Last updated: 07/21/2020 18:50:11

Impact of Disease Activity on Mortality and Damage Progression in Systemic Lupus Erythematosus (SLE) Patients with Active Disease despite Standard of Care in the Toronto Lupus Cohort

GSK study ID
201390
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Impact of Disease Activity on Mortality and Damage Progression in Systemic Lupus Erythematosus (SLE) Patients with Active Disease despite Standard of Care in the Toronto Lupus Cohort
Trial description: This study will explore the relationship between disease activity on organ damage and mortality in lupus patients with active lupus (defined as SLE Disease Activity Index-2000; SLEDAI-2K >=6 despite standard of care).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Primary

Timeframe: Minimum of 3 years of follow-up

Secondary outcomes:

Secondary

Timeframe: Minimum of 3 years of follow-up

Interventions:
  • Other: N/A
    • Enrollment:
    0
    Primary completion date:
    2014-27-10
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Murray Urowitz, Dafna Gladman, Dominique Ibañez, Jiandong Su, Sara Mursleen, Amyn Sayani, Jorge Alfonso Ross Terres, Sandra Iczkovitz. Impact of disease activity on organ damage progression in systemic lupus erythematosus: University of Toronto Lupus Clinic Cohort. J Rheumatol. 2020;47(4) DOI: 10.3899/jrheum.190259
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    Not applicable
    Study date(s)
    August 2014 to October 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • American College of Rheumatology (ACR) >=4 for lupus
    • SLE Disease Activity Index-2000 (SLEDAI-2K) >=6
    • Patients with severe active lupus kidney disesse (defined as proteinura >6 g/24 hour or equivalent suring
    Inclusion and exclusion criteria
    Inclusion criteria:
    • American College of Rheumatology (ACR) >=4 for lupus
    • SLE Disease Activity Index-2000 (SLEDAI-2K) >=6
    • Clinician's diagnosis based on his/her assessment
    • Patients with "regular" follow-up, defined as having been in the Toronto Lupus Clinic for at least 5 visits over a minimum of 3 years follow-up and never having been away from the clinic for a period excedding 18 consecutve. For patients with a period away exceeding 18 months after the initial 3 years of follow-up, the follow-up will be broken down into components of time intervals where regular visits are observed.
    Exclusion criteria:
    • Patients with severe active lupus kidney disesse (defined as proteinura >6 g/24 hour or equivalent suring

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    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
    Study complete
    Actual primary completion date
    2014-27-10
    Actual study completion date
    2014-27-10

    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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