Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis
Launched by ALFASIGMA S.P.A. · Jan 17, 2017
Trial Information
Current as of April 25, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at the long-term safety and effectiveness of a medication called filgotinib for adults with rheumatoid arthritis (RA). If you've previously participated in a related study and found filgotinib helpful, you might be eligible to join this long-term extension study. To qualify, you need to have completed one of the earlier studies on filgotinib or be a participant who did not respond to standard treatments for RA. It's important for women who can become pregnant to have a negative pregnancy test and agree to use specific birth control methods during the trial.
Participants in this study will continue to receive filgotinib and will be monitored to ensure they are safe and tolerating the medication well. This trial is currently active but not recruiting new participants, which means they are focusing on those already involved. If you're considering this study, it’s a chance to continue receiving a treatment that may benefit you while contributing to important research on RA.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- * Males or females who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below:
- • Have completed GS-US-417-0301, GS-US-417-0302 or GS-US-417-0303 on study drug
- • OR
- • Have completed GS-US-417-0302 on standard of care therapy due to RA non-responder status
- • Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the long term extension (LTE)
- • Females of childbearing potential who engage in heterosexual intercourse must agree to protocol-approved methods of contraception
- Key Exclusion Criteria:
- • Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator
- • Known hypersensitivity to the study drug or its excipients
- • Any medical condition which would put the participant at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator
- • NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial Officials
Alfasigma Study Director
Study Director
Alfasigma S.p.A.
About Alfasigma S.P.A.
Alfasigma S.p.A. is a leading Italian pharmaceutical company dedicated to the research, development, and commercialization of innovative therapeutic solutions. With a strong focus on gastroenterology, central nervous system disorders, and cardiovascular health, Alfasigma leverages advanced scientific expertise to address unmet medical needs. The company is committed to enhancing patient outcomes through rigorous clinical trials and collaborations with healthcare professionals, ensuring the highest standards of quality and safety in its products. Alfasigma's global presence and dedication to innovation underscore its role as a key player in the pharmaceutical industry, driving progress in healthcare worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kansas City, Kansas, United States
Brussels, , Belgium
Lebanon, New Hampshire, United States
Valencia, , Spain
Madrid, , Spain
Detroit, Michigan, United States
Duncansville, Pennsylvania, United States
Clearwater, Florida, United States
Wichita, Kansas, United States
Elizabethtown, Kentucky, United States
Taipei, , Taiwan
Dallas, Texas, United States
Visakhapatnam, , India
Belgrade, , Serbia
Kaohsiung, , Taiwan
Wheaton, Maryland, United States
Hiroshima, , Japan
Tokyo, , Japan
Palm Desert, California, United States
Sapporo, , Japan
Greenville, North Carolina, United States
Oklahoma City, Oklahoma, United States
Okayama, , Japan
Seoul, , Korea, Republic Of
Madrid, , Spain
Kuala Lumpur, , Malaysia
New Port Richey, Florida, United States
Kyoto, , Japan
Hong Kong, , Hong Kong
Daejeon, , Korea, Republic Of
