Trial document




This trial has been registered retrospectively.
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  DRKS00011052

Trial Description

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Title

Lupus long-term study (LuLa) - extension of a cross-sectional study with initiation of an inception cohort

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Trial Acronym

LuLa

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URL of the Trial

http://www.lula-studie.de

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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?

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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
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Secondary IDs

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Health Condition or Problem studied

  •   M32 -  Systemic lupus erythematosus
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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).
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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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.

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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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2011/12/22
  •   700
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- Return of the questionnaire
AND
- Diagnosis of systemic lupus erythematosus by a physician

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Exclusion Criteria

Not being able to read or fill in paper questionnaires.

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Addresses

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    • Heinrich-Heine Universität Düsseldorf
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Lupus Erythematodes Selbsthilfegemeinschaft e.V.
    • Döppersberg 20
    • 42103  Wuppertal
    • Germany
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    • Policlinic for Rheumatology & Hiller Research Centre for Rheumatology; Heinrich-Heine University Duesseldorf
    • Mr.  Dr. med.  Gamal  Chehab 
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
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    • Policlinic for Rheumatology & Hiller Research Centre for Rheumatology; Heinrich-Heine University Duesseldorf
    • Mr.  Dr. med.  Gamal  Chehab 
    • Moorenstr. 5
    • 40225  Duesseldorf
    • Germany
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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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    • 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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* This entry means the parameter is not applicable or has not been set.