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| ID | Type | Description | Link |
|---|---|---|---|
| 1275148SCD2001 | Other Identifier | Centocor | |
| 2009-010714-30 | EudraCT Number |
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This study tests the safety and effectiveness of ustekinumab or golimumab compared to placebo (placebo looks like the drugs being studied, but has no active ingredients). The purpose of this research study is to determine if ustekinumab or golimumab is safe and to determine its effects (good and bad) on patients with chronic sarcoidosis with pulmonary and/or skin involvement. Patients with pulmonary involvement constitute the primary population for analysis, and patients with skin involvement constitute the secondary population; a patient may be in both populations. The study will be conducted at approximately 40 sites globally.
Ustekinumab is approved for dosing in patients with psoriasis and golimumab is approved for dosing in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. This study will use either drug in patients with chronic sarcoidosis. Ustekinumab and golimumab are being tested to see if they may be useful in treating chronic sarcoidosis. This study will compare the effects (both good and bad) of ustekinumab and golimumab to those of placebo. The purpose of this study is to evaluate the safety and effectiveness of ustekinumab and golimumab (administered as individual treatments) in patients with chronic sarcoidosis with lung and/or skin involvement who still have symptoms even though receiving current therapy. About 180 patients will take part in the study. While in this study, patients may not take part in any other medical research studies. Ustekinumab and golimumab are not approved by the national health authorities for treatment of chronic sarcoidosis; therefore, they can only be used in a research setting to treat this condition. The screening phase of the study, where the doctor will determine if a patient is eligible for the study, will last 1 to 4 weeks. Patients are put into 1 of 3 groups and each group will get a different treatment. The results of the golimumab group and the ustekinumab group are compared to placebo. Patients will either receive ustekinumab, golimumab or placebo. Placebo looks like ustekinumab and golimumab and is given in the same way, by injection, but contains no active drug. Patients will receive study agent until Week 24 and will continue to be followed through Week 44 for assessment of safety and any other effects after discontinuation of therapy. The patient will continue to take all sarcoidosis medication(s) at current, stable dose for the first part of the study. If the patient remained on a stable steroid dose from Week 0 through Week 16 of the study, the study doctor will begin to taper (lower) the steroid dose. The steroid taper will continue through to the end of the Week 28 visit. The patient will continue to take their other sarcoidosis medication(s) at the same dose for the rest of the study. An independent Data Monitoring Committee will be responsible for reviewing the safety data for the study. Patients will be in the study for about 48 weeks. The end of the study is defined as the last visit of the last patient. A site-specific substudy is being implemented to collect serum and lung samples from patients who are currently enrolled in this study. A separate protocol is being implemented to collect lung fluid and serum samples from normal, healthy subjects to be used as comparators for similar samples obtained in the 1275148SCD2001 substudy. Patients will be randomly assigned to 1 of 3 treatment groups: ustekinumab (180 mg at Week 0, followed by 90 mg at Weeks 8, 16, and 24 with placebo at Weeks 4, 12, and 20), golimumab (200 mg at Week 0, followed by 100 mg at Weeks 4, 8, 12, 16, 20, and 24) or placebo (at Weeks 0, 4, 8, 12, 16, 20, and 24) administered by SC injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching Placebo will be administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24. |
|
| Golimumab | Experimental | Golimumab will be administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24. |
|
| Ustekinumab | Experimental | Ustekinumab will be administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching Placebo will be administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16 | Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness . FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change was calculated as the value at Week 16 minus the baseline value. | Baseline (Day 1) and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 6-minute Walk Distance at Week 28 | Change from Baseline in 6-minute walk distance at Week 28 was calculated as 6-minute walk distance at Week 28 minus 6-minute walk distance at Baseline. The 6-minute walk distance was the total distance walked during the 6-minute walk test. | Baseline (Day 1) and Week 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25594886 | Derived | Judson MA, Mack M, Beaumont JL, Watt R, Barnathan ES, Victorson DE. Validation and important differences for the Sarcoidosis Assessment Tool. A new patient-reported outcome measure. Am J Respir Crit Care Med. 2015 Apr 1;191(7):786-95. doi: 10.1164/rccm.201410-1785OC. | |
| 25428650 | Derived | Crommelin HA, Vorselaars AD, van Moorsel CH, Korenromp IH, Deneer VH, Grutters JC. Anti-TNF therapeutics for the treatment of sarcoidosis. Immunotherapy. 2014;6(10):1127-43. doi: 10.2217/imt.14.65. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24. |
| FG001 | Golimumab | Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Golimumab | Drug | Golimumab will be administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24. |
|
| Ustekinumab | Drug | Ustekinumab will be administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20. |
|
| Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 28 |
St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Change from Baseline was calculated as the value at Week 28 minus value at Baseline. |
| Baseline (Day 1) and Week 28 |
| Percentage of Responders With a Score of Less Than or Equal to 1 on Skin Physician's Global Assessment (SPGA) Scale | The SPGA is 7-point scale used to assess the condition of skin in participants. The physician checks the state of the skin and gives them score from 0 (clear) to 5 (severe). Higher scores indicate worsening of skin condition. | Week 28 |
| Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 28 | Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change is calculated as the value at week 28 minus the baseline value. | Baseline (Day 1) and Week 28 |
| Los Angeles |
| California |
| United States |
| Denver | Colorado | United States |
| New Haven | Connecticut | United States |
| Chicago | Illinois | United States |
| Baltimore | Maryland | United States |
| Ann Arbor | Michigan | United States |
| Detroit | Michigan | United States |
| St Louis | Missouri | United States |
| Lebanon | New Hampshire | United States |
| New York | New York | United States |
| Chapel Hill | North Carolina | United States |
| Charlotte | North Carolina | United States |
| Greenville | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Spartanburg | South Carolina | United States |
| Memphis | Tennessee | United States |
| Dallas | Texas | United States |
| Colchester | Vermont | United States |
| Brussels | Belgium |
| Leuven | Belgium |
| Liège | Belgium |
| Aarhus | Denmark |
| Arhus C | Denmark |
| Hellerup | Denmark |
| København NV | Denmark |
| Bobigny | France |
| Lille | France |
| Marseille | France |
| Montpellier | France |
| Paris | France |
| Bad Berka | Germany |
| Berlin | Germany |
| Essen | Germany |
| Freiburg im Breisgau | Germany |
| Hanover | Germany |
| München | Germany |
| Amsterdam-Zuidoost | Netherlands |
| Rotterdam | Netherlands |
| Sittard | Netherlands |
| Oslo | Norway |
| Trondheim | Norway |
| Bucharest | Romania |
| Bristol | United Kingdom |
| London | United Kingdom |
| Portsmouth | United Kingdom |
| Sheffield | United Kingdom |
| Southampton | United Kingdom |
| 25034562 | Derived | Judson MA, Baughman RP, Costabel U, Drent M, Gibson KF, Raghu G, Shigemitsu H, Barney JB, Culver DA, Hamzeh NY, Wijsenbeek MS, Albera C, Huizar I, Agarwal P, Brodmerkel C, Watt R, Barnathan ES. Safety and efficacy of ustekinumab or golimumab in patients with chronic sarcoidosis. Eur Respir J. 2014 Nov;44(5):1296-307. doi: 10.1183/09031936.00000914. Epub 2014 Jul 17. |
| FG002 | Ustekinumab | Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24. |
| BG001 | Golimumab | Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24. |
| BG002 | Ustekinumab | Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20. |
| 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 | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Number of Participants by stratification factors | Participant allocation to treatment group was performed by interactive voice response system (IVRS) using a permuted block randomization stratified by baseline disease organ involvement (participants with pulmonary involvement only, participants with skin involvement only, and participants with both pulmonary and skin involvement) and prior use of anti-Tumor necrosis factor (TNF) biological therapy (yes or no). | Number | 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 | Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 16 | Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness . FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change was calculated as the value at Week 16 minus the baseline value. | Modified intent-to-treat (mITT) population included all the participants who were randomized and who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | percent of predicted FVC | Baseline (Day 1) and Week 16 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 6-minute Walk Distance at Week 28 | Change from Baseline in 6-minute walk distance at Week 28 was calculated as 6-minute walk distance at Week 28 minus 6-minute walk distance at Baseline. The 6-minute walk distance was the total distance walked during the 6-minute walk test. | mITT population included all the participants who were randomized and who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | meters | Baseline (Day 1) and Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 28 | St. George's Respiratory Questionnaire (SGRQ) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life. Change from Baseline was calculated as the value at Week 28 minus value at Baseline. | mITT population included all the participants who were randomized and who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline (Day 1) and Week 28 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Responders With a Score of Less Than or Equal to 1 on Skin Physician's Global Assessment (SPGA) Scale | The SPGA is 7-point scale used to assess the condition of skin in participants. The physician checks the state of the skin and gives them score from 0 (clear) to 5 (severe). Higher scores indicate worsening of skin condition. | Secondary population included all the participants with chronic sarcoidosis with skin involvement who have received at least 1 dose of study medication. | Posted | Number | Percentage of Participants | Week 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Percent-predicted Forced Vital Capacity (FVC) at Week 28 | Forced vital capacity (FVC) is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Predicted forced vital capacity is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (observed value)/(predicted value) * 100%. Change is calculated as the value at week 28 minus the baseline value. | mITT population included all the participants who were randomized and who received at least 1 dose of study medication. | Posted | Least Squares Mean | Standard Error | percent of predicted FVC | Baseline (Day 1) and Week 28 |
|
Baseline and Week 16
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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 | Placebo | Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24. | 9 | 58 | 52 | 58 | ||
| EG001 | Golimumab | Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24. | 7 | 55 | 49 | 55 | ||
| EG002 | Ustekinumab | Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20. | 10 | 60 | 52 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pharyngeal cyst | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pulmonary sarcoidosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Sudden death | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Obesity | Metabolism and nutrition disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Major depression | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Diabetic gastroparesis | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Diverticular perforation | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Sarcoidosis | Immune system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Non-systematic Assessment |
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| Traumatic renal injury | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Non-systematic Assessment |
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| Psychiatric evaluation | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Non-systematic Assessment |
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| Cerebral sarcoidosis | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Urethral disorder | Renal and urinary disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA Version 15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Chest Discomfort | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Influenza Like Illness | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Injection Site Pruritus | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Non-Cardiac Chest Pain | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Sarcoidosis | Immune system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Herpes Zoster | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Respiratory Tract | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Alanine Aminotransferase Increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Weight Increased | Investigations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Burning Sensation | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Upper Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 15.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director | Johnson & Johnson Pharmaceutical Research & Development | ClinicalTrialDisclosure@its.jnj.com |
| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| D017565 | Sarcoidosis, Pulmonary |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529000 | golimumab |
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| Pulmonary Only |
|
| Skin Only |
|
| No |
| Superiority or Other |
| Units | Counts |
|---|---|
| Participants |
|
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|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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