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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003553-16 | EudraCT Number |
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The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 210 mg brodalumab | Experimental | Administered via subcutaneous injections. |
|
| 140 mg brodalumab | Experimental | Administered via subcutaneous injection. |
|
| Placebo | Placebo Comparator | Administered via subcutaneous injection until week 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 210 mg brodalumab | Drug | 210 mg brodalumab administered via subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 | ACR20 is used as a measurement of the proportion of subjects who are reaching a 20% improvement of tender an swollen joint counts. The higher percent of subjects reaching a higher improvement percentage shows greater success. | Baseline and 16 Weeks |
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Inclusion Criteria:
Subjects has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding distal interphalangeal joints). Subjects must have at least
1 psoriatic skin lesion. Exclusion Criteria:
• -Subject has known history of active tuberculosis.
Subject has severe depression measured by Personal Health Questionnaire Depression Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating Scale (e-CSSRS)
• Subject has a history or evidence of psychiatric disorder or substance abuse considered by the Investigator to pose a risk to subject safety
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Peoria | Arizona | 85381 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 210 mg Brodalumab | Administered via subcutaneous injections. 210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection. |
| FG001 | 140 mg Brodalumab | Administered via subcutaneous injection. 140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 140 mg brodalumab | Drug | 140 mg brodalumab administered via subcutaneous injection. |
|
|
| Placebo | Drug | Placebo administered via subcutaneous injection until week 24. |
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| Research Site | Cypress | California | 90630 | United States |
| Research Site | Hemet | California | 92543 | United States |
| Research Site | Huntington Beach | California | 92646 | United States |
| Research Site | La Jolla | California | 92037 | United States |
| Research Site | Palm Desert | California | 92260 | United States |
| Research Site | Palo Alto | California | 94304 | United States |
| Research Site | Victorville | California | 92395 | United States |
| Research Site | Sarasota | Florida | 34239 | United States |
| Research Site | St. Petersburg | Florida | 33705 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Tampa | Florida | 33614 | United States |
| Research Site | Chicago | Illinois | 60611 | United States |
| Research Site | Paducah | Kentucky | 42003 | United States |
| Research Site | Baton Rouge | Louisiana | 70809 | United States |
| Research Site | Wheaton | Maryland | 20902 | United States |
| Research Site | Boston | Massachusetts | 02111 | United States |
| Research Site | Battle Creek | Michigan | 49017 | United States |
| Research Site | Grand Rapids | Michigan | 49546 | United States |
| Research Site | Lansing | Michigan | 48910 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Las Vegas | Nevada | 89102 | United States |
| Research Site | Rochester | New York | 14642 | United States |
| Research Site | Oklahoma City | Oklahoma | 73103 | United States |
| Research Site | Tulsa | Oklahoma | 74104 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | Waco | Texas | 76708 | United States |
| Research Site | Chesapeake | Virginia | 23320 | United States |
| Research Site | Seattle | Washington | 98104 | United States |
| Research Site | Calgary | Alberta | T3A 2N1 | Canada |
| Research Site | Victoria | British Columbia | V8V 3P9 | Canada |
| Research Site | Winnipeg | Manitoba | R3A 1M3 | Canada |
| Research Site | St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| Research Site | St. John's | Newfoundland and Labrador | A1C 5B8 | Canada |
| Research Site | Waterloo | Ontario | N2J 1C4 | Canada |
| Research Site | Québec | Quebec | G1V 3M7 | Canada |
| Research Site | Québec | Quebec | G1V 4X7 | Canada |
| Research Site | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Research Site | Bordeaux | 33076 | France |
| Research Site | Le Kremlin-Bicêtre | 94270 | France |
| Research Site | Lille | 59037 | France |
| Research Site | Lyon Cédex 3 | 69437 | France |
| Research Site | Nantes | 44093 | France |
| Research Site | Paris | 75018 | France |
| Research Site | Paris | 75475 | France |
| Research Site | Reims | 51092 | France |
| Research Site | Frankfurt | 60528 | Germany |
| Research Site | Hanover | 30625 | Germany |
| Research Site | Hildesheim | 31134 | Germany |
| Research Site | Leipzig | 04103 | Germany |
| Research Site | Lübeck | 23538 | Germany |
| Research Site | Athens | 11527 | Greece |
| Research Site | Athens | 14561 | Greece |
| Research Site | Athens | 16673 | Greece |
| Research Site | Larissa | 41110 | Greece |
| Research Site | Thessaloniki | 56429 | Greece |
| Research Site | Budapest | 1023 | Hungary |
| Research Site | Budapest | 1036 | Hungary |
| Research Site | Eger | 3300 | Hungary |
| Research Site | NyÃregyháza | 4400 | Hungary |
| Research Site | Székesfehérvár | 8000 | Hungary |
| Research Site | Szolnok | 5000 | Hungary |
| Research Site | Szombathely | 9700 | Hungary |
| Research Site | Riga | 1001 | Latvia |
| Research Site | Riga | 1002 | Latvia |
| Research Site | Riga | 1003 | Latvia |
| Research Site | Riga | 1005 | Latvia |
| Research Site | Mexicali | Baja California Norte | 21100 | Mexico |
| Research Site | Guadalajara | Jalisco | 44160 | Mexico |
| Research Site | Guadalajara | Jalisco | 44620 | Mexico |
| Research Site | Guadalajara | Jalisco | 44650 | Mexico |
