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Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA) (contRAst X)

Primary Purpose

Arthritis, Rheumatoid

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Otilimab (GSK3196165)

csDMARD(s)

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Rheumatoid arthritis, GSK3196165, Otilimab, Long-term safety, Long-term efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Participants receiving GSK3196165 in qualifying study

Participants receiving comparator in qualifying study

Arm Description

Participants receiving GSK3196165 in their qualifying study will continue to receive GSK3196165 at the same dose level (90 mg or 150 mg weekly) in this study.

Participants receiving a comparator (e.g. tofacitinib or sarilumab) in their qualifying study will be re-randomized to receive either GSK3196165 90 mg or 150 mg weekly in this study.

Outcomes

Primary Outcome Measures

Incidence of adverse events (AEs) , serious adverse events (SAEs) and adverse events of special interests (AESI)

An AE is 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. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or other important medical event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before. Protocol defined AESIs will be included.

Change from Baseline in platelet count, neutrophils lymphocytes, monocytes, eosinophils, and basophils (Giga cells per liter [giga cells/L])

Blood samples will be collected for the assessment of hematology parameters.

Change from Baseline in hemoglobin level (Grams per liter)

Blood samples will be collected for the assessment of hemoglobin.

Change from Baseline in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol, triglycerides and other lipoprotein tests as needed (Millimoles per Liter)

Blood samples will be collected for the assessment of clinical chemistry parameters

Change from Baseline in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP) gamma-glutamyl transferase (GGT) levels, lactate dehydrogenase (LDH), and creatine phosphokinase (CPK) (International units per liter)

Blood samples will be collected for the assessment of clinical chemistry parameters.

Change from Baseline in total and direct bilirubin (Micromoles per liter)

Blood samples will be collected for the assessment of clinical chemistry parameters

Change from Baseline in albumin level (Grams per Liter)

Blood samples will be collected for the assessment of clinical chemistry parameters

Proportion of participants with National Cancer Institute-Common terminology criteria for adverse events (NCI-CTCAE) more than or equal to (>=)Grade 3 hematological/clinical chemistry abnormalities

Hematological/clinical chemistry abnormalities will be evaluated using NCI-CTCAE grading.

Secondary Outcome Measures

Proportion of participants achieving Clinical disease activity index (CDAI) total score less than or equal to (<=10) (CDAI Low disease activity [LDA]) at Week 24

CDAI for RA is a clinical composite score to determine disease severity using only clinical data. It will be calculated by the simple sum of the 4 following parameters: Tender joint count (28), Swollen joint count (28), Patient's global assessment of arthritis (PtGA) and Physician's global assessment of arthritis (PhGA) both transformed to a 0-10 scale. Total score approximate range 0-76, higher score indicates more severe disease. Proportion of participants achieving CDAI total score <=10 will be summarized.

Proportion of participants achieving CDAI total score <=10 (CDAI LDA) at Week 48 and every 48 weeks thereafter

CDAI for RA is a clinical composite score to determine disease severity using only clinical data. It will be calculated by the simple sum of the 4 following parameters: Tender joint count (28), Swollen joint count (28), PtGA and PhGA both transformed to a 0-10 scale. Total score approximate range 0-76, higher score indicates more severe disease. Proportion of participants achieving CDAI total score <=10 will be summarized.

Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 24

Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 48 and every 48 weeks thereafter

Proportion of participants achieving Disease Activity Score using 28 joint count (DAS28)-C-reactive protein (CRP) <2.6 (DAS28-CRP Remission) at Week 24

DAS28-CRP is a measure of RA disease activity calculated using the number of tender joints and swollen joints (28 joint count), high sensitivity (hs)CRP (mg/L) and PtGA (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicates more severe disease. Proportion of participants achieving DAS28-CRP <2.6 will be summarized.

Proportion of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 48 and every 48 weeks thereafter

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 PtGA (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicates more severe disease. Proportion of participants achieving DAS28-CRP <2.6 will be summarized.

Proportion of participants with DAS28- Erythrocyte sedimentation rate (ESR)<2.6 (DAS28-ESR Remission) at 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 (millimeters per hour [mm/hour]) and PtGA (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicates more severe disease. Proportion of participants achieving DAS28-ESR <2.6 will be summarized.

Proportion of participants with DAS28-ESR<2.6 (DAS28-ESR Remission) at Week 48 and every 48 weeks thereafter

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 PtGA (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicates more severe disease. Proportion of participants achieving DAS28-ESR <2.6 will be summarized.

Proportion of participants achieving American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) remission (Boolean and simplified disease activity index [SDAI]) at Week 24

ACR/EULAR remission in RA clinical trials will be assessed using both Boolean and SDAI definitions. For the Boolean definition, this includes: Tender/Painful Joint Count (28), Swollen Joint Count (28), hsCRP, PtGA For the SDAI definition, this includes: Tender/Painful Joint Count (28), Swollen Joint Count (28), hsCRP, PtGA, and PhGA.

