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
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2014-27-10
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)
No location data available.
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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