| Research Site | Ciudad Obregón | Sonora | 85000 | Mexico |
| Research Site | Mérida | Yucatán | 97133 | Mexico |
| Research Site | Gdansk | 80-952 | Poland |
| Research Site | Gdynia | 81-384 | Poland |
| Research Site | Grodzisk Mazowiecki | 05-825 | Poland |
| Research Site | Katowice | 40-040 | Poland |
| Research Site | Lodz | 90-242 | Poland |
| Research Site | Lodz | 90-436 | Poland |
| Research Site | Lublin | 20-607 | Poland |
| Research Site | Poznan | 61-113 | Poland |
| Research Site | Stalowa Wola | 37-450 | Poland |
| Research Site | Åšwidnik | 21-040 | Poland |
| Research Site | Warsaw | 01-192 | Poland |
| Research Site | Warsaw | 02-118 | Poland |
| Research Site | Warsaw | 02-653 | Poland |
| Research Site | Warsaw | 04-141 | Poland |
| Research Site | Wroclaw | 50-088 | Poland |
| Research Site | Wroclaw | 50-368 | Poland |
| Research Site | Wroclaw | 51-318 | Poland |
| Research Site | Wroclaw | 53-658 | Poland |
| Research Site | Chelyabinsk | 454076 | Russia |
| Research Site | Kemerovo | 650099 | Russia |
| Research Site | Kursk | 305007 | Russia |
| Research Site | Moscow | 125284 | Russia |
| Research Site | Petrozavodsk | 185019 | Russia |
| Research Site | Saint Petersburg | 192242 | Russia |
| Research Site | Saratov | 410012 | Russia |
| Research Site | Smolensk | 214025 | Russia |
| Research Site | Voronezh | 394066 | Russia |
| Research Site | Yekaterinburg | 620076 | Russia |
| FG002 | Placebo | Administered via subcutaneous injection until week 24. Placebo: Placebo administered via subcutaneous injection until week 24. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 210 mg Brodalumab | Administered via subcutaneous injections. 210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection. |
| BG001 | 140 mg Brodalumab | Administered via subcutaneous injection. 140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection. |
| BG002 | Placebo | Administered via subcutaneous injection until week 24. Placebo: Placebo administered via subcutaneous injection until week 24. |
| 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 | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | 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 | ACR20 (American College of Rheumatology 20% Improvement) Response Rate Through Week 16 | ACR20 is used as a measurement of the proportion of subjects who are reaching a 20% improvement of tender an swollen joint counts. The higher percent of subjects reaching a higher improvement percentage shows greater success. | The Primary Analysis Set consists of all randomized subjects who had the opportunity to complete the week 16 visit prior to termination of the study. The numbers in the outcome measure data table reflect the percentage of subjects achieving ACR20. | Posted | Number | Percentage of Participants | Baseline and 16 Weeks |
|
|
|
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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 | 210 mg Brodalumab | Administered via subcutaneous injections. 210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection. | 5 | 163 | 91 | 163 | ||
| EG001 | 140 mg Brodalumab | Administered via subcutaneous injection. 140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection. | 3 | 160 | 85 | 160 | ||
| EG002 | Placebo | Administered via subcutaneous injection until week 24. Placebo: Placebo administered via subcutaneous injection until week 24. | 5 | 161 | 83 | 161 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT increased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Bursitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Fibula Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Psoriatic Arthropathy | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin Infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Abortion Induced | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| AST Increased | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Carotid Artery Stenosis | Vascular disorders | Non-systematic Assessment |
| ||
| Cerebrovascular Accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Haemorrhoidal haemorrhage | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Upper Respiratory Tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Sinusitus | Infections and infestations | Non-systematic Assessment |
| ||
| Oral Herpes | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Non-systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Laryngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Herpes Zoster | Infections and infestations | Non-systematic Assessment |
| ||
| Gout | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Psoriatic Arthropathy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Spinal Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Chest Pain | General disorders | Non-systematic Assessment |
| ||
| peripheral Swelling | General disorders | Non-systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Ligament Sprain | General disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Bausch Health | 310-770-7750 | anya.loncaric@bauschhealth.com |
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C571216 | brodalumab |
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| Male |
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| Canada |
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| Latvia |
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| Russian Federation |
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| Hungary |
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| United States |
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| Poland |
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| Mexico |
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| France |
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| Germany |
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