Proportion of participants achieving ACR and EULAR remission (Boolean and SDAI) at Week 48 and every 48 weeks thereafter

Absolute values of CDAI total score at Week 24

CDAI is a clinical composite score to determine disease severity using only clinical data. It will be calculated by the simple sum of the 4 following parameters: Tender joint count (28), Swollen joint count (28), PtGA and PhGA both transformed to a 0-10 scale. Total score approximate range 0-76, higher score indicates severe disease.

Absolute values of CDAI total score at Week 48 and every 48 weeks thereafter

Absolute values of DAS28-CRP at Week 24

DAS28-CRP will be calculated using number of tender joints and swollen joints (28 joint count), hsCRP (mg/L) and PtGA (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicates severe disease.

Absolute values of DAS28-CRP at Week 48 and every 48 weeks thereafter

Absolute values of DAS28-ESR at Week 24

DAS28-ESR will be calculated using number of tender joints and swollen joints (28 joint count), ESR (mm/hour) and PtGA (transformed to a 0-10 scale). Total score approximate range 0-9.4, higher score indicates severe disease.

Absolute values of DAS28-ESR at Week 48 and every 48 weeks thereafter

Absolute values of van der Heijde modified total sharp score (mTSS) (in participants from 201790 [NCT03980483] and 201791 [NCT03970837] only) at Week 24

Van der Heijde mTSS is a measure of the level of joint damage. Radiographs of the hands and feet will be obtained. Joints will be scored for erosions on a scale of 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale of 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores will be added to obtain the mTSS (range = 0 [normal] to 398 [maximal disease]).

Absolute values of van der Heijde mTSS (in participants from 201790 [NCT03980483] and 201791 [NCT03970837] only) at Week 48 and every 48 weeks thereafter

Absolute values of Health assessment questionnaire-disability index (HAQ-DI) at Week 24

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 (2 items), Hygiene (3 items), Arising (2 items), Reach (2 items), Eating (3 items), Grip (3 items), Walking (2 items), Common Daily Activities (3 items). The questions assess usual abilities ranging from 0 "without any difficulty" to 3 "unable to do." A lower HAQ-DI score indicates better quality of life.

Absolute values of HAQ-DI at Week 48 and every 48 weeks thereafter

Absolute values of Arthritis pain visual analogue scale (VAS) at Week 24

Participant's 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).

Absolute values of Arthritis pain VAS at Week 48 and every 48 weeks thereafter

Participant's 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).

Absolute values of the physical component scores of short form (SF)-36 at 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. Scores on each item will be summed and averaged (range = 0 [poorer health] to 100 [better health]).

Absolute values of the mental component scores of SF-36 at Week 24

Absolute values of domain scores of SF-36 at Week 24

Absolute values of the physical component scores of SF-36 at Week 48 and every 48 weeks thereafter

Absolute values of the mental component scores of SF-36 at Week 48 and every 48 weeks thereafter

Absolute values of domain scores of SF-36 at Week 48 and every 48 weeks thereafter

Absolute values of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 24

FACIT-fatigue questionnaire is a validated participant-reported measure developed originally to assess fatigue in individuals with cancer and has been subsequently used and validated in numerous chronic conditions, including RA.

Absolute values of FACIT-Fatigue at Week 48 and every 48 weeks thereafter

Proportion of participants with anti-GSK3196165 antibodies

Presence of anti-GSK3196165 antibodies will be determined.

Full Information

NCT ID

NCT04333147

First Posted

March 27, 2020

Last Updated

October 6, 2023

Sponsor

GlaxoSmithKline

Collaborators

Iqvia Pty Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04333147

Brief Title

Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

Acronym

contRAst X

Official Title

A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Terminated

Why Stopped

Study is early terminated due to Limited efficacy demonstrated in the contRAst program does not support a suitable benefit/risk profile for otilimab as a potential treatment for RA. GSK has decided not to progress with regulatory submissions.

Study Start Date

May 12, 2020 (Actual)

Primary Completion Date

February 24, 2023 (Actual)

Study Completion Date

February 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

Collaborators

Iqvia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

Keywords

Rheumatoid arthritis, GSK3196165, Otilimab, Long-term safety, Long-term efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Participants who received GSK3196165 in their qualifying study will continue in this study on the same dose. Participants who received a comparator (tofacitinib or sarilumab) in their qualifying study will be centrally randomized using interactive response technology (IRT) in a ratio of 1:1 to either GSK3196165 90 mg or 150 mg.

Masking

ParticipantInvestigator

Masking Description

This is a parallel group treatment study with two arms that are initially participant and investigator blinded. A participant's treatment allocation will remain blinded at least until their qualifying study has been reported.

Allocation

Randomized

Enrollment

2916 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Participants receiving GSK3196165 in qualifying study

Arm Type

Experimental

Arm Description

Participants receiving GSK3196165 in their qualifying study will continue to receive GSK3196165 at the same dose level (90 mg or 150 mg weekly) in this study.

