| ID | Type | Description | Link |
|---|---|---|---|
| C0524T16 | Other Identifier | Janssen Research & Development, LLC | |
| 2006-003397-94 | Other Identifier | Janssen Research & Development, LLC |
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Protocol was cancelled by company based on overall efficacy, no safety concern
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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 active ulcerative colitis (UC) (sores in the colon).
This is a randomized (study medication assigned by chance), double-blind (neither the Physician nor the participant know about the study medication), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions [treatments]) study to evaluate an appropriate intravenous (through a vein in the arm) golimumab induction dose and to demonstrate the safety and efficacy of intravenous induction dosing with golimumab in participants with moderately to severely active UC. 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 at Week 16. The duration of study will be 6 weeks for participants who enter the 1-year golimumab maintenance study and 16 weeks for participant who do not enter the 1-year golimumab maintenance study.There are 2 parts in this study. Part 1 is Phase 2 "dose-ranging" portion of study. Participants enrolled in Part 1, will receive a single intravenous infusion of either matching placebo for golimumab or 1 milligram (mg) per kilogram(kg), 2 mg per kg or 4 mg per kg of golimumab. Part 2 of the study is called "dose-confirming" and newly enrolled participants will receive same doses studied in Part 1, until the doses for Part 2 are selected and Phase 3 begins. At the time that the final doses are selected, all newly enrolled participants will receive 1 of the selected doses or matching placebo; this is the start of the Phase 3 portion of the study. Participants will primarily be assessed using Mayo Score (it is a score developed for measuring disease activity). Participants' safety and quality of life will also be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0 |
|
| Golimumab 1 milligram (mg) per kilogram (kg) | Experimental | Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0. |
|
| Golimumab 2 mg per kg | Experimental | Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0. |
|
| Golimumab 4 mg per kg | Experimental | Golimumab 4 mg per kg, intravenous (IV) infusion administered at Week 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Matching placebo for golimumab, intravenous infusion administered at Week 0 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Response | 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 a 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. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Remission | 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 a 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 |
|---|---|---|---|---|---|---|
| Orange | California | 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. | |
| 26119226 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0. |
| FG001 | Golimumab 1 Milligram (mg) Per Kilogram (kg) | Golimumab 1 mg per kg intavenous infusion was administered at Week 0. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Golimumab 1 mg per kg |
| Drug |
Golimumab 1 mg per kg intravenous (IV) infusion administered at Week 0 |
|
|
| Golimumab 2 mg per kg | Drug | Golimumab 2 mg per kg intravenous (IV) infusion administered at Week 0 |
|
|
| Golimumab 4 mg per kg | Drug | Golimumab 4 mg per kg intravenous (IV) infusion at Week 0 |
|
| Week 6 |
| Roseville |
| California |
| United States |
| Littleton | Colorado | United States |
| Bristol | Connecticut | United States |
| Tampa | Florida | United States |
| Fort Dodge | Iowa | United States |
| Topeka | Kansas | United States |
| Louisville | Kentucky | United States |
| Laurel | Maryland | United States |
| Dearborn | Michigan | United States |
| Troy | Michigan | United States |
| Mexico | Missouri | United States |
| St Louis | Missouri | United States |
| Lebanon | New Hampshire | United States |
| Great Neck | New York | United States |
| Huntington | New York | United States |
| New York | New York | United States |
| Charlotte | North Carolina | United States |
| Kinston | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Cleveland | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Tulsa | Oklahoma | United States |
| Philadelphia | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Columbia | South Carolina | United States |
| Germantown | Tennessee | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| Galveston | Texas | United States |
| Burlington | Vermont | United States |
| Christiansburg | Virginia | United States |
| Richmond | Virginia | United States |
| Bellevue | Washington | United States |
| Madison | Wisconsin | United States |
| Milwaukee | Wisconsin | United States |
| Adelaide | Australia |
| Brisbane | Australia |
| Malvern | Australia |
| Innsbruck | Austria |
| Bonheiden | Belgium |
| Leuven | Belgium |
| Rousse | Bulgaria |
| Varna | Bulgaria |
| Calgary | Alberta | Canada |
