Two different doses of IgPro20 for the treatment of CIDP

• Research type

  Research Study

• Full title

  Randomised, multicentre, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study

• IRAS ID

  96579

• Contact name

  Siraj Misbah

• Sponsor organisation

  CSL Behring GmbH

• Eudract number

  2011-003448-28

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is designed to answer the question: Is subcutaneous immunoglobulin (SCIG) treatment effective in the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). This is a prospective, multicenter, randomised, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20 compared with placebo for maintenance treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Patients on intravenous immunoglobulin (IVIG) maintenance therapy enrolled in the study will be assessed during 3 separate study periods. In order to avoid recruiting patients whose disease may have gone into remission, patients first undergo an IVIG withdrawal period of up to 12 weeks to assess the need for ongoing immunoglobulin treatment. Those patients experiencing CIDP relapse during the withdrawal period will be administered IVIG during an IVIG Re-stabilisation Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilisation Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomised to receive weekly infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo. The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the INCAT score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  12/SC/0153

• Date of REC Opinion

  23 May 2012

• REC opinion

  Further Information Favourable Opinion