Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS

NCT05694130 | Unknown Phase 2

• 1 other identifier: I-22PJ1065b
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sjogren Syndrome With Other Organ Involvement

Keywords

Sjogren's syndrome; Thrombocytopenia; Tacrolimus

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  Complete response (platelet counts \> 100×10\^9/L) rates at week 12.

  week 12

Secondary Outcomes (4)

• Complete response rate

  week 4 and week 8

• Partial response rate

  week 4, week 8 and week 12

• ESSDAI improvement

  week 12

• ESSPRI improvement

  week 12

Other Outcomes (2)

• Immunoglobulins

  week 12

• Rheumatoid Factor

  week 12

Study Arms (2)

Prednisolone monotherapy

PLACEBO COMPARATOR

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

Drug: Prednisolone

Prednisolone plus Tacrolimus

EXPERIMENTAL

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.

Drug: Prednisolone; Drug: Tacrolimus

Interventions

Prednisolone DRUG

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

Prednisolone monotherapy; Prednisolone plus Tacrolimus

Tacrolimus DRUG

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

Prednisolone plus Tacrolimus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Sjogren's Syndrome; Thrombocytopenia

Interventions

Prednisolone; Tacrolimus

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Macrolides; Lactones; Organic Chemicals

Central Study Contacts

Hua Chen, Dr.

CONTACT

861069159962; chenhua@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: February 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 23, 2023

Record last verified: 2023-01