Leflunomide Treatment for IgG4-RD

NCT03715699 | Unknown DMC

• 1 other identifier: Treatment for IgG4-RD
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label randomized controlled trial aiming to investigate whether the efficacy and side effect of Leflunpomide plus glucocorticoid.

Conditions

Autoimmune Disease

Outcome Measures

Primary Outcomes (1)

• Response of Leflunomide treatment for IgG4-RD

  Complete response rate; Partial response rate; No response

  1 year

Secondary Outcomes (1)

• Relapse of Leflunomide treatment for IgG4-RD

  1 year

Study Arms (2)

Group 1

EXPERIMENTAL

Patients treated with single glucocorticoid

Drug: Prednisone; Drug: Prednisone and Leflunomide

Group 2

EXPERIMENTAL

Patients treated with Leflunomide and glucocorticoid

Drug: Prednisone; Drug: Prednisone and Leflunomide

Interventions

Prednisone DRUG

Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 7.5mg to 10mg/d to 12 months.

Group 1; Group 2

Prednisone and Leflunomide DRUG

Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months. Leflunomide: 20mg qd for 6 months and 10mg qd for 6 months.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females
• Aged 18 to 70 years old with informed consent
• All patients must meet the following diagnostic criteria of IgG4RD (2011):
• swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
• elevated serum IgG4 (\>1.35 g/L);
• histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD;

You may not qualify if:

• Patients will not be included if meets any of the following criteria:
• Patients who were diagnosed as other autoimmune diseases;
• Patients who were diagnosed as malignant diseases;
• Pregnant and lactating women；
• Active infection: HIV, HCV, HBV, TB；
• Serious organ function failure, expected life time less than 6 months.
• Presenting with Mikulicz disease without other manifestations.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Yunyun Fei

Beijing, Beijing Municipality, 100032, China

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

Prednisone; Leflunomide

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Yunyun FEI

CONTACT

+8613681125226; feiyunyun2013@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 23, 2018
• Study Start: July 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 23, 2018

Record last verified: 2018-10

Locations

CN (1)