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

Study Overview
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Brief Summary
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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.

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

Conditions
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Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing

Intervention / Treatment
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* Drug: Simponi®
* Drug: Methotrexate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis and treatment with Simponi® by autoinjector device is to be initiated for the first time Exclusion Criteria: No specific exclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Rheumatoid Arthritis<br>Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended. | Drug: Simponi®<br> <br> * Other names: Golimumab;Drug: Methotrexate<br>* Given concomitantly with Simponi®<br>|
| Participants with Psoriatic Arthritis<br>Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection. | Drug: Simponi®<br> <br> * Other names: Golimumab;|
| Participants with Ankylosing Spondylitis<br>Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection. | Drug: Simponi®<br> <br> * Other names: Golimumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression (CGI) Disease Status | 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. | Baseline (BL; Month 0), Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24 | 
| Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score | 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. | Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24 | 
| Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | 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. | Baseline and Months 3, 6, 12, 18, 24 | 
| Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score | 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. | Baseline and Months 6, 12, 18, 24 | 
| Number of Participants Who Experienced at Least One Adverse Event | 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. | Up to 24 months | 
| Number of Participants Who Experienced at Least One Serious Adverse Event | 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. | Up to 24 months |