A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA Cohort
Who is this study for? Patients with Takayasu Arteritis
What treatments are being studied? Adalimumab
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 100
Healthy Volunteers: f
View:
⁃ age≥14 years old;
⁃ active: Kerr score≥ 2;
⁃ severe:
∙ Blood pressure \> 180/110mmHg;
‣ ≥ 3 branches with the stenotic rate \> 70% involved;
‣ high degree of organ insufficiency: NYHF III\
• IV; eGFR (MRDR) 15\
• 60ml/min;
Locations
Other Locations
China
Department of Rheumatology in Zhongshan hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Rongyi Chen, PhD
chenry825@hotmail.com
+8615221160538
Backup
Lili Ma, PhD
zsh-rheum@hotmail.com
+8615221160538
Time Frame
Start Date: 2020-03-01
Estimated Completion Date: 2023-12-31
Participants
Target number of participants: 40
Treatments
Active_comparator: Tocilizumab
This group of 20 TAK cases are prescribed with tocilizumab (Dose: 8mg/kg. qm. ivgtt.) for 24 weeks.
Experimental: Adalimumab
This group of 20 TAK cases are prescribed with adalimumab (Dose: 40mg.bim.IH.) for 24 weeks.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital