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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504417-67-00 | Registry Identifier | EU CT NUMBER |
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The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab s.c. | Experimental | Participants will be started on 75 mg, 150 mg or 300 mg s.c. Q4W depending on what dose the participant was receiving in the parent trial (for trials with i.v. formulation the starting dose will be 300 mg s.c.). The study medication dose may be modified basedu pon clinical need, the judgement of the investigator and health authority guidelines (if applicable). For pediatric participants, the dose should not be increased beyond the maximum dose evaluated in the respective weight category in the parent protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab s.c. injection | Biological | Secukinumab pre-filled syringes (PFS) for s.c. injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate long term safety as assessed by occurrence of AEs/SAEs | Serious adverse events (SAEs), adverse events (AEs), and injection site reactions | up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact | +41613241111 |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Medical Foundation | Completed | Fullerton | California | 92835 | United States | |
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| Purushotham Akther and Roshan Kotha MD Inc |
| Completed |
| La Mesa |
| California |
| 91942 |
| United States |
| Precn Comprehensive Clnl Rsch Solns | Completed | San Leandro | California | 94578 | United States |
| Orrin Troum MD and Medical Associates | Completed | Santa Monica | California | 90404 | United States |
| Inland Rheumatology Clinical Trials INC | Completed | Upland | California | 91786 | United States |
| Medvin Clinical Research | Completed | Van Nuys | California | 91405 | United States |
| Center for Rheumatology Research | Completed | West Hills | California | 91307 | United States |
| Denver Arthritis Clinic | Completed | Denver | Colorado | 80230 | United States |
| Rheumatology Associates of South Florida | Recruiting | Boca Raton | Florida | 33486 | United States |
|
| Homestead Assoc In Research Inc | Completed | Homestead | Florida | 33033 | United States |
| IRIS Research and Development | Completed | Plantation | Florida | 33324 | United States |
| Conquest Research | Completed | Winter Park | Florida | 32789 | United States |
| FL Medical Clinic Orlando Health | Recruiting | Zephyrhills | Florida | 33542 | United States |
|
| Willow Rheumatology Wellness | Completed | Willowbrook | Illinois | 60527 | United States |
| Dawes Fretzin Clinical Rea Group | Completed | Indianapolis | Indiana | 46256 | United States |
| Klein and Associates | Completed | Hagerstown | Maryland | 21740 | United States |
| Ahmed Arif Medical Research Center | Completed | Grand Blanc | Michigan | 48439 | United States |
| Physician Research Collaboration | Completed | Lincoln | Nebraska | 68516 | United States |
| Arthritis Rheumatology and Bone Disease Associates PA | Completed | Voorhees Township | New Jersey | 08043 | United States |
| St Lawrence Health System | Completed | Potsdam | New York | 13676 | United States |
| Oregon Health Sciences University | Completed | Portland | Oregon | 97239 | United States |
| Altoona Center for Clin Res | Active, not recruiting | Duncansville | Pennsylvania | 16635 | United States |
| West Tennessee Research Institute | Active, not recruiting | Jackson | Tennessee | 38305 | United States |
| Austin Regional Clinic Rheumatology | Completed | Austin | Texas | 78731 | United States |
| Accurate Clinical Research Inc | Active, not recruiting | Houston | Texas | 77089 | United States |
| Southwest Rheum Rsrch LLC | Completed | Mesquite | Texas | 75150 | United States |
