Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP

Launched by OCTAPHARMA · Oct 19, 2010

Keywords

ClinConnect Summary

This is a Phase 2/3 study that will take place in 2 stages. The primary objective of Stage 1 (Phase 2 dose-finding part)is to determine and select one dosage from three NewGam maintenance dosage arms in comparison with a placebo arm, based on the percentage of responders (response defined as a decrease, meaning improvement, in the adjusted INCAT disability score by at least 1 point). The selected NewGam dosage and placebo will be employed and compared in Stage 2.

The primary objective of Stage 2 (Phase 3 confirmatory part) is to demonstrate superiority of the maintenance dosage regimen sel...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients diagnosed as having CIDP based on fulfilment of clinical criteria of the INCAT Group and the definite electrophysiological criteria for CIDP ; patients with MADSAM or pure motor CIDP will be included provided they fulfil these criteria
• • Worsening of disability and objective increase in weakness or sensory deficit during the 6 months prior to screening
• • \>=18 years of age
• Exclusion Criteria:
• • Unifocal forms of CIDP
• • Pure sensory CIDP
• • MMN with conduction block
• • Treatment of CIDP with immunoglobulins (intravenous or subcutaneous) at any time prior to study entry
• • Steroids of any type equivalent to prednisolone or prednisone \> 10 mg/day or equivalent plasma exchange (PE) during the last 3 months prior to baseline visit
• • Treatment with cyclosporin, methotrexate, mitoxantrone, mycophenolate mofetil, interferon or other immunosuppressive or immunomodulatory drugs during the three months prior to baseline visit
• • Clinical evidence of peripheral neuropathy from another
• • Known diabetes mellitus
• • Other serious medical condition complicating assessment or treatment
• • Thromboembolic events: patients with a history of deep vein thrombosis (DVT) within the last year prior to baseline visit or pulmonary embolism ever
• • Known IgA deficiency with antibodies to IgA
• • History of hypersensitivity, anaphylaxis or severe systemic response to immunoglobulin, blood or plasma derived products, or any component of NewGam
• • Known blood hyperviscosity