Trials / Unknown
UnknownNCT04762784
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
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Peking Union Medical College Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tocilizumab | Tocilizumab treatment: Tocilizumab infusion 8mg/Kg，Once per month for 3 months. |
| 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. |
Timeline
- Start date
- 2020-07-01
- Primary completion
- 2023-02-10
- Completion
- 2023-02-10
- First posted
- 2021-02-21
- Last updated
- 2021-03-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04762784. Inclusion in this directory is not an endorsement.