Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

Arthritis, Rheumatoid Clinical Trial

— contRAst X  

Official title:

A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04333147
• Other study ID #: 209564
• Status: Terminated
• Phase: Phase 3
• Start date: May 12, 2020
• Est. completion date: February 24, 2023

Study information

• Verified date: January 2024
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RA is a chronic, systemic inflammatory autoimmune disease which requires treatment for a long time period, hence it is important to study the long-term safety and efficacy of the continuous treatment with GSK3196165 over several years. This is a Phase 3, multicenter, parallel group treatment and long-term extension study primarily to assess safety with efficacy assessment as a secondary objective. Adult participants with RA who have completed the treatment phase of a qualifying GSK3196165 clinical studies (Phase 3 studies contRAst 1 (201790: NCT03980483), contRAst 2 (201791: NCT03970837) and contRAst 3 (202018: NCT04134728) and who, in investigator's judgement will benefit from extended treatment with GSK3196165 will be included in this study (contRAst X [209564: NCT04333147]). Participants will continue to receive the same background conventional synthetic disease modifying anti-rheumatic drug(s) [csDMARD(s)] treatment as they received in their qualifying study. Eligible participants will be enrolled to receive weekly GSK3196165 90 milligrams (mg) or 150 mg by subcutaneous (SC) injection. The anticipated study duration is approximately 4 years which will enable participants to receive treatment with GSK3196165 until it is expected to become commercially available. Approximately 3000 participants from the qualifying studies will participate in this long-term extension study

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2916
• Est. completion date: February 24, 2023
• Est. primary completion date: February 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Biological:
• Otilimab (GSK3196165)
GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.

Drug:
• csDMARD(s)
Stable dose of csDMARD(s) as standard of care (SoC).

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma Buenos aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autónoma de Buenos Aires
Argentina	GSK Investigational Site	Cordoba
Argentina	GSK Investigational Site	Cordoba	Córdova
Argentina	GSK Investigational Site	La Palta	Buenos Aires
Argentina	GSK Investigational Site	Mar del Plata	Buenos Aires
Argentina	GSK Investigational Site	Nueva Cordoba
Argentina	GSK Investigational Site	Quilmes	Buenos Aires
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Salta
Argentina	GSK Investigational Site	San Isidro	Buenos Aires
Argentina	GSK Investigational Site	San Juan
Argentina	GSK Investigational Site	San Miguel de Tucuman	Tucumán
Argentina	GSK Investigational Site	San Miguel de Tucumán	Tucumán
Argentina	GSK Investigational Site	San Nicolas	Buenos Aires
Australia	GSK Investigational Site	Gold Coast	Queensland
Australia	GSK Investigational Site	Woodville	South Australia
Belgium	GSK Investigational Site	Mons
Bulgaria	GSK Investigational Site	Blagoevgrad
Bulgaria	GSK Investigational Site	Pleven
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Ruse
Bulgaria	GSK Investigational Site	Sevlievo
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Sofia
Bulgaria	GSK Investigational Site	Vidin
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Trois-Rivieres	Quebec
China	GSK Investigational Site	Baotou	Inner Mongolia
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Bengbu	Anhui
China	GSK Investigational Site	Changchun	Jilin
China	GSK Investigational Site	Changsha	Hunan
China	GSK Investigational Site	Chengdu	Sichuan
China	GSK Investigational Site	Guangzhou
China	GSK Investigational Site	Guilin	Guangxi
China	GSK Investigational Site	Hangzhou
China	GSK Investigational Site	Huzhou	Zhejiang
China	GSK Investigational Site	Jinzhou	Liaoning
China	GSK Investigational Site	Nanchang,	Jiangxi
China	GSK Investigational Site	Nanjing
China	GSK Investigational Site	Pingxiang	Jiangxi
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Shijiazhuang	Hebei
China	GSK Investigational Site	Taizhou	Jiangsu
China	GSK Investigational Site	Tianjin
China	GSK Investigational Site	Tongliao	Inner Mongolia
China	GSK Investigational Site	Wuhan	Hubei
China	GSK Investigational Site	Xuzhou	Jiangsu
China	GSK Investigational Site	Yangzhou
China	GSK Investigational Site	Yanji
China	GSK Investigational Site	ZhuZhou	Hunan
Colombia	GSK Investigational Site	Barranquilla
Colombia	GSK Investigational Site	Barranquilla
Colombia	GSK Investigational Site	Bogotá
Colombia	GSK Investigational Site	Bucaramanga
Czechia	GSK Investigational Site	Brno
Czechia	GSK Investigational Site	Brno
Czechia	GSK Investigational Site	Ostrava
Czechia	GSK Investigational Site	Praha 10
Czechia	GSK Investigational Site	Praha 11
Czechia	GSK Investigational Site	Praha 2
Czechia	GSK Investigational Site	Praha 4
Czechia	GSK Investigational Site	Praha 4 Nusle
Czechia	GSK Investigational Site	Praha 5
Czechia	GSK Investigational Site	Uherske Hradiste
Czechia	GSK Investigational Site	Zlin
Estonia	GSK Investigational Site	Parnu
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Estonia	GSK Investigational Site	Tartu
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Magdeburg
Germany	GSK Investigational Site	Rendsburg	Schleswig-Holstein
Hungary	GSK Investigational Site	Baja
Hungary	GSK Investigational Site	Balatonfured
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Budapest
Hungary	GSK Investigational Site	Szekesfehervar
Hungary	GSK Investigational Site	Székesfehérvár
Hungary	GSK Investigational Site	Szentes
Hungary	GSK Investigational Site	Veszprem
India	GSK Investigational Site	Ahmedabad
India	GSK Investigational Site	Ahmedabad
India	GSK Investigational Site	Belagavi
India	GSK Investigational Site	Hubli
India	GSK Investigational Site	Hyderabad
India	GSK Investigational Site	Jaipur
India	GSK Investigational Site	Jaipur
India	GSK Investigational Site	Kolkata
India	GSK Investigational Site	Nagpur
India	GSK Investigational Site	Nagpur
India	GSK Investigational Site	New Delhi
India	GSK Investigational Site	Pune
India	GSK Investigational Site	Surat
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Aichi
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Fukuoka
