CIDP - Chronic Inflammatory Demyelinating Polyneuropathy Clinical Trial
— SIDECOfficial title:
Randomized, Parallel Study of Subcutaneous Versus Intravenous Immunoglobulin in Treatment-naïve Patients With Chronic Inflammatory Demyelinating Polyneuropathy
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | December 31, 2030 |
| Est. primary completion date | December 31, 2030 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 conduction velocity =30% below LLN in two nerves, or 3. Prolongation of F-wave latency =30% above ULN in two nerves (=50% if amplitude of distal negative peak CMAP =80% of LLN values), or 4. Absence of F-waves in two nerves of these nerves have distal negative peak CMAP amplitudes =20% of LLN + =1 other demyelinating parameter in =1 other nerve, or 5. Partial motor conduction block: =50% amplitude reduction of the proximal negative peak CMAP relative to distal, if distal negative peak CMAP >20% of LLN, in two nerves, or in one nerve + =1 other demyelinating parameter in =1 other nerve, or 6. Abnormal dispersion (=30% duration increase between the proximal and distal negative peak CMAP) in =2 nerves, or 7. Distal CMAP duration (interval between onset of the first negative peak an return to baseline of the last negative peak) increase in =1 nerve (median =6.6 ms, ulnar =6.7 ms, peroneal =7.6 ms, tibial =8.8 ms) + =1 other demyelinating parameter in =1 other nerve Electrophysiological criteria for probable CIDP (a) =30% amplitude reduction of the proximal negative peak CMAP relative to distal, excluding the posterior tibial nerve, if distal negative peak CMAP =20% of LLN, in two nerves, or in one nerve + =1 other demyelinating parameter in =1 other nerve Exclusion Criteria: - Other causes of neuropathy - Increased risk of thromboembolism - Pregnancy (Plasma HCG is tested at inclusion in all fertile women) - Breast feeding - Malignancy - Severe medical disease - Other immune modulating treatment than low dose steroid (prednisolon < 25 mg daily) within the last 6 months prior to inclusion - Hepatitis B or C or HIV infection (screening at inclusion) - Known IgA deficiency - Known allergy to consents in PRIVIGEN or HIZENTRA - Body weight > 120 kg After treatment initiation: - Pregnancy - Serious medical disease that affects treatment or examinations - Non-compliance to treatment - Initiation of other immune modulating therapy - Unacceptable side effects - Withdrawal of consent to participate (drop-out) |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| University of Aarhus | Aalborg University Hospital, Aarhus University Hospital, Odense University Hospital, Rigshospitalet, Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | Week 26 to 86 | |
| Primary | Change in disability | Evaluated with overall disability sum score (ODSS) | Week 0 to 26 | |
| Secondary | Change in grip strength | Grip strength (JAMAR) | Week 0 to 26 | |
| Secondary | Change in general muscle strength | MRC-score | Week 0 to 26 | |
| Secondary | Change in sensation | INCAT-Sensory Sum Score (ISS) | Week 0 to 26 | |
| Secondary | Change in walking performance | 10-meter-walk test (10-MWT) | Week 0 to 26 | |
| Secondary | Change in walking performance and imbalance | 6-spot-step test (6-SST) | Week 0 to 26 | |
| Secondary | Change in dexterity | 9-hole-peg test (9-HPT) | Week 0 to 26 | |
| Secondary | Change in quality of life | QoL (EQ-5D-5L incl. VAS) | Week 0 to 26 | |
| Secondary | Change in fatigue severity | Fatigue Severity Scale (FSS) | Week 0 to 26 | |
| Secondary | Change in pain severity | Neuropathic Pain Symptom Inventory (NPSI) | Week 0 to 26 | |
| Secondary | Change in disability | Rasch built overall disability scale (RODS) | Week 0 to 26 | |
| Secondary | Change in treatment satisfaction | Life Quality Index (LQI) | Week 2 to 26 | |
| Secondary | Serum samples | Plasma IgG Hematology: hemoglobin, reticulocyte count, haptoglobin, bilirubin, plasma haemoglobin, leukocyte count, thrombocyte count.
Inflammatory biomarkers: sCD163 and neurofilament |
Week 0 to 26 | |
| Secondary | 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) | Week 0 to 26 |