Clinical Research Directory

Real-world Immunogenicity of Anti-IL5/5a Antibody

This study aims to evaluate the immunogenicity of the drug by measuring anti-drug antibody (ADA) formation and titers. The presence of ADAs will be assesses to determine their potential impact on the drug's efficacy and safety.

Quantify the Value of Transmural Inflammation in the Treatment of Crohn's Disease With Ustekinumab:an Analysis Based on Imaging Science

Crohn's disease(CD),a type of inflammatory bowel disease(IBD), is a chronic intestinal recurrent inflammatory disease involving the entire digestive tract. And Ustekinumab, a monoclonal antibody against the p40 subunit of interleukin-12 and interleukin-23, is a newly targeted drug approved for the treatment of Crohn's disease in recent years.Based on the high-throughput imaging characteristic analysis technique, this study quantitatively analyzed the transmural inflammation of Crohn's disease, and discussed its prognostic value in the treatment of Ustekinumab, and further analyzed the increment of its relative clinical index.

Efficacy of Mesalazine Combined With Biologics in the Treatment of Moderate to Severe Ulcerative Colitis

Endocopic remission rates of moderate to severe ulcerative colitis are low. Biologics including Vedolizumab, infliximab, and adalimumab are effective in induction and maintainence of ulcerative colitis. The role of 5-ASA in promoting a higher rate of endocsopic remission is unclear. We aim to evaluate the efficacy of combination of 5-ASA and biologics in treating ulcerative colitis.

A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA

To evaluate the efficacy and safety of biological agents in patients with allergic bronchopulmonary aspergillosis.

A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)

The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.

Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD

This is a prospective, multicenter, observational cohort study, which plans to enroll patients with active IBD who are scheduled to initiate IFX or VDZ treatment between October 2025 and October 2027 at Xijing Hospital, Tang-du Hospital, and Air Force 986 Hospital. All patients will undergo HRV monitoring at baseline, Week 2, Week 6, and Week 14. The HRV monitoring results will be blinded to both physicians and patients. Based on the efficacy assessment at Week 14, patients will be divided into response and non-response groups for comparison, to analyze the strength of association between baseline HRV parameters and the achievement of clinical response. The study plans to enroll 100 IBD patients, with 50 in the IFX treatment group and 50 in the VDZ treatment group.

A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers

The inclusion criteria for this study were patients aged 18 to 75 years with a confirmed diagnosis of psoriasis by a dermatologist or psoriatic arthritis by a rheumatologist. Patients with active infections or suspected malignancies were excluded. A total of 40 patients with psoriasis, with or without psoriatic arthritis, were enrolled from multiple centers in Taiwan. All participants were recruited from the outpatient clinics of either the Department of Allergy, Immunology, and Rheumatology or the Department of Dermatology in tertiary hospitals across Taiwan. Participants were randomly assigned to one of two groups: Prescreen Strategy-Based Biologics Selection Group Standard-Based Biologics Selection Group Patients will be followed up at weeks 4, 8, 12, 24, 32, 40, 48, 56, 64, and 72. Follow-up may be extended up to 3 years if necessary. Clinical assessments will include: Primary endpoints: PASI (Psoriasis Area and Severity Index), painful joint count, swollen joint count, and DAPSA (Disease Activity in Psoriatic Arthritis) score. Secondary endpoints: DLQI (Dermatology Life Quality Index), BSA (Body Surface Area), pruritus score, and internal carotid artery thickness measured at 6 months, 1 year, and 2 years.