Arm Title

Participants receiving comparator in qualifying study

Arm Type

Experimental

Arm Description

Participants receiving a comparator (e.g. tofacitinib or sarilumab) in their qualifying study will be re-randomized to receive either GSK3196165 90 mg or 150 mg weekly in this study.

Intervention Type

Biological

Intervention Name(s)

Otilimab (GSK3196165)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

csDMARD(s)

Intervention Description

Stable dose of csDMARD(s) as standard of care (SoC).

Primary Outcome Measure Information:

Title

Incidence of adverse events (AEs) , serious adverse events (SAEs) and adverse events of special interests (AESI)

Description

Time Frame

Up to 4 years

Title

Change from Baseline in platelet count, neutrophils lymphocytes, monocytes, eosinophils, and basophils (Giga cells per liter [giga cells/L])

Description

Blood samples will be collected for the assessment of hematology parameters.

Time Frame

Baseline (Day 1) and up to 4 years

Title

Change from Baseline in hemoglobin level (Grams per liter)

Description

Blood samples will be collected for the assessment of hemoglobin.

Time Frame

Baseline (Day 1) and up to 4 years

Title

Change from Baseline in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol, triglycerides and other lipoprotein tests as needed (Millimoles per Liter)

Description

Blood samples will be collected for the assessment of clinical chemistry parameters

Time Frame

Baseline (Day 1) and up to 4 years

Title

Description

Blood samples will be collected for the assessment of clinical chemistry parameters.

Time Frame

Baseline (Day 1) and up to 4 years

Title

Change from Baseline in total and direct bilirubin (Micromoles per liter)

Description

Blood samples will be collected for the assessment of clinical chemistry parameters

Time Frame

Baseline (Day 1) and up to 4 years

Title

Change from Baseline in albumin level (Grams per Liter)

Description

Blood samples will be collected for the assessment of clinical chemistry parameters

Time Frame

Baseline (Day 1) and up to 4 years

Title

Proportion of participants with National Cancer Institute-Common terminology criteria for adverse events (NCI-CTCAE) more than or equal to (>=)Grade 3 hematological/clinical chemistry abnormalities

Description

Hematological/clinical chemistry abnormalities will be evaluated using NCI-CTCAE grading.

Time Frame

Up to 4 years

Secondary Outcome Measure Information:

Title

Proportion of participants achieving Clinical disease activity index (CDAI) total score less than or equal to (<=10) (CDAI Low disease activity [LDA]) at Week 24

Description

Time Frame

Week 24

Title

Proportion of participants achieving CDAI total score <=10 (CDAI LDA) at Week 48 and every 48 weeks thereafter

Description

CDAI for RA is a clinical composite score to determine disease severity using only clinical data. It will be calculated by the simple sum of the 4 following parameters: Tender joint count (28), Swollen joint count (28), PtGA and PhGA both transformed to a 0-10 scale. Total score approximate range 0-76, higher score indicates more severe disease. Proportion of participants achieving CDAI total score <=10 will be summarized.

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 24

Description

Time Frame

Week 24

Title

Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 48 and every 48 weeks thereafter

Description

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Proportion of participants achieving Disease Activity Score using 28 joint count (DAS28)-C-reactive protein (CRP) <2.6 (DAS28-CRP Remission) at Week 24

Description

Time Frame

Week 24

Title

Proportion of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 48 and every 48 weeks thereafter

Description

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Proportion of participants with DAS28- Erythrocyte sedimentation rate (ESR)<2.6 (DAS28-ESR Remission) at Week 24

Description

Time Frame

Week 24

Title

Proportion of participants with DAS28-ESR<2.6 (DAS28-ESR Remission) at Week 48 and every 48 weeks thereafter

Description

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Proportion of participants achieving American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) remission (Boolean and simplified disease activity index [SDAI]) at Week 24

Description

Time Frame

Week 24

Title

Proportion of participants achieving ACR and EULAR remission (Boolean and SDAI) at Week 48 and every 48 weeks thereafter

Description

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Absolute values of CDAI total score at Week 24

Description

Time Frame

Week 24

Title

Absolute values of CDAI total score at Week 48 and every 48 weeks thereafter

Description

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Absolute values of DAS28-CRP at Week 24

Description

Time Frame

Week 24

Title

Absolute values of DAS28-CRP at Week 48 and every 48 weeks thereafter

Description

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Absolute values of DAS28-ESR at Week 24

Description

Time Frame

Week 24

Title

Absolute values of DAS28-ESR at Week 48 and every 48 weeks thereafter

Description

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Absolute values of van der Heijde modified total sharp score (mTSS) (in participants from 201790 [NCT03980483] and 201791 [NCT03970837] only) at Week 24

Description

Time Frame

Week 24

Title

Absolute values of van der Heijde mTSS (in participants from 201790 [NCT03980483] and 201791 [NCT03970837] only) at Week 48 and every 48 weeks thereafter

Description

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Absolute values of Health assessment questionnaire-disability index (HAQ-DI) at Week 24

Description

Time Frame

Week 24

Title

Absolute values of HAQ-DI at Week 48 and every 48 weeks thereafter

Description

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Absolute values of Arthritis pain visual analogue scale (VAS) at Week 24

Description

Participant's 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).

