TELITACICEPT IN INFLAMMATORY MYOPATHIES(TELITACICEPT-IM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telitacicept 240mg.
- Who it may be relevant to
- Registry conditions: Inflammatory Myopathy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety and Efficacy of Telitacicept in Inflammatory Myopathies
Overview
The goal of this clinical trial is to evaluate the efficacy of Telitacicept in the treatment of inflammatory myopathy in patients with inflammatory diseases. The main question it aims to answer is: the safety and effectiveness of Telitacicept in treating inflammatory myopathy.
Interventions
- Drug Telitacicept 240mg
On the basis of the original foundational medication regimen, add Telitacicept 240mg administered via subcutaneous injection once a week for a total of 12 weeks.
Primary outcome measures
- Physician's Global Assessment (PGA) Score [Time frame: From enrollment to the end of treatment at 12 weeks]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years and ≤ 70 years.
- Patient has a confirmed diagnosis of inflammatory myopathy, meeting the 2017 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for idiopathic inflammatory myopathies.
- Inadequate response or intolerance to glucocorticoids and/or at least one immunosuppressant.
- The patient or their legal guardian provides written informed consent.
Exclusion criteria
- Female patients who are pregnant, breastfeeding, or planning a pregnancy during the trial period.
- Patients with active infections, such as herpes zoster, HIV, active tuberculosis, active hepatitis, HBsAg-positive patients, or HCV antibody-positive patients.
- Patients with positive test results indicating COVID-19 infection within 1 month prior to baseline.
- Patients with a history of or currently diagnosed malignancy.
- Patients with significant cardiovascular diseases (including severe arrhythmia), hepatic, renal, respiratory, endocrine, or hematological disorders, or any other medical condition that, in the investigator's judgment, would interfere with participation in the study or require hospitalization during the trial.
- Patients who have received intravenous immunoglobulin (IVIG) or plasmapheresis within 1 month prior to baseline.
- Patients who have received other targeted biologic therapies, such as rituximab, eculizumab, tocilizumab, etc., within 3 months prior to baseline.
- Patients who have received any live vaccine within 3 months prior to baseline or plan to receive any vaccine during the study period.
- Patients with a known allergy to human-derived biologics.
- Patients currently participating in another clinical trial.
- Patients deemed unsuitable for participation by the investigator for other reasons (e.g., severe psychiatric disorders).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07355257 · 2025-362