To study the safety and effectiveness of Investigational product GSK versus placebo and tofacitinib in subjects who have moderate to severe Rheumatoid Arthritis who have limited response to methotrexate
Phase 3
Completed
- Conditions
- Rheumatoid arthritis, unspecified,
- Registration Number
- CTRI/2019/12/022313
- Lead Sponsor
- GlaxoSmithKline Research and Development Limited
- Brief Summary
This is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165, in combination with methotrexate (MTX), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to MTX. The study will consist of a screening phase of up to 6 weeks followed by a 52-week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with MTX. Following the treatment phase, there will be an 8-week safety follow up period for those participants who do not continue into the long term-extension study
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1500
Inclusion Criteria
- Has had RA for more than or equal to 6 months and was not diagnosed before 16 years of age B.
- Has active disease, as defined by having both: (1) C.
- More than or equal to 6/68 tender/painful joints, and D.
- More than or equal to 6/66 swollen joints E.
- Has at least 1 bone erosion present on hand/wrist or foot radiographs F.
- Has had an inadequate response to MTX, despite currently taking MTX 15-25 mg/week (2) oral or injected 1.
- f surgical treatment of a joint has been performed, that joint cannot be counted in the TJC or SJC.
- A lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to MTX or per local requirement.
Exclusion Criteria
- Has had any active and/or recurrent infection excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections.
- Has received prior treatment with an antagonist of GM-CSF or its receptor or targeted synthetic DMARDs (either experimental or approved, including Janus kinase (JAK) inhibitors Has received prior treatment with a biologic DMARD that was discontinued due to an inadequate response.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants achieving 20% improvement in American College of Rheumatology Criteria (ACR20) at Week 12: superiority comparison with placebo Proportion of participants achieving 20% improvement in American College of Rheumatology Criteria (ACR20) at Week 12: superiority comparison with placebo | Time point: Week 12
- Secondary Outcome Measures
Name Time Method Proportion of participants achieving Clinical disease activity index (CDAI) total score less than or equals to 10 [CDAI Low disease activity (LDA)] at Week 12 [ Time Frame: Week 12 ] CDAI for rheumatoid arthritis determines composite score determining disease severity using only clinical data. It is calculated by sum of 4 following parameters Tender joint and Swollen joint count (28 each), Patients and Physicians global assessment of arthritis both transformed to a 0 to 10 scale. Total score approximate range 0 to 76, higher score indicating more severe disease. Proportion of participants achieving CDAI total score less than or equal to10 at Week 12 will be summarized Change from Baseline in health assessment questionnaire - disability index (HAQ-DI) at Week 12 [ Time Frame: Week 12 ] HAQ-DI: 20-questions which assesses the degree of difficulty a participant has in accomplishing tasks in eight functional areas: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Proportion of participants achieving CDAI total score less than or equal to10 (CDAI LDA) at Week 52 [ Time Frame: Week 52 ] CDAI: a composite score to determine disease severity using only clinical data: Tender joint count (28), Swollen joint count (28), Patients global assessment of arthritis and Physicians global assessment of arthritis. Proportion of participants achieving CDAI total score less than or equal to10 at Week 52 will be summarized. Proportion of participants achieving ACR20/50/70 at Week 12 [ Time Frame: Week 12 ] ACR20/50/70 is calculated as a 20%/50%/70% improvement from baseline in both tender and swollen joint counts and a 20%/50%/70% improvement in 3 of the following 5 measures: patient global assessment of disease activity, physician global assessment of disease activity, pain VAS, HAQ-DI and an acute-phase reactant (hsCRP or ESR). Proportion of participants achieving ACR20/50/70 at Week 12 will be summarized Proportion of participants achieving ACR20 at Week 12: non-inferiority comparison with tofacitinib [ Time Frame: Week 12 ] ACR20 is calculated as a 20% improvement from baseline in both tender and swollen joint counts and a 20% improvement in 3 of the following 5 measures: patient and physician global assessment of disease activity, pain VAS, HAQ-DI and an acute-phase reactant (high sensitivity C-reactive protein [hsCRP] or erythrocyte sedimentation rate [ESR]). Proportion of participants achieving ACR20 at Week 12 will be summarized. Proportion of participants achieving CDAI total score less than or equal to (CDAI LDA) at Week 