Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
Launched by GLAXOSMITHKLINE · Apr 1, 2020
Trial Information
Current as of April 24, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Participants with rheumatoid arthritis who are aged \>=18 years at the time of signing informed consent, who have completed one of the qualifying GSK3196165 clinical studies and who, in the opinion of the investigator, may benefit from treatment with GSK3196165.
- • Body weight \>=40 kilograms (kg).
- • Male or female participants are eligible to participate as long as they meet the contraceptive eligibility criteria and agree to abide by the contraceptive requirements.
- • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- • For participants on methotrexate (MTX): must be willing to continue treatment with oral folic acid (at least 5 mg/week) or equivalent while receiving MTX (mandatory co-medication for MTX treatment).
- Exclusion Criteria:
- • Had study intervention permanently discontinued at any time during a qualifying study except any participant with a new diagnosis of latent Mycobacterium tuberculosis (TB) at the end of study assessment in a qualifying study and currently undertaking or willing to complete at least 4 weeks of anti-TB treatment off study treatment, per world health organization (WHO) or national guidelines prior to re-commencing therapy and complete the remainder of anti-TB treatment while on study.
- • Evidence of latent TB (as documented by a positive QuantiFERON-TB Gold plus test or T-SPOT.TB test, no findings on medical history or clinical examination consistent with active TB, and a normal chest radiograph) except for participants that
- • Are currently undertaking or willing to complete at least 4 weeks of anti-TB therapy off study treatment, as per WHO or national guidelines prior to re- commencing study treatment and agree to complete the remainder of anti-TB treatment while in the study or
- • Had documented evidence of satisfactory anti-TB treatment as per WHO or national guidelines following review by a physician specializing in TB on entry to a qualifying study.
- • Current or previous active TB regardless of treatment.
- • Were temporarily discontinued from study intervention at the time of the final study visit of a qualifying study and, in the opinion of the investigator, participation in the extension study poses an unacceptable risk for the participant's participation.
- • A new cancer or malignancy except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured by the investigator.
- • Have developed any lymphoproliferative disorder during a qualifying study, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, or signs and symptoms suggestive of current lymphatic disease.
- • Have significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a qualifying study that, in the opinion of the investigator, poses an unacceptable risk for the participant's participation.
- • Participants who are expected to be non-compliant with restrictions on medications and vaccinations prior to the study, during the study or during the 8-week safety follow-up of the study.
- • Participants who are currently participating in any interventional clinical study other than a qualifying GSK3196165 clinical study.
- • Abnormal chest radiograph within the last 12 weeks judged by the investigator as clinically-significant.
- • Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding.
- • History of sensitivity to any of the study treatments, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Trial Officials
GSK Clinical Trials
Study Director
GlaxoSmithKline
About Glaxosmithkline
GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Barcelona, , Spain
