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Withdraw Drug in Stable IgG4-Related Disease

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ClinicalTrials.gov Identifier: NCT04124861
Recruitment Status : Not yet recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Collaborators:
Chinese PLA General Hospital
Peking University People's Hospital
The People's Hospital of Hebei Province
Shengjing Hospital
Tongji Hospital
Information provided by (Responsible Party):
Wen Zhang, Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Autoimmune Diseases Drug: Drug free, IS monotherapy and GC combined with IS Not Applicable

Detailed Description:
IgG4-related disease (IgG4-RD) is a chronic autoimmune disease with a relapsing-remitting course. For patients in remission, glucocorticoid (GC) and immunosuppressant are used to be maintained for a long time in fear of disease flare. Long-term GC and immunosuppressant could bring a lot of side-effects and economic burden. Whether and when patients with stable disease should withdraw GC or immunosuppressant? How about the relapse risk respectively? What are the risk factors for disease flare? All the above remain unclear. The aim of this study is to explore the relapse risk after GC or immunosuppressant withdrawal in IgG4-RD patients with stable disease and to establish a predictive model for risk stratification. Meanwhile the investigators aim to testify the effects of immunosuppressant in preventing IgG4-RD relapse. This study is a prospective cohort clinical trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation and Prediction of Relapse Risk After Glucocorticoid and Immunosuppressant Withdrawal in Patients With Stable IgG4 Related Disease: An Open-labeled Multi-centric Randomized Controlled Study From China
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : April 15, 2022
Estimated Study Completion Date : October 15, 2022


Arm Intervention/treatment
Experimental: Drug free
Drug:free Glucocorticoid(GC)is tapered and stopped in 8 weeks. Immunosuppressant treatment is also stopped after admission.
Drug: Drug free, IS monotherapy and GC combined with IS
Follow-up intervals: Every 3 months (3th, 6th, 9th, 12th, 15th, 18th month).

Experimental: IS monotherapy
Drug: Immunosuppressant 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 (<=12.5mg/w) or Azathioprine (<=100mg/d)
Drug: Drug free, IS monotherapy and GC combined with IS
Follow-up intervals: Every 3 months (3th, 6th, 9th, 12th, 15th, 18th month).

Experimental: GC combined with IS
Drug: 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
Follow-up intervals: Every 3 months (3th, 6th, 9th, 12th, 15th, 18th month).




Primary Outcome Measures :
  1. Percent of recurrence of IgG4-RD. [ Time Frame: One and half year ]
    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.


Secondary Outcome Measures :
  1. IgG4-RD Responder Index [ Time Frame: One and half year ]
    According to IgG4-RD responder Index Validation Study (Version: 13, December, 2015)

  2. Serum IgG4 level [ Time Frame: One and half year ]
    Level of serum IgG4(mg/dL)

  3. Serum IgG level [ Time Frame: One and half year ]
    Level of serum IgG(g/L)

  4. Serum hsCRP level [ Time Frame: One and half year ]
    Level of serum high-sensitivity C-reactive protein level(mg/L)

  5. ESR [ Time Frame: One and half year ]
    Serum erythrocyte sedimentation rate(mm/h)

  6. Adverse effect [ Time Frame: One and half year ]
    Adverse effect of drugs



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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. exclusion of other diseases.
  2. Disease stabilized more than one year (Responder Index < 2 points)
  3. Dose of Glucocorticoid(GC): prednisone (or equivalent) ≤ 7.5mg/d for more than 6 months
  4. 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).

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124861


Contacts
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Contact: linyi peng, MD. +8615810395901 drpenglinyi@163.com

Sponsors and Collaborators
Peking Union Medical College Hospital
Chinese PLA General Hospital
Peking University People's Hospital
The People's Hospital of Hebei Province
Shengjing Hospital
Tongji Hospital
Investigators
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Principal Investigator: Wen Zhang, MD. Peking Union Medical College Hospital

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Responsible Party: Wen Zhang, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04124861     History of Changes
Other Study ID Numbers: Withdraw drug in IgG4-RD
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wen Zhang, Peking Union Medical College Hospital:
Immunoglobulin G4-Related Disease
Additional relevant MeSH terms:
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Autoimmune Diseases
Immunoglobulin G4-Related Disease
Immune System Diseases
Glucocorticoids
Immunosuppressive Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunologic Factors