The Effect and Safety of Tocilizumab Treatment on IRPF

Overview

This is a prospective study to investigate the treatment response of Tocilizumab on patients with idiopathic retroperitoneal fibrosis(IRPF). Methods: All the patients fulfilling diagnostic criteria of IRPF would be enrolled. The IRPF patients will accept Tocilizumab or Glucocorticoid monotherapy for 3 months. Endpoints: The primary endpoint is to investigate the response of Tocilizumab on IRPF patients; the secondary endpoints include the decrease of inflammatory markers, side effect.

Full Title of Study: “A Prospective Study of Tocilizumab Treatment on Idiopathic Retroperitoneal Fibrosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 30, 2021

Interventions

  • Drug: Tocilizumab treatment
    • Tocilizumab treatment: Tocilizumab infusion 8mg/Kg,Once per month.
  • Drug: Prednisone Monotherapy
    • Prednisone/prednisolone: started at 0.6-0. 8mg/kg.d for 2 to 4 weeks, tapered at 5mg per 1-2 weeks to equal to or less than 15mg per day in 3 months.

Arms, Groups and Cohorts

  • Experimental: Tocilizumab treatment
  • Active Comparator: Glucocorticoids monotherapy

Clinical Trial Outcome Measures

Primary Measures

  • Response rate at 3 months
    • Time Frame: Three months

Participating in This Clinical Trial

Inclusion Criteria

1. Male or female adults, ≥ 18 years of age at time of informed consent; 2. Written informed consent; 3. Diagnosed with retroperitoneal fibrosis and normal level of Serum IgG4; 4. Higher level of ESR and CRP than normal; 5. Pathologic results show fibrosis and IgG4/IgG <50%. Exclusion Criteria:

1. Combined with other connective tissue disease. 2. Known immunodeficiency disorder. 3. Active malignancy or history of malignancy that was active within the last 10 years. 4. Pregnancy, lactation, or planning to become pregnant within 6 months of the test. 5. Positive test for, or prior treatment for, hepatitis B or HIV infection. A positive test for hepatitis B is detection of hepatitis B surface antigen (HBsAg) or HBV-DNA. 6. Evidence of active tuberculosis (TB), including Chest X-ray and PPD. 7. Severe abnormal liver function or cardiac insufficiency. 8. Any reason the investigator think that should not attend this trial.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking Union Medical College Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wen Zhang, Professor – Peking Union Medical College Hospital
  • Overall Contact(s)
    • Yunyun Fei, +8613681125226, feiyunyun2013@sina.com

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