Hiroshima, , Japan
Taichung City, , Taiwan
San Antonio, Texas, United States
Bethlehem, Pennsylvania, United States
Sapporo, , Japan
Taipei, , Taiwan
Huntsville, Alabama, United States
Upland, California, United States
Debary, Florida, United States
Springfield, Illinois, United States
Frederick, Maryland, United States
Tupelo, Mississippi, United States
Salisbury, North Carolina, United States
Lutsk, , Ukraine
Belgrade, , Serbia
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Buenos Aires, , Argentina
Tokyo, , Japan
Taipei, , Taiwan
Lexington, Kentucky, United States
Lincoln, Nebraska, United States
Mesquite, Texas, United States
Hlucin, , Czechia
Praha 4, , Czechia
Daegu, , Korea, Republic Of
Gwangju, , Korea, Republic Of
Seoul, , Korea, Republic Of
Batu Caves, Selangor, Malaysia
Timaru, , New Zealand
Hamilton, , New Zealand
New Delhi, , India
Victorville, California, United States
Hattiesburg, Mississippi, United States
Hong Kong, , Hong Kong
Merksem, , Belgium
Secunderabad, , India
Kobe, , Japan
Tokyo, , Japan
Albuquerque, New Mexico, United States
Taipei, , Taiwan
Fukuoka, , Japan
Berlin, , Germany
Dublin, , Ireland
Phoenix, Arizona, United States
Memphis, Tennessee, United States
Daegu, , Korea, Republic Of
Incheon, , Korea, Republic Of
Worcester, Massachusetts, United States
Delhi, , India
Tokyo, , Japan
Fukuoka, , Japan
Bialystok, , Poland
Wakayama, , Japan
Miami, Florida, United States
Taichung, , Taiwan
Eagan, Minnesota, United States
Wyomissing, Pennsylvania, United States
Ome, , Japan
Corpus Christi, Texas, United States
Hagerstown, Maryland, United States
Niska Banja, , Serbia
Middleburg Heights, Ohio, United States
Leuven, , Belgium
Saint Clair Shores, Michigan, United States
Changhua City, , Taiwan
Cumberland, Maryland, United States
Maroochydore, Queensland, Australia
Krakow, , Poland
Johannesburg, , South Africa
Victoria Park, Western Australia, Australia
Charlotte, North Carolina, United States
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Kyoto Shi, , Japan
Suita Shi, , Japan
Beaumont, Texas, United States
Saint Louis, Missouri, United States
Toms River, New Jersey, United States
Haifa, , Israel
Narashino, Chiba, Japan
Haifa, , Israel
Stellenbosch, , South Africa
Chihuahua, , Mexico
Covina, California, United States
Whittier, California, United States
Jacksonville, Florida, United States
Brooklyn, New York, United States
Carrollton, Texas, United States
Gdynia, , Poland
North Shields, , United Kingdom
Sapporo, , Japan
Aventura, Florida, United States
Nagoya, , Japan
Daejeon, , Korea, Republic Of
Petah Tikva, , Israel
Poznan, , Poland
Brooklyn, New York, United States
Kawagoe, , Japan
Daejeon, , Korea, Republic Of
Barakaldo, , Spain
Tokyo, , Japan
Aachen, , Germany
Monterrey, , Mexico
Freehold, New Jersey, United States
Summerville, South Carolina, United States
Uherske Hradiste, , Czechia
Hyderabad, , India
Jaipur, , India
Ramat Gan, , Israel
Edinburgh, , United Kingdom
Gilbert, Arizona, United States
Tucson, Arizona, United States
Hemet, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Riverside, California, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Decatur, Georgia, United States
Worcester, Massachusetts, United States
Saint Louis, Missouri, United States
Tulsa, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Columbia, South Carolina, United States
Myrtle Beach, South Carolina, United States
Orangeburg, South Carolina, United States
Plano, Texas, United States
Ciudad Autonoma, Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma Buenos Aires, , Argentina
Ciudad Autonoma De Buenos Aire, , Argentina
Ciudad Autonoma, , Argentina
Mendoza, , Argentina
Quilmes, , Argentina
San Isidro, , Argentina
