Leflunomide Treatment for IgG4-RD

• Sponsor: Peking Union Medical College Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03715699
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Disease	Drug: Prednisone; Drug: Prednisone and Leflunomide	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Leflunomide Treatment for IgG4-RD
• Actual Study Start Date: Jul 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Patients treated with single glucocorticoid	Drug: Prednisone; 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.; Drug: Prednisone and Leflunomide; 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.
Experimental: Group 2 Patients treated with Leflunomide and glucocorticoid	Drug: Prednisone; 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.; Drug: Prednisone and Leflunomide; 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.

Outcome Measures

Primary Outcome Measures

1. Response of Leflunomide treatment for IgG4-RD [1 year]

   Complete response rate; Partial response rate; No response

Secondary Outcome Measures

1. Relapse of Leflunomide treatment for IgG4-RD [1 year]

   Clinical relapse; Serological relapse

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: 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):

1. 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;

2. elevated serum IgG4 (>1.35 g/L);

3. 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;

4. exclusion of other diseases.

Exclusion Criteria:

• Patients will not be included if meets any of the following criteria:

1. Patients who were diagnosed as other autoimmune diseases;

2. Patients who were diagnosed as malignant diseases;

3. Pregnant and lactating women；

4. Active infection: HIV, HCV, HBV, TB；

5. Serious organ function failure, expected life time less than 6 months.

6. Presenting with Mikulicz disease without other manifestations.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yunyun Fei	Beijing	Beijing	China	100032

Sponsors and Collaborators

• Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wen Zhang, Professor, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT03715699
• Other Study ID Numbers: Treatment for IgG4-RD
• First Posted: Oct 23, 2018
• Last Update Posted: Oct 23, 2018
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Autoimmune Diseases; Prednisone; Leflunomide

Study Results

No Results Posted as of Oct 23, 2018