Saint Louis, Missouri, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Idaho Falls, Idaho, United States
Bangkok, , Thailand
Poway, California, United States
Skokie, Illinois, United States
Marietta, Georgia, United States
Fort Collins, Colorado, United States
San Diego, California, United States
Cincinnati, Ohio, United States
Phoenix, Arizona, United States
Upland, California, United States
Van Nuys, California, United States
Aventura, Florida, United States
New Port Richey, Florida, United States
Tamarac, Florida, United States
Lebanon, New Hampshire, United States
Dallas, Texas, United States
Mons, , Belgium
Sofia, , Bulgaria
Dresden, Sachsen, Germany
Nagasaki, , Japan
Elblag, , Poland
Saratov, , Russian Federation
Valencia, , Spain
Wichita, Kansas, United States
Brooklyn, New York, United States
Glendale, Arizona, United States
Greenville, South Carolina, United States
Bowling Green, Kentucky, United States
Lake Charles, Louisiana, United States
Clearwater, Florida, United States
Tomball, Texas, United States
Anniston, Alabama, United States
Brandon, Florida, United States
Tampa, Florida, United States
Evansville, Indiana, United States
Greensboro, North Carolina, United States
Oklahoma City, Oklahoma, United States
Praha 5, , Czechia
Kuala Lumpur, , Malaysia
Pleven, , Bulgaria
Székesfehérvár, , Hungary
Klaipeda, , Lithuania
Somerset West, , South Africa
Northwood, Middlesex, United Kingdom
Atlanta, Georgia, United States
Lansing, Michigan, United States
Cordoba, , Spain
Plovdiv, , Bulgaria
Austin, Texas, United States
Denver, Colorado, United States
Tucson, Arizona, United States
Wheaton, Maryland, United States
Ciudad Autónoma De Buenos Aires, , Argentina
San Juan, , Argentina
Trois Rivieres, Quebec, Canada
Budapest, , Hungary
Anyang Si, , Korea, Republic Of
Yaroslavl, , Russian Federation
Kempton Park, , South Africa
Kharkiv, , Ukraine
Corpus Christi, Texas, United States
Novi, Michigan, United States
Rendsburg, Schleswig Holstein, Germany
Woodville, South Australia, Australia
Praha 4, , Czechia
Grand Blanc, Michigan, United States
Santander, , Spain
Lubbock, Texas, United States
Cherkasy, , Ukraine
Shanghai, , China
Colleyville, Texas, United States
Szentes, , Hungary
Vilnius, , Lithuania
Amarillo, Texas, United States
Kagawa, , Japan
Mesa, Arizona, United States
Wuhan, Hubei, China
Changchun, Jilin, China
Chengdu, Sichuan, China
Bloemfontein, , South Africa
Hamburg, , Germany
Praha 10, , Czechia
Torun, , Poland
Pune, , India
Aichi, , Japan
Tianjin, , China
Krasnoyarsk, , Russian Federation
Odessa, , Ukraine
Ruse, , Bulgaria
Kaunas, , Lithuania
Veszprem, , Hungary
Belgrade, , Serbia
Bellville, , South Africa
Tokyo, , Japan
Sevilla, , Spain
Tokyo, , Japan
Yukon, Oklahoma, United States
Lincoln, Nebraska, United States
Daytona Beach, Florida, United States
Hiroshima, , Japan
Grodzisk Mazowiecki, , Poland
Minot, North Dakota, United States
Zlin, , Czechia
Bialystok, , Poland
Saint Petersburg, , Russian Federation
San Miguel De Tucuman, Tucumán, Argentina
Tallinn, , Estonia
Tartu, , Estonia
Magdeburg, , Germany
Plano, Texas, United States
Jaipur, , India
Seremban, Negeri Sembilan, , Malaysia
Chiba, , Japan
Tver, , Russian Federation
San Nicolas, Buenos Aires, Argentina
Kanagawa, , Japan
Houston, Texas, United States
Brampton, Ontario, Canada
Taizhou, Jiangsu, China
Zamosc, , Poland
Miyagi, , Japan
Parnu, , Estonia
Surat, , India
Whittier, California, United States
Beijing, , China
Kanagawa, , Japan
Ibaraki, , Japan
Flagstaff, Arizona, United States
Freehold, New Jersey, United States
Waco, Texas, United States
Cordoba, Córdova, Argentina
Blagoevgrad, , Bulgaria
Sevlievo, , Bulgaria
Vidin, , Bulgaria
Baotou, Inner Mongolia, China