| Vancouver | British Columbia | Canada |
| Victoria | British Columbia | Canada |
| Hamilton | Ontario | Canada |
| Kingston | Ontario | Canada |
| London | Ontario | Canada |
| Montreal | Quebec | Canada |
| Saskatoon | Saskatchewan | Canada |
| Clichy | France |
| Lille | France |
| Nice | France |
| Hamburg | Free and Hanseatic City of Hamburg | Germany |
| Berlin | State of Berlin | Germany |
| Herne | Germany |
| Magdeburg | Germany |
| Békéscsaba | Hungary |
| Budapest | Hungary |
| Gyõr | Hungary |
| Gyulai Ut 18 | Hungary |
| Miskolc | Hungary |
| Pécs | Hungary |
| Székesfehérvár | Hungary |
| Szombathely | Hungary |
| Hyderabad Andh Prad | India |
| Jaipur | India |
| Lucknow | India |
| Ludhiana | India |
| Pune | India |
| Afula | Israel |
| Hedera | Israel |
| Jerusalem | Israel |
| Kfar Saba | Israel |
| Tel Aviv | Israel |
| Daugavpils | Latvia |
| Riga | Latvia |
| Klaipėda | Lithuania |
| Šiauliai | Lithuania |
| Vilnius LT | Lithuania |
| Amsterdam | Netherlands |
| Groningen | Netherlands |
| Leiden | Netherlands |
| Rotterdam | Netherlands |
| Auckland | New Zealand |
| Hastings | New Zealand |
| Bialystok | Poland |
| Częstochowa | Poland |
| Krakow | Poland |
| Lodz | Poland |
| Skierniewice | Poland |
| Sopot | Poland |
| Bucharest | Romania |
| Timișoara | Romania |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Yaroslavl | Russia |
| Belgrade | Serbia |
| Bratislava | Slovakia |
| Nitra | Slovakia |
| Prešov | Slovakia |
| Gothenburg | Sweden |
| Donetsk | Ukraine |
| Ivano | Ukraine |
| Kiev | Ukraine |
| Vynnytsya | Ukraine |
| Rutgeerts P, Feagan BG, Marano CW, Padgett L, Strauss R, Johanns J, Adedokun OJ, Guzzo C, Zhang H, Colombel JF, Reinisch W, Gibson PR, Sandborn WJ; PURSUIT-IV study group. Randomised clinical trial: a placebo-controlled study of intravenous golimumab induction therapy for ulcerative colitis. Aliment Pharmacol Ther. 2015 Sep;42(5):504-14. doi: 10.1111/apt.13291. Epub 2015 Jun 29. |
| FG002 | Golimumab 2 mg Per kg | Golimumab 2 mg per kg intravenous infusion was administered at Week 0. |
| FG003 | Golimumab 4 mg Per kg | Golimumab 4 mg per kg intavenous infusion was administered at Week 0. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0. |
| BG001 | Golimumab 1 mg Per kg | Golimumab 1 mg per kg intavenous infusion was administered at Week 0. |
| BG002 | Golimumab 2 mg Per kg | Golimumab 2 mg per kg intravenous infusion was administered at Week 0. |
| BG003 | Golimumab 4 mg Per kg | Golimumab 4 mg per kg intavenous infusion was administered at Week 0. |
| 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 |
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| 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 | 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 a 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. | The efficay analysis population included all the participants who were randomly assigned to receive study medication. Here 'N' signifies participants who were evaluated for this outcome measure. | Posted | Number | Participants | Week 6 |
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| Secondary | Number of Participants With Clinical Remission | 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 a 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. | The efficay analysis population included all the participants who were randomly assigned to receive study medication. Here 'N' signifies participants who were evaluated for this outcome measure. | Posted | Number | Participants | Week 6 |
|
Baseline up to 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 for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0. | 3 | 77 | 15 | 77 | ||
| EG001 | Golimumab 1 mg Per kg | Golimumab 1 mg per kg intravenous infusion was administered at Week 0. | 2 | 63 | 13 | 63 | ||
| EG002 | Golimumab 2 mg Per kg | Golimumab 2 mg per kg intravenous infusion was administered at Week 0. | 3 | 74 | 15 | 74 | ||
| EG003 | Golimumab 4 mg Per kg | Golimumab 4 mg per kg intravenous infusion was administered at Week 0. | 3 | 76 | 9 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Multiple Injuries | Injury, poisoning and procedural complications | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 12.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 12.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 12.0 | Non-systematic Assessment |
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Data collection was not considered complete for primary outcome measure because study was terminated prematurely.
Twelve months after study ends, Sponsor will be provided with a copy of 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 written request that 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 |
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| ID | Term |
|---|---|
| C529000 | golimumab |
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| Male |
|
| No |
| Superiority or Other |
| Chi-squared | 0.145 | No | Superiority or Other |
Golimumab 4 mg per kg intravenous infusion was administered at Week 0. |
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