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RECRUITING
NCT04589299
PHASE4

Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)

Sponsor: University of Aarhus

View on ClinicalTrials.gov

Summary

SIDEC - (Subcutaneous Immunoglobulin in De-novo CIDP) ia a study designed as a randomized, parallel study with an open-label extension phase. The aims are to compare the effect of SCIG and IVIG in 60 treatment-naïve CIDP patients, and to detect the lowest effective dosage for maintenance treatment.

Official title: Randomized, Parallel Study of Subcutaneous Versus Intravenous Immunoglobulin in Treatment-naïve Patients With Chronic Inflammatory Demyelinating Polyneuropathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2020-06-04

Completion Date

2030-12-31

Last Updated

2024-05-17

Healthy Volunteers

No

Interventions

BIOLOGICAL

Immunoglobulin

Randomization 1:1 to the same total dose of either SCIG or IVIG for 26 weeks of stable dose + 60 weeks of redcution.

Locations (4)

Department of Neurology, Aalborg University Hospital

Aalborg, Denmark

Department of Neurology, Aarhus University Hospital

Aarhus C, Denmark

Department of Neurology, Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

Department of Neurology, Odense University Hospital

Odense, Denmark