Skip to main content
Clinical Trials/NCT03715699
NCT03715699UnknownNot Applicable

Leflunomide Treatment for IgG4-RD

Peking Union Medical College Hospital1 site in 1 country70 target enrollmentStarted: July 1, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
70
Locations
1
Primary Endpoint
Response of Leflunomide treatment for IgG4-RD

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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;
  • exclusion of other diseases.

Exclusion Criteria

  • 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.

Arms & Interventions

Group 1

Experimental

Patients treated with single glucocorticoid

Intervention: Prednisone (Drug)

Group 1

Experimental

Patients treated with single glucocorticoid

Intervention: Prednisone and Leflunomide (Drug)

Group 2

Experimental

Patients treated with Leflunomide and glucocorticoid

Intervention: Prednisone (Drug)

Group 2

Experimental

Patients treated with Leflunomide and glucocorticoid

Intervention: Prednisone and Leflunomide (Drug)

Outcomes

Primary Outcomes

Response of Leflunomide treatment for IgG4-RD

Time Frame: 1 year

Complete response rate; Partial response rate; No response

Secondary Outcomes

  • Relapse of Leflunomide treatment for IgG4-RD(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wen Zhang

Professor

Peking Union Medical College Hospital

Study Sites (1)

Loading locations...

Similar Trials

Leflunomide Treatment for IgG4-RD | Clinical Trial