Effect of Tofacitinib in Treating ANCA-associated Vasculitis

NCT04973033 | Completed

• 1 other identifier: TofAV
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the efficacy and safety of tofacitinib 5 mg twice daily in AAV patients.

Conditions

ANCA Associated Vasculitis; Drug Use; JAK-STAT Pathway Deregulation

Keywords

ANCA associated vasculitis; tofacitinib; safety; efficacy

Outcome Measures

Primary Outcomes (1)

• The response rate (CR, PR and TR)

  The percent of patients who achieved disease response. The disease response includes:(1) complete remission (CR), defined as the absence of disease activity (BVAS = 0); (2) partial remission (PR) defined as at least 50% reduction of BVAS and no new manifestations; (3) treatment resistance (TR) was defined as less than a 50% reduction or increased disease activity after 4 \~ 6 weeks of treatment.

  From the enrollment to the end of follow-up [0 to 13 months.]

Secondary Outcomes (4)

• The rate of adverse event

  From the enrollment to the end of follow-up [0 to 13 months].

• Changes in erythrocyte sedimentation rate (ESR)

  From the enrollment to the end of follow-up [0 to 13 months].

• Changes in CRP

  From the enrollment to the end of follow-up [0 to 13 months].

• Changes in glucocorticoids steroids (GCs) dosage

  From the enrollment to the end of follow-up [0 to 13 months].

Study Arms (1)

Tofactitinib

EXPERIMENTAL

Tofacitinib 5mg twice a day

Drug: Tofacitinib

Interventions

Tofacitinib DRUG

patients enrolled were prescribed tofacitinib 5mg twice a day orally.

Also known as: Tofacitinib 5mg.bid.po.

Tofactitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with active AAV met the criteria of 1990 ACR and 2012 Chapel Hill criteria
• Age 18 to 75 years
• Written informed consent obtained before taking part in the study

You may not qualify if:

• Severe AAV defined as potentially organ- or life-threatening disease (i.e. alveolar haemorrhage, heart failure caused by myocarditis or pericarditis, progressive neurological symptoms, deaf, blindness, et al.)
• Serum creatinine\>120umol/L or proteinuria\>1.0g/d
• Receipt of a JAKi therapy previously
• Co-existence of another systemic autoimmune disease
• Secondary vasculitis (following neoplastic disease, an infection or antithyroid drugs)
• Malignancy or history of malignancy
• Infection by HIV, HCV, HBV or tuberculosis-
• Severe uncontrolled cardiovascular, pulmonary, liver, gastrointestinal, endocrine, hematological, neurological, or psychiatric diseases that are not related to systemic vasculitis
• Allergic to JAKi
• Blood dyscrasias including confirmed: Hemoglobin \<9 g/dL or Hematocrit \<30%; White blood cell count \<3.0 x 109/L; Absolute neutrophil count \<1.5 x 109/L; Platelet count \<100 x 109/L; Alanine transaminase or aspartate aminotransferase or total bilirubin\>1.5 upper normal limit; Estimated glomerular filtration rate\<60ml/min/1.73m2
• Incapacity or refusal to understand or sign the informed consent form.
• Pregnancy, breastfeeding.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Department of Rheumatology in Zhongshan hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lindi Jiang, PhD

  Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 22, 2021
• Study Start: December 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

CN (1)