Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
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
Titles & IDs
Public title
Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)
Query!
Scientific title
A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis
Query!
Secondary ID [1]
0
0
209564
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
contRAst X
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Intervention/exposure
Study type
Interventional
Query!
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).
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to approximately 145 Weeks
Query!
Primary outcome [2]
0
0
Change From Baseline in Hematology Parameter of Platelet Count at Week 24
Query!
Assessment method [2]
0
0
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.
Query!
Timepoint [2]
0
0
Baseline (Day 01) and Week 24
Query!
Primary outcome [3]
0
0
Change From Baseline in Hematology Parameter of Platelet Count at Week 48
Query!
Assessment method [3]
0
0
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.
Query!
Timepoint [3]
0
0
Baseline (Day 01) and Week 48
Query!
Primary outcome [4]
0
0
Change From Baseline in Hematology Parameter of Platelet Count at Week 96
Query!
Assessment method [4]
0
0
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.
Query!
Timepoint [4]
0
0
Baseline (Day 01) and Week 96
Query!
Primary outcome [5]
0
0
Change From Baseline in Hematology Parameter of Platelet Count at Week 144
Query!
Assessment method [5]
0
0
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count.
Query!
Timepoint [5]
0
0
Baseline (Day 01) and Week 144
Query!
Primary outcome [6]
0
0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 24
Query!
Assessment method [6]
0
0
Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.
Query!
Timepoint [6]
0
0
Baseline (Day 01) and Week 24
Query!
Primary outcome [7]
0
0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 48
Query!
Assessment method [7]
0
0
Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.
Query!
Timepoint [7]
0
0
Baseline (Day 01) and Week 48
Query!
Primary outcome [8]
0
0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 96
Query!
Assessment method [8]
0
0
Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.
Query!
Timepoint [8]
0
0
Baseline (Day 01) and Week 96
Query!
Primary outcome [9]
0
0
Change From Baseline in Hematology Parameter of Hemoglobin at Week 144
Query!
Assessment method [9]
0
0
Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin.
Query!
Timepoint [9]
0
0
Baseline (Day 01) and Week 144
Query!
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
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Baseline (Day 01) and Week 24
Query!
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
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Baseline (Day 01) and Week 48
Query!
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
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Baseline (Day 01) and Week 96
Query!
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
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Baseline (Day 01) and Week 144
Query!
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
Query!
Assessment method [14]
0
0
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.
Query!
Timepoint [14]
0
0
Baseline (Day 01) and Week 24
Query!
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
Query!
Assessment method [15]
0
0
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.
Query!
Timepoint [15]
0
0
Baseline (Day 01) and Week 48
Query!
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
Query!
Assessment method [16]
0
0
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.
Query!
Timepoint [16]
0
0
Baseline (Day 01) and Week 96
Query!
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
Query!
Assessment method [17]
0
0
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK.
Query!
Timepoint [17]
0
0
Baseline (Day 01) and Week 144
Query!
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
Query!
Assessment method [18]
0
0
Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides
Query!
Timepoint [18]
0
0
Baseline (Day 01) and Week 24
Query!
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
Query!
Assessment method [19]
0
0
Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides
Query!
Timepoint [19]
0
0
Baseline (Day 01) and Week 48
Query!
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
Query!
Assessment method [20]
0
0
Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides
Query!
Timepoint [20]
0
0
Baseline (Day 01) and Week 96
Query!
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
Query!
Assessment method [21]
0
0
Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides
Query!
Timepoint [21]
0
0
Baseline (Day 01) and Week 144
Query!
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
Query!
Assessment method [22]
0
0
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.
Query!
Timepoint [22]
0
0
Up to approximately 145 Weeks
Query!
Primary outcome [23]
0
0
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24
Query!
Assessment method [23]
0
0
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.
Query!
Timepoint [23]
0
0
Baseline (Day 01) and Week 24
Query!
Primary outcome [24]
0
0
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48
Query!
Assessment method [24]
0
0
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.
Query!
Timepoint [24]
0
0
Baseline (Day 01) and Week 48
Query!
Primary outcome [25]
0
0
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96
Query!
Assessment method [25]
0
0
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.
Query!
Timepoint [25]
0
0
Baseline (Day 01) and Week 96
Query!
Primary outcome [26]
0
0
Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144
Query!
Assessment method [26]
0
0
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin.
Query!
Timepoint [26]
0
0
Baseline (Day 01) and Week 144
Query!
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
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 24, 48, 96 and 144
Query!
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
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Week 24, 48, 96 and 144
Query!
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
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Week 24, 48, 96 and 144
Query!
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
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Week 24, 48, 96 and 132
Query!
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
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Week 24, 48, 96 and 144
Query!
Secondary outcome [6]
0
0
Absolute Values for Clinical Disease Activity Index (CDAI) Total Score
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Week 24, 48, 96 and 144
Query!
Secondary outcome [7]
0
0
Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP)
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Week 24, 48, 96 and 144
Query!
Secondary outcome [8]
0
0
Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR)
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Week 24, 48, 96 and 132
Query!
Secondary outcome [9]
0
0
Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS)
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Week 24 and 48
Query!
Secondary outcome [10]
0
0
Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI)
Query!
Assessment method [10]
0
0
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.
Query!
Timepoint [10]
0
0
Week 24, 48, 96 and 144
Query!
Secondary outcome [11]
0
0
Absolute Values for Arthritis Pain Visual Analogue Scale (VAS)
Query!
Assessment method [11]
0
0
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.
Query!
Timepoint [11]
0
0
Week 24, 48, 96 and 144
Query!
Secondary outcome [12]
0
0
Absolute Values Short Form (SF)-36 Mental Component Scores (MCS)
Query!
Assessment method [12]
0
0
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.
Query!
Timepoint [12]
0
0
Week 24, 48, 96 and 144
Query!
Secondary outcome [13]
0
0
Absolute Values SF-36 Domain Scores
Query!
Assessment method [13]
0
0
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.
Query!
Timepoint [13]
0
0
Week 24, 48, 96 and 144
Query!
Secondary outcome [14]
0
0
Absolute Values SF-36 Physical Component Scores (PCS)
Query!
Assessment method [14]
0
0
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.
Query!
Timepoint [14]
0
0
Week 24, 48, 96 and 144
Query!
Secondary outcome [15]
0
0
Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
Week 24, 48, 96 and 144
Query!
Secondary outcome [16]
0
0
Number of Participants With Anti-GSK3196165 Antibodies
Query!
Assessment method [16]
0
0
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
Query!
Timepoint [16]
0
0
Week 120
Query!
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).
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
12/05/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
24/02/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2916
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Gold Coast
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Woodville
Query!
Recruitment postcode(s) [1]
0
0
4222 - Gold Coast
Query!
Recruitment postcode(s) [2]
0
0
5011 - Woodville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Idaho
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kansas
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Kentucky
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Louisiana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maryland
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Missouri
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nebraska
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New Hampshire
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
New Jersey
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New York
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
North Carolina
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Dakota
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Ohio
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oklahoma
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
South Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Texas
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Wisconsin
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
Buenos Aires
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Córdova
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Santa Fe
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Tucumán
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Ciudad Autonoma Buenos Aires
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Ciudad Autónoma de Buenos Aires
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Cordoba
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Nueva Cordoba
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Salta
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
San Juan
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Mons
Query!
Country [38]
0
0
Bulgaria
Query!
State/province [38]
0
0
Blagoevgrad
Query!
Country [39]
0
0
Bulgaria
Query!
State/province [39]
0
0
Pleven
Query!
Country [40]
0
0
Bulgaria
Query!
State/province [40]
0
0
Plovdiv
Query!
Country [41]
0
0
Bulgaria
Query!
State/province [41]
0
0
Ruse
Query!
Country [42]
0
0
Bulgaria
Query!
State/province [42]
0
0
Sevlievo
Query!
Country [43]
0
0
Bulgaria
Query!
State/province [43]
0
0
Sofia
Query!
Country [44]
0
0
Bulgaria
Query!
State/province [44]
0
0
Vidin
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Ontario
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Quebec
Query!
Country [47]
0
0
China
Query!
State/province [47]
0
0
Anhui
Query!
Country [48]
0
0
China
Query!
State/province [48]
0
0
Guangxi
Query!
Country [49]
0
0
China
Query!
State/province [49]
0
0
Hebei
Query!
Country [50]
0
0
China
Query!
State/province [50]
0
0
Hubei
Query!
Country [51]
0
0
China
Query!
State/province [51]
0
0
Hunan
Query!
Country [52]
0
0
China
Query!
State/province [52]
0
0
Inner Mongolia
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Jiangsu
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Jiangxi
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Jilin
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Liaoning
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Sichuan
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Zhejiang
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Beijing
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Guangzhou
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Hangzhou
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Nanjing
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Shanghai
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Tianjin
Query!
Country [65]
0
0
China
Query!
State/province [65]
0
0
Yangzhou
Query!
Country [66]
0
0
China
Query!
State/province [66]
0
0
Yanji
Query!
Country [67]
0
0
Colombia
Query!
State/province [67]
0
0
Barranquilla
Query!
Country [68]
0
0
Colombia
Query!
State/province [68]
0
0
Bogotá
Query!
Country [69]
0
0
Colombia
Query!
State/province [69]
0
0
Bucaramanga
Query!
Country [70]
0
0
Czechia
Query!
State/province [70]
0
0
Brno
Query!
Country [71]
0
0
Czechia
Query!
State/province [71]
0
0
Ostrava
Query!
Country [72]
0
0
Czechia
Query!
State/province [72]
0
0
Praha 10
Query!
Country [73]
0
0
Czechia
Query!
State/province [73]
0
0
Praha 11
Query!
Country [74]
0
0
Czechia
Query!
State/province [74]
0
0
Praha 2
Query!
Country [75]
0
0
Czechia
Query!
State/province [75]
0
0
Praha 4 Nusle
Query!
Country [76]
0
0
Czechia
Query!
State/province [76]
0
0
Praha 4
Query!
Country [77]
0
0
Czechia
Query!
State/province [77]
0
0
Praha 5
Query!
Country [78]
0
0
Czechia
Query!
State/province [78]
0
0
Uherske Hradiste
Query!
Country [79]
0
0
Czechia
Query!
State/province [79]
0
0
Zlin
Query!
Country [80]
0
0
Estonia
Query!
State/province [80]
0
0
Parnu
Query!
Country [81]
0
0
Estonia
Query!
State/province [81]
0
0
Tallinn
Query!
Country [82]
0
0
Estonia
Query!
State/province [82]
0
0
Tartu
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Sachsen
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Schleswig-Holstein
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Hamburg
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Magdeburg
Query!
Country [87]
0
0
Hungary
Query!
State/province [87]
0
0
Baja
Query!
Country [88]
0
0
Hungary
Query!
State/province [88]
0
0
Balatonfured
Query!
Country [89]
0
0
Hungary
Query!
State/province [89]
0
0
Budapest
Query!
Country [90]
0
0
Hungary
Query!
State/province [90]
0
0
Szekesfehervar
Query!
Country [91]
0
0
Hungary
Query!
State/province [91]
0
0
Szentes
Query!
Country [92]
0
0
Hungary
Query!
State/province [92]
0
0
Székesfehérvár
Query!
Country [93]
0
0
Hungary
Query!
State/province [93]
0
0
Veszprem
Query!
Country [94]
0
0
India
Query!
State/province [94]
0
0
Ahmedabad
Query!
Country [95]
0
0
India
Query!
State/province [95]
0
0
Belagavi
Query!
Country [96]
0
0
India
Query!
State/province [96]
0
0
Hubli
Query!
Country [97]
0
0
India
Query!
State/province [97]
0
0
Hyderabad
Query!
Country [98]
0
0
India
Query!
State/province [98]
0
0
Jaipur
Query!
Country [99]
0
0
India
Query!
State/province [99]
0
0
Kolkata
Query!
Country [100]
0
0
India
Query!
State/province [100]
0
0
Nagpur
Query!
Country [101]
0
0
India
Query!
State/province [101]
0
0
New Delhi
Query!
Country [102]
0
0
India
Query!
State/province [102]
0
0
Pune
Query!
Country [103]
0
0
India
Query!
State/province [103]
0
0
Surat
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Aichi
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Chiba
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Fukuoka
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Hiroshima
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Hokkaido
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Hyogo
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Ibaraki
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Kagawa
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Kagoshima
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Kanagawa
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Kochi
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Kumamoto
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Miyagi
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Nagano
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Nagasaki
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Niigata
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Okayama
Query!
Country [121]
0
0
Japan
Query!
State/province [121]
0
0
Saitama
Query!
Country [122]
0
0
Japan
Query!
State/province [122]
0
0
Tokyo
Query!
Country [123]
0
0
Japan
Query!
State/province [123]
0
0
Wakayama
Query!
Country [124]
0
0
Japan
Query!
State/province [124]
0
0
Yamaguchi
Query!
Country [125]
0
0
Korea, Republic of
Query!
State/province [125]
0
0
Anyang-Si
Query!
Country [126]
0
0
Korea, Republic of
Query!
State/province [126]
0
0
Cheonan-si
Query!
Country [127]
0
0
Korea, Republic of
Query!
State/province [127]
0
0
Daegu
Query!
Country [128]
0
0
Korea, Republic of
Query!
State/province [128]
0
0
Gwangju
Query!
Country [129]
0
0
Korea, Republic of
Query!
State/province [129]
0
0
Incheon
Query!
Country [130]
0
0
Korea, Republic of
Query!
State/province [130]
0
0
Seongnam-si
Query!
Country [131]
0
0
Korea, Republic of
Query!
State/province [131]
0
0
Seoul
Query!
Country [132]
0
0
Korea, Republic of
Query!
State/province [132]
0
0
Suwon-si, Gyeonggi-do
Query!
Country [133]
0
0
Latvia
Query!
State/province [133]
0
0
Adazi
Query!
Country [134]
0
0
Latvia
Query!
State/province [134]
0
0
Liepaja
Query!
Country [135]
0
0
Lithuania
Query!
State/province [135]
0
0
Kaunas
Query!
Country [136]
0
0
Lithuania
Query!
State/province [136]
0
0
Klaipeda
Query!
Country [137]
0
0
Lithuania
Query!
State/province [137]
0
0
Siauliai
Query!
Country [138]
0
0
Lithuania
Query!
State/province [138]
0
0
Vilnius
Query!
Country [139]
0
0
Malaysia
Query!
State/province [139]
0
0
Klang
Query!
Country [140]
0
0
Malaysia
Query!
State/province [140]
0
0
Kuala Lumpur
Query!
Country [141]
0
0
Malaysia
Query!
State/province [141]
0
0
Seremban, Negeri Sembilan
Query!
Country [142]
0
0
Malaysia
Query!
State/province [142]
0
0
Sibu
Query!
Country [143]
0
0
Mexico
Query!
State/province [143]
0
0
Baja California Sur
Query!
Country [144]
0
0
Mexico
Query!
State/province [144]
0
0
Durango
Query!
Country [145]
0
0
Mexico
Query!
State/province [145]
0
0
Guanajuato
Query!
Country [146]
0
0
Mexico
Query!
State/province [146]
0
0
Jalisco
Query!
Country [147]
0
0
Mexico
Query!
State/province [147]
0
0
Yucatán
Query!
Country [148]
0
0
Mexico
Query!
State/province [148]
0
0
Mexico
Query!
Country [149]
0
0
Mexico
Query!
State/province [149]
0
0
San Luis Potosí
Query!
Country [150]
0
0
Poland
Query!
State/province [150]
0
0
Bialystok
Query!
Country [151]
0
0
Poland
Query!
State/province [151]
0
0
Bydgoszcz
Query!
Country [152]
0
0
Poland
Query!
State/province [152]
0
0
Czestochowa
Query!
Country [153]
0
0
Poland
Query!
State/province [153]
0
0
Elblag
Query!
Country [154]
0
0
Poland
Query!
State/province [154]
0
0
Gdansk
Query!
Country [155]
0
0
Poland
Query!
State/province [155]
0
0
Gdynia
Query!
Country [156]
0
0
Poland
Query!
State/province [156]
0
0
Grodzisk Mazowiecki
Query!
Country [157]
0
0
Poland
Query!
State/province [157]
0
0
Katowice
Query!
Country [158]
0
0
Poland
Query!
State/province [158]
0
0
Krakow
Query!
Country [159]
0
0
Poland
Query!
State/province [159]
0
0
Kraków
Query!
Country [160]
0
0
Poland
Query!
State/province [160]
0
0
Lodz
Query!
Country [161]
0
0
Poland
Query!
State/province [161]
0
0
Lublin
Query!
Country [162]
0
0
Poland
Query!
State/province [162]
0
0
Nowa Sol
Query!
Country [163]
0
0
Poland
Query!
State/province [163]
0
0
Olsztyn
Query!
Country [164]
0
0
Poland
Query!
State/province [164]
0
0
Poznan
Query!
Country [165]
0
0
Poland
Query!
State/province [165]
0
0
Siedlce
Query!
Country [166]
0
0
Poland
Query!
State/province [166]
0
0
Sochaczew
Query!
Country [167]
0
0
Poland
Query!
State/province [167]
0
0
Staszow
Query!
Country [168]
0
0
Poland
Query!
State/province [168]
0
0
Torun
Query!
Country [169]
0
0
Poland
Query!
State/province [169]
0
0
Warsaw
Query!
Country [170]
0
0
Poland
Query!
State/province [170]
0
0
Warszawa
Query!
Country [171]
0
0
Poland
Query!
State/province [171]
0
0
Wroclaw
Query!
Country [172]
0
0
Poland
Query!
State/province [172]
0
0
Zamosc
Query!
Country [173]
0
0
Russian Federation
Query!
State/province [173]
0
0
Ekaterinburg
Query!
Country [174]
0
0
Russian Federation
Query!
State/province [174]
0
0
Kemerovo
Query!
Country [175]
0
0
Russian Federation
Query!
State/province [175]
0
0
Korolev
Query!
Country [176]
0
0
Russian Federation
Query!
State/province [176]
0
0
Krasnoyarsk
Query!
Country [177]
0
0
Russian Federation
Query!
State/province [177]
0
0
Moscow
Query!
Country [178]
0
0
Russian Federation
Query!
State/province [178]
0
0
Novosibirsk
Query!
Country [179]
0
0
Russian Federation
Query!
State/province [179]
0
0
Omsk
Query!
Country [180]
0
0
Russian Federation
Query!
State/province [180]
0
0
Saint Petersburg
Query!
Country [181]
0
0
Russian Federation
Query!
State/province [181]
0
0
Saint-Petersburg
Query!
Country [182]
0
0
Russian Federation
Query!
State/province [182]
0
0
Saratov
Query!
Country [183]
0
0
Russian Federation
Query!
State/province [183]
0
0
Smolensk
Query!
Country [184]
0
0
Russian Federation
Query!
State/province [184]
0
0
Tomsk
Query!
Country [185]
0
0
Russian Federation
Query!
State/province [185]
0
0
Tver
Query!
Country [186]
0
0
Russian Federation
Query!
State/province [186]
0
0
Ulyanovsk
Query!
Country [187]
0
0
Russian Federation
Query!
State/province [187]
0
0
Yaroslavl
Query!
Country [188]
0
0
Serbia
Query!
