NCT04300686 A Pilot Study in Severe Patients With Takayasu Arteritis.
| NCT ID | NCT04300686 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Takayasu Arteritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2020-03-01 |
| Primary Completion | 2022-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2020-03-01 with a primary completion date of 2022-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. We classify TAK patients into 3 levels, including mild, moderate, and severe. And the biological agents tocilizumab and adalimumab are randomly prescribed in severe patients, to find out the relatively better treatment strategy, facilitating better intervention strategy in severe TAK patients.
Eligibility Criteria
Inclusion Criteria: 1. age≥14 years old; 2. active: Kerr score≥ 2; 3. severe: 1. Blood pressure \> 180/110mmHg; 2. ≥ 3 branches with the stenotic rate \> 70% involved; 3. high degree of organ insufficiency: NYHF III\~IV; eGFR (MRDR) 15\~ 60ml/min; Exclusion Criteria: 1. Severe organ insufficiency; 2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.; 3. Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease; 4. malignant tumors; 5. history of severe drug allergy; 6. successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients)
Contact & Investigator
Lindi Jiang, PhD
STUDY CHAIR
Fudan University
Frequently Asked Questions
Who can join the NCT04300686 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 100 Years, studying Takayasu Arteritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04300686 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04300686 currently recruiting?
Yes, NCT04300686 is actively recruiting participants. Contact the research team at chenry825@hotmail.com for enrollment information.
Where is the NCT04300686 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04300686 clinical trial?
NCT04300686 is sponsored by Shanghai Zhongshan Hospital. The principal investigator is Lindi Jiang, PhD at Fudan University. The trial plans to enroll 40 participants.