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Tofacitinib treatment in patients with primary Sjogren syndrome: a prospective pilot trial

Tofacitinib treatment in patients with primary Sjogren syndrome: a prospective pilot trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057578
Enrollment
Unknown
Registered
2022-03-15
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren Syndrome

Interventions

Control group:Same dose of hydroxychloroquine sulfate as before
Intervention group:Tofacitinib 5mg bid po+the same dose of hydroxychloroquine sulfate as before

Sponsors

Ningbo Medical Center Lihuili Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. All patients fulfilled the 2002 American-European Consensus Group classification criteria or 2016 ACR/EULAR Consensus Group classification criteria; 2. All patients still showed oral dryness and xerophthalmia after a 6-mouths treatment of hydroxychloroquine sulfate.

Exclusion criteria

Exclusion criteria: 1. Patients with the existence of other connective tissue diseases; 2. Acute sialadenitis, or existence of a relevant, active infection, hepatitis B or C, tuberculosis, HIV or other immunodeficiency, malignancies within 5 years prior, recent organ transplant; 3. Serious cardiovascular diseases, kidney, liver, and other important organ damage, Serious diseases of the blood system and endocrine system; 4. Severe intercurring neurological or psychiatric disease; 5. Pregnancy/lactation and unwillingness to use contraception throughout the study.

Design outcomes

Primary

MeasureTime frame
Unstimulated whole saliva flow;Stimulated whole saliva flow;Schirmer test;Corneal fluorescence staining;Tear break-up time;EULAR Sjogren's Syndrome Patient Reported Index (ESSPI) Score;EULAR Sjogren's syndrome (SS) disease activity index (ESSDAI) Score;

Secondary

MeasureTime frame
XI Score;COD Score;Chinese version of the symptom assessment in dry eye (SANDE) score;Blood routine examination;Erythrocyte sedimentation rate;Immunologic function;

Countries

China

Contacts

Public ContactZhang Jin

Ningbo Medical Center Lihuili Hospital

751860714@qq.com+86 13486089482

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026