal fistula, or suspected intra-abdominal abscess; potential need for surgery or situations not conducive to DAIBD and efficacy assessment; any form of intestinal resection or other abdominal surgery within 6 months before baseline; presence of a functioning (i.e., patent) stoma or ostomy;
12. Patients requiring parenteral nutrition due to disease severity;
13. Pregnant, lactating, or planning pregnancy soon;
14. Patients unwilling or unable to comply with regular visits;
15. History of severe thrombotic events or chronic cardiovascular events.

Where it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Jinjing Liu, M.D.
• Email: pumch_followup@126.com
• Phone: 86-10-69151188

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.