Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

1.Patients with diagnosis of definite or probable CIDP according to the EFNS/PNS Guideline 2010; including patients with Multifocal Acquired Demyelinating Sensory And Motor Neuropathy (MADSAM) or pure motor CIDP
2.Patients currently depending on treatment with immunoglobulins or corticosteroids
3.Patients with active disease, i.e. not being in remission, who are progressive or relapsing prior to trial start or during the Wash-out Phase
4.Weakness of at least 2 limbs
5.= 18 to < 80 years of age
6.Adjusted INCAT disability score between 2 and 9 (with a score of 2 coming exclusively from leg disability)
7.Voluntarily given, fully informed written consent obtained from patient before any study-related procedures are conducted

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 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.Unifocal forms of CIDP
2.Pure sensory CIDP
3.MMN with conduction block
4.Patients who previously failed immunoglobulin therapy
5.Treatment with immunomodulatory/suppressive agents (cyclosporin, methotrexate, mitoxantrone, mycophenolate mofetil or azathioprine) during the six months prior to baseline visit
6.Patients on or treated with rituximab, alemtuzumab, cyclophosphamide, or other intensive chemotherapeutic regimens, previous lymphoid irradiation or stem cell transplantation during the 12 months prior to baseline visit
7.Respiratory impairment requiring mechanical ventilation
8.Myelopathy or evidence of central nervous system demyelination or significant persisting neurological deficits from stroke, or central nervous system (CNS) trauma
9.Clinical evidence of peripheral neuropathy from another cause such as:
a.connective tissue disease or systemic lupus erythematosus (SLE)
b.HIV infection, hepatitis, Lyme disease
c.cancer (with the exception of basal cell skin cancer)
d.IgM paraproteinemia with anti-myelin associated glycoprotein antibodies
10.Diabetic neuropathy
11.Cardiac insufficiency (New York Heart Association [NYHA] III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease
12.Severe liver disease (ALAT 3x > normal value)
13.Severe kidney disease (creatinine 1.5x > normal value)
14.Hepatitis B, hepatitis C or HIV infection
15.Thromboembolic events: patients with a history of deep vein thrombosis (DVT) within the last year prior to baseline visit or pulmonary embolism ever; patients with susceptibility to embolism or DVT
16.Body mass index (BMI) =40 kg/m2
17.Patients with uncompensated hypothyroidism (abnormally high Thyroid-Stimulating Hormone [TSH] and abnormally low Thyroxine [T4]) or known vitamin B12 deficiency if they don’t receive adequate substitution therapy
18.Medical conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
19.Known IgA deficiency with antibodies to IgA
20.History of severe hypersensitivity, e.g. anaphylaxis or severe systemic response to immuno-globulin, blood or plasma derived products, or any component of NewGam
21.Known blood hyperviscosity, or other hypercoagulable states
22.Use of other blood or plasma-derived products within three months prior to Visit 2
23.Patients with a past or present history of drug abuse or alcohol abuse within the preceding five years prior to baseline visit
24.Patients unable or unwilling to understand or comply with the study protocol
25.Participation in another interventional clinical study with IMP treatment currently or during the three months prior to Visit 2
26.Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to use an effective birth control method (such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasect

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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