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

A Prospective, Controlled, Interventional Study to Evaluate the Efficacy and Safety of Tocilizumab in the Treatment of Idiopathic Retroperitoneal Fibrosis

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04762784

Enrollment

Registered

2021-02-21

Start date

2020-07-01

Completion date

2023-02-10

Last updated

2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Retroperitoneal Fibrosis

Keywords

idiopathic retroperitoneal fibrosis, Tocilizumab, Response

Brief 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.

Interventions

DRUGTocilizumab

Tocilizumab treatment: Tocilizumab infusion 8mg/Kg，Once per month for 3 months.

DRUGGlucocorticoids

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
remission	5 years	Remission is achieved when symptoms are alleviated and laboratory tests return to normal levels or radiologic improvement is observed.

Secondary

Measure	Time frame	Description
relapse	5 years	Participants have recurrence of symptoms and laboratory abnormalities.

Other

Measure	Time frame	Description
adverse events	5 years	Participants suffer from adverse events due to the drug treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026