Time Frame

Week 24

Title

Absolute values of Arthritis pain VAS at Week 48 and every 48 weeks thereafter

Description

Participant's 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).

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Absolute values of the physical component scores of short form (SF)-36 at Week 24

Description

Time Frame

Week 24

Title

Absolute values of the mental component scores of SF-36 at Week 24

Description

Time Frame

Week 24

Title

Absolute values of domain scores of SF-36 at Week 24

Description

Time Frame

Week 24

Title

Absolute values of the physical component scores of SF-36 at Week 48 and every 48 weeks thereafter

Description

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Absolute values of the mental component scores of SF-36 at Week 48 and every 48 weeks thereafter

Description

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Absolute values of domain scores of SF-36 at Week 48 and every 48 weeks thereafter

Description

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Absolute values of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 24

Description

Time Frame

Week 24

Title

Absolute values of FACIT-Fatigue at Week 48 and every 48 weeks thereafter

Description

Time Frame

Week 48 and every 48 weeks thereafter, up to 4 years

Title

Proportion of participants with anti-GSK3196165 antibodies

Description

Presence of anti-GSK3196165 antibodies will be determined.

Time Frame

Up to 4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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). 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Anniston

State/Province

Alabama

ZIP/Postal Code

36207

Country

United States

Facility Name

GSK Investigational Site

City

Flagstaff

State/Province

Arizona

ZIP/Postal Code

86001

Country

United States

Facility Name

GSK Investigational Site

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85297

Country

United States

Facility Name

GSK Investigational Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

GSK Investigational Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85037

Country

United States

Facility Name

GSK Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

GSK Investigational Site

City

Covina

State/Province

California

ZIP/Postal Code

91722

Country

United States

Facility Name

GSK Investigational Site

City

Poway

State/Province

California

ZIP/Postal Code

92064

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92128

Country

United States

Facility Name

GSK Investigational Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

GSK Investigational Site

City

Van Nuys

State/Province

California

ZIP/Postal Code

91405

Country

United States

Facility Name

GSK Investigational Site

City

Whittier

State/Province

California

ZIP/Postal Code

90602

Country

United States

Facility Name

GSK Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

GSK Investigational Site

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Facility Name

GSK Investigational Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

GSK Investigational Site

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

GSK Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

GSK Investigational Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

GSK Investigational Site

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

GSK Investigational Site

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

GSK Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

GSK Investigational Site

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

GSK Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32835

Country

United States

Facility Name

GSK Investigational Site

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Facility Name

GSK Investigational Site

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33603

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318

Country

United States

Facility Name

GSK Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

GSK Investigational Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

GSK Investigational Site

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60076

Country

United States

Facility Name

GSK Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47715

Country

United States

Facility Name

GSK Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

GSK Investigational Site

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

GSK Investigational Site

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

GSK Investigational Site

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71203

Country

United States

Facility Name

GSK Investigational Site

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

GSK Investigational Site

City

Grand Blanc

State/Province

Michigan

ZIP/Postal Code

48439

Country

United States

Facility Name

GSK Investigational Site

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

GSK Investigational Site

City

Novi

State/Province

Michigan

ZIP/Postal Code

48375

Country

United States

Facility Name

GSK Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

GSK Investigational Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

GSK Investigational Site

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

GSK Investigational Site

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

GSK Investigational Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

GSK Investigational Site

City

Fayetteville

State/Province

North Carolina

ZIP/Postal Code

30214

Country

United States

Facility Name

GSK Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

GSK Investigational Site

City

Minot

State/Province

North Dakota

ZIP/Postal Code

58701

Country

United States

Facility Name

GSK Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

GSK Investigational Site

City

Vandalia

State/Province

Ohio

ZIP/Postal Code

45377

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

GSK Investigational Site

City

Yukon

State/Province

Oklahoma

ZIP/Postal Code

73099

Country

United States

Facility Name

GSK Investigational Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Facility Name

