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This is a randomized, double-blind, parallel group, 3 dosage level, placebo-controlled, Phase 1/2 study designed to evaluate the pharmacokinetics, safety, tolerability, and efficacy of the monoclonal antibody GSK3196165, in Japanese subjects with active moderate-severe rheumatoid arthritis (RA) despite treatment with methotrexate(MTX). The subjects will receive GSK3196165 in combination with methotrexate therapy for the 12 weeks of treatment period. Approximately 55 subjects will be screened to achieve 40 randomized subjects, so as to have approximately 10 subjects in each treatment group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK3196165 Dose 1 | Experimental | Participants will receive GSK3196165 Dose 1 weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There will be 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants will also receive a stable dose of methotrexate during the Treatment Period. |
|
| GSK3196165 Dose 2 | Experimental | Participants will receive GSK3196165 Dose 2 weekly as a single SC injection by an un-blinded administrator. There will be 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants will also receive a stable dose of methotrexate during the Treatment Period. |
|
| GSK3196165 Dose 3 | Experimental | Participants will receive GSK3196165 Dose 3 weekly as a single SC injection by an un-blinded administrator. There will be 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants will also receive a stable dose of methotrexate during the Treatment Period. |
|
| Placebo | Placebo Comparator | Participants will receive placebo weekly as a single SC injection by an un-blinded administrator. There will be 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants will also receive a stable dose of methotrexate during the Treatment Period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3196165 Dose 1 | Drug | GSK3196165 is supplied as liquid and will be administered as SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of GSK3196165 | Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71). Only those participants whose parameters could be determined were analyzed. PK Population included all GSK3196165-treated participants from whom PK samples were collected and analyzed. | Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155 |
| Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]), AUC From Time Zero Extrapolated to Infinity (AUC [0-inf]), AUC Over the Dosing Interval (AUCtau) of GSK3196165 | Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71). NA indicates data was not available as geometric mean and/or 95 percent confidence interval could not be calculated when number of participant was not sufficient. | Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155 |
| Time to Reach Cmax (Tmax) of GSK3196165 | Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71). | Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155 |
| Terminal Half-life (t1/2) of GSK3196165 | Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by standard non-compartmental analysis from the concentration data after last dosing (Day 71). NA indicates data was not available as 95 percent confidence interval could not be calculated when number of participant was not sufficient. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Vital sign measurements including SBP and DBP were measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. | Baseline and up to 22 weeks |
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Inclusion Criteria:
Age: >=20 years at the time of signing informed consent - Japanese rheumatoid arthritis (RA) subjects who meets American College of Rheumatology or European League Against Rheumatism (ACR/EULAR) 2010 RA Classification Criteria
Functional class I, II or III defined by the 1992 ACR Classification of Functional Status in RA
Disease duration of >=12 weeks (time from onset of subject-reported symptoms of either pain or stiffness or swelling in hands, feet or wrists).
Swollen joint count of >=4 (66-joint count) and tender joint count of >=4 (68-joint count) at screening and at Day 1
DAS28(CRP) >=3.2 at screening
C-Reactive Protein (CRP) >=0.5 milligrams (mg)/deciliter (dL) at screening
Must have previously received methotrexate (MTX) (8-16 mg weekly) orally for at least 12 weeks before screening, with a stable and tolerated dose for >=4 weeks prior to Day 1
>=40 kilograms (kg) - Male or female subjects are eligible to participate so long as they meet and agree to abide by the contraceptive criteria
Written informed consent prior to any of the screening procedures including discontinuation of prohibited medications
Willing to continue or initiate treatment with oral folic acid (5 mg/week) and be treated during the entire study (mandatory co-medication for MTX treatment)
Diffusing capacity of lung for carbon monoxide (DLCO) >=60% predicted; forced expiratory volume in 1 second (FEV1) >=70% predicted; forced vital capacity (FVC) >=80% predicted
No evidence of active or latent infection with Mycobacterium tuberculosis (TB), as defined by all of the following:
Exclusion Criteria:
Pregnant or lactating women
History of other inflammatory rheumatologic or autoimmune disorders, other than Sjögren's syndrome secondary to RA
History of any respiratory disease which (in the opinion of the investigator) would compromise subject safety or the ability of the subject to complete the study (e.g. significant interstitial lung disease, such as pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), moderate-severe asthma, bronchiectasis, previous pulmonary alveolar proteinosis (PAP)
Clinically-significant or unstable (in the opinion of the investigator) persistent cough or dyspnea that is unexplained
QT interval corrected for heart rate (QTc) >450 milliseconds (msec) or QTc >480 msec for subjects with bundle branch block. The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF)
Liver function tests: alanine aminotransferase (ALT) >=1.5x upper limit of normal (ULN); aspartate transaminase (AST) >=1.5xULN; alkaline phosphatase and bilirubin >=1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment)
Clinically significant unstable or uncontrolled acute or chronic disease (e.g., cardiovascular including uncompensated congestive cardiac failure New York Heart Association [NYHA] III or IV, myocardial infarction within 12 months, unstable angina pectoris, uncontrolled hypertension, uncontrolled hypercholesterolemia) pulmonary, hematologic, gastrointestinal (including Crohn's Disease or ulcerative colitis), hepatic, renal, neurological, psychiatric, malignancy, endocrinological or infectious diseases, which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk
A history of malignant neoplasm within the last 10 years or breast cancer within the last 20 years, except for non-melanoma skin cancers that have been excised and cured or carcinoma in situ of the uterine cervix
Kidney disease: Current or history of renal disease, or estimated creatinine clearance <60 milliliter (mL)/minute (min)/1.73 m2 (MDRD formula) or serum creatinine >1.5xULN within 4 weeks of Day 1
Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency
History of infected joint prosthesis at any time, with the prosthesis still in situ. History of leg ulcers, catheters, chronic sinusitis or recurrent chest or urinary tract infections
Active infections, or history of recurrent infections (excluding recurrent fungal infections of the nail bed), or have required management of acute or chronic infections, as follows:
A vaccination (live or attenuated) within 30 days of Day 1 or Bacillus Calmette-Guérin (BCG) vaccination within 1 year of Day 1, or a live vaccination planned during the course of the study (including follow-up period).
Any surgical procedure, including bone or joint surgery/synovectomy within 12 weeks prior to Day 1 or any planned surgery within the duration of the study (including follow-up period)
Use of prohibited medications Prior to AND throughout the study:
Any conventional DMARDs other than MTX (including sulfasalazine, bucillamine, iguratimod, tacrolimus) should be withdrawn at least 2 weeks prior to Day 1.
Subjects may require longer to discontinue azathioprine or leflunomide prior to Day 1: Azathioprine must be discontinued >=4 weeks prior to randomization; Leflunomide must be discontinued >=12 weeks prior to Day 1 (or >=14 days after 11 days of standard cholestyramine or activated charcoal washout).
Corticosteroids:
Any Intramascular (IM), Intravenous (IV) or Intra-arterial (IA) corticosteroids within 8 weeks of Day 1.
Oral corticosteroids:
Non-steroidal anti-inflammatory drugs (NSAIDs):
Any non-anti-rheumatic investigational treatment must be discontinued for at least 4 weeks or 5 half-lives, whichever is longer, prior to Day 1
Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within a year prior to Day 1
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
Abnormal chest X-ray within 12 weeks of Day 1 (locally read and reported by a radiologist) judged by the investigator as clinically-significant
Any Grade 3 or 4 hematology or clinical chemistry laboratory abnormality, within 4 weeks of Day 1
Hemoglobin ≤9 g/dL; white blood cell count ≤3.0 x 109/L; platelet count ≤100 x 109/L; absolute neutrophil count ≤1.5 x 109/L; lymphocyte count ≤0.5 x 109/L within 4 weeks of Day 1
Serologic evidence of current/previous Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg) and anti-Hepatitis B core (anti-HBc) antibody as follows within 4 weeks of Day 1
Hepatitis C: Positive test for Hepatitis C virus (HCV) antibody confirmed on a subsequent blood sample by ribonucleic acid - polymerized chain reaction (RNA-PCR) assay within 4 weeks of Day 1.
Positive serology for human immunodeficiency virus (HIV) 1 or 2 (within 4 weeks of Day 1)
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aichi | 440-8510 | Japan | |||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| IPD for this study will be made available via the Clinical Study Data Request site. | View source |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD is available via the Clinical Study Data Request site (click on the link provided below)
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.
A total of 35 participants were screened, and 20 participants failed screening because of not met eligibility criteria (18 participants) and withdrawal by participant (2 participants). Hence, a total of 15 participants were enrolled and randomized to study treatment.
This study was conducted to assess pharmacokinetics (PK), safety, tolerability and efficacy of GSK3196165 for 12 weeks, in combination with Methotrexate (MTX), in Japanese participants with active moderate-severe rheumatoid arthritis (RA) despite treatment with MTX. Participants were enrolled at 15 centers in Japan from 24-Jan-2017 to 30-Jun-2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2017 | Jul 23, 2018 |
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| GSK3196165 Dose 2 | Drug | GSK3196165 is supplied as liquid and will be administered as SC injection. |
|
| GSK3196165 Dose 3 | Drug | GSK3196165 is supplied as liquid and will be administered as SC injection. |
|
| Methotrexate | Drug | Methotrexate capsule/tablet 8-16 mg per week is given orally. |
|
| Placebo | Drug | Placebo is supplied as liquid as sterile 0.9% sodium chloride solution and will be administered as SC injection. |
|
| Folic acid | Drug | Folic acid tablet 5 mg per week is given orally. |
|
| Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155. |
| Number of Participants With Any Adverse Event (AE), Serious AE (SAE) and Adverse Events of Special Interest (AESI) | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. AESI included serious infections including serious respiratory infections and tuberculosis and opportunistic infections, neutropenia (grade 3 or 4), respiratory events, pulmonary alveolar proteinosis, hypersensitivity reactions including anaphylaxis and injection site reactions. | Up to 22 weeks |
| Change From Baseline in Heart Rate (HR) | Vital sign measurements including HR was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. | Baseline and up to 22 weeks |
| Change From Baseline in Body Temperature | Vital sign measurements including body temperature was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. | Baseline and up to 22 weeks |
| Change From Baseline in Respiratory Rate | Vital sign measurements including respiratory rate was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. | Baseline and up to 22 weeks |
| Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | 12-Lead ECGs were taken using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) intervals. Number of participants with any abnormal findings in ECG recordings were summarized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | At Week 12 |
| Number of Participants With Emergent Hematology Results Relative to Normal Range | Blood samples were collected to evaluate hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), erythrocytes, reticulocytes, white blood cells (WBC), total neutrophils, eosinophils, basophils, monocytes, lymphocytes, platelet count, activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen, erythrocyte sedimentation rate (ESR). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged (e.g. High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if they had values that changed 'To Low' and 'To High', so the percentages may not add to 100% in such instances. | Up to 22 weeks |
| Number of Participants With Emergent Clinical Chemistry Results Relative to Normal Range | Blood samples were collected to evaluate Albumin, Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Total Bilirubin, Calcium, Cholesterol, Creatine Kinase, C-Reactive protein (CRP), Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, High Density Lipids (HDL), Potassium, Lactate Dehydrogenase, Low Density Lipids (LDL), Sodium, Phosphorus inorganic, Triglycerides, Total Protein and Urea. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged (e.g. High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if they had values that changed 'To Low' and 'To High', so the percentages may not add to 100% in such instances. | Up to 22 weeks |
| Number of Participants With Urinalysis Dipstick Findings | Urine samples were collected for analysis of presence of glucose and protein in urine by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein and glucose can be read as negative, Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample | Up to 22 weeks |
| Number of Participants With Anti-GSK3196165 Antibody Test Results | Serum samples were collected and tested for presence of antibodies that bind to GSK3196165. The presence of treatment emergent anti-drug antibodies (ADA) were determined using a GSK3196165 bridging style ADA assay with a bio-analytically determined cut point determined during assay validation. Samples taken after dosing with GSK3196165 that have a value at or above the cut-point were considered treatment-emergent ADA-positive. These ADA positive samples were further evaluated in a confirmatory assay, and confirmed positive samples were further characterized by assessment of titer. Baseline was considered as the latest pre-dose assessment. Number of participants with post-Baseline negative or positive anti-GSK3196165 antibody test results were presented. | Weeks 2, 4, 12 and 22 |
| Change From Baseline in Disease Activity Score for 28 Different Joints C-reactive Protein (DAS28 [CRP]) at All Indicated Timepoints | DAS28 (CRP) is a measure of disease activity in rheumatoid arthritis obtained by examination of 28 joints for swelling and tenderness using CRP as a blood biomarker for inflammation. Its components include: Tender/Painful Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), CRP and Patient's Global Assessment of Arthritis. DAS28 (CRP) was calculated by 0.56 (square root of TJC28)+ 0.28 (square root of SJC28)+ 0.36 (natural logarithm [CRP+1])+ (0.014*patients global assessment)+0.96. Scores ranges from 0 to infinity, where higher scores indicates high disease activity. Scores higher than 5.1 indicates high disease activity and scores lower than 2.6 indicates remission. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. Adjusted mean and standard error of adjusted mean are presented using Mixed Model for Repeated Measures. | Baseline, up to Week 22 |
| Aichi |
| 440-85 |
| Japan |
| GSK Investigational Site | Aichi | 455-8530 | Japan |
| GSK Investigational Site | Aichi | 455-85 | Japan |
| GSK Investigational Site | Aichi | 457-8511 | Japan |
| GSK Investigational Site | Aichi | 457-85 | Japan |
| GSK Investigational Site | Chiba | 260-8712 | Japan |
| GSK Investigational Site | Chiba | 260-87 | Japan |
| GSK Investigational Site | Chiba | 270-2296 | Japan |
| GSK Investigational Site | Chiba | 270-22 | Japan |
| GSK Investigational Site | Fukuoka | 810-8563 | Japan |
| GSK Investigational Site | Fukuoka | 810-85 | Japan |
| GSK Investigational Site | Fukuoka | 814-0180 | Japan |
| GSK Investigational Site | Fukuoka | 814-01 | Japan |
| GSK Investigational Site | Hyōgo | 665-0827 | Japan |
| GSK Investigational Site | Hyōgo | 665-08 | Japan |
| GSK Investigational Site | Hyōgo | 673-1462 | Japan |
| GSK Investigational Site | Hyōgo | 673-14 | Japan |
| GSK Investigational Site | Ibaraki | 312-0057 | Japan |
| GSK Investigational Site | Ibaraki | 312-00 | Japan |
| GSK Investigational Site | Kanagawa | 222-0036 | Japan |
| GSK Investigational Site | Kanagawa | 240-8521 | Japan |
| GSK Investigational Site | Kanagawa | 240-85 | Japan |
| GSK Investigational Site | Kanagawa | 245-8575 | Japan |
| GSK Investigational Site | Kanagawa | 245-85 | Japan |
| GSK Investigational Site | Nagasaki | 857-1195 | Japan |
| GSK Investigational Site | Nagasaki | 857-11 | Japan |
| GSK Investigational Site | Osaka | 543-8555 | Japan |
| GSK Investigational Site | Osaka | 543-85 | Japan |
| GSK Investigational Site | Osaka | 586-8521 | Japan |
| GSK Investigational Site | Wakayama | 649-2211 | Japan |
| GSK Investigational Site | Wakayama | 649-22 | Japan |
| FG001 |
| GSK3196165 45 mg |
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| FG002 | GSK3196165 90 mg | Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| FG003 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| BG001 | GSK3196165 45 mg | Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| BG002 | GSK3196165 90 mg | Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| BG003 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Concentration (Cmax) of GSK3196165 | Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71). Only those participants whose parameters could be determined were analyzed. PK Population included all GSK3196165-treated participants from whom PK samples were collected and analyzed. | PK Population. Only those participants with data available at the specified time points were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Nanogram per milliliter (ng/mL) | Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155 |
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| Primary | Area Under the Concentration-time Curve (AUC) From Time Zero to the Time of the Last Quantifiable Concentration (AUC [0-t]), AUC From Time Zero Extrapolated to Infinity (AUC [0-inf]), AUC Over the Dosing Interval (AUCtau) of GSK3196165 | Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71). NA indicates data was not available as geometric mean and/or 95 percent confidence interval could not be calculated when number of participant was not sufficient. | PK Population. Only those participants whose parameters could be determined were analyzed (represented by n=X in the category titles). | Posted | Geometric Mean | 95% Confidence Interval | Hour*Nanogram per milliliter (hr*ng/mL) | Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155 |
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| Primary | Time to Reach Cmax (Tmax) of GSK3196165 | Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by non-compartmental analysis using the concentration data after last dosing (Day 71). | PK Population. Only those participants whose parameters could be determined were analyzed. | Posted | Median | Full Range | Hour | Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155 |
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| Primary | Terminal Half-life (t1/2) of GSK3196165 | Blood samples were collected at pre-dose on Days 1, 8, 15, 29, 57 and 71; and at any time during visit on Days 3, 74, 85, 106, 127 and 155. PK parameters were calculated by standard non-compartmental analysis from the concentration data after last dosing (Day 71). NA indicates data was not available as 95 percent confidence interval could not be calculated when number of participant was not sufficient. | PK Population. Only those participants whose parameters could be determined were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Hour | Pre-dose on Days 1, 8, 15, 29, 57 and 71; anytime during visit on Days 3, 74, 85, 106, 127 and 155. |
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| Primary | Number of Participants With Any Adverse Event (AE), Serious AE (SAE) and Adverse Events of Special Interest (AESI) | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. AESI included serious infections including serious respiratory infections and tuberculosis and opportunistic infections, neutropenia (grade 3 or 4), respiratory events, pulmonary alveolar proteinosis, hypersensitivity reactions including anaphylaxis and injection site reactions. | Intent-to-Treat (ITT) Population. It included all participants who were randomized to treatment and who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to 22 weeks |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Vital sign measurements including SBP and DBP were measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. | ITT Population | Posted | Mean | Standard Deviation | Millimeter of mercury | Baseline and up to 22 weeks |
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| Secondary | Change From Baseline in Heart Rate (HR) | Vital sign measurements including HR was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. | ITT Population | Posted | Mean | Standard Deviation | Beats per minute | Baseline and up to 22 weeks |
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| Secondary | Change From Baseline in Body Temperature | Vital sign measurements including body temperature was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. | ITT Population | Posted | Mean | Standard Deviation | Celsius | Baseline and up to 22 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Respiratory Rate | Vital sign measurements including respiratory rate was measured after 5 minutes rest before each reading. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. | ITT Population | Posted | Mean | Standard Deviation | Breaths per minute | Baseline and up to 22 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings | 12-Lead ECGs were taken using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) intervals. Number of participants with any abnormal findings in ECG recordings were summarized as clinically significant and not clinically significant. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | ITT Population | Posted | Count of Participants | Participants | At Week 12 |
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| Secondary | Number of Participants With Emergent Hematology Results Relative to Normal Range | Blood samples were collected to evaluate hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), erythrocytes, reticulocytes, white blood cells (WBC), total neutrophils, eosinophils, basophils, monocytes, lymphocytes, platelet count, activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen, erythrocyte sedimentation rate (ESR). Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged (e.g. High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if they had values that changed 'To Low' and 'To High', so the percentages may not add to 100% in such instances. | ITT Population | Posted | Count of Participants | Participants | Up to 22 weeks |
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| Secondary | Number of Participants With Emergent Clinical Chemistry Results Relative to Normal Range | Blood samples were collected to evaluate Albumin, Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Total Bilirubin, Calcium, Cholesterol, Creatine Kinase, C-Reactive protein (CRP), Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, High Density Lipids (HDL), Potassium, Lactate Dehydrogenase, Low Density Lipids (LDL), Sodium, Phosphorus inorganic, Triglycerides, Total Protein and Urea. Participants were counted in the worst case category that their value changes to (low, normal or high), unless there is no change in their category. Participants whose lab value category was unchanged (e.g. High to High), or whose value became normal, are recorded in the 'To Normal or No Change' category. Participants were counted twice if they had values that changed 'To Low' and 'To High', so the percentages may not add to 100% in such instances. | ITT Population | Posted | Count of Participants | Participants | Up to 22 weeks |
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| Secondary | Number of Participants With Urinalysis Dipstick Findings | Urine samples were collected for analysis of presence of glucose and protein in urine by dipstick method. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein and glucose can be read as negative, Trace, 1+, 2+ and 3+, indicating proportional concentrations in the urine sample | ITT Population | Posted | Count of Participants | Participants | Up to 22 weeks |
