A Prospective Study of Tocilizumab in the Treatment of Idiopathic Retroperitoneal Fibrosis

• Status: Recruiting
• Trial end date: 2023-02-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Glucocorticoids

Criteria

Inclusion Criteria:

• age 18-75 diagnosed as IRPF: The diagnosis of idiopathic retroperitoneal fibrosis is based on the following aspects :(1) the swelling of retroperitoneal tissue , which seems neoplastic; (2) A large number of lymphocytes proliferated and infiltrated in the affected tissues and organs, and tissues showed inflammation, fibrosis and sclerosis, in which IgG4-positive cells accounted for less than 50% of plasma cells; (3) Increased inflammatory markers, such as ESR and CRP; (4) Good response to glucocorticoid therapy.

Exclusion Criteria:

• malignancy retroperitoneal fibrosis secondary to other diseases or drug treatment or abdominal surgeries.