24 [ Time Frame: Week 24 ] CDAI a composite score to determine disease severity using only clinical data: Tender joint count (28), Swollen joint count (28), Patients global assessment of arthritis and Physicians global assessment of arthritis. Proportion of participants achieving CDAI total score less than or equal to10 at Week 24 will be summarized. Proportion of participants achieving CDAI total score less than or equal to 2.8 (CDAI Remission) at Week 52 [ Time Frame: Week 52 ] CDAI: a composite score to determine disease severity using only clinical data: Tender joint count (28), Swollen joint count (28), Patients global assessment of arthritis and Physicians global assessment of arthritis. Proportion of participants achieving CDAI total score less than or equal to 2.8 at Week 52 will be summarized. Proportion of participants achieving DAS28 Erythrocyte Sedimentation Rate (ESR) less than or equal to 3.2 (DAS28-ESR LDA) at Week 12 [ Time Frame: Week 12 ] DAS28-ESR is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), ESR (mm/hour) and patients global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28 ESR less than or equal to 3.2 at Week 12 will be summarize Proportion of participants achieving CDAI total score less than or equal to 2.8 (CDAI Remission) at Week 12 [ Time Frame: Week 12 ] CDAI: a composite score to determine disease severity using only clinical data: Tender joint count (28), Swollen joint count (28), Patients global assessment of arthritis and Physicians global assessment of arthritis. Proportion of participants achieving CDAI total score less than or equal to 2.8 at Week 12 will be summarized Proportion of participants achieving ACR20/50/70 at Week 24 [ Time Frame: Week 24 ] ACR20/50/70 is calculated as a 20%/50%/70% improvement from baseline in both tender and swollen joint counts and a 20%/50%/70% improvement in 3 of the following 5 measures: patient global assessment of disease activity, physician global assessment of disease activity, pain VAS, HAQ-DI and an acute-phase reactant (hsCRP or ESR). Proportion of participants achieving ACR20/50/70 at Week 24 will be summarized Proportion of participants achieving ACR20/50/70 at Week 52 [ Time Frame: Week 52 ] ACR20/50/70 is calculated as a 20%/50%/70% improvement from baseline in both tender and swollen joint counts and a 20%/50%/70% improvement in 3 of the following 5 measures: patient global assessment of disease activity, physician global assessment of disease activity, pain VAS, HAQ-DI and an acute-phase reactant (hsCRP or ESR). Proportion of participants achieving ACR20/50/70 at Week 52 will be summarized Proportion of participants achieving Disease Activity Score using 28 joint count and C-Reactive Protein (DAS28-CRP) less than or equal to 3.2 (DAS28-CRP LDA) at Week 12 [ Time Frame: Week 12 ] DAS28-CRP is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), hsCRP (mg/L) and patients global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28-CRP less than or equal to 3.2 at Week 12 will be summarized. Proportion of participants achieving CDAI total score less than or equal to 2.8 (CDAI Remission) at Week 24 [ Time Frame: Week 24 ] Proportion of participants achieving DAS28-CRP less than or equal to 3.2 (DAS28-CRP LDA) at Week 24 [ Time Frame: Week 24 ] DAS28-CRP is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), hsCRP (mg/L) and patients global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28-CRP less than or equal to 3.2 at Week 24 will be summarized. Proportion of participants achieving DAS28 ESR less than 2.6 (DAS28-ESR Remission) at Week 12 [ Time Frame: Week 12 ] DAS28-ESR is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), ESR (mm/hour) and patients global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28-ESR less than 2.6 at Week 12 will be summarized. Proportion of participants achieving a good/moderate EULAR response at Week 12 [ Time Frame: Week 12 ] Proportion of participants achieving a good/moderate EULAR response at Week 12 will be summarized. Proportion of participants achieving a good/moderate EULAR response at Week 24 [ Time Frame: Week 24 ] Proportion of participants achieving a good/moderate EULAR response at Week 24 will be summarized. Proportion of participants achieving a good/moderate EULAR response at Week 52 [ Time Frame: Week 52 ] Proportion of participants achieving a good/moderate EULAR response at Week 52 will be summarized. Proportion of participants achieving ACR/EULAR remission at Week 12 [ Time Frame: Week 12 ] Proportion of participants achieving ACR/EULAR remission at Week 12 will be summarized. Proportion of participants achieving DAS28-ESR less than or equal to 3.2 (DAS28-ESR LDA) at Week 24 [ Time Frame: Week 24 ] DAS28-ESR is a derived measurement with differential weighting given to each component: tender joint count and swollen joint count (28-joint count), ESR (mm/hour) and patients global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, higher score indicating more disease activity. Proportion of participants achieving DAS28 ESR less than or equal to 3.2 at Week 24 will be summarized. Proportion of participants achieving DAS28-CRP less than or equal to 3.2 (DAS28-CRP LDA) at Week 52 [ Time Frame: Week 52 ] DAS28-CRP is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), hsCRP (mg/L) and patients global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28-CRP less than or equal to 3.2 at Week 52 will be summarized. Proportion of participants achieving DAS28-CRP less than 2.6 (DAS28-CRP Remission) at Week 12 [ Time Frame: Week 12 ] DAS28-CRP is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), hsCRP (mg/L) and patients global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28-CRP less than 2.6 at Week 12 will be summarized Proportion of participants achieving ACR/EULAR remission at Week 24 [ Time Frame: Week 24 ] Proportion of participants achieving ACR/EULAR remission at Week 24 will be summarized. Proportion of participants achieving ACR/EULAR remission at Week 52 [ Time Frame: Week 52 ] Proportion of participants achieving ACR/EULAR remission at Week 52 will be summarized. Proportion of participants achieving no radiographic progression at Week 12 [ Time Frame: Week 12 ] Van der Heijde mTSS is a scoring method which utilized for scoring radiographs of hands and feet in rheumatoid arthritis. No radiographic progression defined as a change from baseline in van der Heijde modified total sharp score (mTSS) score of more than or equal to 0.5. Proportion of participants achieving no radiographic progression at Week 12 will be summarized. Proportion of participants achieving no radiographic progression at Week 24 [ Time Frame: Week 24 ] Van der Heijde mTSS is a scoring method which utilized for scoring radiographs of hands and feet in rheumatoid arthritis. No radiographic progression defined as a change from baseline in van der Heijde modified total sharp score (mTSS) score of more than or equal to 0.5. Proportion of participants achieving no radiographic progression at Week 24 will be summarized. Proportion of participants achieving DAS28-ESR less than or equal to 3.2 (DAS28-ESR LDA) at Week 52 [ Time Frame: Week 52 ] DAS28-ESR is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), ESR (mm/hour) and patients global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28 ESR less than or equal to 3.2 at Week 52 will be summarized Proportion of participants achieving DAS28-CRP less than 2.6 (DAS28-CRP Remission) at Week 24 [ Time Frame: Week 24 ] DAS28-CRP is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), hsCRP (mg/L) and patients global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28-CRP less than 2.6 at Week 24 will be summarized. Proportion of participants achieving DAS28 ESR less than 2.6 (DAS28-ESR Remission) at Week 24 [ Time Frame: Week 24 ] DAS28-ESR is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), ESR (mm/hour) and patients global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28-ESR less than 2.6 at Week 24 will be summarized. Proportion of participants achieving DAS28-CRP less than 2.6 (DAS28-CRP Remission) at Week 52 [ Time Frame: Week 52 ] DAS28-CRP is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), hsCRP (mg/L) and patients global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28-CRP less than 2.6 at Week 52 will be summarized. Proportion of participants achieving DAS28 ESR less than 2.6 (DAS28-ESR Remission) at Week 52 [ Time Frame: Week 52 ] DAS28-ESR is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), ESR (mm/hour) and patients global assessment of disease activity (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicating more severe disease. Proportion of participants achieving DAS28-ESR less than 2.6 at Week 52 will be summarized Proportion of participants achieving no radiographic progression at Week 52 [ Time Frame: Week 52 ] Van der Heijde mTSS is a scoring method which utilized for scoring radiographs of hands and feet in rheumatoid arthritis. No radiographic progression defined as a change from baseline in van der Heijde modified total sharp score (mTSS) score of more than or equal to 0.5. Proportion of participants achieving no radiographic progression at Week 52 will be summarized. Change from Baseline in CDAI total score at Week 12 [ Time Frame: Week 12 ] CDAI: a composite score to determine disease severity using only clinical data: Tender joint count (28), Swollen joint count (28), Patients global assessment of arthritis and Physicians global assessment of arthritis. Change from Baseline in CDAI total score at Week 24 [ Time Frame: Week 24 ] CDAI: a composite score to determine disease severity using only clinical data: Tender joint count (28), Swollen joint count (28), Patients global assessment of arthritis and Physicians global assessment of arthritis. Change from