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JAKs inhibitor tofacitinib reduces skin thickness and improves lung function in patients with systemic sclerosis

JAKs inhibitor tofacitinib reduces skin thickness and improves lung function in patients with systemic sclerosis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074515
Enrollment
Unknown
Registered
2023-08-09
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

systemic sclerosis

Interventions

Non-tofacitinib group:Without tofacitinib

Sponsors

The Second Hospital of Shanxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: All the patients fulfilled the 2013 American College of Rheumatology and European Union League Against Rheumatism classification criteria of SSc. These patients enrolled in the study were aged between 18 and 80 years and had active disease (Rodnan Skin Score (mRSS) units = 10). SSc-ILD patients were defined as those with evidence of fibrosis on High-resolution CT (HRCT) findings, and a predicted forced vital capacity (FVC) of at least 50%

Exclusion criteria

Exclusion criteria: The patients were excluded from this study if they were allergic or intolerant to tofacitinib, suffering malignant disease, had a history of malignancy, a recent clinically significant infection, or had any other connective tissue disease, pulmonary interstitial lesions due to other causes, such as idiopathic and pharmaceutical, or coal dust and asbestos asthma.

Design outcomes

Primary

MeasureTime frame
Rodnan Skin Score (mRSS);

Secondary

MeasureTime frame
the patients with an AE leading to withdrawal or a serious AE (SAE);a decrease in doses of prednisone or disease-modifying antirheumatic drugs (DMARDs) required to control disease activity;

Countries

China

Contacts

Public ContactHong-yan Wen

The Second Hospital of Shanxi Medical University

wenhongyan0509@aliyun.com+86 138 3514 2566

Outcome results

None listed

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