Subcutaneous Immunoglobulin in De-novo CIDP (SIDEC)
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.
| Condition(s) | CIDP - Chronic Inflammatory Demyelinating Polyneuropathy |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * 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. Clinical criteria for typical CIDP * Chronically progressive, stepwise, or recurrent symmetric proximal and distal weakness and sensory dysfunction of all extremities, developing over at least 2 months; cranial nerves may be affected. * Absent or reduced tendon reflexes in all extremities. Criteria for pure motor CIDP • Pure motor affection; otherwise as for typical CIDP. Electrophysiological criteria for CIDP 1. Motor distal latency prolongation ≥50% above ULN in two nerves (excluding median neuropathy at the wrist from carpal tunnel syndrome), or 2. Reduction of motor c |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Aarhus |
| Locations | Aalborg, Denmark; Aarhus C, Denmark; Copenhagen, Denmark; Odense, Denmark |
| Start date | 2020-06-04 |
| NCT ID | NCT04589299 |
| Official listing | https://clinicaltrials.gov/study/NCT04589299 |