GSK Investigational Site

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29486

Country

United States

Facility Name

GSK Investigational Site

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79124

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78745

Country

United States

Facility Name

GSK Investigational Site

City

Baytown

State/Province

Texas

ZIP/Postal Code

77521

Country

United States

Facility Name

GSK Investigational Site

City

Colleyville

State/Province

Texas

ZIP/Postal Code

76034

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77065

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77084

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77089

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

GSK Investigational Site

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79410

Country

United States

Facility Name

GSK Investigational Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75024

Country

United States

Facility Name

GSK Investigational Site

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77382

Country

United States

Facility Name

GSK Investigational Site

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

GSK Investigational Site

City

Waco

State/Province

Texas

ZIP/Postal Code

76710

Country

United States

Facility Name

GSK Investigational Site

City

Glendale

State/Province

Wisconsin

ZIP/Postal Code

53217

Country

United States

Facility Name

GSK Investigational Site

City

Ciudad Autonoma Buenos aires

State/Province

Buenos Aires

ZIP/Postal Code

C1046AAQ

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1114ABH

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1417

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1430EGF

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

1426

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1128AAF

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1431FWO

Country

Argentina

Facility Name

GSK Investigational Site

City

La Palta

State/Province

Buenos Aires

ZIP/Postal Code

B1900AXI

Country

Argentina

Facility Name

GSK Investigational Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

B7600FYK

Country

Argentina

Facility Name

GSK Investigational Site

City

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

B1878GEG

Country

Argentina

Facility Name

GSK Investigational Site

City

San Isidro

State/Province

Buenos Aires

ZIP/Postal Code

1643

Country

Argentina

Facility Name

GSK Investigational Site

City

San Nicolas

State/Province

Buenos Aires

ZIP/Postal Code

B2900DMH

Country

Argentina

Facility Name

GSK Investigational Site

City

Cordoba

State/Province

Córdova

ZIP/Postal Code

X5003DCE

Country

Argentina

Facility Name

GSK Investigational Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DSV

Country

Argentina

Facility Name

GSK Investigational Site

City

San Miguel de Tucuman

State/Province

Tucumán

ZIP/Postal Code

T4000AXL

Country

Argentina

Facility Name

GSK Investigational Site

City

San Miguel de Tucumán

State/Province

Tucumán

ZIP/Postal Code

T4000BRD

Country

Argentina

Facility Name

GSK Investigational Site

City

Buenos Aires

ZIP/Postal Code

C1430CKE

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autónoma de Buenos Aires

ZIP/Postal Code

C1426BOR

Country

Argentina

Facility Name

GSK Investigational Site

City

Cordoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

GSK Investigational Site

City

Nueva Cordoba

ZIP/Postal Code

X5000AVE

Country

Argentina

Facility Name

GSK Investigational Site

City

Salta

ZIP/Postal Code

A4400ANW

Country

Argentina

Facility Name

GSK Investigational Site

City

San Juan

ZIP/Postal Code

5400

Country

Argentina

Facility Name

GSK Investigational Site

City

Gold Coast

State/Province

Queensland

ZIP/Postal Code

4222

Country

Australia

Facility Name

GSK Investigational Site

City

Woodville

State/Province

South Australia

ZIP/Postal Code

5011

Country

Australia

Facility Name

GSK Investigational Site

City

Mons

ZIP/Postal Code

7000

Country

Belgium

Facility Name

GSK Investigational Site

City

Blagoevgrad

ZIP/Postal Code

2700

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Ruse

ZIP/Postal Code

7000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sevlievo

ZIP/Postal Code

5400

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Vidin

ZIP/Postal Code

3700

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Brampton

State/Province

Ontario

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

GSK Investigational Site

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

GSK Investigational Site

City

Bengbu

State/Province

Anhui

ZIP/Postal Code

233004

Country

China

Facility Name

GSK Investigational Site

City

Guilin

State/Province

Guangxi

ZIP/Postal Code

541001

Country

China

Facility Name

GSK Investigational Site

City

Shijiazhuang

State/Province

Hebei

ZIP/Postal Code

050051

Country

China

Facility Name

GSK Investigational Site

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Facility Name

GSK Investigational Site

City

Changsha

State/Province

Hunan

ZIP/Postal Code

410013

Country

China

Facility Name

GSK Investigational Site

City

ZhuZhou

State/Province

Hunan

ZIP/Postal Code

412007

Country

China

Facility Name

GSK Investigational Site

City

Baotou

State/Province

Inner Mongolia

ZIP/Postal Code

014010

Country

China

Facility Name

GSK Investigational Site

City

Tongliao

State/Province

Inner Mongolia

ZIP/Postal Code

10050

Country

China

Facility Name

GSK Investigational Site

City

Taizhou

State/Province

Jiangsu

ZIP/Postal Code

225300

Country

China

Facility Name

GSK Investigational Site

City

Xuzhou

State/Province

Jiangsu

ZIP/Postal Code

221009

Country

China

Facility Name

GSK Investigational Site

City

Nanchang,

State/Province

Jiangxi

ZIP/Postal Code

330006

Country

China

Facility Name

GSK Investigational Site

City

Pingxiang

State/Province

Jiangxi

ZIP/Postal Code

337055

Country

China

Facility Name

GSK Investigational Site

City

Changchun

State/Province

Jilin

ZIP/Postal Code

130021

Country

China

Facility Name

GSK Investigational Site

City

Jinzhou

State/Province

Liaoning

ZIP/Postal Code

121000

Country

China

Facility Name

GSK Investigational Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Facility Name

GSK Investigational Site

City

Huzhou

State/Province

Zhejiang

ZIP/Postal Code

313000

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100015

Country

China

Facility Name

GSK Investigational Site

City

Beijing

ZIP/Postal Code

100144

Country

China

Facility Name

GSK Investigational Site

City

Guangzhou

ZIP/Postal Code

510080

Country

China

Facility Name

GSK Investigational Site

City

Hangzhou

ZIP/Postal Code

310005

Country

China

Facility Name

GSK Investigational Site

City

Nanjing

ZIP/Postal Code

210008

Country

China

Facility Name

GSK Investigational Site

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

GSK Investigational Site

City

Tianjin

ZIP/Postal Code

300052

Country

China

Facility Name

GSK Investigational Site

City

Yangzhou

ZIP/Postal Code

225000

Country

China

Facility Name

GSK Investigational Site

City

Yanji

ZIP/Postal Code

133000

Country

China

Facility Name

GSK Investigational Site

City

Barranquilla

ZIP/Postal Code

110221

Country

Colombia

Facility Name

GSK Investigational Site

City

Barranquilla

ZIP/Postal Code

80020

Country

Colombia

Facility Name

GSK Investigational Site

City

Bogotá

ZIP/Postal Code

110221

Country

Colombia

Facility Name

GSK Investigational Site

City

Bucaramanga

ZIP/Postal Code

680003

Country

Colombia

Facility Name

GSK Investigational Site

City

Brno

ZIP/Postal Code

638 00

Country

Czechia

Facility Name

GSK Investigational Site

City

Brno

ZIP/Postal Code

65691

Country

Czechia

Facility Name

GSK Investigational Site

City

Ostrava

ZIP/Postal Code

70200

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 10

ZIP/Postal Code

10000

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 11

ZIP/Postal Code

148 00

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 2

ZIP/Postal Code

12850

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 4 Nusle

ZIP/Postal Code

140 00

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 4

ZIP/Postal Code

140 00

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 5

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

GSK Investigational Site

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

GSK Investigational Site

City

Zlin

ZIP/Postal Code

760 01

Country

Czechia

Facility Name

GSK Investigational Site

City

Parnu

ZIP/Postal Code

80010

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

10117

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

10128

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

50106

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

50708

Country

Estonia

Facility Name

GSK Investigational Site

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

Facility Name

GSK Investigational Site

City

Rendsburg

State/Province

Schleswig-Holstein

ZIP/Postal Code

24768

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20095

Country

Germany

Facility Name

GSK Investigational Site

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

GSK Investigational Site

City

Baja

ZIP/Postal Code

6500

Country

Hungary

Facility Name

GSK Investigational Site

City

Balatonfured

ZIP/Postal Code

8230

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

GSK Investigational Site

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

GSK Investigational Site

City

Szentes

ZIP/Postal Code

6600

Country

Hungary

Facility Name

GSK Investigational Site

City

Székesfehérvár

ZIP/Postal Code

8000

Country

Hungary

Facility Name

GSK Investigational Site

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

GSK Investigational Site

City

Ahmedabad

ZIP/Postal Code

380005

Country

India

Facility Name

GSK Investigational Site

City

Ahmedabad

ZIP/Postal Code

380016

Country

India

Facility Name

GSK Investigational Site

City

Belagavi

ZIP/Postal Code

590010

Country

India

Facility Name

GSK Investigational Site

City

Hubli

ZIP/Postal Code

580021

Country

India

Facility Name

GSK Investigational Site

City

Hyderabad

ZIP/Postal Code

500018

Country

India

Facility Name

GSK Investigational Site

City

Jaipur

ZIP/Postal Code

302001

Country

India

Facility Name

GSK Investigational Site

City

Jaipur

ZIP/Postal Code

302006

Country

India

Facility Name

GSK Investigational Site

City

Kolkata

ZIP/Postal Code

700020

Country

India

Facility Name

GSK Investigational Site

City

Nagpur

ZIP/Postal Code

440009

Country

India

Facility Name

GSK Investigational Site

City

Nagpur

ZIP/Postal Code

440012

Country

India

Facility Name

GSK Investigational Site

City

New Delhi

ZIP/Postal Code

110026

Country

India

Facility Name

GSK Investigational Site

City

Pune

ZIP/Postal Code

411004

Country

India

Facility Name

GSK Investigational Site

City

Surat

ZIP/Postal Code

395002

Country

India

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

455-8530

Country

Japan

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

457-8511

Country

Japan

Facility Name

GSK Investigational Site

City

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

GSK Investigational Site

City

Chiba

ZIP/Postal Code

260-8712

Country

Japan

Facility Name

GSK Investigational Site

City

Chiba

ZIP/Postal Code

270-2296

Country

Japan

Facility Name

GSK Investigational Site

City

Chiba

ZIP/Postal Code

284-0003

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

804-0025

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

807-8555

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

814-0180

Country

Japan

Facility Name