| Overlake Arthritis and Osteoporosis | Completed | Bellevue | Washington | 98004 | United States |
| Rheumatology Pulmonary Clinic | Completed | Beckley | West Virginia | 25801 | United States |
| Novartis Investigative Site | Completed | Vitória | Espírito Santo | 29055 450 | Brazil |
| Novartis Investigative Site | Completed | Salvador | Estado de Bahia | 40150 150 | Brazil |
| Novartis Investigative Site | Completed | Juiz de Fora | Minas Gerais | 36010 570 | Brazil |
| Novartis Investigative Site | Completed | São Paulo | São Paulo | 01244-030 | Brazil |
| Novartis Investigative Site | Completed | São Paulo | São Paulo | 04266 010 | Brazil |
| Novartis Investigative Site | Completed | Rio de Janeiro | 20241-180 | Brazil |
| Novartis Investigative Site | Completed | Sao Jose Rio Preto | 15090 000 | Brazil |
| Novartis Investigative Site | Active, not recruiting | Pleven | 5800 | Bulgaria |
| Novartis Investigative Site | Completed | Plovdiv | 4002 | Bulgaria |
| Novartis Investigative Site | Active, not recruiting | Sofia | 1407 | Bulgaria |
| Novartis Investigative Site | Completed | Sofia | 1431 | Bulgaria |
| Novartis Investigative Site | Completed | Sofia | 1784 | Bulgaria |
| Novartis Investigative Site | Active, not recruiting | Stara Zagora | 6000 | Bulgaria |
| Novartis Investigative Site | Active, not recruiting | Hefei | Anhui | 230001 | China |
| Novartis Investigative Site | Active, not recruiting | Hefei | Anhui | 230601 | China |
| Novartis Investigative Site | Active, not recruiting | Beijing | Beijing Municipality | 100044 | China |
| Novartis Investigative Site | Completed | Chongqing | Chongqing Municipality | 400010 | China |
| Novartis Investigative Site | Active, not recruiting | Xiamen | Fujian | 361001 | China |
| Novartis Investigative Site | Completed | Guangzhou | Guangdong | 510080 | China |
| Novartis Investigative Site | Completed | Guangzhou | Guangdong | 510120 | China |
| Novartis Investigative Site | Active, not recruiting | Guangzhou | Guangdong | 510515 | China |
| Novartis Investigative Site | Active, not recruiting | Shantou | Guangdong | 515000 | China |
| Novartis Investigative Site | Active, not recruiting | Shenzhen | Guangdong | 518020 | China |
| Novartis Investigative Site | Active, not recruiting | Wuhan | Hubei | 430030 | China |
| Novartis Investigative Site | Active, not recruiting | Changsha | Hunan | 410011 | China |
| Novartis Investigative Site | Completed | Zhuzhou | Hunan | 412000 | China |
| Novartis Investigative Site | Active, not recruiting | Baotou | Inner Mongolia | 014010 | China |
| Novartis Investigative Site | Completed | Hohhot | Inner Mongolia | 010050 | China |
| Novartis Investigative Site | Active, not recruiting | Nanjing | Jiangsu | 210008 | China |
| Novartis Investigative Site | Active, not recruiting | Nanjing | Jiangsu | 210009 | China |
| Novartis Investigative Site | Active, not recruiting | Yangzhou | Jiangsu | 225001 | China |
| Novartis Investigative Site | Completed | Nanchang | Jiangxi | 330006 | China |
| Novartis Investigative Site | Active, not recruiting | Pingxiang | Jiangxi | 337000 | China |
| Novartis Investigative Site | Active, not recruiting | Changchun | Jilin | 130021 | China |
| Novartis Investigative Site | Active, not recruiting | Linyi | Shandong | 276000 | China |
| Novartis Investigative Site | Completed | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Active, not recruiting | Ürümqi | Xinjiang | 830001 | China |
| Novartis Investigative Site | Active, not recruiting | Kunming | Yunnan | 650000 | China |
| Novartis Investigative Site | Active, not recruiting | Ningbo | Zhejiang | 315016 | China |
| Novartis Investigative Site | Active, not recruiting | Wenzhou | Zhejiang | 325000 | China |
| Novartis Investigative Site | Active, not recruiting | Beijing | 100000 | China |
| Novartis Investigative Site | Completed | Beijing | 100050 | China |
