Withdraw Drug in Stable IgG4-Related Disease

NCT04124861 | Unknown DMC

• 1 other identifier: Withdraw drug in IgG4-RD
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation and prediction of relapse risk after glucocorticoid or immunosuppressant withdrawal in patients with stable IgG4 related disease: a prospective cohort study from china.

Conditions

Autoimmune Diseases

Keywords

Immunoglobulin G4-Related Disease

Outcome Measures

Primary Outcomes (1)

• The difference of recurrent rate of IgG4-RD among three groups.

  Clinical recurrence definition: any item of IgG4-RD Responder Index \>=2，new organ involvement; with or without elevated serum IgG4 levels. Serum recurrence definition: Serum IgG4 level was higher than baseline level, IgG4-RD Responder Index was higher than or equal to 1 point, without clinical symptom or imaging deterioration.

  One and half year

Secondary Outcomes (6)

• The changes of IgG4-RD Responder Index

  One and half year

• The changes of serum IgG4 levels

  One and half year

• The changes of serum IgG level

  One and half year

• The changes of serum hsCRP level

  One and half year

• The changes of ESR

  One and half year

Study Arms (3)

Drug free

EXPERIMENTAL

Arm A: Drug free Glucocorticoid（GC）is tapered and stopped in 8 weeks(GCs at a dose of ≤ 2.5 mg of prednisone or equivalent for treatment of adrenal insufficiency) . Immunosuppressant is also tapered and discontinues in 8 weeks.

Drug: Drug free, IS monotherapy and GC combined with IS

IS monotherapy

EXPERIMENTAL

Arm B: Immunosuppressant only Glucocorticoid（GC）is tapered and stopped in 8 weeks. The same type and dosage of immunosuppressive agent before admission, including Mycophenolate mate(\<= 1g/d) or Leflunomide (\<=20mg/d) or Methotrexate (\<=15mg/w) or Azathioprine (\<=100mg/d)

Drug: Drug free, IS monotherapy and GC combined with IS

GC combined with IS

EXPERIMENTAL

Arm C: GC+Immunosuppressant Both Glucocorticoid(GC) (no more than 7.5mg/d) and immunosuppressant are kept as maintaining dose.

Drug: Drug free, IS monotherapy and GC combined with IS

Interventions

Drug free, IS monotherapy and GC combined with IS DRUG

Follow-up intervals: Every 3 months (3th, 6th, 9th, 12th, 15th, 18th month).

Drug free; GC combined with IS; IS monotherapy

Eligibility Criteria

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

You may qualify if:

• Disease stabilized more than one year (Responder Index \< 2 points)
• Dose of Glucocorticoid(GC): prednisone (or equivalent) ≤ 7.5mg/d for more than 6 months
• Immunosuppressant: one of the following drugs, the same dose maintain at least 3 months (Mycophenolate mate \<= 1g/d or Leflunomide \<=20mg/d or Methotrexate \<=12.5mg/w or Azathioprine \<=100mg/d).

You may not qualify if:

• Patient was diagnosed other connective tissue diseases
• Patient with tumor
• Women during pregnancy or planning pregnancy
• Patient with active infections, including HIV, HCV, HBV, TB, etc.
• Patient with severe irreversible organ damage
• Active IgG4-RD, responder index \>= 2 points
• Stable condition less than one year.
• Patient with two or more immunosuppressive agents.
• Biological agents (such as CD20 monoclonal antibody and TNF-a inhibitor) have been used for half a year before admission.
• Patient with IgG4-RD recurrence during hormone reduction in the past.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Chinese PLA General Hospital: collaborator
• Peking University People's Hospital: collaborator
• The People's Hospital of Hebei Province: collaborator
• Shengjing Hospital: collaborator
• Tongji Hospital: collaborator

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Related Publications (1)

• Peng L, Nie Y, Zhou J, Wu L, Chen X, Wang F, Li J, Peng Y, Lu H, Zhao L, Li M, Zhao Y, Zeng X, Fei Y, Zhang W. Withdrawal of immunosuppressants and low-dose steroids in patients with stable IgG4-RD (WInS IgG4-RD): an investigator-initiated, multicentre, open-label, randomised controlled trial. Ann Rheum Dis. 2024 Apr 11;83(5):651-660. doi: 10.1136/ard-2023-224487.

  PMID: 38216319 DERIVED

MeSH Terms

Conditions

Autoimmune Diseases; Immunoglobulin G4-Related Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Wen Zhang, MD.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Yunyun Fei, MD

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Central Study Contacts

linyi peng, MD.

CONTACT

+8615810395901; drpenglinyi@163.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: February 13, 2019
• First Posted: October 11, 2019
• Study Start: June 23, 2020
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: February 7, 2022

Record last verified: 2022-01

Locations

CN (1)