Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
Qualifiers
Fulfilling EFNS/PNS criteria for definite, probable or pure motor CIDP.
No previous treatment with IVIG or SCIG.
Age ≥ 18.
ODSS ≥ 2 - either (arm/leg): 1/1, 2/0 or 0/2 at the time of inclusion.
Disqualifiers
Other causes of neuropathy
Increased risk of thromboembolism
Pregnancy (Plasma HCG is tested at inclusion in all fertile women)
Breast feeding
Trial design
Treatments tested in this trial
- Immunoglobulin
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Aarhus
Lead sponsor
Rigshospitalet, Denmark
Collaborator
Aarhus University Hospital
Collaborator
Odense University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Source ClinicalTrials.gov