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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Immunoglobulin
Biological/VaccineRandomization 1:1 to the same total dose of either SCIG or IVIG for 26 weeks of stable dose + 60 weeks of redcution.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Patients treated with immunoglobulin intravenously (IVIG)Active comparator 1 intervention
Group B: Patients treated with immunoglobulin subcutaneously (SCIG)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in disability
Evaluated with overall disability sum score (ODSS)
Time frame
Week 0 to 26Secondary outcomes
1
Change in grip strength
Grip strength (JAMAR)
Time frame
Week 0 to 262
Change in general muscle strength
MRC-score
Time frame
Week 0 to 263
Change in sensation
INCAT-Sensory Sum Score (ISS)
Time frame
Week 0 to 264
Change in walking performance
10-meter-walk test (10-MWT)
Time frame
Week 0 to 26Other outcomes
1
The lowest dose of IVIG or SCIG reached during the 60 weeks of reduction (Fase II).
Monitored on ODSS and the same secondary parameters as in week 0 to 26
Time frame
Week 26 to 86Sponsors and contacts
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University of Aarhus
Lead sponsor
Rigshospitalet, Denmark
Collaborator
Aarhus University Hospital
Collaborator
Odense University Hospital
Collaborator
Aalborg University Hospital
Collaborator
Source ClinicalTrials.gov