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NOT YET RECRUITING
NCT06689982
EARLY_PHASE1

Tofacitinib in Patients With Amyotrophic Lateral Sclerosis

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease, of which motor-neuron's degeneration may be associated with neuroinflammation. Tofacitinib is a Janus kinase (JAK) inhibitor that affects cellular hematopoiesis and cellular immune function. At the same time, tofacitinib is suitable for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This study is a single center, single arm, proof of concept, clinical trial study, and it is planned to use tofacitinib to carry out a clinical trial to observe the treatment effect of ALS patients.

Official title: Tofacitinib in Patients With Amyotrophic Lateral Sclerosis: A Proof-of-concept Clinical Trials

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-12-01

Completion Date

2026-06-01

Last Updated

2024-11-15

Healthy Volunteers

No

Interventions

DRUG

Tofacitinib tablets

All patients should be closely monitored for signs and symptoms of infection during and after treatment with tofacitinib tablets. If a patient develops a severe infection, opportunistic infection, or sepsis, medication should be discontinued. During treatment, patients with lymphocyte counts \< 500 cells/mm\^3 or ANC \< 500 cells/mm\^3 confirmed by repeated testing should be stopped. When 500≤ANC≤1000 cells/mm\^3, administration should be interrupted, and if ANC returns to more than 1000 cells/mm\^3, administration should be resumed. When hemoglobin \< 8 g/dL or decreases by more than 2 g/dL, administration should be interrupted until hemoglobin values return to normal.

Locations (1)

Beijing Tiantan Hospital

Beijing, China