Trial · NCT01313858
A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)
NCT01313858, Completed, Merck Sharp & Dohme LLC; results first posted 2016-11-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554). Trials, record NCT01313858. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01313858
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Use of Golimumab (Simponi®) in Participants With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis (P06554)
- NCT number
- NCT01313858
- Status
- Completed
- Enrollment
- 1,613 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Spondylitis, Ankylosing
- Interventions
- Simponi®, Methotrexate
- First posted
- 2011-03-14
- Last updated
- 2016-11-01
- Results first posted
- 2016-11-01
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 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. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in FFbH (Funktionsfragebogen Hannover) Questionnaire Score | Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24 | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | Baseline and Months 3, 6, 12, 18, 24 | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in EuroQol- 5 Dimension 3 Level Version (EQ-5D-3L) Questionnaire Score | Baseline and Months 6, 12, 18, 24 | 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. | Units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants Who Experienced at Least One Adverse Event | Up to 24 months | The safety population consists of all participants with at least one injection of Simponi®. | Participants | NUMBER |
| PRIMARY | Number of Participants Who Experienced at Least One Serious Adverse Event | Up to 24 months | The safety population consists of all participants with at least one injection of Simponi®. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group84
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Global Impression (CGI) Disease Status | Participants With Rheumatoid Arthritis | BL | 5.7 | Standard Deviation 2.21 | Units on a scale |
| Clinical Global Impression (CGI) Disease Status | Participants With Psoriatic Arthritis | BL | 5.5 | Standard Deviation 2.17 | Units on a scale |
| Clinical Global Impression (CGI) Disease Status | Participants With Ankylosing Spondylitis | BL | 5.7 | Standard Deviation 2.19 | Units on a scale |
| Clinical Global Impression (CGI) Disease Status | Participants With Rheumatoid Arthritis | Month 3 | 3.4 | Standard Deviation 2.27 | Units on a scale |
| Clinical Global Impression (CGI) Disease Status | Participants With Psoriatic Arthritis | Month 3 | 3.2 | Standard Deviation 2.25 | Units on a scale |
| Clinical Global Impression (CGI) Disease Status | Participants With Ankylosing Spondylitis | Month 3 | 2.9 | Standard Deviation 2.13 | Units on a scale |
| Clinical Global Impression (CGI) Disease Status | Participants With Rheumatoid Arthritis | Month 6 | 3.1 | Standard Deviation 2.25 | Units on a scale |
| Clinical Global Impression (CGI) Disease Status | Participants With Psoriatic Arthritis | Month 6 | 2.8 | Standard Deviation 2.19 | Units on a scale |
| Clinical Global Impression (CGI) Disease Status | Participants With Ankylosing Spondylitis | Month 6 | 2.5 | Standard Deviation 2.09 | Units on a scale |
| Clinical Global Impression (CGI) Disease Status | Participants With Rheumatoid Arthritis | Month 9 | 2.7 | Standard Deviation 1.99 | Units on a scale |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With Rheumatoid Arthritis | 524 | |
| Overall Study | STARTED | Participants With Psoriatic Arthritis | 546 | |
| Overall Study | STARTED | Participants With Ankylosing Spondylitis | 543 | |
| Overall Study | COMPLETED | Participants With Rheumatoid Arthritis | 238 | |
| Overall Study | COMPLETED | Participants With Psoriatic Arthritis | 276 | |
| Overall Study | COMPLETED | Participants With Ankylosing Spondylitis | 305 | |
| Overall Study | NOT COMPLETED | Participants With Rheumatoid Arthritis | 286 | |
| Overall Study | NOT COMPLETED | Participants With Psoriatic Arthritis | 270 | |
| Overall Study | NOT COMPLETED | Participants With Ankylosing Spondylitis | 238 |
Source ClinicalTrials.gov
Adverse events207
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | DRUG INEFFECTIVE | General disorders | All Participants | 315 | 1,613 | 315 |
| serious | ANAEMIA | Blood and lymphatic system disorders | All Participants | 1 | 1,613 | 1 |
| serious | LEUKOPENIA | Blood and lymphatic system disorders | All Participants | 1 | 1,613 | 1 |
| serious | NORMOCHROMIC NORMOCYTIC ANAEMIA | Blood and lymphatic system disorders | All Participants | 1 | 1,613 | 1 |
| serious | THROMBOCYTOPENIA | Blood and lymphatic system disorders | All Participants | 1 | 1,613 | 1 |
| serious | ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | All Participants | 1 | 1,613 | 1 |
| serious | ANGINA PECTORIS | Cardiac disorders | All Participants | 1 | 1,613 | 1 |
| serious | ANGINA UNSTABLE | Cardiac disorders | All Participants | 1 | 1,613 | 1 |
| serious | ATRIAL FIBRILLATION | Cardiac disorders | All Participants | 1 | 1,613 | 1 |
| serious | CARDIOVASCULAR INSUFFICIENCY | Cardiac disorders | All Participants | 1 | 1,613 | 1 |
1 to 10 of 207Source ClinicalTrials.gov
See all 207 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | ||
| Total, other adverse events | All Participants | 315 | 1,613 |
| Total, serious adverse events | All Participants | 204 | 1,613 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01313858
GET https://conductscience.org/api/trials/v1/NCT01313858/results?page=2