Last updated: 08/27/2020 14:20:11

Validation of Lupus Impact Tracker™ in five European clinical practice settings

GSK study ID
117212
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: Validation of Lupus Impact Tracker™ in five European clinical practice settings
Trial description: It is a European, multi-centre cross-sectional study. It will be carried out in 5 European countries (France, Spain, Italy, Germany and Sweden).
The study could include inpatients and outpatients.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

To assess the acceptability and feasibility of the LUPUS IMPACT TRACKER™ questionnaire from the perspectives of the patient and physician

Timeframe: approximately 6 months

Evaluate the cross-cultural validity of the LUPUS IMPACT TRACKER™ questionnaire in five European clinical practice settings

Timeframe: approximately 6 months

Secondary outcomes:

To evaluate if the LUPUS IMPACT TRACKER™ questionnaire has any effect on communication between the physician and the patient

Timeframe: approximately 6 months

Interventions:
Not applicable
Enrollment:
1
Primary completion date:
2015-16-01
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
November 2013 to January 2015
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18 - 95 Year
Accepts healthy volunteers
none
  • Patient is at least 18 years of age or older
  • Is willing and able to provide informed consent or agreement (according to local requirements)
  • Patient with other autoimmune diseases (e.g. other connective tissue disease, anti-phospholipid syndrome, rheumatoid arthritis, Sjogren’s syndrome, etc.)
  • Women pregnant at the time of inclusion visit.
Inclusion and exclusion criteria
Inclusion criteria:
  • Patient is at least 18 years of age or older
  • Is willing and able to provide informed consent or agreement (according to local requirements)
  • s able to read, understand the local language, and complete the questionnaire
  • Is diagnosed with SLE: meets 4 out of the 11 ACR classification criteria for SLE (2,3)
  • Is willing to participate in the cross-sectional study.
Exclusion criteria:
  • Patient with other autoimmune diseases (e.g. other connective tissue disease, anti-phospholipid syndrome, rheumatoid arthritis, Sjogren’s syndrome, etc.)
  • Women pregnant at the time of inclusion visit.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

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
2015-16-01
Actual study completion date
2015-16-01

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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