Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Telitacicept 240mg

    Drug

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Experimental: Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Physician's Global Assessment (PGA) Score

Time frame
From enrollment to the end of treatment at 12 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhongming Qiu

Lead sponsor

Xinqiao Hospital of Chongqing

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: