Arthritis, RheumatoidGO-NICENCT01313858

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

An observational study of Arthritis, Rheumatoid and Arthritis, Psoriatic, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing
What is being tested?: Simponi® and Methotrexate
Type of treatment: Injection or infusion
How many people: 1,613 participants
Where: No sites listed yet
Study dates: Apr 2010to Sep 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants in a primary care clinic or office with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis for whom the treatment with Simponi® by autoinjector device is to be initiated for the first time

Who may be able to join

Has rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis and treatment with Simponi® by autoinjector device is to be initiated for the first time

Who cannot join

No specific exclusion criteria

About this study

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

Conditions: Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing
Being tested: Simponi®, Methotrexate
Medical subject headings: Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Simponi®Drug
Also called Golimumab
MethotrexateDrug
Given concomitantly with Simponi®

Study groups in NCT01313858
Study group	Role	What they receive
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. Receives: Drug: Simponi®; Drug: Methotrexate
Participants with Psoriatic Arthritis		Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Receives: Drug: Simponi®
Participants with Ankylosing Spondylitis		Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection. Receives: Drug: Simponi®

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Sep 2015

First posted14 Mar 2011 (estimated)
Study startApr 2010
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,613 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01313858
Sponsor's protocol ID: P06554
Other IDs: MK-8259-005
Acronym: GO-NICE
Status last verified: Sep 2016
First submitted: 10 Mar 2011
Last updated: 1 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kruger K, Burmester GR, Wassenberg S, Thomas MH. Golimumab as the First-, Second-, or at Least Third-Line Biologic Agent in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis: Post Hoc Analysis of a Noninterventional Study in Germany. Rheumatol Ther. 2020 Jun;7(2):371-382. doi: 10.1007/s40744-020-00204-9. Epub 2020 Apr 17.
PubMed 32303994
Kruger K, Burmester GR, Wassenberg S, Bohl-Buhler M, Thomas MH. Patient-reported outcomes with golimumab in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: non-interventional study GO-NICE in Germany. Rheumatol Int. 2019 Jan;39(1):131-140. doi: 10.1007/s00296-018-4180-4. Epub 2018 Nov 10.
PubMed 30415451
Kruger K, Burmester GR, Wassenberg S, Bohl-Buhler M, Thomas MH. Effectiveness and safety of golimumab in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis under real-life clinical conditions: non-interventional GO-NICE study in Germany. BMJ Open. 2018 Jun 14;8(6):e021082. doi: 10.1136/bmjopen-2017-021082.
PubMed 29903793

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Arthritis, Rheumatoid trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Interventional Study Investigating the Use of Golimumab (Simponi®) in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
ClinicalTrials.gov ID: NCT01313858
Acronym / sponsor ID: GO-NICE / P06554
Conditions: Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing
Study type: Observational
Recruitment status: Completed
Enrolment: 1,613 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Apr 2010
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 14 Mar 2011 (estimated)
Results: Posted 1 Nov 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Participants with Rheumatoid Arthritis	–	Drug: Simponi®, Drug: MethotrexateSimponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
Participants with Psoriatic Arthritis	–	Drug: Simponi®Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
Participants with Ankylosing Spondylitis	–	Drug: Simponi®Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants in a primary care clinic or office with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis for whom the treatment with Simponi® by autoinjector device is to be initiated for the first time

Key inclusion criteria (1 listed)

Has rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis and treatment with Simponi® by autoinjector device is to be initiated for the first time

Key exclusion criteria (1 listed)

No specific exclusion criteria

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Simponi®Also: Golimumab	Drug	Participants with Ankylosing Spondylitis, Participants with Psoriatic Arthritis, Participants with Rheumatoid Arthritis
MethotrexateGiven concomitantly with Simponi®	Drug	Participants with Rheumatoid Arthritis

Primary outcome

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.

Results and safety

Results posted to the registry on 1 Nov 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With Rheumatoid Arthritis	524	238
Participants With Psoriatic Arthritis	546	276
Participants With Ankylosing Spondylitis	543	305

Primary outcome: 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. Least squares mean (Standard Deviation). Unit: Units on a scale

Measure	Participants With Rheumatoid Arthritis n = 474	Participants With Psoriatic Arthritis n = 501	Participants With Ankylosing Spondylitis n = 483
BL	5.7 (2.21)	5.5 (2.17)	5.7 (2.19)
Month 3	3.4 (2.27)	3.2 (2.25)	2.9 (2.13)
Month 6	3.1 (2.25)	2.8 (2.19)	2.5 (2.09)
Month 9	2.7 (1.99)	2.6 (2.07)	2.4 (1.87)
Month 12	2.8 (2.11)	2.4 (2.01)	2.3 (1.94)
Month 15	2.5 (1.89)	2.3 (1.96)	2.2 (1.85)
Month 18	2.4 (1.97)	2.2 (1.86)	2.2 (1.91)
Month 21	2.5 (1.99)	2.1 (1.84)	2.2 (1.78)

Population analysed: 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.

Primary outcome: Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score

Time frame: Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24. Least squares mean (Standard Deviation). Unit: Units on a scale

Measure	Participants With Rheumatoid Arthritis n = 474	Participants With Psoriatic Arthritis n = 501	Participants With Ankylosing Spondylitis n = 483
Month 3 (n=348;361;375)	5.29 (1.56)	5.82 (1.54)	8.66 (1.31)
Month 6 (n=263;310;297)	5.71 (1.69)	6.31 (1.61)	10.01 (1.40)
Month 9 (n=226;265;262)	5.78 (1.77)	7.07 (1.69)	9.67 (1.45)
Month 12 (n=218;247;247)	5.70 (1.79)	7.86 (1.73)	8.34 (1.48)
Month 15 (n=188;222;234)	5.63 (1.89)	6.64 (1.79)	9.04 (1.50)
Month 18 (n=168;211;216)	6.98 (1.96)	8.99 (1.82)	8.79 (1.54)
Month 21 (n=166;198;200)	5.43 (1.97)	9.18 (1.86)	7.95 (1.59)
Month 24 (n=167;198;211)	7.42 (1.97)	7.71 (1.86)	9.51 (1.56)

Participants With Rheumatoid Arthritis: p = 0.0007, Repeated measures analysis
Participants With Rheumatoid Arthritis: p = 0.0007, Repeated measures analysis
Participants With Rheumatoid Arthritis: p = 0.0011, Repeated measures analysis

Primary outcome: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score

Time frame: Baseline and Months 3, 6, 12, 18, 24. Least squares mean (Standard Deviation). Unit: Units on a scale

Measure	Participants With Rheumatoid Arthritis n = 474	Participants With Psoriatic Arthritis n = 501	Participants With Ankylosing Spondylitis n = 483
Month 3 (n=344;356;368)	2.85 (0.79)	4.39 (0.83)	5.21 (0.78)
Month 6 (n=264;311;300)	3.71 (0.85)	4.40 (0.86)	5.71 (0.82)
Month 12 (n=215;242;243)	4.81 (0.91)	5.62 (0.93)	5.86 (0.88)
Month 18 (n=167;212;216)	5.05 (0.99)	6.87 (0.97)	6.29 (0.91)
Month 24 (n=162;196;211)	5.99 (1.00)	5.94 (1.00)	8.01 (0.92)

Participants With Rheumatoid Arthritis: p = 0.0003, Repeated measures analysis
Participants With Rheumatoid Arthritis: p <0.0001, Repeated measures analysis
Participants With Rheumatoid Arthritis: p <0.0001, Repeated measures analysis

Primary outcome: Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score

Time frame: Baseline and Months 6, 12, 18, 24. Least squares mean (Standard Deviation). Unit: Units on a scale

Measure	Participants With Rheumatoid Arthritis n = 474	Participants With Psoriatic Arthritis n = 501	Participants With Ankylosing Spondylitis n = 483
Month 6 (n=254;302;293)	-0.69 (0.15)	-1.07 (0.14)	-1.18 (0.14)
Month 12 (n=211;236;242)	-0.97 (0.16)	-1.35 (0.15)	-1.24 (0.14)
Month 18 (n=161;206;211)	-1.11 (0.17)	-1.35 (0.16)	-1.25 (0.15)
Month 24 (n=162;191;210)	-1.08 (0.17)	-1.29 (0.17)	-1.51 (0.15)

Participants With Rheumatoid Arthritis: p <0.0001, Repeated measures analysis
Participants With Rheumatoid Arthritis: p <0.0001, Repeated measures analysis
Participants With Rheumatoid Arthritis: p <0.0001, Repeated measures analysis

Adverse events

Time frame: Up to 24 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	204 of 1,613 (12.6%)	315 of 1,613 (19.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32303994Kruger K, Burmester GR, Wassenberg S, Thomas MH. Golimumab as the First-, Second-, or at Least Third-Line Biologic Agent in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis: Post Hoc Analysis of a Noninterventional Study in Germany. Rheumatol Ther. 2020 Jun;7(2):371-382. doi: 10.1007/s40744-020-00204-9. Epub 2020 Apr 17.
Derived from this study: PubMed 30415451Kruger K, Burmester GR, Wassenberg S, Bohl-Buhler M, Thomas MH. Patient-reported outcomes with golimumab in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: non-interventional study GO-NICE in Germany. Rheumatol Int. 2019 Jan;39(1):131-140. doi: 10.1007/s00296-018-4180-4. Epub 2018 Nov 10.
Derived from this study: PubMed 29903793Kruger K, Burmester GR, Wassenberg S, Bohl-Buhler M, Thomas MH. Effectiveness and safety of golimumab in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis under real-life clinical conditions: non-interventional GO-NICE study in Germany. BMJ Open. 2018 Jun 14;8(6):e021082. doi: 10.1136/bmjopen-2017-021082.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

An observational study of Arthritis, Rheumatoid and Arthritis, Psoriatic, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01313858, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.