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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8259-005 | Other Identifier | Merck |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Participants with Psoriatic Arthritis | Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection. |
| |
| Participants with Ankylosing Spondylitis | Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simponi® | Drug |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32303994 | Derived | 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. | |
| 30415451 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Participants With Psoriatic Arthritis |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Methotrexate | Drug | Given concomitantly with Simponi® |
|
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 |
| 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. |
| 29903793 | Derived | 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. |
Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection. |
| FG002 | Participants With Ankylosing Spondylitis | Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Modified Intention to Treat Population (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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Participants With Psoriatic Arthritis | Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection. |
| BG002 | Participants With Ankylosing Spondylitis | Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | 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. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Deviation | Units on a scale | Baseline (BL; Month 0), Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24 |
|
|
| |||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Deviation | Units on a scale | Baseline and Months 3, 6, 9, 12, 15, 18, 21, 24 |
| |||||||||||||||||||||||||||||||||
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Deviation | Units on a scale | Baseline and Months 3, 6, 12, 18, 24 |
| |||||||||||||||||||||||||||||||||
| 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. | 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. | Posted | Least Squares Mean | Standard Deviation | Units on a scale | Baseline and Months 6, 12, 18, 24 |
| |||||||||||||||||||||||||||||||||
| Primary | 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. | The safety population consists of all participants with at least one injection of Simponi®. | Posted | Number | Participants | Up to 24 months |
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | The safety population consists of all participants with at least one injection of Simponi®. | Posted | Number | Participants | Up to 24 months |
|
Up to 24 months
Adverse events are described for the safety population consisting of all participants with at least one injection of Simponi®. Results are reported for the entire study population, not for the individual reporting groups according to underlying disease indication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Simponi®-naïve participants with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection. | 204 | 1,613 | 315 | 1,613 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| NORMOCHROMIC NORMOCYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CARDIOVASCULAR INSUFFICIENCY | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| SINOATRIAL BLOCK | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| TACHYARRHYTHMIA | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ACUTE VESTIBULAR SYNDROME | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
| |
| EXOSTOSIS OF EXTERNAL EAR CANAL | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
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| HYPOACUSIS | Ear and labyrinth disorders | MedDRA 13.1 | Systematic Assessment |
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| EXOPHTHALMOS | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| EYELID OEDEMA | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| PAROPHTHALMIA | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| RETINAL DETACHMENT | Eye disorders | MedDRA 13.1 | Systematic Assessment |
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| ABDOMINAL ADHESIONS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| COLITIS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| DYSPHAGIA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| ENTERITIS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| ILEUS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| MELAENA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| OESOPHAGEAL VARICES HAEMORRHAGE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| SUBILEUS | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| SWOLLEN TONGUE | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CONDITION AGGRAVATED | General disorders | MedDRA 13.1 | Systematic Assessment |
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| DEATH | General disorders | MedDRA 13.1 | Systematic Assessment |
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| DRUG INEFFECTIVE | General disorders | MedDRA 13.1 | Systematic Assessment |
| |
| FACIAL PAIN | General disorders | MedDRA 13.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 13.1 | Systematic Assessment |
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| MASS | General disorders | MedDRA 13.1 | Systematic Assessment |
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| PAIN | General disorders | MedDRA 13.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 13.1 | Systematic Assessment |
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| HEPATIC CYST | Hepatobiliary disorders | MedDRA 13.1 | Systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA 13.1 | Systematic Assessment |
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| ATYPICAL PNEUMONIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| BRONCHOPNEUMONIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| CHLAMYDIAL INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| DIVERTICULITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| ENCEPHALITIC INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| ERYSIPELAS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| FEBRILE INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| KIDNEY INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| LOBAR PNEUMONIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| PERITONITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| PULMONARY SEPSIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| PYELONEPHRITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| SALPINGO-OOPHORITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| SEPSIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| SINOBRONCHITIS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| CRANIOCEREBRAL INJURY | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| FEMORAL NECK FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| LIGAMENT RUPTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| LOWER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| PERIPROSTHETIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
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| SKULL FRACTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| SPLENIC RUPTURE | Injury, poisoning and procedural complications | MedDRA 13.1 | Systematic Assessment |
| |
| ANTI-CYCLIC CITRULLINATED PEPTIDE ANTIBODY POSITIVE | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| COLONOSCOPY | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| HAEMOGLOBIN DECREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| INVESTIGATION | Investigations | MedDRA 13.1 | Systematic Assessment |
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| PLATELET COUNT INCREASED | Investigations | MedDRA 13.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DIABETES MELLITUS INADEQUATE CONTROL | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ANKYLOSING SPONDYLITIS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| ARTHROFIBROSIS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| FACET JOINT SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HAND DEFORMITY | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| JAW CYST | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| JOINT EFFUSION | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PSORIATIC ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| SYNOVITIS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| VERTEBRAL FORAMINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| BRAIN NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| CHOLESTEATOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| CHRONIC MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| FIBROMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| GASTROINTESTINAL STROMAL TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| LIP AND/OR ORAL CAVITY CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| MELANOCYTIC NAEVUS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| METASTASES TO BONE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| NON-HODGKIN'S LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| OESOPHAGEAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| PROSTATIC ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| RENAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| SALIVARY GLAND NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| |
| BURNING SENSATION | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CARPAL TUNNEL SYNDROME | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CEREBELLAR INFARCTION | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CEREBRAL ISCHAEMIA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CEREBROVASCULAR DISORDER | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CUBITAL TUNNEL SYNDROME | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DEMYELINATION | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| FACIAL PARESIS | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| MONOPARESIS | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
| |
| BURNOUT SYNDROME | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA 13.1 | Systematic Assessment |
| |
| CALCULUS URETERIC | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| NEUROGENIC BLADDER | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| RENAL FAILURE | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
| |
| EPIDIDYMITIS | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| MENORRHAGIA | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| VAGINAL EROSION | Reproductive system and breast disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ALVEOLITIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| BRONCHIECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PNEUMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PUSTULAR PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| SKIN ULCER | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
| |
| AUTONOMIC GANGLIONECTOMY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| BLADDER OPERATION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| BURSA REMOVAL | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| CARDIAC OPERATION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| CHOLECYSTECTOMY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| CHOLESTEATOMA REMOVAL | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| DRUG THERAPY CHANGED | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| ENDOMETRIAL ABLATION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| FOOT OPERATION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| GALLBLADDER OPERATION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| HIP ARTHROPLASTY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| HOSPITALISATION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| HYSTERECTOMY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| JOINT ARTHROPLASTY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| KNEE ARTHROPLASTY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| KNEE OPERATION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| LAXATIVE SUPPORTIVE CARE | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| LIMB OPERATION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| POLYPECTOMY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| PROSTHESIS IMPLANTATION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| RADIOACTIVE IODINE THERAPY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| SHOULDER ARTHROPLASTY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| SHOULDER OPERATION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| SPINAL DECOMPRESSION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| SPINAL FUSION SURGERY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| SPINAL OPERATION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| SYNOVECTOMY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| TENDON SHEATH INCISION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| TENOTOMY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| TOE OPERATION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| VARICOSE VEIN OPERATION | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| VASCULAR GRAFT | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| WRIST SURGERY | Surgical and medical procedures | MedDRA 13.1 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| LYMPHOEDEMA | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
| |
| VENOUS INSUFFICIENCY | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DRUG INEFFECTIVE | General disorders | MedDRA 13.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D000089183 | Axial Spondyloarthritis |
| D000844 | Ankylosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C529000 | golimumab |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Month 3 |
|
| Month 6 |
|
| Month 9 |
|
| Month 12 |
|
| Month 15 |
|
| Month 18 |
|
| Month 21 |
|
| Month 24 |
|
| OG002 | Participants With Ankylosing Spondylitis | Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection. |
|
|
|
| OG002 | Participants With Ankylosing Spondylitis | Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection. |
|
|
|
Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|