The Effect and Safety of Tocilizumab Treatment on RPF

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05133895

Collaborator

(none)

Enrollment

Location

Arms

23.9

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective study to investigate the treatment response of Tocilizumab on patients with retroperitoneal fibrosis(RPF), with or without IgG4 elevation.

Methods: All the patients fulfill diagnostic criteria of retroperitoneal fibrosis with or without IgG4 elevation . The RPF patients will accept Tocilizumab or Glucocorticoid monotherapy for 3 months.

Endpoints: The primary endpoint is to investigate the response of Tocilizumab on RPF patients; the secondary endpoints include the decrease of inflammatory markers, side effect.

Condition or Disease	Intervention/Treatment	Phase
Retroperitoneal Fibrosis Tocilizumab Treatment	Drug: Tocilizumab treatment Drug: Prednisone Monotherapy	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective Study of Tocilizumab Treatment on Retroperitoneal Fibrosis

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tocilizumab treatment	Drug: Tocilizumab treatment Tocilizumab treatment: Tocilizumab infusion 8mg/Kg，once per month for longer than 3 months.
Active Comparator: Glucocorticoids monotherapy	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.

Arm

Intervention/Treatment

Experimental: Tocilizumab treatment

Drug: Tocilizumab treatment

Tocilizumab treatment: Tocilizumab infusion 8mg/Kg，once per month for longer than 3 months.

Active Comparator: Glucocorticoids monotherapy

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.

Outcome Measures

Primary Outcome Measures

Response rate at 3 months [Three months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female adults, ≥ 18 years of age at time of informed consent;
Written informed consent;
Diagnosed with retroperitoneal fibrosis, with or without Serum IgG4 elevation;
Higher level of ESR and CRP than normal;

Exclusion Criteria:

Combined with other connective tissue disease.
Known immunodeficiency disorder.
Active malignancy or history of malignancy that was active within the last 10 years.
Pregnancy, lactation, or planning to become pregnant within 6 months of the test.
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.
Evidence of active tuberculosis (TB), including Chest X-ray and PPD.
Severe abnormal liver function or cardiac insufficiency.
Any reason the investigator think that should not attend this trial.