Baseline in CDAI total score at Week 52 [ Time Frame: Week 52 ] CDAI: a composite score to determine disease severity using only clinical data: Tender joint count (28), Swollen joint count (28), Patients global assessment of arthritis and Physicians global assessment of arthritis. Change from Baseline in DAS28-CRP/DAS28-ESR at Week 12 [ Time Frame: Week 12 ] DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using tender joint count and swollen joint count (28-joint count), hsCRP (mg/L) / ESR (mm/hour) and patients global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, higher score indicating more disease activity Change from Baseline in DAS28-CRP/DAS28-ESR at Week 24 [ Time Frame: Week 24 ] DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using tender joint count and swollen joint count (28-joint count), hsCRP (mg/L) / ESR (mm/hour) and patients global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, higher score indicating more disease activity Change from Baseline in DAS28-CRP/DAS28-ESR at Week 52 [ Time Frame: Week 52 ] DAS28-CRP and DAS28-ESR are measure of RA disease activity calculated using tender joint count and swollen joint count (28-joint count), hsCRP (mg/L) / ESR (mm/hour) and patients global assessment of disease activity (PtGA) transformed to a 0-10 scale. Total score approximate range 0-9.4, higher score indicating more disease activity. Change from Baseline in Van der Heijde mTSS at Week 12 [ Time Frame: Week 12 ] Van der Heijde mTSS is a scoring method which utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes, in each hand, 16 areas of erosions, and 15 areas for joint space narrowing, and in each foot, 6 areas for erosions and 6 areas joint space narrowing. Change from Baseline in Van der Heijde mTSS at Week 24 [ Time Frame: Week 24 ] Van der Heijde mTSS is a scoring method which utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes, in each hand, 16 areas of erosions, and 15 areas for joint space narrowing, and in each foot, 6 areas for erosions and 6 areas joint space narrowing. Change from Baseline in Van der Heijde mTSS at Week 52 [ Time Frame: Week 52 ] Van der Heijde mTSS is a scoring method which utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes, in each hand, 16 areas of erosions, and 15 areas for joint space narrowing, and in each foot, 6 areas for erosions and 6 areas joint space narrowing. Change from Baseline in HAQ-DI at Week 24 [ Time Frame: Week 24 ] HAQ-DI: 20-questions which assesses the degree of difficulty a participant has in accomplishing tasks in eight functional areas: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Change from Baseline in HAQ-DI at Week 52 [ Time Frame: Week 52 ] HAQ-DI: 20-questions which assesses the degree of difficulty a participant has in accomplishing tasks in eight functional areas: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Change from Baseline in Arthritis pain Visual analogue scale (VAS) at Week 12 [ Time Frame: Week 12 ] Participants assessment of the severity of their arthritis pain over the past week, using a 100 unit VAS, with anchors "0" (no pain) and "100" (most severe pain). Change from Baseline in Arthritis pain VAS at Week 24 [ Time Frame: Week 24 ] Participants assessment of the severity of their arthritis pain over the past week, using a 100 unit VAS, with anchors "0" (no pain) and "100" (most severe pain). Change from Baseline in Arthritis pain VAS at Week 52 [ Time Frame: Week 52 ] Participants assessment of the severity of their arthritis pain over the past week, using a 100 unit VAS, with anchors "0" (no pain) and "100" (most severe pain). Change from Baseline in Short form (36) (SF-36) physical component scores at Week 12 [ Time Frame: Week 12 ] SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Change from Baseline in SF-36 mental component scores at Week 12 [ Time Frame: Week 12 ] SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Change from Baseline in SF-36 domain scores at Week 12 [ Time Frame: Week 12 ] SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Change from Baseline in SF-36 physical component scores at Week 24 [ Time Frame: Week 24 ] SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Change from Baseline in SF-36 mental component scores at Week 24 [ Time Frame: Week 24 ] SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Change from Baseline in SF-36 domain scores at Week 24 [ Time Frame: Week 24 ] SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Change from Baseline in SF-36 physical component scores at Week 52 [ Time Frame: Week 52 ] SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Change from Baseline in SF-36 mental component scores at Week 52 [ Time Frame: Week 52 ] Change from Baseline in SF-36 domain scores at Week 52 [ Time Frame: Week 52 ] SF-36 is a generic health survey that contains 36 questions covering eight domains of health: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue and general health perceptions. SF-36 scores each item on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Change from Baseline in Functional assessment of chronic illness therapy (FACIT)-Fatigue at Week 12 [ Time Frame: Week 12 ] FACIT-fatigue is a validated patient-reported measure developed originally to assess fatigue in individuals with cancer and has subsequently been used and validated in numerous chronic conditions, including RA. Change from Baseline in FACIT-Fatigue at Week 24 [ Time Frame: Week 24 ] FACIT-fatigue is a validated patient-reported measure developed originally to assess fatigue in individuals with cancer and has subsequently been used and validated in numerous chronic conditions, including RA. Change from Baseline in FACIT-Fatigue at Week 52 [ Time Frame: Week 52 ] FACIT-fatigue is a validated patient-reported measure developed originally to assess fatigue in individuals with cancer and has subsequently been used and validated in numerous chronic conditions, including RA. Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI) [ Time Frame: Up to Week 59 ] AE: any untoward medical occurrence in clinical study participant, temporally associated with use of study intervention, whether or not considered related to study intervention. SAEs are any untoward medical occurrence that, at any dose: results in death, cause life threatening events requiring inpatient hospitalization or prolongation of existing hospitalization, resulting persistent disability or incapacity and birth defect or congenital anomaly. Protocol defined AESIs will be included. Change from Baseline in white blood cell count [ Time Frame: Baseline and up to Week 59 ] Blood samples will be collected for the assessment of white blood cell count. Change from Baseline in hematology parameter of platelet count, neutrophils, lymphocytes [ Time Frame: Baseline and up to Week 59 ] Blood samples will be collected for the assessment of hematology parameters. Change from Baseline in hematology parameter of haemoglobin [ Time Frame: Baseline and up to Week 59 ] Blood samples will be collected for the assessment of hematology parameters. Change from Baseline in clinical chemistry parameter of aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), γ-Glutamyl transpeptidase (GGT) [ Time Frame: Baseline and up to Week 59 ] Blood samples will be collected for the assessment of clinical chemistry parameters. Change from Baseline in clinical chemistry parameter of total bilirubin [ Time Frame: Baseline and up to Week 59 ] Blood samples will be collected for the assessment of clinical chemistry parameters. Change from Baseline in clinical chemistry parameter of albumin [ Time Frame: Baseline and up to Week 59 ] Blood samples will be collected for the assessment of clinical chemistry parameters. Change from Baseline in fasting lipid profile parameter of total cholesterol [ Time Frame: Baseline and up to Week 59 ] Blood samples will be collected for the assessment of fasting lipid profile parameters. Change from Baseline in fasting lipid profile parameter of low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol [ Time Frame: Baseline and up to Week 59 ] Blood samples will be collected for the assessment of fasting lipid profile parameters. Change from Baseline in fasting lipid profile parameter of triglycerides [ Time Frame: Baseline and up to Week 59 ] Blood samples will be collected for the assessment of fasting lipid profile parameters. Proportion of participants with National Cancer Institute (NCI) CTCAE more than or equal to Grade 3 hematological/clinical chemistry abnormalities [ Time Frame: Up to Week 59 ] Proportion of participants with NCI-CTCAE more than or equal to Grade 3 hematological/clinical chemistry abnormalities will be summarized. Concentrations of Granulocyte-macrophage colony stimulating factor (GM-CSF) autoantibody [ Time Frame: Up to Week 59 ] Concentrations of GM-CSF autoantibodies will be determined. Number of participants with anti-GSK3196165 antibodies [ Time Frame: Up to Week 59 ] Presence of anti-GSK3196165 antibodies will be determined.
Trial Locations
- Locations (26)
7 Orange Hospital
🇮🇳Pune, MAHARASHTRA, India
Avron Multispecialty Hospitals
🇮🇳Ahmadabad, GUJARAT, India
B.J. Medical Collage & Civil Hospital
🇮🇳Ahmadabad, GUJARAT, India
Chopda Medicare & Research Centre Pvt. Ltd;
🇮🇳Nashik, MAHARASHTRA, India
Deenanath Mangeshkar Hospital & Research Centre
🇮🇳Pune, MAHARASHTRA, India
Dept of Orthopaedics, Nehru Hospital, PGIMER
🇮🇳Chandigarh, CHANDIGARH, India
Government Medical College and SSG Hospital Baroda
🇮🇳Vadodara, GUJARAT, India
Grant Medical Foundation Ruby Hall Clinic
🇮🇳Pune, MAHARASHTRA, India
IPGME&R / SSKM Hospital
🇮🇳Kolkata, WEST BENGAL, India
JSS Medical College and Hospital
🇮🇳Mysore, KARNATAKA, India
Scroll for more (16 remaining)7 Orange Hospital🇮🇳Pune, MAHARASHTRA, IndiaDr Girish BhatiaPrincipal investigator7350055754drgirishbhatia@gmail.com