| Novartis Investigative Site | Completed | Beijing | 100730 | China |
| Novartis Investigative Site | Active, not recruiting | Bengbu | 233004 | China |
| Novartis Investigative Site | Completed | Jinan | 250012 | China |
| Novartis Investigative Site | Active, not recruiting | Shanghai | 200040 | China |
| Novartis Investigative Site | Active, not recruiting | Shanghai | 200050 | China |
| Novartis Investigative Site | Completed | Shanghai | 200127 | China |
| Novartis Investigative Site | Active, not recruiting | Tianjin | 300052 | China |
| Novartis Investigative Site | Completed | Bogota | Cundinamarca | 110221 | Colombia |
| Novartis Investigative Site | Completed | Chía | Cundinamarca | 250001 | Colombia |
| Novartis Investigative Site | Completed | Bucaramanga | Santander Department | 680003 | Colombia |
| Novartis Investigative Site | Completed | Ibague | Tolima Department | 730006 | Colombia |
| Novartis Investigative Site | Recruiting | Ostrava | Czech Republic | 772 00 | Czechia |
| Novartis Investigative Site | Recruiting | Brno-Zidonice | CZE | 61500 | Czechia |
| Novartis Investigative Site | Active, not recruiting | Prague | Prague 1 | 11000 | Czechia |
| Novartis Investigative Site | Recruiting | Brno | 625 00 | Czechia |
| Novartis Investigative Site | Recruiting | Brno | 638 00 | Czechia |
| Novartis Investigative Site | Active, not recruiting | Hradec Králové | 500 05 | Czechia |
| Novartis Investigative Site | Recruiting | Prague | 128 00 | Czechia |
| Novartis Investigative Site | Recruiting | Prague | 140 59 | Czechia |
| Novartis Investigative Site | Recruiting | Prague | 148 00 | Czechia |
| Novartis Investigative Site | Recruiting | Prague | 150 06 | Czechia |
| Novartis Investigative Site | Recruiting | Uherské Hradiště | 686 01 | Czechia |
| Novartis Investigative Site | Withdrawn | Pátrai | 26443 | Greece |
| Novartis Investigative Site | Completed | Guatemala City | 01001 | Guatemala |
| Novartis Investigative Site | Completed | Guatemala City | 01009 | Guatemala |
| Novartis Investigative Site | Completed | Guatemala City | 01010 | Guatemala |
| Novartis Investigative Site | Completed | Guatemala City | 01011 | Guatemala |
| Novartis Investigative Site | Completed | Surat | Gujarat | 395009 | India |
| Novartis Investigative Site | Completed | Bangalore | Karnataka | 560 079 | India |
| Novartis Investigative Site | Completed | Mumbai | Maharashtra | 400 053 | India |
| Novartis Investigative Site | Completed | Nashik | Maharashtra | 422101 | India |
| Novartis Investigative Site | Completed | Hyderabad | Telangana | 500082 | India |
| Novartis Investigative Site | Completed | New Delhi | 110029 | India |
| Novartis Investigative Site | Completed | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Completed | Reggio Emilia | RE | 42123 | Italy |
| Novartis Investigative Site | Completed | Kuching | Sarawak | 93586 | Malaysia |
| Novartis Investigative Site | Completed | Kuala Lumpur | 59100 | Malaysia |
| Novartis Investigative Site | Completed | Guadalajara | Jalisco | 44160 | Mexico |
| Novartis Investigative Site | Completed | Culiacan | State of Mexico | 80000 | Mexico |
| Novartis Investigative Site | Completed | Metepec | State of Mexico | 52140 | Mexico |
| Novartis Investigative Site | Active, not recruiting | Krakow | Lesser Poland Voivodeship | 30-727 | Poland |
| Novartis Investigative Site | Completed | Wroclaw | Lower Silesian Voivodeship | 52-210 | Poland |
| Novartis Investigative Site | Completed | Bialystok | 15-351 | Poland |
| Novartis Investigative Site | Recruiting | Bydgoszcz | 85-168 | Poland |
| Novartis Investigative Site | Recruiting | Krakow | 30-002 | Poland |
| Novartis Investigative Site | Completed | Poznan | 60-218 | Poland |
| Novartis Investigative Site | Completed | Sochaczew | 96-500 | Poland |
| Novartis Investigative Site | Recruiting | Torun | 87-100 | Poland |
