drugset / Trial / NCT00640328

Ofatumumab Dose-finding in Relapsing Remitting Multiple Sclerosis (RRMS) Patients

NCT00640328

Phase 2 Completed 38 enrolled GlaxoSmithKline
RandomizedCrossoverQuadruple-blindTreatment

Summary

The trial consists of a dose escalation, to establish the safety of ofatumumab in RRMS patients. A 48-week treatment period followed by an individualized follow-up period until normalization of peripheral B-cell counts or Immunoglobulin G (IgG) levels.

Timeline

Start
2008-05
Primary completion
2010-05
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Ofatumumab Monoclonal antibody 100 mg
Subject Ofatumumab Monoclonal antibody 300 mg
Subject Ofatumumab Monoclonal antibody 700 mg

Indications