Non-inferiority and safety/tolerance of Hyqvia compared to IVIg in 20 MMN patients with at least one conduction block on EMG and stable on IVIg.
Conditions
Interventions
Trade Name: Hyqvia
Product Name: Hyqvia
Pharmaceutical Form: Concentrate for solution for injection/infusion
Sponsors
UMC Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age at onset of MMN, 18 – 65 years. (2) 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. (3) Decreased or absent tendon reflexes in affected limbs. (4) Electrophysiological evidence of one site with definite motor conduction block or one site with probable conduction block according to previously defined criteria. (5) Response to IGIV according to criteria that were described in previous studies. (6) stable on IGIV maintenance treatment in the year preceding the study. (7) Patients have given written informed consent, prior to the study, with the understanding that consent may be withdrawn at any time without prejudice. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: (1) Bulbar signs or symptoms. (2) Upper motor neuron signs (spasticity, hyperreflexia, extensor plantar response). (3) Sensory symptoms and signs with sensory deficits on examination (except for vibration sense) and abnormal results of sensory nerve conduction studies (4) 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). (5) Treatment with other immunosuppressive drugs (cyclophosphamide, azathioprine, cyclosporin) in the 6 months preceding the study. (6) 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 spermacide or d) being sexually inactive. (7) Age < 18 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Test safety/tolerance of Hyqvia compared to IVIg;Secondary Objective: Test non-inferiority of Hyqvia compared to IVIg;Primary end point(s): Test safety/tolerance of Hyqvia compared to IVIg;Timepoint(s) of evaluation of this end point: Final timepoint :After around 9 months usage of Hyqvia per patient. In total eight visits of the outpatient clinic will be organized to monitor safety. In case of intolerability as described in the protocol the patient can be re-switsched to IVIg. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Test non-inferiority of Hyqvia compared to IVIg. ;Timepoint(s) of evaluation of this end point: Final timepoint :After around 9 months usage of Hyqvia per patient. In total eight visits of the outpatient clinic will be organized to monitor non-inferiority. In case of clinical deterioration as described in the protocol the patient can be re-switsched to IVIg. | — |
Countries
Netherlands
Contacts
Public Contactneuromuscular clinical trial nurse
UMC Utrecht
Outcome results
None listed