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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04333147




Registration number
NCT04333147
Ethics application status
Date submitted
27/03/2020
Date registered
3/04/2020
Date last updated
7/02/2024

Titles & IDs
Public title
Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
Scientific title
A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis
Secondary ID [1] 0 0
209564
Universal Trial Number (UTN)
Trial acronym
contRAst X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Otilimab (GSK3196165)
Treatment: Drugs - csDMARD(s)

Experimental: Otilimab 90 mg - Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly.

Experimental: Otilimab 150 mg - Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.


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

Treatment: Drugs: csDMARD(s)
Stable dose of csDMARD(s) as standard of care (SoC).
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Timepoint [1] 0 0
Up to approximately 145 Weeks
Primary outcome [2] 0 0
Change From Baseline in Hematology Parameter of Platelet Count at Week 24
Timepoint [2] 0 0
Baseline (Day 01) and Week 24
Primary outcome [3] 0 0
Change From Baseline in Hematology Parameter of Platelet Count at Week 48
Timepoint [3] 0 0
Baseline (Day 01) and Week 48
Primary outcome [4] 0 0
Change From Baseline in Hematology Parameter of Platelet Count at Week 96
Timepoint [4] 0 0
Baseline (Day 01) and Week 96
Primary outcome [5] 0 0
Change From Baseline in Hematology Parameter of Platelet Count at Week 144
Timepoint [5] 0 0
Baseline (Day 01) and Week 144
Primary outcome [6] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24
Timepoint [6] 0 0
Baseline (Day 01) and Week 24
Primary outcome [7] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 48
Timepoint [7] 0 0
Baseline (Day 01) and Week 48
Primary outcome [8] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 96
Timepoint [8] 0 0
Baseline (Day 01) and Week 96
Primary outcome [9] 0 0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 144
Timepoint [9] 0 0
Baseline (Day 01) and Week 144
Primary outcome [10] 0 0
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24
Timepoint [10] 0 0
Baseline (Day 01) and Week 24
Primary outcome [11] 0 0
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48
Timepoint [11] 0 0
Baseline (Day 01) and Week 48
Primary outcome [12] 0 0
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96
Timepoint [12] 0 0
Baseline (Day 01) and Week 96
Primary outcome [13] 0 0
Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144
Timepoint [13] 0 0
Baseline (Day 01) and Week 144
Primary outcome [14] 0 0
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
Timepoint [14] 0 0
Baseline (Day 01) and Week 24
Primary outcome [15] 0 0
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
Timepoint [15] 0 0
Baseline (Day 01) and Week 48
Primary outcome [16] 0 0
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
Timepoint [16] 0 0
Baseline (Day 01) and Week 96
Primary outcome [17] 0 0
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
Timepoint [17] 0 0
Baseline (Day 01) and Week 144
Primary outcome [18] 0 0
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24
Timepoint [18] 0 0
Baseline (Day 01) and Week 24
Primary outcome [19] 0 0
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48
Timepoint [19] 0 0
Baseline (Day 01) and Week 48
Primary outcome [20] 0 0
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96
Timepoint [20] 0 0
Baseline (Day 01) and Week 96
Primary outcome [21] 0 0
Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144
Timepoint [21] 0 0
Baseline (Day 01) and Week 144
Primary outcome [22] 0 0
Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities
Timepoint [22] 0 0
Up to approximately 145 Weeks
Primary outcome [23] 0 0
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24
Timepoint [23] 0 0
Baseline (Day 01) and Week 24
Primary outcome [24] 0 0
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48
Timepoint [24] 0 0
Baseline (Day 01) and Week 48
Primary outcome [25] 0 0
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96
Timepoint [25] 0 0
Baseline (Day 01) and Week 96
Primary outcome [26] 0 0
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144
Timepoint [26] 0 0
Baseline (Day 01) and Week 144
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 24, 48, 96 and 144
Secondary outcome [2] 0 0
Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144
Timepoint [2] 0 0
Week 24, 48, 96 and 144
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Week 24, 48, 96 and 144
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Week 24, 48, 96 and 132
Secondary outcome [5] 0 0
Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144
Timepoint [5] 0 0
Week 24, 48, 96 and 144
Secondary outcome [6] 0 0
Absolute Values for Clinical Disease Activity Index (CDAI) Total Score
Timepoint [6] 0 0
Week 24, 48, 96 and 144
Secondary outcome [7] 0 0
Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP)
Timepoint [7] 0 0
Week 24, 48, 96 and 144
Secondary outcome [8] 0 0
Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)
Timepoint [8] 0 0
Week 24, 48, 96 and 132
Secondary outcome [9] 0 0
Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS)
Timepoint [9] 0 0
Week 24 and 48
Secondary outcome [10] 0 0
Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI)
Timepoint [10] 0 0
Week 24, 48, 96 and 144
Secondary outcome [11] 0 0
Absolute Values for Arthritis Pain Visual Analogue Scale (VAS)
Timepoint [11] 0 0
Week 24, 48, 96 and 144
Secondary outcome [12] 0 0
Absolute Values Short Form (SF)-36 Mental Component Scores (MCS)
Timepoint [12] 0 0
Week 24, 48, 96 and 144
Secondary outcome [13] 0 0
Absolute Values SF-36 Domain Scores
Timepoint [13] 0 0
Week 24, 48, 96 and 144
Secondary outcome [14] 0 0
Absolute Values SF-36 Physical Component Scores (PCS)
Timepoint [14] 0 0
Week 24, 48, 96 and 144
Secondary outcome [15] 0 0
Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Timepoint [15] 0 0
Week 24, 48, 96 and 144
Secondary outcome [16] 0 0
Number of Participants With Anti-GSK3196165 Antibodies
Timepoint [16] 0 0
Week 120

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/02/2023
Sample size
Target
Accrual to date
Final
2916
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Gold Coast
Recruitment hospital [2] 0 0
GSK Investigational Site - Woodville
Recruitment postcode(s) [1] 0 0
4222 - Gold Coast
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Idaho
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
New Hampshire
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
North Dakota
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
Argentina
State/province [27] 0 0
Buenos Aires
Country [28] 0 0
Argentina
State/province [28] 0 0
Córdova
Country [29] 0 0
Argentina
State/province [29] 0 0
Santa Fe
Country [30] 0 0
Argentina
State/province [30] 0 0
Tucumán
Country [31] 0 0
Argentina
State/province [31] 0 0
Ciudad Autonoma Buenos Aires
Country [32] 0 0
Argentina
State/province [32] 0 0
Ciudad Autónoma de Buenos Aires
Country [33] 0 0
Argentina
State/province [33] 0 0
Cordoba
Country [34] 0 0
Argentina
State/province [34] 0 0
Nueva Cordoba
Country [35] 0 0
Argentina
State/province [35] 0 0
Salta
Country [36] 0 0
Argentina
State/province [36] 0 0
San Juan
Country [37] 0 0
Belgium
State/province [37] 0 0
Mons
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Blagoevgrad
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Pleven
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Plovdiv
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Ruse
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Sevlievo
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Sofia
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Vidin
Country [45] 0 0
Canada
State/province [45] 0 0
Ontario
Country [46] 0 0
Canada
State/province [46] 0 0
Quebec
Country [47] 0 0
China
State/province [47] 0 0
Anhui
Country [48] 0 0
China
State/province [48] 0 0
Guangxi
Country [49] 0 0
China
State/province [49] 0 0
Hebei
Country [50] 0 0
China
State/province [50] 0 0
Hubei
Country [51] 0 0
China
State/province [51] 0 0
Hunan
Country [52] 0 0
China
State/province [52] 0 0
Inner Mongolia
Country [53] 0 0
China
State/province [53] 0 0
Jiangsu
Country [54] 0 0
China
State/province [54] 0 0
Jiangxi
Country [55] 0 0
China
State/province [55] 0 0
Jilin
Country [56] 0 0
China
State/province [56] 0 0
Liaoning
Country [57] 0 0
China
State/province [57] 0 0
Sichuan
Country [58] 0 0
China
State/province [58] 0 0
Zhejiang
Country [59] 0 0
China
State/province [59] 0 0
Beijing
Country [60] 0 0
China
State/province [60] 0 0
Guangzhou
Country [61] 0 0
China
State/province [61] 0 0
Hangzhou
Country [62] 0 0
China
State/province [62] 0 0
Nanjing
Country [63] 0 0
China
State/province [63] 0 0
Shanghai
Country [64] 0 0
China
State/province [64] 0 0
Tianjin
Country [65] 0 0
China
State/province [65] 0 0
Yangzhou
Country [66] 0 0
China
State/province [66] 0 0
Yanji
Country [67] 0 0
Colombia
State/province [67] 0 0
Barranquilla
Country [68] 0 0
Colombia
State/province [68] 0 0
Bogotá
Country [69] 0 0
Colombia
State/province [69] 0 0
Bucaramanga
Country [70] 0 0
Czechia
State/province [70] 0 0
Brno
Country [71] 0 0
Czechia
State/province [71] 0 0
Ostrava
Country [72] 0 0
Czechia
State/province [72] 0 0
Praha 10
Country [73] 0 0
Czechia
State/province [73] 0 0
Praha 11
Country [74] 0 0
Czechia
State/province [74] 0 0
Praha 2
Country [75] 0 0
Czechia
State/province [75] 0 0
Praha 4 Nusle
Country [76] 0 0
Czechia
State/province [76] 0 0
Praha 4
Country [77] 0 0
Czechia
State/province [77] 0 0
Praha 5
Country [78] 0 0
Czechia
State/province [78] 0 0
Uherske Hradiste
Country [79] 0 0
Czechia
State/province [79] 0 0
Zlin
Country [80] 0 0
Estonia
State/province [80] 0 0
Parnu
Country [81] 0 0
Estonia
State/province [81] 0 0
Tallinn
Country [82] 0 0
Estonia
State/province [82] 0 0
Tartu
Country [83] 0 0
Germany
State/province [83] 0 0
Sachsen
Country [84] 0 0
Germany
State/province [84] 0 0
Schleswig-Holstein
Country [85] 0 0
Germany
State/province [85] 0 0
Hamburg
Country [86] 0 0
Germany
State/province [86] 0 0
Magdeburg
Country [87] 0 0
Hungary
State/province [87] 0 0
Baja
Country [88] 0 0
Hungary
State/province [88] 0 0
Balatonfured
Country [89] 0 0
Hungary
State/province [89] 0 0
Budapest
Country [90] 0 0
Hungary
State/province [90] 0 0
Szekesfehervar
Country [91] 0 0
Hungary
State/province [91] 0 0
Szentes
Country [92] 0 0
Hungary
State/province [92] 0 0
Székesfehérvár
Country [93] 0 0
Hungary
State/province [93] 0 0
Veszprem
Country [94] 0 0
India
State/province [94] 0 0
Ahmedabad
Country [95] 0 0
India
State/province [95] 0 0
Belagavi
Country [96] 0 0
India
State/province [96] 0 0
Hubli
Country [97] 0 0
India
State/province [97] 0 0
Hyderabad
Country [98] 0 0
India
State/province [98] 0 0
Jaipur
Country [99] 0 0
India
State/province [99] 0 0
Kolkata
Country [100] 0 0
India
State/province [100] 0 0
Nagpur
Country [101] 0 0
India
State/province [101] 0 0
New Delhi
Country [102] 0 0
India
State/province [102] 0 0
Pune
Country [103] 0 0
India
State/province [103] 0 0
Surat
Country [104] 0 0
Japan
State/province [104] 0 0
Aichi
Country [105] 0 0
Japan
State/province [105] 0 0
Chiba
Country [106] 0 0
Japan
State/province [106] 0 0
Fukuoka
Country [107] 0 0
Japan
State/province [107] 0 0
Hiroshima
Country [108] 0 0
Japan
State/province [108] 0 0
Hokkaido
Country [109] 0 0
Japan
State/province [109] 0 0
Hyogo
Country [110] 0 0
Japan
State/province [110] 0 0
Ibaraki
Country [111] 0 0
Japan
State/province [111] 0 0
Kagawa
Country [112] 0 0
Japan
State/province [112] 0 0
Kagoshima
Country [113] 0 0
Japan
State/province [113] 0 0
Kanagawa
Country [114] 0 0
Japan
State/province [114] 0 0
Kochi
Country [115] 0 0
Japan
State/province [115] 0 0
Kumamoto
Country [116] 0 0
Japan
State/province [116] 0 0
Miyagi
Country [117] 0 0
Japan
State/province [117] 0 0
Nagano
Country [118] 0 0
Japan
State/province [118] 0 0
Nagasaki
Country [119] 0 0
Japan
State/province [119] 0 0
Niigata
Country [120] 0 0
Japan
State/province [120] 0 0
Okayama
Country [121] 0 0
Japan
State/province [121] 0 0
Saitama
Country [122] 0 0
Japan
State/province [122] 0 0
Tokyo
Country [123] 0 0
Japan
State/province [123] 0 0
Wakayama
Country [124] 0 0
Japan
State/province [124] 0 0
Yamaguchi
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Anyang-Si
Country [126] 0 0
Korea, Republic of
State/province [126] 0 0
Cheonan-si
Country [127] 0 0
Korea, Republic of
State/province [127] 0 0
Daegu
Country [128] 0 0
Korea, Republic of
State/province [128] 0 0
Gwangju
Country [129] 0 0
Korea, Republic of
State/province [129] 0 0
Incheon
Country [130] 0 0
Korea, Republic of
State/province [130] 0 0
Seongnam-si
Country [131] 0 0
Korea, Republic of
State/province [131] 0 0
Seoul
Country [132] 0 0
Korea, Republic of
State/province [132] 0 0
Suwon-si, Gyeonggi-do
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Iqvia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT04333147
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04333147