Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adults With gMG

Korábbi kezelés

• History of thymectomy or any other thymic surgery within 6 months prior to Screening. Participants with a history of treated thymic malignancy or carcinoma are eligible if they meet all of the following conditions:
  • Treatment completed > 5 years prior to the Screening Visit
  • No recurrence within the 5 years prior to the Screening Visit
  • No radiological indication of recurrence in a computed tomography (CT) or magnetic resonance imaging (MRI) scan, including administration of intravenous (IV) contrast, performed within 6 months of first dose on Day 1

Más betegség

• Any untreated thymic malignancy, carcinoma, or thymoma
• History of N meningitidis infection or unresolved meningococcal disease

Egyéb

• Weakness only affecting ocular or peri-ocular muscles (MGFA Class I)
• MG crisis at Screening (MGFA Class V). However, such participants may be rescreened with Alexion approval once they are treated and medically stable, in the opinion of the Investigator

• Diagnosis of MG must be made by the following tests:
  • Positive serologic test for anti-AChR Abs as confirmed at Screening, and
  • One of the following:
  • Abnormal neuromuscular transmission demonstrated by repetitive nerve stimulation, or
  • History of positive anticholinesterase test, eg, neostigmine test, or
  • Participant has demonstrated improvement in MG signs on oral cholinesterase inhibitors as assessed by the treating physician
• MGFA Clinical Classification Class II to IV at Screening
• MG-ADL total score must be ≥ 6 at Screening and Day 1
• Participants who have:
  • Failed treatment with 2 or more ISTs over one year (either in combination or as monotherapy), ie, continue to have impairment ADLs (persistent weakness, experience crisis, or unable to tolerate IST) despite ISTs or,
  • Failed at least one IST and require chronic PE or IVIg to control symptoms, ie, participants who require PE or IVIg on a regular basis for the management of muscle weakness at least 2 cycles over last 12 months