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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Treatment: Other - 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.


Treatment: Other: 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
Treatment: Other
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
Stopped early
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
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United States of America
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Indiana
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United States of America
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Kansas
Country [11] 0 0
United States of America
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Kentucky
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United States of America
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Louisiana
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Maryland
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Michigan
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Missouri
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United States of America
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Nebraska
Country [17] 0 0
United States of America
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New Hampshire
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United States of America
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New Jersey
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United States of America
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New York
Country [20] 0 0
United States of America
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North Carolina
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United States of America
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North Dakota
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United States of America
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Ohio
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Oklahoma
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United States of America
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South Carolina
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Texas
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United States of America
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Córdova
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Argentina
State/province [29] 0 0
Santa Fe
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Argentina
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Tucumán
Country [31] 0 0
Argentina
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Ciudad Autonoma Buenos Aires
Country [32] 0 0
Argentina
State/province [32] 0 0
Ciudad Autónoma de Buenos Aires
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Argentina
State/province [33] 0 0
Cordoba
Country [34] 0 0
Argentina
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Nueva Cordoba
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Argentina
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Salta
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Argentina
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San Juan
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Belgium
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Mons
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Bulgaria
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Blagoevgrad
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Sevlievo
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Bulgaria
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Sofia
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Bulgaria
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Vidin
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Canada
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Ontario
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Canada
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Quebec
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China
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Anhui
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Guangxi
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China
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Hebei
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China
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Hubei
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China
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Hunan
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China
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Inner Mongolia
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China
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Jiangsu
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China
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Jiangxi
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China
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Jilin
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China
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Liaoning
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China
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Sichuan
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China
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Zhejiang
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China
State/province [59] 0 0
Beijing
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China
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Guangzhou
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China
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Hangzhou
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China
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Nanjing
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Shanghai
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China
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Tianjin
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China
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Yangzhou
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China
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Yanji
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Colombia
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Barranquilla
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Colombia
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Bogotá
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Colombia
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Bucaramanga
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Czechia
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Brno
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Czechia
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Ostrava
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Praha 10
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Praha 11
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Czechia
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Praha 2
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Czechia
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Praha 4 Nusle
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Praha 4
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Czechia
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Praha 5
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Czechia
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Uherske Hradiste
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Czechia
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Zlin
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Estonia
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Parnu
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Estonia
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Tallinn
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Estonia
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Tartu
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Germany
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Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Hamburg
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Germany
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Magdeburg
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Hungary
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Baja
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Hungary
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Balatonfured
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Hungary
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Budapest
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Hungary
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Szekesfehervar
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Hungary
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Szentes
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Hungary
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Székesfehérvár
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Hungary
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Veszprem
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India
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Ahmedabad
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India
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Belagavi
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India
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Hubli
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India
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Hyderabad
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India
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Jaipur
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India
State/province [99] 0 0
Kolkata
Country [100] 0 0
India
State/province [100] 0 0
Nagpur
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India
State/province [101] 0 0
New Delhi
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India
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Pune
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India
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Surat
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Japan
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Aichi
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Japan
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Chiba
Country [106] 0 0
Japan
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Fukuoka
Country [107] 0 0
Japan
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Hiroshima
Country [108] 0 0
Japan
State/province [108] 0 0
Hokkaido
Country [109] 0 0
Japan
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Hyogo
Country [110] 0 0
Japan
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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
Country [133] 0 0
Latvia
State/province [133] 0 0
Adazi
Country [134] 0 0
Latvia
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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/study/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/study/NCT04333147