Trial document




This trial has been registered retrospectively.
drksid header

  DRKS00011052

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

LuLa

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.lula-studie.de

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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?

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011052
  •   2016/10/04
  •   [---]*
  •   yes
  •   Approved
  •   3708, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M32 -  Systemic lupus erythematosus
end of 1:N-Block indications
start of 1:N-Block interventions

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).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/12/22
  •   700
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Not being able to read or fill in paper questionnaires.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Heinrich-Heine Universität Düsseldorf
    • Moorenstraße 5
    • 40225  Düsseldorf
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Lupus Erythematodes Selbsthilfegemeinschaft e.V.
    • Döppersberg 20
    • 42103  Wuppertal
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    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-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • 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-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • GlaxoSmithKline GmbH & Co. KG
    • Theresienhöhe 11
    • 80339  München
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • UCB Pharma, S.A.
    • Allée de la Recherche 60
    • 1070  Brüssel
    • Belgium
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.