Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Sjogren Syndrome With Other Organ Involvement

Treatments: Drug: Prednisolone; Drug: Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT05694130

I-22PJ1065b

Details and patient eligibility

About

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.

Full description

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

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups, including a placebo group

Prednisolone monotherapy

Placebo Comparator group

Description:

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

Treatment:

Drug: Prednisolone

Prednisolone plus Tacrolimus

Experimental group

Description:

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.

Treatment:

Drug: Tacrolimus

Drug: Prednisolone