San Juan, , Argentina
San Miguel De Tucuman, , Argentina
Hobart, , Australia
Genk, , Belgium
Dobrich, , Bulgaria
Haskovo, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Vidin, , Bulgaria
Barrie, , Canada
Trois Rivieres, , Canada
Santiago, , Chile
Santiago, , Chile
Temuco, , Chile
Brno, , Czechia
Ostrava Poruba, , Czechia
Prague 2, , Czechia
Prague Praha 10, , Czechia
Praha 4, , Czechia
Montpellier Cedex 5, , France
Frankfurt Am Main, , Germany
Hamburg, , Germany
Ratingen, , Germany
Hong Kong, , Hong Kong
Budapest, , Hungary
Budapest, , Hungary
Eger, , Hungary
Gyula, , Hungary
Kalocsa, , Hungary
Kistarcsa, , Hungary
Szentes, , Hungary
Székesfehérvár, , Hungary
Ahmedabad, , India
Ahmedabad, , India
Bangalore, , India
Chennai, , India
Gurgaon, , India
Hyderabad, , India
Jaipur, , India
Jaipur, , India
Kolkata, , India
Kolkata, , India
Lucknow, , India
Mangalore, , India
Mangalore, , India
Mysuru, , India
Nagpur, , India
New Delhi, , India
Pune, , India
Pune, , India
Srikakulam, , India
Surat, , India
Vadodara, , India
Tel Aviv, , Israel
Bologna, , Italy
Milano, , Italy
Tokorozawa, Saitama, Japan
Takaoka, Toyama, Japan
Chiba Shi, , Japan
Hamamatsu, , Japan
Hiroshima Shi, , Japan
Iizuka Shi, , Japan
Iruma Gun, , Japan
Izumo, , Japan
Kagoshima Shi, , Japan
Kato, , Japan
Kitakyushu Shi, , Japan
Kumamoto Shi, , Japan
Kurume Shi, , Japan
Miyagi Gun, , Japan
Miyazaki, , Japan
Morioka Shi, , Japan
Nagaoka, , Japan
Nagasaki Shi, , Japan
Nagoya, , Japan
Nishinomiya, , Japan
Okayama City, , Japan
Sagamihara, , Japan
Sanuki Shi, , Japan
Sapporo, , Japan
Sasebo Shi, , Japan
Sayama Shi, , Japan
Shibata City, , Japan
Shizuoka, , Japan
Takasaki Shi, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tomigusuku Shi, , Japan
Tsukuba Shi, , Japan
Yokohama Shi, , Japan
Busan Si, , Korea, Republic Of
Jeonju, , Korea, Republic Of
Seoul, , Korea, Republic Of
Morelia, Michoacan, Mexico
Mérida, Yucatan, Mexico
Ciudad De Mexico, , Mexico
Ciudad De México, , Mexico
Merida, , Mexico
Mexico, , Mexico
Papatoetoe, Auckland, New Zealand
Auckland, , New Zealand
Newtown, , New Zealand
Bialystok, , Poland
Bydgoszcz, , Poland
Bytom, , Poland
Dabrówka, , Poland
Elblag, , Poland
Kartuzy, , Poland
Katowice, , Poland
Nowa Sol, , Poland
Poznan, , Poland
Poznan, , Poland
Tomaszów Lubelski, , Poland
Torun, , Poland
Warszawa, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Bacau, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Targu Mures, , Romania
Barnaul, , Russian Federation
Chelyabinsk, , Russian Federation
Kazan, , Russian Federation
Kemerovo, , Russian Federation
Kemerovo, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Nizhny Novgorod, , Russian Federation
Saint Petersburg, , Russian Federation
Saratov, , Russian Federation
St.Petersburg, , Russian Federation
Vladimir, , Russian Federation
Yaroslavl, , Russian Federation
Belgrade, , Serbia
Bratislava, , Slovakia
Rimavská Sobota, , Slovakia
Topolcany, , Slovakia
Cape Town, , South Africa
Durban, , South Africa
Durban, , South Africa
La Coruña, , Spain
Málaga, , Spain
Sabadell, , Spain
Santiago De Compostela, , Spain
Santiago De Compostela, , Spain
Keelung, , Taiwan
Tainan City, , Taiwan
Taoyuan, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Chiangmai, , Thailand
Songkla, , Thailand
Dnipro, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kharkiv, , Ukraine
Kherson, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Vinnytsia, , Ukraine
Vinnytsya, , Ukraine
Zaporizhzhya, , Ukraine
Zaporizhzhya, , Ukraine
Zaporizhzhya, , Ukraine
Harlow, , United Kingdom
Warrington, , United Kingdom
Hamilton, Waikato, New Zealand
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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