Guangzhou, , China
Sibu, , Malaysia
Katowice, , Poland
Novosibirsk, , Russian Federation
Saint Petersburg, , Russian Federation
Ulyanovsk, , Russian Federation
Ivano Frankivsk, , Ukraine
Zhytomyr, , Ukraine
Vinnytsya, , Ukraine
Baja, , Hungary
Poltava, , Ukraine
Rajathevee, , Thailand
Okayama, , Japan
Seoul, , Korea, Republic Of
Miami Lakes, Florida, United States
The Woodlands, Texas, United States
Durban, Kwazulu Natal, South Africa
Suwon Si, Gyeonggi Do, , Korea, Republic Of
Praha 2, , Czechia
Covina, California, United States
Summerville, South Carolina, United States
San Miguel De Tucumán, Tucumán, Argentina
Kemerovo, , Russian Federation
Liepaja, , Latvia
Lutsk, , Ukraine
Stellenbosch, , South Africa
Mamelodi East, , South Africa
Changsha, Hunan, China
Durango, , Mexico
Elche, , Spain
Johannesburg, , South Africa
Balatonfured, , Hungary
Merida, Yucatán, Mexico
Uherske Hradiste, , Czechia
Warszawa, , Poland
Palmetto Bay, Florida, United States
San Luis Potosí, , Mexico
Coruña, , Spain
Gwangju, , Korea, Republic Of
Krakow, , Poland
Santiago De Compostela. La Coruña., , Spain
Nowa Sol, , Poland
Daegu, , Korea, Republic Of
Miami, Florida, United States
Hyogo, , Japan
Wakayama, , Japan
Vandalia, Ohio, United States
Siedlce, , Poland
Baytown, Texas, United States
Gold Coast, Queensland, Australia
Staszow, , Poland
Niigata, , Japan
Monroe, Louisiana, United States
Quilmes, Buenos Aires, Argentina
Bengbu, Anhui, China
Guilin, Guangxi, China
Shijiazhuang, Hebei, China
Zhuzhou, Hunan, China
Tongliao, Inner Mongolia, China
Xuzhou, Jiangsu, China
Nanchang,, Jiangxi, China
Jinzhou, Liaoning, China
Huzhou, Zhejiang, China
Hangzhou, , China
Nanjing, , China
Xian, , China
Yangzhou, , China
Yanji, , China
Bucaramanga, , Colombia
Szekesfehervar, , Hungary
Fukuoka, , Japan
Hokkaido, , Japan
Kagoshima, , Japan
Kochi, , Japan
Kochi, , Japan
Nagano, , Japan
Nagasaki, , Japan
Okayama, , Japan
Saitama, , Japan
Yamaguchi, , Japan
Seongnam Si, , Korea, Republic Of
Mexico City, Durango, Mexico
Bydgoszcz, , Poland
Czestochowa, , Poland
Gdansk, , Poland
Lodz, , Poland
Nowy Targ, , Poland
Olsztyn, , Poland
Sochaczew, , Poland
Wroclaw, , Poland
Korolev, , Russian Federation
Moscow, , Russian Federation
Omsk, , Russian Federation
Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina
La Palta, Buenos Aires, Argentina
Mar Del Plata, Buenos Aires, Argentina
San Isidro, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Buenos Aires, , Argentina
Salta, , Argentina
Pingxiang, Jiangxi, China
Brno, , Czechia
Ostrava, , Czechia
Praha 4 Nusle, , Czechia
Ahmedabad, , India
Belagavi, , India
Hubli, , India
Hyderabad, , India
Kolkata, , India
Nagpur, , India
Nashik, , India
Adazi, , Latvia
Siauliai, , Lithuania
Klang, , Malaysia
Mexicali, Baja California Sur, Mexico
Leon, Guanajuato, Mexico
Guadalajara, Jalisco, Mexico
Mexico, , Mexico
Gdynia, , Poland
Kraków, , Poland
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Wrocław, , Poland
Ekaterinburg, , Russian Federation
Smolensk, , Russian Federation
Pretoria, Gauteng, South Africa
Cape Town, , South Africa
Vinnytsia, , Ukraine
Zaporizhzhia, , Ukraine
Zaporizhzia, , Ukraine
Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina
Praha 11, , Czechia
Gilbert, Arizona, United States
Fayetteville, North Carolina, United States
Barranquilla, , Colombia
Bogotá, , Colombia
Incheon, , Korea, Republic Of
Tomsk, , Russian Federation
Kyiv, , Ukraine
Coventry, , United Kingdom
Orpington, Kent, United Kingdom
Cordoba, , Spain
Nueva Cordoba, , Argentina
New Delhi, , India
Kumamoto, , Japan
Cheonan Si, , Korea, Republic Of
Elche, , Spain
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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