Last updated: 11/03/2018 19:34:12
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.

Drug Use Investigation for ARZERRA® Chronic Lymphocytic Leukemia (CLL)

GSK study ID
116789
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Drug Use Investigation for ARZERRA® Chronic Lymphocytic Leukemia (CLL)
Trial description: This is a post-marketing surveillance (PMS) study conducted in Japan. The study aims to collect the safety and effectiveness information of ofatumumab in clinical practice and identify the status of occurrence of adverse drug reactions (ADRs) and factors affecting the safety and effectiveness.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of ADRs

Timeframe: 3 months

Secondary outcomes:
Not applicable
Interventions:
  • Drug: ofatumumab
    • Enrollment:
    300
    Primary completion date:
    Not applicable
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Leukaemia, Lymphocytic, Chronic
    Product
    ofatumumab
    Collaborators
    Not applicable
    Study date(s)
    July 2013 to March 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Patients with relapsed or refractory CD20-positive CLL
    • Patients treated with ofatumumab
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patients with relapsed or refractory CD20-positive CLL
    • Patients treated with ofatumumab
    Exclusion criteria:
    • None

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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    Access to clinical trial data by researchers
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