A Pilot Study in Severe Patients With Takayasu Arteritis.

NCT04300686 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: TACTIC-SS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Takayasu Arteritis; Tocilizumab; Adalimumab; Treatment

Keywords

Takayasu Arteritis; Tocilizumab; Adalimumab; treatment

Outcome Measures

Primary Outcomes (1)

• Disease remission at 24 weeks.

  comparison of clinical remission rate between adalimumab and tocilizumab groups at the end of 24th week follow-up;

  24 weeks

Secondary Outcomes (7)

• Disease remission at 48 weeks.

  48 weeks

• Prednisone dose reduction at endpoint

  24 weeks and 48 weeks.

• disease relapse in the follow-up

  At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.

• Vascular progression in angiographic examination at 6 months and 12 months.

  24 weeks and 48 weeks.

• Change of the quality of life with questionnaire SF-36

  At the time point of 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 36 weeks, 48 weeks.

Study Arms (2)

Tocilizumab

ACTIVE COMPARATOR

This group of 20 TAK cases are prescribed with tocilizumab (Dose: 8mg/kg. qm. ivgtt.) for 24 weeks.

Biological: Tocilizumab

Adalimumab

EXPERIMENTAL

This group of 20 TAK cases are prescribed with adalimumab (Dose: 40mg.bim.IH.) for 24 weeks.

Biological: Adalimumab

Interventions

Tocilizumab BIOLOGICAL

The tocilizumab group is prescribed with tocilizumab (8mg/kg.qm.ivgtt.) for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint). After 24 weeks of treatment, if the disease is alleviated (remission), then the usage of tocilizumab is maintained for another 24 weeks, otherwise (resistant), patients would be given adalimumab (40mg.bim.IH.) for 24 weeks instead.

Also known as: IL-6R alpha antibody

Tocilizumab

Adalimumab BIOLOGICAL

The adalimumab group is prescribed with adalimumab (40mg.bim.IH) for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint). After 24 weeks of treatment, if the disease is alleviated (remission), then the usage of adalimumab would be maintained for another 24 weeks, otherwise (resistant), patients would be given tocilizumab (8mg/kg.qm.ivgtt.) for 24 weeks instead.

Also known as: TNF-alpha antibody

Adalimumab

Eligibility Criteria

• Age: 14 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Severe organ insufficiency;
• Acute or chronic active infections including tuberculosis, hepatitis virus, etc.;
• Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease;
• malignant tumors;
• history of severe drug allergy;
• successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients)

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Department of Rheumatology in Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• Wang J, Kong X, Ma L, Ding Z, Chen H, Chen R, Jin X, Chen C, Lin J, Jiang L. Treatment efficacy and safety of adalimumab versus tocilizumab in patients with active and severe Takayasu arteritis: an open-label study. Rheumatology (Oxford). 2024 May 2;63(5):1359-1367. doi: 10.1093/rheumatology/kead387.

  PMID: 37540159 DERIVED

MeSH Terms

Conditions

Takayasu Arteritis

Interventions

tocilizumab; Adalimumab

Condition Hierarchy (Ancestors)

Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lindi Jiang, PhD

  Fudan University

  STUDY CHAIR

Central Study Contacts

Rongyi Chen, PhD

CONTACT

+8615221160538; chenry825@hotmail.com

Lili Ma, PhD

CONTACT

+8615221160538; zsh-rheum@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None. Open-label.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Severe TAK patients were divided into two groups, with 20 cases for each group at the randomized ratio 1:1, prescribed with adalimumab (40mg.bim.IH) and tocilizumab (8mg/kg.qm.ivgtt) respectively, in the presence of prednisone. After the 24 weeks of treatment, the disease remission is evaluated (primary endpoint). If the disease activity is alleviated (remission), the strategy would be maintained for another 24weeks, otherwise (resistant), the treatment strategy would be shifted to the opposite for 24weeks. After 48 weeks, the disease remission would be evaluated once again (secondary endpoint).

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: March 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: December 31, 2023
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)