Comparing precision treatment to conventional treatment for Takayasu's arteritis
A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on Clinical-molecular Phenotypes with a Conventional Treatment Regimen in the Treatment of Patients with Active Takayasu's Arteritis
This study is testing if a personalized treatment plan for Takayasu's arteritis works better than standard treatment for people with this condition.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Drugs / interventions | rituximab, methotrexate, cyclophosphamide, prednisone |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06498089 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of a precision treatment regimen tailored to clinical-molecular phenotypes against a conventional treatment regimen for patients with active Takayasu's arteritis. Participants will be randomly assigned to either the precision therapy group or the conventional therapy group, with the study spanning 14 months, including a 6-month induction period followed by an 8-month maintenance period. The primary objective is to assess the efficacy of both treatment approaches after six months, while secondary objectives include evaluating relapse rates, safety, and changes in cytokine profiles. The trial will involve patients who meet specific criteria related to their condition and treatment history.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 who meet the classification criteria for aortitis and are experiencing active disease.
Not a fit: Patients with stable disease or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with Takayasu's arteritis.
How similar studies have performed: Other studies have shown promise in using precision medicine approaches for various conditions, suggesting potential success for this novel approach in Takayasu's arteritis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\) Meet the 2022 ACR/EULAR classification criteria for aortitis; 2) Women or men aged 18-65 years; 4) Be in active disease: a National Institutes of Health (NIH) score of ≥2; 5) Females with negative serum or urine pregnancy test results and no plans to have children during the clinical trial; (6) If the patient is taking prednisone or its equivalent, the pre-enrolment dose does not exceed 0.6 mg/kg/day and the dose has been stable for at least 4 weeks; 7) If the patient is receiving other medications for aortitis that are inconsistent with the assigned regimen, discontinuation is required for ≥4 weeks for methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, and tacrolimus; for leflunomide, discontinuation is required for 11 days if elimination methods are used (kolexanil or activated charcoal), or ≥8 weeks if elimination is not used; for cyclophosphamide, discontinuation is required for ≥6 months; for biologics, stopping for ≥ 3 weeks is required for etanercept, ≥ 4 weeks for IL-6 receptor antagonists and tumour necrosis factor inhibitors, and ≥ 6 months for rituximab. 8)For patients with no obvious active tuberculosis lesions but elevated T-spot, it is recommended that infectious specialists evaluate them, and preventive anti-tuberculosis therapy should be performed first if necessary. After T-spot declines, researchers will assess the relevant risks before deciding whether they are suitable to participate in this study, and continue preventive anti-tuberculosis therapy for a total of 9 months. 9)For patients with HBV, if the viral replication was detected, it is recommended to take anti-viral treatment for 2-4 weeks, and researchers will evaluate whether they are suitable to participate in this study when no DNA replication is detected. Exclusion Criteria: 1. Presence of organ failure; 2. undergoing haemodialysis or major surgery (grade III and above) within 3 months; 3. the presence of other autoimmune diseases; 4. severe, progressive organ damage; 5. Subjects with other comorbidities that may result in the need for additional moderate to high doses of glucocorticoids (prednisone ≥ 10 mg/day or equivalent doses of prednisone equivalents) during the study period; 6. Have a history of malignancy; 7. Have any serious acute or chronic infection, including hepatitis B surface antigen positive, active tuberculosis.
Where this trial is running
Shanghai, Shanghai Municipality
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xiufang Kong, PhD
- Email: kongxiufang2007@163.com
- Phone: +8618317070593
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.