This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of Telitacicept in patients with refractory chronic inflammatory demyelinating polyneuropathy (CIDP). Eligible patients will be randomly assigned to receive either conventional therapy alone or Telitacicept plus conventional therapy for 24 weeks. Efficacy will be assessed using CIDP-related clinical and functional measures, including the Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Inflammatory Rasch-built Overall Disability Scale (I-RODS), Medical Research Council (MRC) sum score, grip strength, and the Timed Up and Go (TUG) test. Safety will be evaluated by monitoring adverse events, including their onset, duration, clinical manifestations, and management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Conventional therapy may include intravenous immunoglobulin or corticosteroids, with immunosuppressive agents permitted when clinically indicated.
Telitacicept will be administered by subcutaneous injection in addition to conventional therapy for 24 weeks.
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Percentage of Participants With Confirmed Evidence of Clinical Improvement
Percentage of participants with confirmed evidence of clinical improvement, defined according to prespecified improvements in CIDP-related clinical and functional assessments.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in Adjusted INCAT Disability Score
Change from baseline in the adjusted Inflammatory Neuropathy Cause and Treatment disability score.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in MRC Sum Score
Change from baseline in the Medical Research Council sum score.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in I-RODS Score
Change from baseline in the Inflammatory Rasch-built Overall Disability Scale score.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in Timed Up and Go Test
Change from baseline in the Timed Up and Go test.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in Mean Grip Strength
Change from baseline in mean grip strength.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Incidence of Adverse Events
Incidence of adverse events during the study period, including the time of onset, duration, clinical manifestations, severity, relationship to study treatment, and actions taken.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
Change From Baseline in Serum IgG Levels
Change from baseline in serum immunoglobulin G levels during the study period.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 16, and Week 24
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