Brief Title
Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy
Official Title
Prospective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy
Brief Summary
Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy
Detailed Description
Prospective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy ("ProCID trial")
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
Secondary Outcome
Decrease in the Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score
Condition
Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy
Intervention
NewGam
Study Arms / Comparison Groups
0.5 g/kg NewGam
Description: All patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (0.5g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
142
Start Date
September 27, 2017
Completion Date
September 5, 2019
Primary Completion Date
September 5, 2019
Eligibility Criteria
Inclusion Criteria: 1. Patients with diagnosis of definite or probable Chronic inflammatory demyelinating polyneuropathy (CIDP) according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) Guideline 2010 [van den Bergh et al., 2010]; including patients with Multifocal Acquired Demyelinating Sensory And Motor Neuropathy (MADSAM) or pure motor Chronic inflammatory demyelinating polyneuropathy (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 Inflammatory Neuropathy Cause and Treatment (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 Exclusion Criteria: 1. Unifocal forms of Chronic inflammatory demyelinating polyneuropathy (CIDP) 2. Pure sensory Chronic inflammatory demyelinating polyneuropathy (CIDP) 3. Multifocal motor neuropathy (MMN) with conduction block [van den Bergh et al., 2010] 4. Patients who previously failed immunoglobulin treatment 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 1. connective tissue disease or systemic lupus erythematosus (SLE) 2. HIV infection, hepatitis, Lyme disease 3. cancer (with the exception of basal cell skin cancer) 4. 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 deep vein thrombosis (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 patients don't receive adequate substitution therapy 18. Medical conditions whose symptoms and effects could alter protein catabolism and/or Immunoglobulin G (IgG) utilization (e.g. protein-losing enteropathies, nephrotic syndrome) 19. Known Immunoglobulin A (IgA) deficiency with antibodies to Immunoglobulin A (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 investigational medicinal product (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 vasectomized partner) while on study
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Wolfgang Frenzel, MD, ,
Location Countries
Bulgaria
Location Countries
Bulgaria
Administrative Informations
NCT ID
NCT02638207
Organization ID
NGAM-08
Responsible Party
Sponsor
Study Sponsor
Octapharma
Study Sponsor
Wolfgang Frenzel, MD, Study Director, Octapharma
Verification Date
January 2021