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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01313858

Acronym

GO-NICE

Enrollment

1613

Registered

2011-03-14

Start date

2010-04-30

Completion date

2015-09-30

Last updated

2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Psoriatic, Arthritis, Rheumatoid, Spondylitis, Ankylosing

Brief summary

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.

Interventions

DRUGSimponi®

DRUGMethotrexate

Given concomitantly with Simponi®

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical Global Impression (CGI) Disease Status	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	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	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	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	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	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.

Participant flow

Participants by arm

Arm	Count
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.	474
Participants With Psoriatic Arthritis Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.	501
Participants With Ankylosing Spondylitis Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.	483
Total	1,458

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	35	51	47
Overall Study	Premature Treatment Termination	251	219	191

Baseline characteristics

Characteristic	Participants With Rheumatoid Arthritis	Participants With Psoriatic Arthritis	Participants With Ankylosing Spondylitis	Total
Age, Continuous	54.9 Years STANDARD_DEVIATION 13.38	50.3 Years STANDARD_DEVIATION 12.07	43.6 Years STANDARD_DEVIATION 12.29	49.6 Years STANDARD_DEVIATION 13.39
Sex: Female, Male Female	345 Participants	271 Participants	162 Participants	778 Participants
Sex: Female, Male Male	129 Participants	230 Participants	321 Participants	680 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	315 / 1,613
serious Total, serious adverse events	204 / 1,613

Outcome results

Primary

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.

Time frame: Baseline and Months 6, 12, 18, 24

Population: The mITT population consists of all participants who were treated with Simponi® and have a baseline assessment and at least one additional visit, regardless of any protocol violations during the study.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Participants With Rheumatoid Arthritis	Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score	Month 6 (n=254;302;293)	-0.69 Units on a scale	Standard Deviation 0.15
Participants With Rheumatoid Arthritis	Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score	Month 12 (n=211;236;242)	-0.97 Units on a scale	Standard Deviation 0.16
Participants With Rheumatoid Arthritis	Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score	Month 18 (n=161;206;211)	-1.11 Units on a scale	Standard Deviation 0.17
Participants With Rheumatoid Arthritis	Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score	Month 24 (n=162;191;210)	-1.08 Units on a scale	Standard Deviation 0.17
Participants With Psoriatic Arthritis	Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score	Month 24 (n=162;191;210)	-1.29 Units on a scale	Standard Deviation 0.17
Participants With Psoriatic Arthritis	Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score	Month 6 (n=254;302;293)	-1.07 Units on a scale	Standard Deviation 0.14
Participants With Psoriatic Arthritis	Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score	Month 18 (n=161;206;211)	-1.35 Units on a scale	Standard Deviation 0.16
Participants With Psoriatic Arthritis	Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score	Month 12 (n=211;236;242)	-1.35 Units on a scale	Standard Deviation 0.15
Participants With Ankylosing Spondylitis	Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score	Month 24 (n=162;191;210)	-1.51 Units on a scale	Standard Deviation 0.15
Participants With Ankylosing Spondylitis	Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score	Month 12 (n=211;236;242)	-1.24 Units on a scale	Standard Deviation 0.14
Participants With Ankylosing Spondylitis	Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score	Month 18 (n=161;206;211)	-1.25 Units on a scale	Standard Deviation 0.15
Participants With Ankylosing Spondylitis	Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score	Month 6 (n=254;302;293)	-1.18 Units on a scale	Standard Deviation 0.14

Comparison: Least squares mean difference from baseline in EQ-5D-3L at Month 6 (Month 6 minus BL)p-value: <0.0001Repeated measures analysis

Comparison: Least squares mean difference from baseline in EQ-5D-3L at Month 12 (Month 12 minus BL)p-value: <0.0001Repeated measures analysis

Comparison: Least squares mean difference from baseline in EQ-5D-3L at Month 18 (Month 18 minus BL)p-value: <0.0001Repeated measures analysis

Comparison: Least squares mean difference from baseline in EQ-5D-3L at Month 24 (Month 24 minus BL)p-value: <0.0001Repeated measures analysis