Baricitinib in the Treatment of Intestinal Behçet's Syndrome
ConditionBehcet Syndrome, Intestinal Type
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking Union Medical College Hospital
About this trial
This study aims to conduct a randomized controlled trial to compare the efficacy and safety of Baricitinib and Adalimumab (ADA) in the treatment of refractory intestinal Behçet's Syndrome (BS). The objective is to demonstrate if Baricitinib is non-inferior to ADA in controlling BS inflammation, reducing BS recurrence， alleviating gastrointestinal symptoms and promoting intestinal mucosal healing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Patients have a DAIBD score ≥ 40 points or intestinal symptom score ≥ 3 points at baseline;
Endoscopic examination conducted within 60 days before inclusion suggests active intestinal ulcers;
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;
Disqualifiers
Diagnosis of other diseases such as Crohn's disease, ulcerative colitis, lymphoma, etc.;
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;
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;
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Baricitinib
DrugParticipants randomized to this arm will maintain their original steroids and/or immunomodulators, combined with Baricitinib 4 mg/day for 6 months.
Adalimumab
DrugParticipants randomized to this arm will maintain their original steroids and/or immunomodulators, combined with ADA (initially ADA 160 mg subcutaneous injection, followed by 80 mg ADA after 2 weeks, then 40 mg ADA every 2 weeks thereafter) for 6 months.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Baricitinib for IBSExperimental treatment 1 intervention
Group B: Adalimumab for IBSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients with marked improvement (MI) at week 24 of follow-up
Based on the combined assessment of gastrointestinal symptoms and endoscopy scores\[1\], gastrointestinal symptom scoring is defined as follows: 0 points, asymptomatic; 1 point, does not affect daily life; 2 points, mildly affects daily life; 3 points, moderately affects daily life; 4 points, severely affects daily life. Endoscopy scoring is defined as follows: 0 points, mucosal healing; 1 point, maximum ulcer ≤ original 1/4; 2 points, maximum ulcer between original 1/4 and 1/2; 3 points, maximum ulcer ≥ original 1/2 or enlargement. Marked improvement is defined as gastrointestinal symptom and endoscopy scores both ≤ 1. \[1\]Sugimura, N. et al. Real-world efficacy of adalimumab and infliximab for refractory intestinal Behçet's disease. Dig. Liver Dis. 51, 967-971 (2019).
Time frame
Baseline to week 24Secondary outcomes
1
Proportion of patients with CR (complete response) at week 24 of follow-up
CR is defined as both gastrointestinal symptoms and endoscopy scores being 0.
Time frame
Baseline to week 242
Proportion of patients with improvement of ≥1 point in gastrointestinal symptom scores compared to baseline at week 24 of follow-up
Time frame
Baseline to week 243
Changes in C-reactive protein (CRP) compared to baseline
The hs-CRP is acute phase reactants that are indicative of the patient's disease activity.
Time frame
Baseline to week 244
Changes in erythrocyte sedimentation rate (ESR) compared to baseline
The ESR is acute phase reactants that are indicative of the patient's disease activity.
Time frame
Baseline to week 24Sponsors and contacts
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Source ClinicalTrials.gov