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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04762784
Collaborator
(none)
40
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Controlled, Interventional Study to Evaluate the Efficacy and Safety of Tocilizumab in the Treatment of Idiopathic Retroperitoneal Fibrosis
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Feb 10, 2023
Anticipated Study Completion Date :
Feb 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tocilizumab treatment

Tocilizumab is a recombinant humanized monoclonal antibody against human interleukin-6 (IL-6) receptor. Tocilizumab acts by inhibiting the activity of IL-6 receptor. IL-6 is a pro-inflammatory cytokine whose release can trigger a series of downstream pro-inflammatory responses. Tocilizumab inhibits IL-6 signal transduction by blocking the binding of IL-6 to soluble and membrane-bound IL-6 receptors, thereby reducing pathological inflammatory responses.

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

Active Comparator: Glucocorticoids monotherapy

Glucocorticoids has fast onset of action and multiple anti-inflammatory effects.The conventional protocol is oral prednisone, followed by a slow tapering over 4 weeks. Besides, precautionary measures need to be taken against possible complications brought by the application of corticosteroids such as infections, diabetes mellitus, hypertension, Cushing's syndrome and osteoporosis, etc.

Drug: Glucocorticoids
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

  1. remission [5 years]

    Remission is achieved when symptoms are alleviated and laboratory tests return to normal levels or radiologic improvement is observed.

Secondary Outcome Measures

  1. relapse [5 years]

    Participants have recurrence of symptoms and laboratory abnormalities.

Other Outcome Measures

  1. adverse events [5 years]

    Participants suffer from adverse events due to the drug treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Beijing Beijing China 100032

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Wen Zhang, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT04762784
Other Study ID Numbers:
  • tocilizumab treatment for IRPF
First Posted:
Feb 21, 2021
Last Update Posted:
Mar 22, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wen Zhang, Professor, Peking Union Medical College Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2021