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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of HyQvia (Immunoglobulin 10% with recombinant hyaluronidase) with conventional subcutaneous immunoglobulin treatment in patients with Multifocal Motor Neuropathy (MMN).
Subcutaneous immunoglobulin (SCIG) therapy for MMN is equally efficacious to intravenous immunoglobulin (IGIV), may be self-induced and may induce fewer systemic adverse reactions. Limited SC infusion volumes and reduced bioavailability, however, necessitate multiple infusion sites, more frequent treatment, and dose adjustment to achieve pharmacokinetic equivalence. This is an issue in particular in MMN where relatively high and frequent doses are necessary to maintain long-term improvement of muscle strength. Recombinant human hyaluronidase (rHuPH20) increases subcutaneous tissue permeability and facilitates dispersion and absorption, enabling subcutaneous administration of higher (monthly) doses of Ig. If treatment with HyQvia is at least equally effective and safe as compared with conventional Ig treatment, HyQvia could become the preferred treatment option for patients with MMN as it may have attractive benefits for patients by its mode of administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | 24 weeks of treatment with conventional subcutaneous immunoglobulin (Subcuvia) followed by 24 weeks of treatment with HyQvia |
|
| Group B | Experimental | 24 weeks of treatment with HyQvia followed by 24 weeks of treatment with conventional subcutaneous immunoglobulin (Subcuvia) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HyQvia | Drug | Human immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in isometric muscle strength | Measurement of isometric muscle strength of four involved muscle groups | Evaluation at week 0, 12, 24, 36, 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in disability score | Disability are evaluated by the use of Guy“s Neurological Disability Scale | Evaluation at week 0, 12, 24, 36, 48 |
| Changes in clinical evaluation of muscle strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Jakobsen, DMSc | Neuroscience Center, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Aarhus University Hospital | Aarhus C | 8000 | Denmark | |||
| Department of Neurology, Rigshospitalet |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Subcuvia | Drug | Human immunoglobulin 16% for subcutaneous injection |
|
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Medical Research Council (MRC) sum score of 9 muscle groups bilateral (shoulder abduction, elbow flexion/extension, wrist flexion/extension, hip flexion, knee flexion/extension, ankle dorsal flexion)
| Evaluation at week 0, 12, 24, 36, 48 |
| Development of Headache and Nausea | Participants are asked to register severity of headache and nausea on a VAS scale from 0-100 mm on every day of infusion and the day after. | During the entire study period |
| Development of hemolytic anemia | Blood samples are drawn at every visit and are analyzed for hemoglobin and related parameters | Evaluation at week 0, 12, 24, 36, 48 |
| Development of antibody against hyaluronidase | Blood analyzed for specific antibodies against hyaluronidase | Evaluation at week 0, 12, 24, 36, 48 |
| Patient satisfaction | Patient are asked predefined question about satisfaction with the two treatment regimens and score them on a Visual Analogue Scale from 0-100 mm | Evaluation at week: 6, 12, 18, 24, 30, 36, 42, 48 |
| Changes in grip strength | Grip strength measured by JamarĀ® Hand dynamometer | Evaluation at week 0, 12, 24, 36, 48 |
| Changes in hand/finger function | 9-hole peg test. Standardized test of hand/finger function. | Evaluation at week 0, 12, 24, 36, 48 |
| Changes in gait performance | 40 meter walk test. Standardized test of walking performance. | Evaluation at week 0, 12, 24, 36, 48 |
| Copenhagen |
| 2100 |
| Denmark |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |