Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009454

Trial Description

start of 1:1-Block title

Title

Followup of the Ratingener Rheumakohorte initiated by Rolf Rau

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

Trial Acronym

[---]*

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

URL of the Trial

[---]*

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

Brief Summary in Lay Language

In this study, a longterm followup of patients with rheumatoid arthritis 30 years after starting a baseline treatment with Methotrexate was performed. Therefore, all patients receiving Methotrexate for the first time in Ratingen during the early 1980s were enrolled in this observational study. The study aims at finding differences in disease gravity as well as mortality between patients that respond to MTX and those who do not or did not continue their medication.

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

Brief Summary in Scientific Language

Longterm followup of patients with rheumatoid arthritis 30 years after starting a baseline treatment with Methotrexate.

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

Organizational Data

  •   DRKS00009454
  •   2016/04/18
  •   [---]*
  •   yes
  •   Approved
  •   2015-331-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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

  •   Rheumatoid arthritis
  •   M06.99 -  [generalization M06.9: Rheumatoid arthritis, unspecified]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Methotrexate 15-25mg/week, i.v. or i.m, later switch to p.o possible.
    Examination 30 years after baseline: Swollen, tender joint count as well as deformities (out of 38), patient global assessment and disease activity via questionnaire (Hannover)
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   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

Calculation of mortality and standardized mortality ratios. Date of evaluation: 30 years after baseline.

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

Secondary Outcome

Evaluation of disease activity and patient global assessment via Hannover questionnaire. Determination of swollen and tender joint count as well as deformities. Date of evaluation: 30 years after baseline.

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

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

Recruitment

  •   Actual
  •   2015/08/10
  •   105
  •   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

therapy with Methotrexate in the 1980s

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

Exclusion Criteria

no Methotrexate-therapy

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Ruhr-Uni Bochum
    • Mr.  Dr. med  Dietmar  Krause 
    • Gerschermannweg 3
    • 45357  Essen
    • 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
    • Ruhr-Uni Bochum
    • Mr.  dr. med  Dietmar  Krause 
    • Gerschermannweg 3
    • 45357  Essen
    • 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
    • Evangelisches Fachkrankenhaus Ratingen
    • Ms.  Carolin  Krause 
    • Händelstr 47
    • 50674  Köln
    • 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
    • Ruhr-Uni Bochum
    • Mr.  dr. med  Dietmar  Krause 
    • Gerschermannweg 3
    • 45357  Essen
    • 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
    • Rheumaforschungsgruppe Ruhr e.V.
    • 44623  Herne
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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.