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

Primary Purpose

Primary Sjögren's Syndrome

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Tofacitinib

About this trial

This is an interventional treatment trial for Primary Sjögren's Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female >18 years of age at screening visits
Patients meet the American-European Consensus Group 2002 classification criteria
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.
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:

Laboratory abnormality:
- Hb≤9 g/dl
- Neutrophil <1.0 x 109/l
- lymphocyte<0.5 x 109/l
Diagnosis of other autoimmune disease, or other sicca syndrome.
Use rituximab or other monoclonal antibodies within 6 months.
Received high doses of glucocorticoid (>10 mg/d) within 1 month.
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)
Known allergies, hyperreactivity or intolerance of tofacitinib or its excipients.
Have a serious infection needing hospitalization (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or use intravenous antibiotics to treat infection in 2 months before the enrollment.
Infection with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, it is recommended to consult a doctor who has expertise in treating HIV or hepatitis C virus infection.
Any known history of malignancy in the past 5 years (except for non-melanoma skin cancer, non-melanoma skin cancer or cervical tumor without recurrence within 3 months after surgical cure prior to the first study preparation).
Uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past 3 years, may hinder the successful completion of the study.
Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tofacitinib

Arm Description

Tofacitinib 5mg was taken orally twice a day for 6 months

Outcomes

Primary Outcome Measures

Immunological Responses

Analysis interleukin 17 (IL-17)-producing helper T (Th17) cells before and during tofacitinib treatment. P values below 0.05 are considered statistically significant in this study.

Secondary Outcome Measures

Improvements in EULAR SS patient-reported index (ESSPRI), other clinical and immunological parameters

ESSPRI ranges from 0 to 10. The patient's acceptability/satisfaction of its current state (taking account of his symptoms: dryness, fatigue and pain) should be recorded. For addressing patient-reported outcomes, we define response as an improvement of ESSPRI at least one point or 15% .

Safety and tolerability of tofacitinib as assessed by incidence of adverse events reported and observed

we will report frequency of adverse events.Adverse events includes infection, tumor, abnormal neutrophil and lymphocyte count, anemia,drug-induced liver and kidney damage.

Full Information

NCT ID

NCT05087589

First Posted

October 8, 2021

Last Updated

February 28, 2022

Sponsor

Peking University People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05087589

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 20, 2021 (Actual)

Primary Completion Date

January 1, 2023 (Anticipated)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking University People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Sjögren's Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tofacitinib

Arm Type

Experimental

Arm Description

Tofacitinib 5mg was taken orally twice a day for 6 months

Intervention Type

Drug

Intervention Name(s)

Tofacitinib

Intervention Description

Tofacitinib 5mg was taken orally twice a day for 6 months

Primary Outcome Measure Information:

Title

Immunological Responses

Description

Analysis interleukin 17 (IL-17)-producing helper T (Th17) cells before and during tofacitinib treatment. P values below 0.05 are considered statistically significant in this study.

Time Frame

week 24

Secondary Outcome Measure Information:

Title

Improvements in EULAR SS patient-reported index (ESSPRI), other clinical and immunological parameters

Description

Time Frame

week 24

Title

Safety and tolerability of tofacitinib as assessed by incidence of adverse events reported and observed

Description

we will report frequency of adverse events.Adverse events includes infection, tumor, abnormal neutrophil and lymphocyte count, anemia,drug-induced liver and kidney damage.

Time Frame

up tp 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female >18 years of age at screening visits Patients meet the American-European Consensus Group 2002 classification criteria 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. 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: Laboratory abnormality: Hb≤9 g/dl Neutrophil <1.0 x 109/l lymphocyte<0.5 x 109/l Diagnosis of other autoimmune disease, or other sicca syndrome. Use rituximab or other monoclonal antibodies within 6 months. Received high doses of glucocorticoid (>10 mg/d) within 1 month. 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) Known allergies, hyperreactivity or intolerance of tofacitinib or its excipients. Have a serious infection needing hospitalization (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or use intravenous antibiotics to treat infection in 2 months before the enrollment. Infection with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, it is recommended to consult a doctor who has expertise in treating HIV or hepatitis C virus infection. Any known history of malignancy in the past 5 years (except for non-melanoma skin cancer, non-melanoma skin cancer or cervical tumor without recurrence within 3 months after surgical cure prior to the first study preparation). Uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past 3 years, may hinder the successful completion of the study. Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qinghong Liu

Phone

+86 15774917676

166618530@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jing He

Phone

+86 18611707347

hejing1105@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhanguo Li

Organizational Affiliation

Peking University Institute of Rheuamotology and Immunology

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100044

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jing He, MD and PhD

Phone

+8618611707347

hejing1105@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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