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| Secondary | Number of Participants With Anti-GSK3196165 Antibody Test Results | Serum samples were collected and tested for presence of antibodies that bind to GSK3196165. The presence of treatment emergent anti-drug antibodies (ADA) were determined using a GSK3196165 bridging style ADA assay with a bio-analytically determined cut point determined during assay validation. Samples taken after dosing with GSK3196165 that have a value at or above the cut-point were considered treatment-emergent ADA-positive. These ADA positive samples were further evaluated in a confirmatory assay, and confirmed positive samples were further characterized by assessment of titer. Baseline was considered as the latest pre-dose assessment. Number of participants with post-Baseline negative or positive anti-GSK3196165 antibody test results were presented. | Immunogenicity Population. The immunogenicity Population included all participants in the ITT Population, who had at least one immunogenicity assessment. | Posted | Count of Participants | Participants | Weeks 2, 4, 12 and 22 |
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| Secondary | Change From Baseline in Disease Activity Score for 28 Different Joints C-reactive Protein (DAS28 [CRP]) at All Indicated Timepoints | DAS28 (CRP) is a measure of disease activity in rheumatoid arthritis obtained by examination of 28 joints for swelling and tenderness using CRP as a blood biomarker for inflammation. Its components include: Tender/Painful Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), CRP and Patient's Global Assessment of Arthritis. DAS28 (CRP) was calculated by 0.56 (square root of TJC28)+ 0.28 (square root of SJC28)+ 0.36 (natural logarithm [CRP+1])+ (0.014*patients global assessment)+0.96. Scores ranges from 0 to infinity, where higher scores indicates high disease activity. Scores higher than 5.1 indicates high disease activity and scores lower than 2.6 indicates remission. Baseline was considered as the latest pre-dose assessment. The change from Baseline is defined as the difference between the post-dose visit value and Baseline value. Adjusted mean and standard error of adjusted mean are presented using Mixed Model for Repeated Measures. | ITT Population | Posted | Mean | Standard Error | Scores on a scale | Baseline, up to Week 22 |
|
Serious adverse events (SAEs) and non-serious adverse events (non-serious AEs) were collected from the start of the study treatment up to Week 22.
SAEs and non-serious AEs were reported for the ITT Population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo weekly as a single subcutaneous (SC) injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then every other week (EOW) injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. | 0 | 4 | 1 | 4 | 3 | 4 |
| EG001 | GSK3196165 45 mg | Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG002 | GSK3196165 90 mg | Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. | 0 | 4 | 0 | 4 | 3 | 4 |
| EG003 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. | 0 | 4 | 0 | 4 | 2 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental caries | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Lip oedema | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Periodontal disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Carbon monoxide diffusing capacity decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2018 | Sep 17, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| OG002 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
|
|
Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
|
|
| OG002 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
|
|
| OG001 | GSK3196165 45 mg | Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| OG002 | GSK3196165 90 mg | Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| OG003 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
|
|
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
| OG003 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
|
|
| OG003 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
|
|
| OG003 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
|
|
| OG003 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
|
|
| OG002 |
| GSK3196165 90 mg |
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| OG003 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
|
|
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
| OG002 | GSK3196165 90 mg | Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| OG003 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
|
|
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
| OG002 | GSK3196165 90 mg | Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| OG003 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
|
|
Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
| OG003 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
|
|
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period.
| OG002 | GSK3196165 90 mg | Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| OG003 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
|
|
Participants received GSK3196165 45 milligram (mg) weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| OG002 | GSK3196165 90 mg | Participants received GSK3196165 90 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
| OG003 | GSK3196165 180 mg | Participants received GSK3196165 180 mg weekly as a single SC injection by an un-blinded administrator. There were 5 weekly injections (Days 1, 8, 15, 22 and 29), then EOW injections at Days 43, 57 and 71 (Weeks 6, 8 and 10 respectively). Participants also received a stable dose of MTX during the Treatment Period. |
|
|
|