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

Study Overview
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Brief Summary
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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.

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

Conditions
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Idiopathic Retroperitoneal Fibrosis

Intervention / Treatment
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* Drug: Tocilizumab
* Drug: Glucocorticoids


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tocilizumab treatment<br>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<br>* Tocilizumab treatment: Tocilizumab infusion 8mg/Kg，Once per month for 3 months.<br>|
| Active Comparator: Glucocorticoids monotherapy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse | Participants have recurrence of symptoms and laboratory abnormalities. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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idiopathic retroperitoneal fibrosis, Tocilizumab, Response