State/province [188]
0
0
Belgrade
Query!
Country [189]
0
0
South Africa
Query!
State/province [189]
0
0
Gauteng
Query!
Country [190]
0
0
South Africa
Query!
State/province [190]
0
0
KwaZulu- Natal
Query!
Country [191]
0
0
South Africa
Query!
State/province [191]
0
0
Bellville
Query!
Country [192]
0
0
South Africa
Query!
State/province [192]
0
0
Bloemfontein
Query!
Country [193]
0
0
South Africa
Query!
State/province [193]
0
0
Cape Town
Query!
Country [194]
0
0
South Africa
Query!
State/province [194]
0
0
Johannesburg
Query!
Country [195]
0
0
South Africa
Query!
State/province [195]
0
0
Kempton Park
Query!
Country [196]
0
0
South Africa
Query!
State/province [196]
0
0
Pretoria
Query!
Country [197]
0
0
South Africa
Query!
State/province [197]
0
0
Somerset West
Query!
Country [198]
0
0
South Africa
Query!
State/province [198]
0
0
Stellenbosch
Query!
Country [199]
0
0
Spain
Query!
State/province [199]
0
0
Barcelona
Query!
Country [200]
0
0
Spain
Query!
State/province [200]
0
0
Cordoba
Query!
Country [201]
0
0
Spain
Query!
State/province [201]
0
0
Coruña
Query!
Country [202]
0
0
Spain
Query!
State/province [202]
0
0
Elche
Query!
Country [203]
0
0
Spain
Query!
State/province [203]
0
0
Santander
Query!
Country [204]
0
0
Spain
Query!
State/province [204]
0
0
Santiago De Compostela. La Coruña.
Query!
Country [205]
0
0
Spain
Query!
State/province [205]
0
0
Sevilla
Query!
Country [206]
0
0
Spain
Query!
State/province [206]
0
0
Valencia
Query!
Country [207]
0
0
Thailand
Query!
State/province [207]
0
0
Bangkok
Query!
Country [208]
0
0
Thailand
Query!
State/province [208]
0
0
Rajathevee
Query!
Country [209]
0
0
Ukraine
Query!
State/province [209]
0
0
Cherkasy
Query!
Country [210]
0
0
Ukraine
Query!
State/province [210]
0
0
Ivano-Frankivsk
Query!
Country [211]
0
0
Ukraine
Query!
State/province [211]
0
0
Kharkiv
Query!
Country [212]
0
0
Ukraine
Query!
State/province [212]
0
0
Kyiv
Query!
Country [213]
0
0
Ukraine
Query!
State/province [213]
0
0
Lutsk
Query!
Country [214]
0
0
Ukraine
Query!
State/province [214]
0
0
Odessa
Query!
Country [215]
0
0
Ukraine
Query!
State/province [215]
0
0
Poltava
Query!
Country [216]
0
0
Ukraine
Query!
State/province [216]
0
0
Vinnytsia
Query!
Country [217]
0
0
Ukraine
Query!
State/province [217]
0
0
Vinnytsya
Query!
Country [218]
0
0
Ukraine
Query!
State/province [218]
0
0
Zaporizhzhia
Query!
Country [219]
0
0
Ukraine
Query!
State/province [219]
0
0
Zaporizhzia
Query!
Country [220]
0
0
Ukraine
Query!
State/province [220]
0
0
Zhytomyr
Query!
Country [221]
0
0
United Kingdom
Query!
State/province [221]
0
0
Kent
Query!
Country [222]
0
0
United Kingdom
Query!
State/province [222]
0
0
Middlesex
Query!
Country [223]
0
0
United Kingdom
Query!
State/province [223]
0
0
Coventry
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
GlaxoSmithKline
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Iqvia Pty Ltd
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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
Query!
Trial website
https://clinicaltrials.gov/study/NCT04333147
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
GlaxoSmithKline
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Query!
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: http://clinicalstudydatarequest.com
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/47/NCT04333147/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/47/NCT04333147/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04333147