The Effect and Safety of Tocilizumab Treatment on IRPF

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Prednisone

Criteria

Inclusion Criteria:

1. Male or female adults, ≥ 18 years of age at time of informed consent;

2. Written informed consent;

3. Diagnosed with retroperitoneal fibrosis and normal level of Serum IgG4;

4. Higher level of ESR and CRP than normal;

5. Pathologic results show fibrosis and IgG4/IgG <50%.

Exclusion Criteria:

1. Combined with other connective tissue disease.

2. Known immunodeficiency disorder.

3. Active malignancy or history of malignancy that was active within the last 10 years.

4. Pregnancy, lactation, or planning to become pregnant within 6 months of the test.

5. 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.

6. Evidence of active tuberculosis (TB), including Chest X-ray and PPD.

7. Severe abnormal liver function or cardiac insufficiency.

8. Any reason the investigator think that should not attend this trial.