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immunoglobulin

Phase 2

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Small molecule | Neurology |Baxter International Inc.|Last Updated: Nov 10, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01017159Subcutaneous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)PHASE2 COMPLETED 30 — — Apr 1, 2010Nov 1, 2011Nov 10, 20111 Denmark
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Study Endpoints
Primary Endpoints
Strength assessed by isokinetic strength measurements, in the active treatment group compared with the placebo group.
The study period is 98 days. Isokinetic strength will be measured on day 14, 28, 84 and 98 of the study period. If there is a drop-out before day 84, the strength measurement will take place on this day, and the last two measurements will be left out.
Secondary Endpoints
Efficacy and feasibility of subcutaneous immunoglobulin infusions.
Feasibility will be recorded continously in a patient diary and in the CRF (case report form), and efficacy will be calculated at the end of the study, after approximately three months.
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Subcutaneous immunoglobulinACTIVE_COMPARATOR -
SalinePLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Subcutaneous immunoglobulinDRUGThe subcutaneous immunoglobulin is infused in the subcutaneous tissue on the abdomen twice or thrice a week, with a maximal speed of 2 mL/h. Every time 20 mL is infused, the needle is removed to a new place.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * All patients with typical or pure motor CIDP, who meet the clinical or electrophysiological criteria of the EFNS/PNS for certain or probable CIDP and who are in regular treatment with IVIg on one of the neurological departments in Denmark, are eligible for the study Exclusion...

Countries:Denmark
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