GSK Investigational Site

City

Fukuoka

ZIP/Postal Code

820-8505

Country

Japan

Facility Name

GSK Investigational Site

City

Hiroshima

ZIP/Postal Code

734-8551

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

053-8567

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

060-0001

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

063-0811

Country

Japan

Facility Name

GSK Investigational Site

City

Hokkaido

ZIP/Postal Code

085-0032

Country

Japan

Facility Name

GSK Investigational Site

City

Hyogo

ZIP/Postal Code

673-1462

Country

Japan

Facility Name

GSK Investigational Site

City

Hyogo

ZIP/Postal Code

675-1392

Country

Japan

Facility Name

GSK Investigational Site

City

Ibaraki

ZIP/Postal Code

312-0057

Country

Japan

Facility Name

GSK Investigational Site

City

Kagawa

ZIP/Postal Code

761-0793

Country

Japan

Facility Name

GSK Investigational Site

City

Kagoshima

ZIP/Postal Code

891-0133

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

231-8682

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

232-0024

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

245-8575

Country

Japan

Facility Name

GSK Investigational Site

City

Kanagawa

ZIP/Postal Code

252-0392

Country

Japan

Facility Name

GSK Investigational Site

City

Kochi

ZIP/Postal Code

780-8522

Country

Japan

Facility Name

GSK Investigational Site

City

Kochi

ZIP/Postal Code

781-0112

Country

Japan

Facility Name

GSK Investigational Site

City

Kumamoto

ZIP/Postal Code

862-0975

Country

Japan

Facility Name

GSK Investigational Site

City

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

GSK Investigational Site

City

Miyagi

ZIP/Postal Code

983-8512

Country

Japan

Facility Name

GSK Investigational Site

City

Nagano

ZIP/Postal Code

380-8582

Country

Japan

Facility Name

GSK Investigational Site

City

Nagasaki

ZIP/Postal Code

850-0832

Country

Japan

Facility Name

GSK Investigational Site

City

Nagasaki

ZIP/Postal Code

852-8501

Country

Japan

Facility Name

GSK Investigational Site

City

Nagasaki

ZIP/Postal Code

857-1195

Country

Japan

Facility Name

GSK Investigational Site

City

Niigata

ZIP/Postal Code

940-2085

Country

Japan

Facility Name

GSK Investigational Site

City

Niigata

ZIP/Postal Code

957-0054

Country

Japan

Facility Name

GSK Investigational Site

City

Okayama

ZIP/Postal Code

700-0013

Country

Japan

Facility Name

GSK Investigational Site

City

Okayama

ZIP/Postal Code

700-8557

Country

Japan

Facility Name

GSK Investigational Site

City

Okayama

ZIP/Postal Code

700-8607

Country

Japan

Facility Name

GSK Investigational Site

City

Saitama

ZIP/Postal Code

359-1111

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

104-8560

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

113-8519

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

153-8515

Country

Japan

Facility Name

GSK Investigational Site

City

Tokyo

ZIP/Postal Code

198-0042

Country

Japan

Facility Name

GSK Investigational Site

City

Wakayama

ZIP/Postal Code

649-2211

Country

Japan

Facility Name

GSK Investigational Site

City

Yamaguchi

ZIP/Postal Code

750-8520

Country

Japan

Facility Name

GSK Investigational Site

City

Anyang-Si

ZIP/Postal Code

431-070

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Cheonan-si

ZIP/Postal Code

31151

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Daegu

ZIP/Postal Code

41944

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Gwangju

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Incheon

ZIP/Postal Code

22332

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

3080

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Suwon-si, Gyeonggi-do

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Adazi

ZIP/Postal Code

LV2164

Country

Latvia

Facility Name

GSK Investigational Site

City

Liepaja

ZIP/Postal Code

LV-3401

Country

Latvia

Facility Name

GSK Investigational Site

City

Kaunas

ZIP/Postal Code

LT-45130

Country

Lithuania

Facility Name

GSK Investigational Site

City

Kaunas

ZIP/Postal Code

LT-50128

Country

Lithuania

Facility Name

GSK Investigational Site

City

Klaipeda

ZIP/Postal Code

LT-92288

Country

Lithuania

Facility Name

GSK Investigational Site

City

Siauliai

ZIP/Postal Code

76231

Country

Lithuania

Facility Name

GSK Investigational Site

City

Vilnius

ZIP/Postal Code

LT-01117

Country

Lithuania

Facility Name

GSK Investigational Site

City

Klang

ZIP/Postal Code

41200

Country

Malaysia

Facility Name

GSK Investigational Site

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

GSK Investigational Site

City

Seremban, Negeri Sembilan

ZIP/Postal Code

70300

Country

Malaysia

Facility Name

GSK Investigational Site

City

Sibu

ZIP/Postal Code

96000

Country

Malaysia

Facility Name

GSK Investigational Site

City

Mexicali

State/Province

Baja California Sur

ZIP/Postal Code

21100

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico City

State/Province

Durango

ZIP/Postal Code

06700

Country

Mexico

Facility Name

GSK Investigational Site

City

Leon

State/Province

Guanajuato

ZIP/Postal Code

37000

Country

Mexico

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44130

Country

Mexico

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44650

Country

Mexico

Facility Name

GSK Investigational Site

City

Merida

State/Province

Yucatán

ZIP/Postal Code

97070

Country

Mexico

Facility Name

GSK Investigational Site

City

Durango

ZIP/Postal Code

