Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS

January 12, 2023 updated by: Wen Zhang, Peking Union Medical College Hospital

Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in Sjogren's Syndrome

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Prednisolone monotherapy
Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.
Drug: Prednisolone
Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.
Experimental: 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.
Drug: Tacrolimus
Oral Tacrolimus 1-2mg twice daily for 12 weeks.
Drug: Prednisolone
Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate
Time Frame: week 12
Complete response (platelet counts > 100×10^9/L) rates at week 12.
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response rate
Time Frame: week 4 and week 8
Complete response (platelet counts > 100×10^9/L) rates at week 4 and week 8.
week 4 and week 8
Partial response rate
Time Frame: week 4, week 8 and week 12
Partial response (platelet counts 50-100×10^9/L) rates at week 4, week 8 and week 12
week 4, week 8 and week 12
ESSDAI improvement
Time Frame: week 12
Change from baseline in ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index) score (0-123, higher is worse) at week 12.
week 12
ESSPRI improvement
Time Frame: week 12
Change from baseline in ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score (0-10, higher is worse) at week 12.
week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunoglobulins
Time Frame: week 12
Change from baseline in Immunoglobulin (IgG, IgM and IgA) levels at week 12.
week 12
Rheumatoid Factor
Time Frame: week 12
Change from baseline in rheumatoid factor level at week 12.
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-22PJ1065b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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