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Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)

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ClinicalTrials.gov Identifier: NCT02556437
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Johannes Jakobsen, Rigshospitalet, Denmark

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Multifocal Motor Neuropathy Drug: HyQvia Drug: Subcuvia Phase 2

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Single-blind, Cross-over Study Investigating the Non-inferiority of Efficacy and Safety of HyQvia in Comparison With Conventional Subcutaneous Ig Therapy in Multifocal Motor Neuropathy
Study Start Date : June 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
24 weeks of treatment with conventional subcutaneous immunoglobulin (Subcuvia) followed by 24 weeks of treatment with HyQvia
Drug: HyQvia
Human immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection
Other Name: Human immunoglobulin

Drug: Subcuvia
Human immunoglobulin 16% for subcutaneous injection
Other Name: Human immunoglobulin

Experimental: Group B
24 weeks of treatment with HyQvia followed by 24 weeks of treatment with conventional subcutaneous immunoglobulin (Subcuvia)
Drug: HyQvia
Human immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection
Other Name: Human immunoglobulin

Drug: Subcuvia
Human immunoglobulin 16% for subcutaneous injection
Other Name: Human immunoglobulin




Primary Outcome Measures :
  1. Changes in isometric muscle strength [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    Measurement of isometric muscle strength of four involved muscle groups


Secondary Outcome Measures :
  1. Changes in disability score [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    Disability are evaluated by the use of Guy´s Neurological Disability Scale

  2. Changes in clinical evaluation of muscle strength [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    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)

  3. Development of Headache and Nausea [ Time Frame: During the entire study period ]
    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.

  4. Development of hemolytic anemia [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    Blood samples are drawn at every visit and are analyzed for hemoglobin and related parameters

  5. Development of antibody against hyaluronidase [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    Blood analyzed for specific antibodies against hyaluronidase

  6. Patient satisfaction [ Time Frame: Evaluation at week: 6, 12, 18, 24, 30, 36, 42, 48 ]
    Patient are asked predefined question about satisfaction with the two treatment regimens and score them on a Visual Analogue Scale from 0-100 mm

  7. Changes in grip strength [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    Grip strength measured by Jamar® Hand dynamometer

  8. Changes in hand/finger function [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    9-hole peg test. Standardized test of hand/finger function.

  9. Changes in gait performance [ Time Frame: Evaluation at week 0, 12, 24, 36, 48 ]
    40 meter walk test. Standardized test of walking performance.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at onset 18 - 65 years.
  • The presence of asymmetrical limb weakness at onset or motor involvement having a motor nerve distribution in at least two peripheral nerve distributions, predominant upper limb involvement, disabling weakness MRC grade 4 or less in at least one muscle.
  • Decreased or absent tendon reflexes in affected limbs.
  • Electrophysiological evidence of one site with definite motor conduction block or one site with probable conduction block according to previously defined criteria.
  • Response to SCIG according to criteria that were described in previous studies
  • On SCIG maintenance treatment for more than 3 months preceding the study.
  • Patients have given written informed consent, prior to the study, with the understanding that consent may be withdrawn at any time without prejudice.

Exclusion Criteria:

  • Bulbar signs or symptoms.
  • Upper motor neuron signs (spasticity, hyperreflexia, extensor plantar response).
  • Sensory symptoms and signs with sensory deficits on examination (except for vibration sense) and abnormal results of sensory nerve conduction studies
  • Other neuropathies (e.g. diabetic, lead, porphyric or vasculitic neuropathy, chronic inflammatory demyelinating polyneuropathy, Lyme neuroborreliosis, post radiation neuropathy, hereditary neuropathy with liability to pressure palsies, Charcot-Marie-Tooth neuropathies, meningeal carcinomatosis).
  • Treatment with other immunosuppressive drugs (cyclophosphamide, azathioprine, cyclosporin) in the 6 months preceding the study.
  • Female patient who is pregnant or breast-feeding or of childbearing potential.
  • Confirmation that the patient is not pregnant will be established by a negative b-HCG test within a 7-day period before inclusion in the study. Lack of childbearing potential is met by a) being post-menopausal, b) being surgically sterile, c) practising contraception with an oral contraceptive, intra-uterine device, diaphragm or condom with spermicide or d) being sexually inactive.
  • Age < 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556437


Locations
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Denmark
Department of Neurology, Aarhus University Hospital
Aarhus C, Denmark, 8000
Department of Neurology, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Johannes Jakobsen
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Johannes Jakobsen, DMSc Neuroscience Center, Rigshospitalet

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Responsible Party: Johannes Jakobsen, Professor, DMSc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02556437     History of Changes
Other Study ID Numbers: RH-2015-200
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Keywords provided by Johannes Jakobsen, Rigshospitalet, Denmark:
Subcutaneous immunoglobulin
MMN
Additional relevant MeSH terms:
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Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs