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| ID | Type | Description | Link |
|---|---|---|---|
| C0524T17 | |||
| 2006-003398-28 | EudraCT Number | ||
| NCT00487539 | Registry Identifier | ClinicalTrials.gov Identifier |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).
This is a multi-center (conducted in more than one center), randomized (study medication assigned by chance), double-blind (neither the physician nor the participant know about the study medication), placebo-controlled (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions) study to evaluate the safety and efficacy of golimumab in participants with moderately to severely active UC. There are 2 parts in this study. Part 1 is "Phase 2 dose-ranging" portion of study. Participants enrolled in Part 1, will receive subcutaneous (under the skin by way of a needle) injections of placebo, golimumab 100 milligram (mg), 200 mg, or 400 mg at Week 0, followed by subcutaneous injections of placebo, golimumab 50 mg, 100 mg, or 200 mg respectively at Week 2. Part 2 is "Phase 3 dose-confirming" portion of study and newly enrolled participants will receive same doses studied in Part 1, until the doses for Part 2 are selected. At the time that the final doses are selected, all newly enrolled participants will receive 1 of the selected doses or matching placebo. At Week 6, participants will be asked to participate in an additional 1-year maintenance study. Participants not entering the 1-year golimumab maintenance study will be evaluated for safety 16 weeks after last administration of study agent. The duration of study will be 6 weeks for participants who enter the 1-year golimumab maintenance study and 16 weeks after last administration of study agent for participants who do not enter the 1-year golimumab maintenance study. Efficacy of the participants will primarily be evaluated by clinical response at Week 6. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2. |
|
| Golimumab 100 mg -> 50 mg | Experimental | Golimumab 100 milligram (mg) subcutaneous injection administered at Week 0 and dose is decreased to 50 mg at Week 2. |
|
| Golimumab 200 mg -> 100 mg | Experimental | Golimumab 200 mg subcutaneous injection administered at Week 0 and dose is decreased to 100 mg at Week 2. |
|
| Golimumab 400 mg -> 200 mg | Experimental | Golimumab 400 mg subcutaneous injection administered at Week 0 and dose is decreased to 200 mg at Week 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | Placebo subcutaneous injection (given under the skin by way of a needle) matching to golimumab administered at Week 0 and Week 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Response at Week 6 | Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Remission at Week 6 | Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31982148 | Derived | Adedokun OJ, Xu Z, Liao S, Strauss R, Reinisch W, Feagan BG, Sandborn WJ. Population Pharmacokinetics and Exposure-Response Modeling of Golimumab in Adults With Moderately to Severely Active Ulcerative Colitis. Clin Ther. 2020 Jan;42(1):157-174.e4. doi: 10.1016/j.clinthera.2019.11.010. Epub 2020 Jan 22. | |
| 30721964 | Derived |
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Participants were assigned to Placebo, Golimumab 100 mg->50 mg, Golimumab 200 mg->100 mg and Golimumab 400 mg->200 mg groups for dose selection. Efficacy results were reported for only newly enrolled participants assigned to Placebo, Golimumab 200 mg->100 mg and Golimumab 400 mg->200 mg groups after dose-selection as per planned analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis). |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Golimumab 100 mg | Biological | Golimumab 100 mg subcutaneous injection administered at Week 0 for Golimumab 100 mg -> 50 mg arm group and at Week 2 for Golimumab 200 mg -> 100 mg arm group. |
|
| Golimumab 200 mg | Biological | Golimumab 200 mg subcutaneous injection administered at Week 0 for Golimumab 200 mg -> 100 mg arm group and at Week 2 for Golimumab 400 mg -> 200 mg arm group. |
|
| Golimumab 400 mg | Biological | Golimumab 400 mg subcutaneous injection administered at Week 0 for Golimumab 400 mg -> 200 mg arm group. |
|
| Golimumab 50 mg | Biological | Golimumab 50 mg subcutaneous injection administered at Week 2 for Golimumab 100 mg -> 50 mg arm group. |
|
| Week 6 |
| Number of Participants With Mucosal Healing at Week 6 | Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). | Week 6 |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6 | The IBDQ is used to measure disease specific quality of life on a 32 Likert-scaled items questionnaire. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function and social function with scores ranging from 10 to 70, 5 to 35, 12 to 84 and 5 to 35 respectively and the total score ranges from 32 to 224. Higher scores indicate better health related quality of life. | Baseline to Week 6 |
| Little Rock |
| Arkansas |
| United States |
| Roseville | California | United States |
| San Diego | California | United States |
| Golden | Colorado | United States |
| Newark | Delaware | United States |
| Boca Raton | Florida | United States |
| Gainesville | Florida | United States |
| Hialeah | Florida | United States |
| Naples | Florida | United States |
| New Port Richey | Florida | United States |
| Port Orange | Florida | United States |
| Winter Park | Florida | United States |
| Zephyrhills | Florida | United States |
| Atlanta | Georgia | United States |
| Savannah | Georgia | United States |
| Arlington Heights | Illinois | United States |
| Chicago | Illinois | United States |
| Clive | Iowa | United States |
| Pratt | Kansas | United States |
| Lexington | Kentucky | United States |
| Monroe | Louisiana | United States |
| Ann Arbor | Michigan | United States |
| Troy | Michigan | United States |
| Rochester | Minnesota | United States |
| Pascagoula | Mississippi | United States |
| Tupelo | Mississippi | United States |
| Egg Harbor | New Jersey | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Asheville | North Carolina | United States |
| Charlotte | North Carolina | United States |
| Morganton | North Carolina | United States |
| New Bern | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Fargo | North Dakota | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Colombus | Ohio | United States |
| Norman | Oklahoma | United States |
| Portland | Oregon | United States |
| Limerick | Pennsylvania | United States |
| Columbia | South Carolina | United States |
| Germantown | Tennessee | United States |
| Nashville | Tennessee | United States |
| Houston | Texas | United States |
| Sugar Land | Texas | United States |
| Logan | Utah | United States |
| Ogden | Utah | United States |
| Chesapeake | Virginia | United States |
| Fairfax | Virginia | United States |
| Richmond | Virginia | United States |
| Spokane | Washington | United States |
| Tacoma | Washington | United States |
| Madison | Wisconsin | United States |
| Milwaukee | Wisconsin | United States |
| Bankstown | Australia |
| Box Hill | Australia |
| Fitzroy | Australia |
| Herston | Australia |
| Launceston | Australia |
| Parkville | Australia |
| Prahran | Australia |
| Westmead | Australia |
| Vienna | Austria |
| Brussels | Belgium |
| Ghent | Belgium |
| Leuven | Belgium |
| Liège | Belgium |
| Roeselare | Belgium |
| Pleven | Bulgaria |
| Rousse | Bulgaria |
| Sofia | Bulgaria |
| Vancouver | British Columbia | Canada |
| Barrie | Ontario | Canada |
| Chatham | Ontario | Canada |
| London | Ontario | Canada |
| Toronto | Ontario | Canada |
| Saskatoon | Saskatchewan | Canada |
| T2n | Canada |
| Windsor | Canada |
| Èeské Budìjovice 1 | Czechia |
| Hradec Králové | Czechia |
| Litoměřice | Czechia |
| Ostrava | Czechia |
| Aalborg | Denmark |
| Aarhus C | Denmark |
| Hvidovre | Denmark |
| Odense C | Denmark |
| Amiens Cedex 1 80 | France |
| Bordeaux | France |
| Lille | France |
| Nice | France |
| Paris | France |
| Berlin | Germany |
| Berlin Be | Germany |
| Bochum | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Haßloch | Germany |
| Kiel | Germany |
| Minden | Germany |
| München | Germany |
| Münster | Germany |
| Stade | Germany |
| Balatonfüred | Hungary |
| Budapest | Hungary |
| Debrecen | Hungary |
| Dunaújváros | Hungary |
| Gyulai Ut 18 | Hungary |
| Mosonmagyaróvár | Hungary |
| Sopron | Hungary |
| Szeged | Hungary |
| Szekszárd | Hungary |
| Székesfehérvár | Hungary |
| Veszprém | Hungary |
| Bangalore | India |
| Chennai | India |
| Hyderabad | India |
| Hyderabad Andh Prad | India |
| Kārnād | India |
| New Delhi | India |
| Pune | India |
| Vishakapatanam | India |
| Beer Yaakov | Israel |
| Beersheba | Israel |
| Haifa | Israel |
| Jerusalem | Israel |
| Kfar Saba | Israel |
| Nazareth | Israel |
| Petah-Tikv | Israel |
| Rehovot | Israel |
| Tel Aviv | Israel |
| Bunkyō City | Japan |
| Chikushinoshi | Japan |
| Fukuoka | Japan |
| Hiroshima | Japan |
| Kagoshima | Japan |
| Kurashiki | Japan |
| Kurume | Japan |
| Nagoya | Japan |
| Nishinomiya | Japan |
| Okayama | Japan |
| Osaka | Japan |
| Sakura | Japan |
| Sapporo | Japan |
| Tokyo | Japan |
| Yokkaichi | Japan |
| Kaunas | Lithuania |
| Vilnius | Lithuania |
| Amsterdam | Netherlands |
| Ede Gld | Netherlands |
| Groningen | Netherlands |
| Leiden | Netherlands |
| Christchurch | New Zealand |
| Dunedin | New Zealand |
| Hamilton | New Zealand |
| Bydgoszcz | Poland |
| Częstochowa | Poland |
| Elblag | Poland |
| Gdansk | Poland |
| Krakow | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Opole | Poland |
| Sopot | Poland |
| Szczecin | Poland |
| Torun | Poland |
| Warsaw | Poland |
| Bucharest | Romania |
| Cluj-Napoca | Romania |
| Iași | Romania |
| Târgu Mureş | Romania |
| Timișoara | Romania |
| Moscow | Russia |
| Novosibirsk | Russia |
| Omsk | Russia |
| Saint Petersburg | Russia |
| Yaroslavl | Russia |
| Belgrade | Serbia |
| Niš | Serbia |
| Zemun | Serbia |
| Bratislava | Slovakia |
| Martin | Slovakia |
| Nitra | Slovakia |
| Nové Mesto nad Váhom | Slovakia |
| Prešov | Slovakia |
| Cape Town | South Africa |
| Cape Town West Cape | South Africa |
| Marianhill Kz-Natal | South Africa |
| Pretoria Gauteng | South Africa |
| Stockholm | Sweden |
| Donetsk | Ukraine |
| Kharkiv | Ukraine |
| Kyiv | Ukraine |
| Simferopol | Ukraine |
| Vynnytsya | Ukraine |
| Zhaporozhia 69104 | Ukraine |
| Li K, Strauss R, Marano C, Greenbaum LE, Friedman JR, Peyrin-Biroulet L, Brodmerkel C, De Hertogh G. A Simplified Definition of Histologic Improvement in Ulcerative Colitis and its Association With Disease Outcomes up to 30 Weeks from Initiation of Therapy: Post Hoc Analysis of Three Clinical Trials. J Crohns Colitis. 2019 Aug 14;13(8):1025-1035. doi: 10.1093/ecco-jcc/jjz022. |
