Tofatib Treatment for IgG4-related Disease

NCT05625581 | Unknown DMC

• 1 other identifier: CHEC2022-175
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Compared with cyclophosphamide, the efficacy and safety of tofacitinib in the treatment of active IgG4-related diseases were evaluated.

Conditions

IgG4-related Disease

Outcome Measures

Primary Outcomes (1)

• Disease remission rate at 1 month, 3 months and 6 months of treatment (%)

  Definition of disease remission: including ① complete remission (CR) (main efficacy index), partial remission (PR), continuous complete remission (CCR) and no change (NC).

  1 month, 3 months and 6 months of treatment

Secondary Outcomes (3)

• Response rate at 1 month, 3 months and 6 months after treatment (%)

  1 month, 3 months and 6 months after treatment

• Disease recurrence rate at 3 and 6 months after treatment (%)

  3 and 6 months after treatment

• Changes in physician's overall assessment (PGA) from baseline at 1 month, 3 months and 6 months of treatment

  1 month, 3 months and 6 months of treatment

Other Outcomes (2)

• Changes in the number of organs involved and IgG4-RD RI scores from the baseline after 6 months of treatment

  6 months of treatment

• Changes of IgG4 level and related immunological indicators from baseline after 6 months of treatment

  6 months of treatment

Study Arms (2)

Glucocorticosteroids combined with Cyclophosphamide Group

Glucocorticoid: 0.5-1.0 mg/kg/d prednisone (or other glucocorticoids of equivalent dose) for 1 month (visit V2-V3), then reduced by 5 mg every 2 weeks, and maintained at 5-10 mg/day to visit V8. Cyclophosphamide: intravenous infusion, once a month, 0.5-1g/m2 each time, 6 times in total, until the end of visit V7.

Drug: tofacitinib

Glucocorticoids combined with tofacitinib Group

Glucocorticoid: 0.5-1.0 mg/kg/d prednisone (or other glucocorticoids of equivalent dose) for 1 month (visit V2-V3), then reduced by 5 mg every 2 weeks, and maintained at 5-10 mg/day to visit V8. Tofacitinib: oral, twice a day, 5mg each time, lasting for 6 months, until the end of visit V8.

Drug: tofacitinib

Interventions

tofacitinib DRUG

All subjects were treated immediately after non randomized enrollment. The treatment scheme of the experimental group: glucocorticoid+tropitib; the treatment scheme of the control group: glucocorticoid+cyclophosphamide.

Also known as: cyclophosphamide

Glucocorticoids combined with tofacitinib Group; Glucocorticosteroids combined with Cyclophosphamide Group

Eligibility Criteria

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

Study Population

IgG4-RD

You may qualify if:

• It meets the 2019 ACR/EULAR classification diagnostic criteria for IgG4 related diseases, and is an active IgG4-RD, defined as an IgG4-RD RI score ≥ 3 points when screening

You may not qualify if:

• \. IgG4 related diseases endangering organ function or life;
• \. Only Mikulicz disease, no other internal organs involved;
• \. People with history of thrombotic disease or high risk of thrombosis;
• \. Have a history of malignant tumor;
• \. Active infection;
• \. Pregnant or lactating women;

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

TB infection screening test, hepatitis B antibody, hepatitis C antibody, syphilis antibody, HIV antibody, tumor full set; Blood routine, liver and kidney function, blood lipid, blood sugar, coagulation function, urine routine; Blood sink, CRP, immunoglobulin, complement, IgG4, ANA profile, RF, ANCA, lymphocyte subsets, and cytokines

MeSH Terms

Conditions

Immunoglobulin G4-Related Disease

Interventions

tofacitinib; Cyclophosphamide

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Gao Jie, doctor

  Changhai Hospital

  STUDY CHAIR

Central Study Contacts

Gao Jie, doctor

CONTACT

13585561861; gaojif@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 23, 2022
• Study Start: November 10, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)