Efficacy and Tolerance of Tocilizumab In Takayasu Arteritis

• Status: Completed
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

Summary

First-line tocilizumab treatment during 6 months could permit rapid steroid-tapering and induction of remission in Takayasu arteritis (TA).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Chugai Pharmaceutical

Criteria

Inclusion Criteria:

• Diagnosis of TA : ACR and /or Ishikawa modified Sharma criteria of TA

• Age of 18 years or older

• Willing to use an effective means of birth control throughout the study

Exclusion Criteria:

• Patients immunosuppressive treatment or biologics other than steroids 4 months before

• Evidence of active infection (including chronic infection)

• HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen

• History of any malignant neoplasm except adequately treated basal or squamous cell carcinoma of the skin or solid tumors treated with curative therapy and disease-free for at least 5 years

• Inability to provide informed consent

• Cytopenia, as defined by platelet count < 100 × 109/L (100,000/mm3), hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L), absolute neutrophil count < 2.0 × 109/L (2000/mm3), absolute lymphocyte count < 0.5 × 109/L (500/mm3)

• Insufficient liver function

• Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or creatinine clearance of 20 ml/min or less

• Positive tuberculin skin test and/or positive Quantiferon

• Radiographic evidence suggestive of tuberculosis

• Contraindication to and precaution in use of Tocilizumab according to the summary product description

• Pregnancy