A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554) (GO-NICE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01313858|
Recruitment Status : Completed
First Posted : March 14, 2011
Results First Posted : November 1, 2016
Last Update Posted : November 1, 2016
|Condition or disease||Intervention/treatment|
|Arthritis, Rheumatoid Arthritis, Psoriatic Spondylitis, Ankylosing||Drug: Simponi® Drug: Methotrexate|
|Study Type :||Observational|
|Actual Enrollment :||1613 participants|
|Official Title:||Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis|
|Study Start Date :||April 2010|
|Primary Completion Date :||September 2015|
|Study Completion Date :||September 2015|
Participants with Rheumatoid Arthritis
Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
Other Name: GolimumabDrug: Methotrexate
Given concomitantly with Simponi®
Participants with Psoriatic Arthritis
Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
Other Name: Golimumab
Participants with Ankylosing Spondylitis
Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
Other Name: Golimumab
- Clinical Global Impression (CGI) Disease Status [ Time Frame: Baseline (BL; Month 0), Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24 ]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.
- Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score [ Time Frame: Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24 ]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.
- Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score [ Time Frame: Baseline and Months 3, 6, 12, 18, 24 ]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.
- Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score [ Time Frame: Baseline and Months 6, 12, 18, 24 ]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.
- Number of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to 24 months ]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.
- Number of Participants Who Experienced at Least One Serious Adverse Event [ Time Frame: Up to 24 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01313858
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|