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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: OPV117059: A Long-Term Extension Study of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris

Brief 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).

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Number of subjects with adverse events(AEs) [ Time Frame: Up to Week 60 ]
  • Severity of adverse events [ Time Frame: Up to Week 60 ]
  • Number of subjects with adverse events related to ofatumumab SC [ Time Frame: Up to Week 60 ]
  • Number of subjects with Serious adverse events (SAEs) [ Time Frame: Up to Week 156 ]
  • Number of subjects withdrawn due to treatment-related AEs [ Time Frame: Up to Week 60 ]
  • Number of subjects with AEs leading to permanent discontinuation of ofatumumab SC [ Time Frame: Up to Week 60 ]
  • Number of subjects with AEs of special interest [ Time Frame: Up to Week 156 ]
    AEs of special interest includes opportunistic infections, serious post-injection (inj) systemic reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B infection or reactivation, severe mucocutaneous reactions, cytopenias, and cardiovascular events
  • Number of subjects with Infections [ Time Frame: Up to Week 60 ]
  • Number of subjects with Post-injection systemic reactions [ Time Frame: Up to Week 60 ]
  • Number of subjects with injection site reactions [ Time Frame: Up to Week 60 ]
  • Change from Baseline in blood pressure [ Time Frame: Baseline (Week 0) and up to Week 60 ]
    Blood pressure includes systolic and diastolic blood pressure measured after at least 5 minut

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Time to sustained remission on minimal steroid therapy [ Time Frame: Up to Week 60 ]
      It is time from baseline (Week 0) to the time the subject initially tapered his/her oral prednisone/prednisolone dose to <=10 milligram (mg)/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or non-healing (established) lesions for >= 8 weeks and maintained that status until Week 60
    • Duration of remission on minimal steroid therapy [ Time Frame: Up to Week 60 ]
      It is total time (sum) of all periods of remission while on minimal steroid therapy (oral prednisone/prednisolone dose <=10 mg/day) up to Week 60
    • Proportion of subjects achieving sustained remission on minimal steroid therapy by Week 60 [ Time Frame: Up to Week 60 ]
      Sustained remission on minimal steroid therapy is the time from baseline to the time the subject initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or nonhealing (established) lesions for >=8 weeks and maintained that status until Week 60
    • Time to remission off steroid therapy by Week 60 [ Time Frame: Up to Week 60 ]
      Remission is defined as absence of new or non-healing (established) lesions for >=8 weeks
    • Proportion of subjects achieving remission while off steroid therapy by Week 60 [ Time Frame: Up to Week 60 ]
    • Proportion of subjects achieving remission on minimal steroid therapy [ Time Frame: Up to Week 60 ]
      Remission is defined as absence of new or nonhealing (established) lesions for >=8 weeks and minimal steroid therapy is defined as an oral prednisone/prednisolone dose of <=10 mg/day
    • Time to remission on minimal steroid therapy [ Time Frame: Up to Week 60 ]
      Time from baseline to the time the subject initially tapered his/her oral prednisone/prednisolone dose to <=10 mg/day and maintained <=10 mg/day of oral prednisone/prednisolone with no new or nonhealing (established) lesions for >=8 weeks by Week 60
    • Duration of remission after completing the ofatumumab SC treatment course (i.e., during the Individualized Follow-up Period) [ Time Frame: Up to Week 60 ]
      Subjects who are in remission on minimal steroid therapy by Week 60 of the extension study
    • Time to initial flare/relapse by Week 60 [ Time Frame: Up to Week 60 ]
      Time to initial flare/relapse is time from baseline to the time of appearance of >= 3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the baseline visit
    • Proportion of subjects who do not flare/relapse [ Time Frame: Up to Week 60 ]
      Appearance of >= 3 new lesions within 1 month that do not heal spontaneously within 1 week, or when there is an extension (worsening) of lesions that were present at the baseline visit
    • Proportion of subjects who do not flare/relapse on minimal steroid therapy [ Time Frame: Up to Week 60 ]
    • Time to initial flare/relapse after completing the ofatumumab SC treatment course that is during the Individualized Follow-up Period [ Time Frame: Up to Week 60 ]
      Time to initial flare/relapse is time from baseline to the time of appearance of >= 3 new lesions within 1 month that do not heal spontaneously within 1 week, or to the time when there is an extension of lesions that were present at the baseline visit
    • Number of days minimal steroid therapy is maintained by Week 60 [ Time Frame: Up to Week 60 ]
      Minimal steroid therapy is an oral prednisone/prednisolone dose of <= 10 mg/day
    • Number of days a subject is off steroid therapy by Week 60 [ Time Frame: Up to Week 60 ]
    • Cumulative dose of corticosteroids [ Time Frame: Up to Week 60 ]
    • Immunogenicity as measured by the incidence, titer, and type of human anti human antibody (HAHA) immune response [ Time Frame: Up to Week 72 ]
      Blood samples for HAHA analysis will be collected at Weeks 12, 24, 36, 48, 60, 72.


    Original Secondary Outcome: Same as current

    Information By: GlaxoSmithKline

    Dates:
    Date Received: November 23, 2015
    Date Started: December 2015
    Date Completion:
    Last Updated: March 9, 2017
    Last Verified: March 2017