TELITACICEPT IN INFLAMMATORY MYOPATHIES(TELITACICEPT-IM)
ConditionInflammatory Myopathy
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhongming Qiu
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Telitacicept 240mg
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Zhongming Qiu
Lead sponsor
Xinqiao Hospital of Chongqing
Sponsor institution
Source ClinicalTrials.gov