Randomized, parallel study of subcutaneous versus intravenous immunoglobulin in treatment-naïve patients with chronic inflammatory demyelinating polyneuropathy

Conditions

Chronic inflammatory demyelinating polyneuropathy (CIDP)

Brief summary

Change in Overall Disability Sum score (ODSS) measured by questionnaire from baseline until end of phase I (26 weeks), Change in Overall Disability Sum score (ODSS) measured by questionnaire from start of phase II and until the lovest effective dosage of immunoglobulin has been reached (up til 60 weeks)

Detailed description

Change in parameters describing muscle strength and sensory: Grip strength, MRC-score, INCAT Sensory Sum Score (ISSS), Change in parameters describing functional ability: 10-meter-walk test (10-MWT), 6-spot-step test (6-SST), 9-hole-peg test (9-HPT), Change in parameters describing disability, quality of life, pain and treatment satisfaction: QoL (EQ-5D-5L), Fatigue Severity Scale (FSS), Neuropathic Pain Symptom Inventory (NPSI), Rasch built overall disability scale (RODS) and Treatment Satisfaction Questionnaire for Medication (TSQM), Serum samples: Plasma IgG, Hematology: hemoglobin, reticulocyte count, haptoglobin, bilirubin, plasma haemoglobin, leukocyte count, thrombocyte count., Fluctuations in describing parameter in each arm at pre-defined time points according to IVIG infusions (pre versus post IVIG): Week 0, 4 and 20 versus week 2, 14 and 26

Related papers

No related papers found yet.

Interventions

DRUGHizentra 200 mg/ml solution for subcutaneous injection

DRUGPrivigen 100 mg/ml solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in Overall Disability Sum score (ODSS) measured by questionnaire from baseline until end of phase I (26 weeks), Change in Overall Disability Sum score (ODSS) measured by questionnaire from start of phase II and until the lovest effective dosage of immunoglobulin has been reached (up til 60 weeks)	—

Secondary

Measure	Time frame
Change in parameters describing muscle strength and sensory: Grip strength, MRC-score, INCAT Sensory Sum Score (ISSS), Change in parameters describing functional ability: 10-meter-walk test (10-MWT), 6-spot-step test (6-SST), 9-hole-peg test (9-HPT), Change in parameters describing disability, quality of life, pain and treatment satisfaction: QoL (EQ-5D-5L), Fatigue Severity Scale (FSS), Neuropathic Pain Symptom Inventory (NPSI), Rasch built overall disability scale (RODS) and Treatment Satisfaction Questionnaire for Medication (TSQM), Serum samples: Plasma IgG, Hematology: hemoglobin, reticulocyte count, haptoglobin, bilirubin, plasma haemoglobin, leukocyte count, thrombocyte count., Fluctuations in describing parameter in each arm at pre-defined time points according to IVIG infusions (pre versus post IVIG): Week 0, 4 and 20 versus week 2, 14 and 26	—

Measure

Time frame

Change in parameters describing muscle strength and sensory: Grip strength, MRC-score, INCAT Sensory Sum Score (ISSS), Change in parameters describing functional ability: 10-meter-walk test (10-MWT), 6-spot-step test (6-SST), 9-hole-peg test (9-HPT), Change in parameters describing disability, quality of life, pain and treatment satisfaction: QoL (EQ-5D-5L), Fatigue Severity Scale (FSS), Neuropathic Pain Symptom Inventory (NPSI), Rasch built overall disability scale (RODS) and Treatment Satisfaction Questionnaire for Medication (TSQM), Serum samples: Plasma IgG, Hematology: hemoglobin, reticulocyte count, haptoglobin, bilirubin, plasma haemoglobin, leukocyte count, thrombocyte count., Fluctuations in describing parameter in each arm at pre-defined time points according to IVIG infusions (pre versus post IVIG): Week 0, 4 and 20 versus week 2, 14 and 26

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Countries

Denmark

Outcome results

None listed