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drugset / Trial / NCT02613910

Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris

NCT02613910 ↗

Phase 3 Terminated 1 enrolled GlaxoSmithKline
NaSingle-groupOpen-labelTreatment

Summary

This study is designed as a multi-country, multicenter, open label extension to Phase III trial OPV116910. The primary objective is to provide continued treatment with ofatumumab subcutaneous (SC) for eligible subjects who complete the OPV116910 trial in order to obtain further long term safety and tolerability information in subjects with pemphigus vulgaris receiving ofatumumab SC every 4 weeks (wk).

Timeline

Start
2015-12-23
Primary completion
2016-03-23
Completion
2016-03-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Ofatumumab Monoclonal antibody 20 mg Subcutaneous
Background Acetaminophen Small molecule 1 g Oral
Background Cetirizine Other / unclassified 10 mg Oral
Background Prednisolone Other / unclassified 2.5 mg Oral
Background Prednisolone Other / unclassified 5 mg Oral
Background Prednisolone Other / unclassified 7.5 mg Oral
Background Prednisolone Other / unclassified 10 mg Oral
Background Prednisolone Other / unclassified 12.5 mg Oral
Background Prednisolone Other / unclassified 15 mg Oral
Background Prednisolone Other / unclassified 17.5 mg Oral
Background Prednisolone Other / unclassified 20 mg Oral
Background Prednisolone Other / unclassified 25 mg Oral
Background Prednisolone Other / unclassified 30 mg Oral
Background Prednisolone Other / unclassified 40 mg Oral
Background Prednisolone Other / unclassified 50 mg Oral
Background Prednisolone Other / unclassified 60 mg Oral
Background Prednisolone Other / unclassified 80 mg Oral
Background Prednisolone Other / unclassified 100 mg Oral
Background Prednisolone Other / unclassified 120 mg Oral
Background Prednisolone Other / unclassified 140 mg Oral
Background Prednisolone Other / unclassified 160 mg Oral
Background Prednisolone Other / unclassified 180 mg Oral
Background Prednisolone Other / unclassified 200 mg Oral
Background Prednisolone Other / unclassified 220 mg Oral
Background Prednisolone Other / unclassified 240 mg Oral
Background Prednisone Other / unclassified 2.5 mg Oral
Background Prednisone Other / unclassified 5 mg Oral
Background Prednisone Other / unclassified 7.5 mg Oral
Background Prednisone Other / unclassified 10 mg Oral
Background Prednisone Other / unclassified 12.5 mg Oral
Background Prednisone Other / unclassified 15 mg Oral
Background Prednisone Other / unclassified 17.5 mg Oral
Background Prednisone Other / unclassified 20 mg Oral
Background Prednisone Other / unclassified 25 mg Oral
Background Prednisone Other / unclassified 30 mg Oral
Background Prednisone Other / unclassified 40 mg Oral
Background Prednisone Other / unclassified 50 mg Oral
Background Prednisone Other / unclassified 60 mg Oral
Background Prednisone Other / unclassified 80 mg Oral
Background Prednisone Other / unclassified 100 mg Oral
Background Prednisone Other / unclassified 120 mg Oral
Background Prednisone Other / unclassified 140 mg Oral
Background Prednisone Other / unclassified 160 mg Oral
Background Prednisone Other / unclassified 180 mg Oral
Background Prednisone Other / unclassified 200 mg Oral
Background Prednisone Other / unclassified 220 mg Oral
Background Prednisone Other / unclassified 240 mg Oral

Indications

pemphigus