Trial document
This trial has been registered retrospectively.
DRKS00011052
Trial Description
Title
Lupus long-term study (LuLa) - extension of a cross-sectional study with initiation of an inception cohort
Trial Acronym
LuLa
URL of the Trial
Brief Summary in Lay Language
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Brief Summary in Scientific Language
The study is an extension of a prospective patient-centered epidemiologic cohort-study on the course of disease of patients with systemic lupus erythematosus that we are conducting since 2001. It is non-interventional, not-experimental, and is performed as an annual postal pseudonymized survey using partly variable patient questionnaires.
Participants of the former study (LuLa 2001-2010) are being included as well as new entrants with disease duration of less than two years.
Patient-centered documentation has the advantage that the effects of the disease are gathered directly from the patient. In the past years such patient- reported data has continuously gained importance for clinical decision making as well as cost-bearers.
Exemplary central questions are:
- What are the therapeutic changes in the past 15 years of treating SLE and what importance does it have on disease activity, damage and comorbidities?
Which factors contribute to the burden of illness?
What is the importance of physical, mental and therapeutic aspects?
What significance has disease activity and damage?
Are there implications for health care costs?
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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Organizational Data
- DRKS00011052
- 2016/10/04
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- yes
- Approved
- 3708, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
Secondary IDs
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Health Condition or Problem studied
- M32 - Systemic lupus erythematosus
Interventions/Observational Groups
- The study is conducted using an annual, pseudonymized postal survey with partly variable questionnaires on different aspects of disease (e.g. physical and mental quality of life, disease activity, treatment, pain, costs, damage, depression, hospitalizations, physical activity, fatigue, sleep disorders, work productivity, vaccination status).
Characteristics
- Non-interventional
- Epidemiological study
- Single arm study
- Open (masking not used)
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- Uncontrolled/Single arm
- Prognosis
- Single (group)
- N/A
- N/A
Primary Outcome
Quality of life (physical and mental) is surveyed annually by a validated questionnaire. Descriptive, univariable and multivariable analysis are being conducted for evaluation.
Secondary Outcome
Treatment, disease activity, concomitant diseases, physical functioning, pain and disease flares are surveyed using appropriate questionnaires and analyzed annually. Other secondary endpoints are analyzed sporadic due to annually changing focus topics in the survey (e.g. costs, damage, depression, hospitalizations, physical activity, fatigue, sleep disorders, work productivity, vaccination status). Descriptive, univariable and multivariable analysis are being conducted.
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
- other
Recruitment
- Actual
- 2011/12/22
- 700
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- no minimum age
- no maximum age
Additional Inclusion Criteria
- Return of the questionnaire
AND
- Diagnosis of systemic lupus erythematosus by a physician
Exclusion Criteria
Not being able to read or fill in paper questionnaires.
Addresses
-
start of 1:1-Block address primary-sponsor
- Heinrich-Heine Universität Düsseldorf
- Moorenstraße 5
- 40225 Düsseldorf
- Germany
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- Lupus Erythematodes Selbsthilfegemeinschaft e.V.
- Döppersberg 20
- 42103 Wuppertal
- Germany
end of 1:1-Block address otherstart of 1:1-Block address contact other- 0202/4968797
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- lupus at rheumanet.org
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end of 1:1-Block address contact other -
start of 1:1-Block address scientific-contact
- Policlinic for Rheumatology & Hiller Research Centre for Rheumatology; Heinrich-Heine University Duesseldorf
- Mr. Dr. med. Gamal Chehab
- Moorenstraße 5
- 40225 Düsseldorf
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- 0211-8117845
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- LuLa-Studie at rheumanet.org
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start of 1:1-Block address public-contact
- Policlinic for Rheumatology & Hiller Research Centre for Rheumatology; Heinrich-Heine University Duesseldorf
- Mr. Dr. med. Gamal Chehab
- Moorenstr. 5
- 40225 Duesseldorf
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- 0211/8118068
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- LuLa-Studie at rheumanet.org
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Sources of Monetary or Material Support
-
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- GlaxoSmithKline GmbH & Co. KG
- Theresienhöhe 11
- 80339 München
- Germany
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start of 1:1-Block address otherSupport
- UCB Pharma, S.A.
- Allée de la Recherche 60
- 1070 Brüssel
- Belgium
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Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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