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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04333147
Other study ID # 209564
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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