Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy

Summary

The objective of this study is to demonstrate the efficacy and safety of Privigen in subjects with CIDP.

Timeline

Start

2010-11

Primary completion

2011-11

Completion

2011-11

Outcome

Met primary endpoint

release “single-arm study investigating the efficacy and safety of Privigen in previously IVIG-treated and untreated patients with CIDP achieved its primary efficacy endpoint” csl.com ↗

Publications

• Results Leger JM, De Bleecker JL, Sommer C, Robberecht W, Saarela M, Kamienowski J, Stelmasiak Z, Mielke O, Tackenberg B, Shebl A, Bauhofer A, Zenker O, Merkies IS; PRIMA study investigators. Efficacy and safety of Privigen((R)) in patients with chronic inflammatory demyelinating polyneuropathy: results of a prospective, single-arm, open-label Phase III study (the PRIMA study). J Peripher Nerv Syst. 2013 Jun;18(2):130-40. doi: 10.1111/jns5.12017.
• Merkies ISJ, Lawo JP, Edelman JM, De Bleecker JL, Sommer C, Robberecht W, Saarela M, Kamienowski J, Stelmasiak Z, Mielke O, Tackenberg B, Leger JM; PRIMA trial investigators. Minimum clinically important difference analysis confirms the efficacy of IgPro10 in CIDP: the PRIMA trial. J Peripher Nerv Syst. 2017 Jun;22(2):149-152. doi: 10.1111/jns.12204. No abstract available.

Drugs

Indications