Tacrolimus for 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: Hydroxychloroquine; Drug: Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT05678335

I-22PJ1065

Details and patient eligibility

About

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

Full description

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

Enrollment: 54 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 within 30-80×109/L.

Exclusion criteria

• Concomitant other systemic autoimmune diseases.
• 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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54 participants in 2 patient groups, including a placebo group

Hydroxychloroquine monotherapy

Placebo Comparator group

Description:

Oral hydroxychloroquine 200mg twice daily for 12 weeks.

Treatment:

Drug: Hydroxychloroquine

Tacrolimus monotherapy

Experimental group

Description:

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

Treatment:

Drug: Tacrolimus