| 23735746 | Derived | Sandborn WJ, Feagan BG, Marano C, Zhang H, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Colombel JF, Reinisch W, Gibson PR, Collins J, Jarnerot G, Hibi T, Rutgeerts P; PURSUIT-SC Study Group. Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis. Gastroenterology. 2014 Jan;146(1):85-95; quiz e14-5. doi: 10.1053/j.gastro.2013.05.048. Epub 2013 Jun 2. |
| Golimumab 100 mg -> 50 mg |
Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2. |
| FG002 | Golimumab 200 mg -> 100 mg | Golimumab 200 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 100 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis). |
| FG003 | Golimumab 400 mg -> 200 mg | Golimumab 400 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 200 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2. |
| BG001 | Golimumab 100 mg -> 50 mg | Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2. |
| BG002 | Golimumab 200 mg -> 100 mg | Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2. |
| BG003 | Golimumab 400 mg -> 200 mg | Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2. |
| BG004 | 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 |
|
| 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 | Number of Participants With Clinical Response at Week 6 | Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. | Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection. | Posted | Number | Participants | Baseline, Week 6 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Remission at Week 6 | Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. | Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection. | Posted | Number | Participants | Week 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Mucosal Healing at Week 6 | Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). | Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection. | Posted | Number | Participants | Week 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 6 | The IBDQ is used to measure disease specific quality of life on a 32 Likert-scaled items questionnaire. The IBDQ scale contains 4 component subscales: bowel symptoms, systemic symptoms, emotional function and social function with scores ranging from 10 to 70, 5 to 35, 12 to 84 and 5 to 35 respectively and the total score ranges from 32 to 224. Higher scores indicate better health related quality of life. | Efficacy analysis population included all the participants who were randomly assigned to the study after the dose selection. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to Week 6 |
|
6 weeks for participants who entered the maintenance study. 16 weeks following the last study agent administration for participants who did not enter the maintenance study.
The safety population reflects the "as treated" population: 1 participant out of the 331 randomized to placebo, received golimumab 100 mg at Week 0 and is included in the 200 mg -> 100 mg group; 1 participant out of the 331 randomized to the 200 mg -> 100 mg group, received 200 mg golimumab at Week 2 and is included in the 400 mg -> 200 mg group.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2. | 20 | 330 | 61 | 330 | ||
| EG001 | Golimumab 100 mg -> 50 mg | Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2. | 3 | 71 | 18 | 71 | ||
| EG002 | Golimumab 200 mg -> 100 mg | Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2. | 10 | 331 | 54 | 331 | ||
| EG003 | Golimumab 400 mg -> 200 mg | Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2. | 15 | 332 | 55 | 332 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Adverse Drug Reaction | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Anal Abscess | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Brain Abscess | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Cytomegalovirus Infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Enterocolitis Infectious | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Haematoma Infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Rectal Abscess | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Volume Blood Decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Carcinoma in Situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Demyelination | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Lung Infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Erythema Nodosum | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Rash Macular | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Oral Herpes | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
12 months after study ends, Sponsor will be provided with a copy of the materials at least 45 days prior to submission, with details of proposed date, journal or conference name of publication & it will have 30 days post receipt to send a written request that the publication be delayed on the basis it exposes intellectual property that requires propriety protection but it will be only for 60 days after which Investigator will be free to publish. The participation of Sponsor will be acknowledged.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director | Janssen Research & Development | 215-793-7540 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C529000 | golimumab |
Not provided
Not provided
Not provided
| Male |
|
| No |
| Superiority or Other |
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|