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Hyogo
Japan	GSK Investigational Site	Ibaraki
Japan	GSK Investigational Site	Kagawa
Japan	GSK Investigational Site	Kagoshima
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Kochi
Japan	GSK Investigational Site	Kochi
Japan	GSK Investigational Site	Kumamoto
Japan	GSK Investigational Site	Miyagi
Japan	GSK Investigational Site	Miyagi
Japan	GSK Investigational Site	Nagano
Japan	GSK Investigational Site	Nagasaki
Japan	GSK Investigational Site	Nagasaki
Japan	GSK Investigational Site	Nagasaki
Japan	GSK Investigational Site	Niigata
Japan	GSK Investigational Site	Niigata
Japan	GSK Investigational Site	Okayama
Japan	GSK Investigational Site	Okayama
Japan	GSK Investigational Site	Okayama
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Wakayama
Japan	GSK Investigational Site	Yamaguchi
Korea, Republic of	GSK Investigational Site	Anyang-Si
Korea, Republic of	GSK Investigational Site	Cheonan-si
Korea, Republic of	GSK Investigational Site	Daegu
Korea, Republic of	GSK Investigational Site	Gwangju
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Seongnam-si
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Suwon-si, Gyeonggi-do
Latvia	GSK Investigational Site	Adazi
Latvia	GSK Investigational Site	Liepaja
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Klaipeda
Lithuania	GSK Investigational Site	Siauliai
Lithuania	GSK Investigational Site	Vilnius
Malaysia	GSK Investigational Site	Klang
Malaysia	GSK Investigational Site	Kuala Lumpur
Malaysia	GSK Investigational Site	Seremban, Negeri Sembilan
Malaysia	GSK Investigational Site	Sibu
Mexico	GSK Investigational Site	Durango
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Guadalajara	Jalisco
Mexico	GSK Investigational Site	Leon	Guanajuato
Mexico	GSK Investigational Site	Merida	Yucatán
Mexico	GSK Investigational Site	Mexicali	Baja California Sur
Mexico	GSK Investigational Site	Mexico
Mexico	GSK Investigational Site	Mexico City	Durango
Mexico	GSK Investigational Site	San Luis Potosí
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Bialystok
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Czestochowa
Poland	GSK Investigational Site	Elblag
Poland	GSK Investigational Site	Gdansk
Poland	GSK Investigational Site	Gdynia
Poland	GSK Investigational Site	Gdynia
Poland	GSK Investigational Site	Grodzisk Mazowiecki
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Kraków
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Lublin
Poland	GSK Investigational Site	Nowa Sol
Poland	GSK Investigational Site	Olsztyn
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Poznan
Poland	GSK Investigational Site	Siedlce
Poland	GSK Investigational Site	Sochaczew
Poland	GSK Investigational Site	Staszow
Poland	GSK Investigational Site	Torun
Poland	GSK Investigational Site	Warsaw
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Warszawa
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Wroclaw
Poland	GSK Investigational Site	Zamosc
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Kemerovo
Russian Federation	GSK Investigational Site	Kemerovo
Russian Federation	GSK Investigational Site	Korolev
Russian Federation	GSK Investigational Site	Krasnoyarsk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Omsk
Russian Federation	GSK Investigational Site	Saint Petersburg
Russian Federation	GSK Investigational Site	Saint-Petersburg
Russian Federation	GSK Investigational Site	Saratov
Russian Federation	GSK Investigational Site	Smolensk
Russian Federation	GSK Investigational Site	Tomsk
Russian Federation	GSK Investigational Site	Tver
Russian Federation	GSK Investigational Site	Ulyanovsk
Russian Federation	GSK Investigational Site	Yaroslavl
Russian Federation	GSK Investigational Site	Yaroslavl
Russian Federation	GSK Investigational Site	Yaroslavl
Serbia	GSK Investigational Site	Belgrade
South Africa	GSK Investigational Site	Bellville
South Africa	GSK Investigational Site	Bloemfontein
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Durban	KwaZulu- Natal
South Africa	GSK Investigational Site	Johannesburg
South Africa	GSK Investigational Site	Johannesburg
South Africa	GSK Investigational Site	Kempton Park
South Africa	GSK Investigational Site	Pretoria
South Africa	GSK Investigational Site	Pretoria	Gauteng
