This is a study to assess the use of golimumab (Simponi®) in participants with rheumatoid
arthritis, psoriatic arthritis, and ankylosing spondylitis. The study objective is to
evaluate the clinical safety of golimumab (Simponi®) under real-life, clinical practice
conditions as assessed by the incidence and type of (serious) adverse events and changes
in clinical status of participants as assessed by clinical parameters.

A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)

Arthritis, Rheumatoid

Arthritis, Psoriatic

Spondylitis, Ankylosing

Simponi®

Methotrexate

Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

The CGI is a non-disease-specific evaluation of participants' overall health status
assessed on a 10 mm visual analogue scale (VAS) ranging from "0" (free of complaints) to
"10" (strong discomfort). The closer the score to 0, the better the health status.

The FFbH is a participant questionnaire assessing disability/functional impairment.
Ability to perform 18 activities of daily living are scored on a 3 point scale (2=Yes,
1=Yes but with effort, and 0=No or with assistance) and summed. Remaining functional
capacity is calculated as the percent of the maximum number of score points (FFbH[%] =
(Attained score*100)/(2*n) where n is the number of completed responses) with range from
0 = total loss of functional capacity to 100 = maximal functional capacity. Increase from
baseline in FFbH score signifies improvement. The FFbH is similar to Health Assessment
Questionnaire (HAQ) but is more widely used in Germany.

The FACIT-F scale assesses self-reported fatigue and its impact upon daily activities and
function. 13 items consisting of fatigue, weakness, listlessness, tiredness, trouble with
starting things, trouble with finishing things, energy, activity, sleep, eating, help
doing activities, frustration, and social activities are scored on a scale of 0 (not at
all) to 4 (very much), except energy and activity which are reversed scored. Individual
item scores are then summed to provide the final FACIT-F score with range from 0 (lowest)
to 52 (highest quality of life). Increase from baseline in FACIT-F score signifies
improvement.

The EQ-5D-3L is a health profile questionnaire that assesses quality of life along 5
dimensions. Participants rate 5 aspects of health (mobility, self-care, usual activities,
pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no
problems; 2=some problems; 3=extreme problems). The summed score ranges from 1-15 with
"1" corresponding to no problems and "15" corresponding to severe problems in the 5
dimensions. Decrease from baseline in EQ-5D-3L signifies improvement.

An adverse event is defined as any unfavorable and unintended sign including an abnormal
laboratory finding, symptom or disease associated with the use of a medical treatment or
procedure, regardless of whether it is considered related to the medical treatment or
procedure.

A serious adverse event is defined as any unfavorable and unintended sign including an
abnormal laboratory finding, symptom or disease associated with the use of a medical
treatment or procedure, regardless of whether it is considered related to the medical
treatment or procedure that results in death, life-threatening adverse event, permanent
or significant disability / unfitness for work, hospital treatment (i.e., admission to
hospital) or prolongation of a patient's length of stay, or congenital deformity or birth
defect.

Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month
as a subcutaneous injection. Combination use with methotrexate was recommended.

Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as
a subcutaneous injection.

Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month
as a subcutaneous injection.

A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

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