| Novartis Investigative Site | Completed | Warsaw | 02-118 | Poland |
| Novartis Investigative Site | Active, not recruiting | Warsaw | 02-637 | Poland |
| Novartis Investigative Site | Completed | Warsaw | 02-962 | Poland |
| Novartis Investigative Site | Completed | Warsaw | 04-305 | Poland |
| Novartis Investigative Site | Completed | Wroclaw | 53-224 | Poland |
| Novartis Investigative Site | Completed | Lisbon | 1649-035 | Portugal |
| Novartis Investigative Site | Completed | Barnaul | 656024 | Russia |
| Novartis Investigative Site | Active, not recruiting | Chelyabinsk | 454048 | Russia |
| Novartis Investigative Site | Completed | Kazan' | 420012 | Russia |
| Novartis Investigative Site | Completed | Kazan' | 420064 | Russia |
| Novartis Investigative Site | Completed | Kemerovo | 650029 | Russia |
| Novartis Investigative Site | Completed | Kemerovo | 650070 | Russia |
| Novartis Investigative Site | Active, not recruiting | Krasnodar | 350020 | Russia |
| Novartis Investigative Site | Completed | Moscow | 115522 | Russia |
| Novartis Investigative Site | Completed | Moscow | 119296 | Russia |
| Novartis Investigative Site | Completed | Moscow | 127473 | Russia |
| Novartis Investigative Site | Completed | Saint Petersburg | 190068 | Russia |
| Novartis Investigative Site | Completed | Saint Petersburg | 197022 | Russia |
| Novartis Investigative Site | Completed | Saint Petersburg | 197198 | Russia |
| Novartis Investigative Site | Recruiting | Saint Petersburg | 197198 | Russia |
| Novartis Investigative Site | Completed | Saint Petersburg | 197341 | Russia |
| Novartis Investigative Site | Completed | Saratov | 410053 | Russia |
| Novartis Investigative Site | Completed | Smolensk | 214019 | Russia |
| Novartis Investigative Site | Completed | Ulyanovsk | 432063 | Russia |
| Novartis Investigative Site | Active, not recruiting | Yaroslavl | 150003 | Russia |
| Novartis Investigative Site | Completed | Yaroslavl | 150054 | Russia |
| Novartis Investigative Site | Completed | Yekaterinburg | 620023 | Russia |
| Novartis Investigative Site | Completed | Yekaterinburg | 620028 | Russia |
| Novartis Investigative Site | Active, not recruiting | Panorama | Western Cape | 7500 | South Africa |
| Novartis Investigative Site | Completed | Stellenbosch | Western Cape | 7600 | South Africa |
| Novartis Investigative Site | Completed | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Completed | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Active, not recruiting | Santiago Compostela | A Coruna | 15706 | Spain |
| Novartis Investigative Site | Completed | Málaga | Andalusia | 29009 | Spain |
| Novartis Investigative Site | Completed | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Novartis Investigative Site | Completed | Bilbao | Bizkaia | 48013 | Spain |
| Novartis Investigative Site | Completed | Santander | Cantabria | 39008 | Spain |
| Novartis Investigative Site | Completed | Vigo | Pontevedra | 36214 | Spain |
| Novartis Investigative Site | Completed | A Coruña | 15006 | Spain |
| Novartis Investigative Site | Recruiting | Madrid | 28009 | Spain |
| Novartis Investigative Site | Completed | Madrid | 28009 | Spain |
| Novartis Investigative Site | Completed | Madrid | 28041 | Spain |
| Novartis Investigative Site | Recruiting | Madrid | 28046 | Spain |
| Novartis Investigative Site | Completed | Madrid | 28046 | Spain |
| Novartis Investigative Site | Withdrawn | Seville | 41009 | Spain |
| Novartis Investigative Site | Completed | Valencia | 46026 | Spain |
| Novartis Investigative Site | Active, not recruiting | Basel | 4031 | Switzerland |
| Novartis Investigative Site | Active, not recruiting | Bern | 3010 | Switzerland |
| Novartis Investigative Site | Completed | Sankt Gallen | 9007 | Switzerland |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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