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Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome

Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjögren's Syndrome:a Prospective Observational Study

NCT05087589•Peking University People's Hospital

View on ClinicalTrials.gov

Summary

This study aims to explore the clinical and immunological efficacy of tofacitinib on primary Sjögren's Syndrome

Detailed Description

The investigators designed a single center, open-label, prospective study. Adults with active primary Sjögren's Syndrome will be enrolled, meeting the American College of Rheumatology(ACR) \& European allance of associations for rheumatology(EULAR)(2016) diagnostic criteria . Tofacitinib 5 mg bd was administered for 6 months to explore its efficacy and safety. The improvement of clinical and laboratory indexes was evaluated. Changes of immune cell subsets and cytokines were monitored.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female \>18 years of age at screening visits
•2. Patients meet the American-European Consensus Group 2002 classification criteria
•3. The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols.
•4. Dosing of antimalarials, prednisone or equivalent, cholinergic stimulants, and topical cyclosporine required to be stable for at least 4 weeks before screening and during study; maximum doses allowed:
•* Hydroxychloroquinone, 400 mg/day;
•* Prednisone, 10 mg/day

Exclusion Criteria

•Any subject meeting any of the following criteria should be excluded:
•1. Laboratory abnormality:
•* Hb≤9 g/dl
•* Neutrophil \<1.0 x 109/l
•* lymphocyte\<0.5 x 109/l
•2. Diagnosis of other autoimmune disease, or other sicca syndrome.
•3. Use rituximab or other monoclonal antibodies within 6 months.
•4. Received high doses of glucocorticoid (\>10 mg/d) within 1 month.
•5. Serious complications: including heart failure (≥ New York Heart Association (NYHA) class III), renal insufficiency (creatinine clearance ≤ 30 ml/min), liver dysfunction (serum Alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of normal, or total bilirubin greater than Normal upper limit)
•6. Known allergies, hyperreactivity or intolerance of tofacitinib or its excipients.
+5 more criteria

Locations (1)

Department of Rheumatology and Immunology, Peking University People's Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

November 20, 2021

Primary Completion Date

January 1, 2023

Completion Date

October 1, 2023

Last Updated

March 2, 2022

Enrollment

ESTIMATED participants

Conditions

Primary Sjögren's Syndrome

Interventions

Tofacitinib

DRUG

Contacts

Qinghong Liu

CONTACT

+86 15774917676 166618530@qq.com

Jing He

CONTACT

+86 18611707347 hejing1105@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome

Inclusion Criteria

Exclusion Criteria

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