Clinical Characteristics and Mechanism Research of Inhibitors of Janus Kinase in the Treatment of Idiopathic Inflammatory Myopathies

Sponsor

Peking University People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05400889

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to explore the clinical characteristics and mechanism research of inhibitors of janus kinase in the treatment of idiopathic inflammatory myopathies

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Inflammatory Myopathies	Drug: tofacitinib	Phase 2

Detailed Description

The investigators designed a single center, open-label, prospective study. Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan & Peter DM/PM or Rheumatology(ACR) & European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria. Inhibitors of janus kinase including tofacitinib 5 mg qd or bid and baricitinib 2mg qd or 4mg qd was administered for 6 months to explore its efficacy and safety, which could help to evaluate inhibitors of janus kinase's clinical characteristics and mechanism. Patients would be evaluated the improvement of clinical and laboratory indexes. Changes of symptoms, immune cell subsets and cytokines were monitored. Symptoms were evaluated by Visual Analogue Scale (VAS) of patient global and physician global, manual muscle testing(MMT-8), the Health Assessment Questionnaire(HAQ), Creatine kinase, Myositis Disease Activity Assessment Tool(MDAAT).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Real-world Experience With Inhibitors of Janus Kinase for the Treatment of Idiopathic Inflammatory Myopathies -- a Prospective Observational Study

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tofacitinib or baricitinib Tofacitinib 5mg was taken orally once or twice a day and baricitinib 2mg or 4mg was taken orally once a day for 6 months.	Drug: tofacitinib Tofacitinib 5mg was taken orally once or twice a day and baricitinib 2mg or 4mg was taken orally once a day for 6 months. Other Names: Baricitinib

Arm

Intervention/Treatment

Experimental: tofacitinib or baricitinib

Tofacitinib 5mg was taken orally once or twice a day and baricitinib 2mg or 4mg was taken orally once a day for 6 months.

Drug: tofacitinib

Tofacitinib 5mg was taken orally once or twice a day and baricitinib 2mg or 4mg was taken orally once a day for 6 months.

Other Names:

Baricitinib

Outcome Measures

Primary Outcome Measures

Immunological Responses [week 24]
Changes of follicular helper CD4+ T cells (TFH) before and after tofacitinib treatment are analysed to evaluate efficacy.

Secondary Outcome Measures

Myositis Disease Activity Assessment Tool(MDAAT) [week 24]
Change of MDAAT(Myositis Disease Activity Assessment Tool) is measurement of effectiveness. MDAAT ranges from 0 to 10cm. The more severe the disease activity, the higher the score. We define response as an improvement of MDAAT at least 5%.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults between 18 years and 75 years of age.
Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan & Peter DM/PM or American College of Rheumatology(ACR) & European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria.
Written informed consent should be obtained from each study subject.
Concomitant immunosuppressive agents or glucocorticoids were allowed, but subjects should have been on these therapies at least 4 weeks and on a stable dose for ≥4 weeks(glucocorticoid doses are lower than <0.5mg/kg/d).
Consent to use effective contraception during the study (women of childbearing age).

Exclusion Criteria:

Any subject meeting either of the following criteria should be excluded:

Laboratory abnormality: Hb<8 g/dl or platelet<60*10^9/L, or combined with severe hepatic, renal and cardiac insufficiency;
Myositis in overlap with another systemic autoimmune rheumatic disorder, cancer-associated myositis, inclusion body myositis or any other non-immune mediated myopathy.
Biologics such as rituximab are not allowed in the 3-month before enrollment.
Patients with malignancy within 3 years of screening.
Patients with hypersensitivity to study drug.
Active infections(including but not limited to hepatitis, HIV).
Uncontrolled mental or emotional disorders.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Rheumatology and Immunology, Peking University People's Hospital	Beijing	Beijing	China

Sponsors and Collaborators

Peking University People's Hospital

Investigators

Principal Investigator: Zhanguo Li, Peking University Institute of Rheuamotology and Immunology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking University People's Hospital

ClinicalTrials.gov Identifier:

NCT05400889

Other Study ID Numbers:

20220420 JAKi-IIM

First Posted:

Jun 2, 2022

Last Update Posted:

Jun 2, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Muscular Diseases

Myositis

Tofacitinib

Study Results

No Results Posted as of Jun 2, 2022