Belimumab Treatment for IgG4-related Disease

NCT04660565 | Unknown Phase 4

• 1 other identifier: IgG4-related disease,Belimumab
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Even though glucocorticoid is the current first line medication for IgG4-RD, it is well accepted in the field that excessive dosage of GC, especially accumulative dosage, is associated with increasing organ damage. Although B cell depletion with rituximab has been verified to be an effective treatment for IgG4-RD, even without concomitant GC therapy, rituximab can increase the risk of infection during the treatment. Belimumab is an IgG1-lambda monoclonal antibody that prevents the survival of B lymphocytes by blocking the binding of soluble human B lymphocyte stimulator protein (BLyS) to receptors on B lymphocytes. Previous studies and trails suggested that the activity of B-cell mediated immunity and autoimmune responses were ameliorated after belimumab without increasing rates of adverse events when compared to standard of care . However, the efficacy and tolerability of belimumab in IgG4-RD patients have not been examined before. This randomized, control clinical trial aimed to evaluate the tolerability and the efficacy of Belimumab for maintenance treatment for IgG4-RD.

Conditions

IgG4-related Disease

Outcome Measures

Primary Outcomes (2)

• Evaluate the efficacy of Belimumab in reducing the risk of flare in patients with IgG4-RD.

  Relapse was defined as the new progress or recurrence of clinical symptoms or imaging findings with or without IgG4 level re-elevation. the new progress or recurrence of imaging findings were evaluated by MRI, CT or Ultrasound. Primary endpoint is the difference of disease relapse rate between two groups.

  Twelve months

• The difference of time to first flare between two groups;

  The date of disease flare is defined as the date of initiation of any flare treatment. The date of disease flare is defined as the date of initiation of any flare treatment (new or increased GC treatment, other immunotherapy, or interventional procedure) deemed necessary by the Investigator for the flare.

  Twelve months

Secondary Outcomes (2)

• The effect of Belimumab on disease activity in IgG4-RD patients.

  Twelve months

• Safety and tolerability of Belimumab in patients with IgG4-RD.

  Twelve months

Study Arms (2)

Glucocorticoid monotherapy Group

EXPERIMENTAL

Patients treated with single glucocorticoid

Drug: Prednisone

Combination therapy Group

EXPERIMENTAL

Patients treated with Belimumab and glucocorticoid

Drug: Prednisone and Belimumab

Interventions

Prednisone and Belimumab DRUG

Prednisone/prednisolone: started at 0.6-0. 8mg/kg.d for 2 to 4 weeks, tapered at 5mg per 1-2 weeks to equal to or less than 5mg per day in 3 months. Belimumab will start at the same time as the prednisone induction.

Also known as: Belimumab treatment

Combination therapy Group

Prednisone DRUG

Prednisone/prednisolone: started at 0.6-0. 8mg/kg.d for 2 to 4 weeks, tapered at 5mg per 1-2 weeks to equal to or less than 5mg per day in 3 months.

Also known as: Prednisone Monotherapy

Glucocorticoid monotherapy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults, ≥ 18 years of age at time of informed consent.
• Written informed consent.
• Fulfillment of the 2019 ACR/EULAR classification criteria, involving at least one of the following organs: pancreas, lacrimal glands, salivary glands, bile ducts/biliary, orbits, lungs, retroperitoneum, aorta, kidneys, or thyroid gland.
• New onset or experiencing an IgG4-RD flare that requires initiation or continuation of GC treatment at the time of informed consent. This GC therapy can either be newly initiated or be increased from a maintenance dose of ≤ 10 mg/day of prednisone or equivalent.

You may not qualify if:

• Severe organ dysfunction.
• Severe infection.
• Having known immunodeficiency disorder.
• History of malignancy within the last 10 years.
• Receipt of any biologic therapy, including B cell-depleting therapy (eg, rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab) or other biologic immunomodulatory agent (abatacept) in the 6 months prior to screening.
• Non-biologic DMARDs or immunosuppressive agent other than GCs (eg, Leflunomide, Cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, others) have been used withing 12 weeks before screening.
• Being pregnant, lactating, or planning to become pregnant within 6 months of the test.
• Positive test for hepatitis B or HIV infection. Positive test for hepatitis B include detection of hepatitis B surface antigen (HBsAg) or HBV-DNA.
• Chest image ,PPD or TB-ELISPOT results show active tuberculosis.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Interventions

Prednisone; belimumab

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Yunyun Fei, Dr.

CONTACT

+8613681125226; Feiyunyun2013@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• 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 23, 2020
• First Posted: December 9, 2020
• Study Start: January 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: January 8, 2021

Record last verified: 2021-01

Locations

CN (1)