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immunoglobulin

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

immunoglobulin · 1 trial · 1 indication

Phase 2 1
NCT01017159Subcutaneous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
COMPLETED30 Analytics
PHASE2COMPLETED
Subcutaneous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingUnlock trial analytics

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 to 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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Frequently asked questions about immunoglobulin

What is immunoglobulin used for in chronic inflammatory demyelinating polyradiculoneuropathy?

Immunoglobulin is being studied for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a neurological condition. It is administered subcutaneously and is currently in Phase 2 clinical development as an investigational therapy for this indication.

Who makes immunoglobulin?

Immunoglobulin is being developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker symbol BAX. The company is conducting clinical research on this therapy for chronic inflammatory demyelinating polyradiculoneuropathy.

What phase is immunoglobulin in?

Immunoglobulin is in Phase 2 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. A Phase 2 clinical trial for this drug has been completed, involving 30 participants with chronic inflammatory demyelinating polyradiculoneuropathy.

What clinical trials is immunoglobulin in?

Immunoglobulin has one completed clinical trial, registered as NCT01017159, titled "Subcutaneous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)." This Phase 2 study enrolled 30 participants in Denmark and was a randomized, double-blind, placebo-controlled trial.

Is immunoglobulin the same as subcutaneous immunoglobulin?

Immunoglobulin is administered subcutaneously in the clinical trial for chronic inflammatory demyelinating polyradiculoneuropathy. The study specifically evaluates subcutaneous immunoglobulin treatment, and the drug is referred to as immunoglobulin in the trial registration.