South Africa	GSK Investigational Site	Somerset West
South Africa	GSK Investigational Site	Stellenbosch
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Cordoba
Spain	GSK Investigational Site	Coruña
Spain	GSK Investigational Site	Elche
Spain	GSK Investigational Site	Santander
Spain	GSK Investigational Site	Santiago De Compostela. La Coruña.
Spain	GSK Investigational Site	Sevilla
Spain	GSK Investigational Site	Valencia
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Rajathevee
Ukraine	GSK Investigational Site	Cherkasy
Ukraine	GSK Investigational Site	Ivano-Frankivsk
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kharkiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Kyiv
Ukraine	GSK Investigational Site	Lutsk
Ukraine	GSK Investigational Site	Lutsk
Ukraine	GSK Investigational Site	Odessa
Ukraine	GSK Investigational Site	Poltava
Ukraine	GSK Investigational Site	Vinnytsia
Ukraine	GSK Investigational Site	Vinnytsia
Ukraine	GSK Investigational Site	Vinnytsia
Ukraine	GSK Investigational Site	Vinnytsia
Ukraine	GSK Investigational Site	Vinnytsya
Ukraine	GSK Investigational Site	Zaporizhzhia
Ukraine	GSK Investigational Site	Zaporizhzia
Ukraine	GSK Investigational Site	Zhytomyr
United Kingdom	GSK Investigational Site	Coventry
United Kingdom	GSK Investigational Site	Northwood	Middlesex
United Kingdom	GSK Investigational Site	Orpington	Kent
United States	GSK Investigational Site	Amarillo	Texas
United States	GSK Investigational Site	Anniston	Alabama
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Aventura	Florida
United States	GSK Investigational Site	Baytown	Texas
United States	GSK Investigational Site	Bowling Green	Kentucky
United States	GSK Investigational Site	Brandon	Florida
United States	GSK Investigational Site	Brooklyn	New York
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Colleyville	Texas
United States	GSK Investigational Site	Covina	California
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Daytona Beach	Florida
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Fayetteville	North Carolina
United States	GSK Investigational Site	Flagstaff	Arizona
United States	GSK Investigational Site	Fort Collins	Colorado
United States	GSK Investigational Site	Freehold	New Jersey
United States	GSK Investigational Site	Gilbert	Arizona
United States	GSK Investigational Site	Glendale	Arizona
United States	GSK Investigational Site	Glendale	Wisconsin
United States	GSK Investigational Site	Grand Blanc	Michigan
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Greenville	South Carolina
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Idaho Falls	Idaho
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Lake Charles	Louisiana
United States	GSK Investigational Site	Lansing	Michigan
United States	GSK Investigational Site	Lebanon	New Hampshire
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Lubbock	Texas
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami Lakes	Florida
United States	GSK Investigational Site	Miami Lakes	Florida
United States	GSK Investigational Site	Minot	North Dakota
United States	GSK Investigational Site	Monroe	Louisiana
United States	GSK Investigational Site	New Port Richey	Florida
United States	GSK Investigational Site	Novi	Michigan
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Palmetto Bay	Florida
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Plano	Texas
United States	GSK Investigational Site	Poway	California
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Skokie	Illinois
United States	GSK Investigational Site	Summerville	South Carolina
United States	GSK Investigational Site	Tamarac	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	The Woodlands	Texas
United States	GSK Investigational Site	Tomball	Texas
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Upland	California
United States	GSK Investigational Site	Van Nuys	California
United States	GSK Investigational Site	Vandalia	Ohio
United States	GSK Investigational Site	Waco	Texas
United States	GSK Investigational Site	Wheaton	Maryland
United States	GSK Investigational Site	Whittier	California
United States	GSK Investigational Site	Wichita	Kansas
United States	GSK Investigational Site	Yukon	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Iqvia Pty Ltd

