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.
In fase I the patients are followed for 26 weeks on a fixed dose of 0.54 g/kg/week in the SCIG group (total 14 g/kg) and 2 g/kg/4week in the IVIG group (total 14 g/kg). The patients automatically continue in fase II in which treatment is reduced every 12 weeks (90%, 75%, 50%, 25% and 0%) over a course 60 weeks. The patients are evaluated at every visit with overall disability sum score (ODSS), grip strength, medical research council score (MRC-score), INCAT-Sensory Sum Score (ISS), 10-meter-walk test (10-MWT), 6-spot-step test (6-SST), 9-hole-peg test (9-HPT), quality of life (EQ-5D-5L), Fatigue Severity Scale (FSS), Neuropathic Pain Symptom Inventory (NPSI), Rasch built overall disability scale (RODS) and Life Quality Index (LQI) and blood samples.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Randomization 1:1 to the same total dose of either SCIG or IVIG for 26 weeks of stable dose + 60 weeks of redcution.
Department of Neurology, Aalborg University Hospital
Aalborg, Denmark
NOT_YET_RECRUITINGDepartment of Neurology, Aarhus University Hospital
Aarhus C, Denmark
RECRUITINGDepartment of Neurology, Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark
NOT_YET_RECRUITINGChange in disability
Evaluated with overall disability sum score (ODSS)
Time frame: Week 0 to 26
Change in grip strength
Grip strength (JAMAR)
Time frame: Week 0 to 26
Change in general muscle strength
MRC-score
Time frame: Week 0 to 26
Change in sensation
INCAT-Sensory Sum Score (ISS)
Time frame: Week 0 to 26
Change in walking performance
10-meter-walk test (10-MWT)
Time frame: Week 0 to 26
Change in walking performance and imbalance
6-spot-step test (6-SST)
Time frame: Week 0 to 26
Change in dexterity
9-hole-peg test (9-HPT)
Time frame: Week 0 to 26
Change in quality of life
QoL (EQ-5D-5L incl. VAS)
Time frame: Week 0 to 26
Change in fatigue severity
Fatigue Severity Scale (FSS)
Time frame: Week 0 to 26
Change in pain severity
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Department of Neurology, Odense University Hospital
Odense, Denmark
NOT_YET_RECRUITINGNeuropathic Pain Symptom Inventory (NPSI)
Time frame: Week 0 to 26
Change in disability
Rasch built overall disability scale (RODS)
Time frame: Week 0 to 26
Change in treatment satisfaction
Life Quality Index (LQI)
Time frame: Week 2 to 26
Serum samples
Plasma IgG Hematology: hemoglobin, reticulocyte count, haptoglobin, bilirubin, plasma haemoglobin, leukocyte count, thrombocyte count. Inflammatory biomarkers: sCD163 and neurofilament
Time frame: Week 0 to 26
Fluctuations in the describing parameters (ODSS and RODS) in both groups (SCIG and IVIG) based on measurement at time points for treatment with IVIG
Average value of examinations made at week 0, 4 and 20 (prior to IVIG infusion) Average value of examinations made at week 2, 14 and 26 (2 weeks after IVIG infusion)
Time frame: Week 0 to 26