Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized, Multicenter, 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
Brief Summary: This is a prospective, multicenter, randomized, 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 CIDP.

Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks before screening will be assessed during 4 separate study periods. Patients first undergo a Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the study. Patients entering the 24 week SC Treatment Period will be randomized 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 Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and electrophysiological evaluations.


Options:
A: Arm Label: IgPro10; Type: EXPERIMENTAL; Interventions: Biological: 10% liquid formulation of human immunoglobulin | Intervention Type: BIOLOGICAL; Name: 10% liquid formulation of human immunoglobulin; Assigned to Arm(s): IgPro10
B: Arm Label: IgPro20 low dose; Type: EXPERIMENTAL; Interventions: Biological: IgPro20 (low dose), Biological: IgPro10 | Arm Label: IgPro20 high dose; Type: EXPERIMENTAL; Interventions: Biological: IgPro10, Biological: IgPro20 (high dose) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo, Biological: IgPro10 | Intervention Type: BIOLOGICAL; Name: IgPro20 (low dose); Assigned to Arm(s): IgPro20 low dose | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: BIOLOGICAL; Name: IgPro10; Assigned to Arm(s): IgPro20 high dose, IgPro20 low dose, Placebo | Intervention Type: BIOLOGICAL; Name: IgPro20 (high dose); Assigned to Arm(s): IgPro20 high dose
C: Arm Label: Group 1; Type: EXPERIMENTAL; Interventions: Drug: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified | Arm Label: Group 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Albumin (Human) 25%, United States Pharmacopeia (USP) | Intervention Type: DRUG; Name: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified; Assigned to Arm(s): Group 1 | Intervention Type: DRUG; Name: Albumin (Human) 25%, United States Pharmacopeia (USP); Assigned to Arm(s): Group 2
D: Arm Label: 0.5 g/kg NewGam; Type: EXPERIMENTAL; Interventions: Drug: NewGam | Arm Label: 1.0 g/kg NewGam; Type: EXPERIMENTAL; Interventions: Drug: NewGam | Arm Label: 2.0 g/kg NewGam; Type: EXPERIMENTAL; Interventions: Drug: NewGam | Intervention Type: DRUG; Name: NewGam; Assigned to Arm(s): 0.5 g/kg NewGam, 1.0 g/kg NewGam, 2.0 g/kg NewGam

Answer: B