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bulgaria,  Canada,  China,  Colombia,  Czechia,  Estonia,  Germany,  Hungary,  India,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Poland,  Russian Federation,  Serbia,  South Africa,  Spain,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)	An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. Protocol defined AESIs were included.	Up to approximately 145 Weeks
Primary	Change From Baseline in Hematology Parameter of Platelet Count at Week 24	Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.	Baseline (Day 01) and Week 24
Primary	Change From Baseline in Hematology Parameter of Platelet Count at Week 48	Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.	Baseline (Day 01) and Week 48
Primary	Change From Baseline in Hematology Parameter of Platelet Count at Week 96	Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.	Baseline (Day 01) and Week 96
Primary	Change From Baseline in Hematology Parameter of Platelet Count at Week 144	Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.	Baseline (Day 01) and Week 144
Primary	Change From Baseline in Hematology Parameter of Hemoglobin at Week 24	Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.	Baseline (Day 01) and Week 24
Primary	Change From Baseline in Hematology Parameter of Hemoglobin at Week 48	Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.	Baseline (Day 01) and Week 48
Primary	Change From Baseline in Hematology Parameter of Hemoglobin at Week 96	Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.	Baseline (Day 01) and Week 96
Primary	Change From Baseline in Hematology Parameter of Hemoglobin at Week 144	Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.	Baseline (Day 01) and Week 144
Primary	Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24	Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.	Baseline (Day 01) and Week 24
Primary	Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48	Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.	Baseline (Day 01) and Week 48
Primary	Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96	Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.	Baseline (Day 01) and Week 96
Primary	Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144	Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils.	Baseline (Day 01) and Week 144
Primary	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.	Baseline (Day 01) and Week 24
Primary	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.	Baseline (Day 01) and Week 48
Primary	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.	Baseline (Day 01) and Week 96
Primary	Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.	Baseline (Day 01) and Week 144
Primary	Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24	Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides	Baseline (Day 01) and Week 24
Primary	Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48	Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides	Baseline (Day 01) and Week 48
Primary	Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96	Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides	Baseline (Day 01) and Week 96
Primary	Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144	Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides	Baseline (Day 01) and Week 144
Primary	Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities	Number of participants with NCI-CTCAE >=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case >=Grade 3 shifts from Baseline.	Up to approximately 145 Weeks
Primary	Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.	Baseline (Day 01) and Week 24
Primary	Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.	Baseline (Day 01) and Week 48
Primary	Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.	Baseline (Day 01) and Week 96
Primary	Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144	Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.	Baseline (Day 01) and Week 144
Secondary	Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. Percentage values are rounded off.	Week 24, 48, 96 and 144
Secondary	Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144	Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score <=2.8. Percentage values are rounded off.	Week 24, 48, 96 and 144
Secondary	Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144	The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off.	Week 24, 48, 96 and 144
Secondary	Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132	The DAS28-ESR is a measure of RA disease activity calculated using TJC28,SJC28, ESR (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off.	Week 24, 48, 96 and 132
Secondary	Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144	Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) <= 1, Swollen Joint Count 66 (SJC66) <= 1, high sensitivity C-reactive Protein (hsCRP) <= 1mg/dl and patient's global assessment of disease activity (PtGA) <= 10. Simple Disease Activity Index based ACR/EULAR remission is achieved if a has SDAI <= 3.3. The SDAI is the sum of the tender/painful joint count and swollen joint count, employing 28 joints; PtGA and PhGA (on a scale of 0-10); and hsCRP (mg/L). Percentage values are rounded off.	Week 24, 48, 96 and 144
Secondary	Absolute Values for Clinical Disease Activity Index (CDAI) Total Score	CDAI total score is a composite score consisting of the sum of TJC28, TJC28, PtGA (visual analogue scale with values from 0=best to 100=worst) and PhGA (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity.	Week 24, 48, 96 and 144
Secondary	Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP)	The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- PtGA is transformed to a 0-10 scale before computing the total score. CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity.	Week 24, 48, 96 and 144
Secondary	Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)	The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter [mm]/hour[hr]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity.	Week 24, 48, 96 and 132
Secondary	Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS)	Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score ranges from 0 to 448 for mTSS with higher values representing higher disease activity.	Week 24 and 48
Secondary	Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI)	The HAQ-DI includes 20 questions which assesses difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming, Hygiene, Arising, Reach, Eating, Grip, Walking, Common Daily Activities. The questions assess domain scores ranging from 0 "without any difficulty" to 3 "unable to do." Scores on each domain were summed and averaged to provide an overall score ranging from 0 to 3, where higher score reflected worse status and a lower score indicates better quality of life.	Week 24, 48, 96 and 144
Secondary	Absolute Values for Arthritis Pain Visual Analogue Scale (VAS)	For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement.	Week 24, 48, 96 and 144
Secondary	Absolute Values Short Form (SF)-36 Mental Component Scores (MCS)	SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health. Quality Metric software was used for scoring.	Week 24, 48, 96 and 144
Secondary	Absolute Values SF-36 Domain Scores	Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. Quality Metric software was used for scoring for SF-36.	Week 24, 48, 96 and 144
Secondary	Absolute Values SF-36 Physical Component Scores (PCS)	SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health. Quality Metric software was used for scoring.	Week 24, 48, 96 and 144
Secondary	Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue	The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life.	Week 24, 48, 96 and 144
Secondary	Number of Participants With Anti-GSK3196165 Antibodies	Serum samples were collected for the determination of anti- GSK3196165 antibodies (ADA) using a validated electrochemiluminescence (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA	Week 120

External Links

•   201790 contRAst 1 NCT03980483
•   201791 contRAst 2 NCT03970837
•   202018 contRAst 3 NCT04134728