Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS

NCT ID: NCT05694130

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2024-12-31

Brief Summary

This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for Sjogren's syndrome patients with severe thrombocytopenia.

Detailed Description

This study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for the treatment of severe thrombocytopenia in Sjogren's syndrome patients.

Conditions

Sjogren Syndrome With Other Organ Involvement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prednisolone monotherapy

Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.

Group Type: PLACEBO_COMPARATOR

Prednisolone

Intervention Type: DRUG

Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.

Prednisolone plus Tacrolimus

Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks. Oral tacrolimus 1-2mg twice daily for 12 weeks.

Group Type: EXPERIMENTAL

Prednisolone

Intervention Type: DRUG

Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.

Tacrolimus

Intervention Type: DRUG

Oral Tacrolimus 1-2mg twice daily for 12 weeks.

Interventions

Prednisolone

Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.

Intervention Type: DRUG

Tacrolimus

Oral Tacrolimus 1-2mg twice daily for 12 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria.
• Baseline platelet counts less than 30×109/L.

Exclusion Criteria

• Concomitant other systemic autoimmune diseases.
• Other severe complications of Sjogren's syndrome.
• Abnormal laboratory tests such as: white blood cell count <2.5x10^9/L, hemoglobin <80 g/L, AST/ALT >1.5 ULN, serum creatine > 1.5 mg/dL.
• Received glucocorticoids, immunosuppressants, or biological agents within 3 months.
• Active acute or chronic infections.
• History of malignancy.
• Pregnancy or breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wen Zhang

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hua Chen, Dr.

Role: CONTACT

chenhua@pumch.cn

861069159962

Other Identifiers

I-22PJ1065b

Identifier Type: -

Identifier Source: org_study_id