34270

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico

ZIP/Postal Code

6700

Country

Mexico

Facility Name

GSK Investigational Site

City

San Luis Potosí

ZIP/Postal Code

78213

Country

Mexico

Facility Name

GSK Investigational Site

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

GSK Investigational Site

City

Bialystok

ZIP/Postal Code

15-879

Country

Poland

Facility Name

GSK Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-065

Country

Poland

Facility Name

GSK Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

GSK Investigational Site

City

Czestochowa

ZIP/Postal Code

42202

Country

Poland

Facility Name

GSK Investigational Site

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

GSK Investigational Site

City

Gdansk

ZIP/Postal Code

80-382

Country

Poland

Facility Name

GSK Investigational Site

City

Gdynia

ZIP/Postal Code

81-338

Country

Poland

Facility Name

GSK Investigational Site

City

Gdynia

ZIP/Postal Code

81-537

Country

Poland

Facility Name

GSK Investigational Site

City

Grodzisk Mazowiecki

ZIP/Postal Code

05-825

Country

Poland

Facility Name

GSK Investigational Site

City

Katowice

ZIP/Postal Code

40-040

Country

Poland

Facility Name

GSK Investigational Site

City

Katowice

ZIP/Postal Code

40-282

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

30-033

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

GSK Investigational Site

City

Kraków

ZIP/Postal Code

30-363

Country

Poland

Facility Name

GSK Investigational Site

City

Lodz

ZIP/Postal Code

90-127

Country

Poland

Facility Name

GSK Investigational Site

City

Lodz

ZIP/Postal Code

90-644

Country

Poland

Facility Name

GSK Investigational Site

City

Lublin

ZIP/Postal Code

20-362

Country

Poland

Facility Name

GSK Investigational Site

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

GSK Investigational Site

City

Nowa Sol

ZIP/Postal Code

67-100

Country

Poland

Facility Name

GSK Investigational Site

City

Olsztyn

ZIP/Postal Code

10-117

Country

Poland

Facility Name

GSK Investigational Site

City

Poznan

ZIP/Postal Code

60-529

Country

Poland

Facility Name

GSK Investigational Site

City

Poznan

ZIP/Postal Code

60-702

Country

Poland

Facility Name

GSK Investigational Site

City

Poznan

ZIP/Postal Code

60-773

Country

Poland

Facility Name

GSK Investigational Site

City

Poznan

ZIP/Postal Code

61-113

Country

Poland

Facility Name

GSK Investigational Site

City

Siedlce

ZIP/Postal Code

08-110

Country

Poland

Facility Name

GSK Investigational Site

City

Sochaczew

ZIP/Postal Code

96-500

Country

Poland

Facility Name

GSK Investigational Site

City

Staszow

ZIP/Postal Code

28-200

Country

Poland

Facility Name

GSK Investigational Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

GSK Investigational Site

City

Warsaw

ZIP/Postal Code

02-673

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

00-465

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

00-874

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

01-192

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

02-118

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

02-793

Country

Poland

Facility Name

GSK Investigational Site

City

Wroclaw

ZIP/Postal Code

52-416

Country

Poland

Facility Name

GSK Investigational Site

City

Wrocław

ZIP/Postal Code

50-381

Country

Poland

Facility Name

GSK Investigational Site

City

Zamosc

ZIP/Postal Code

22-400

Country

Poland

Facility Name

GSK Investigational Site

City

Ekaterinburg

ZIP/Postal Code

620043

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Ekaterinburg

ZIP/Postal Code

620102

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Kemerovo

ZIP/Postal Code

650066

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Kemerovo

ZIP/Postal Code

650070

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Korolev

ZIP/Postal Code

141060

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Krasnoyarsk

ZIP/Postal Code

660022

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

115404

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Novosibirsk

ZIP/Postal Code

630091

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Novosibirsk

ZIP/Postal Code

630099

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Omsk

ZIP/Postal Code

644024

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Smolensk

ZIP/Postal Code

214025

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Tomsk

ZIP/Postal Code

634061

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Tver

ZIP/Postal Code

170036

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Ulyanovsk

ZIP/Postal Code

432063

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Yaroslavl

ZIP/Postal Code

150007

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

GSK Investigational Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

184

Country

South Africa

Facility Name

GSK Investigational Site

City

Durban

State/Province

KwaZulu- Natal

ZIP/Postal Code

4319

Country

South Africa

Facility Name

GSK Investigational Site

City

Bellville

ZIP/Postal Code

7530

Country

South Africa

Facility Name

GSK Investigational Site

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

GSK Investigational Site

City

Cape Town

ZIP/Postal Code

7405

Country

South Africa

Facility Name

GSK Investigational Site

City

Cape Town

ZIP/Postal Code

7500

Country

South Africa

Facility Name

GSK Investigational Site

City

Johannesburg

ZIP/Postal Code

2113

Country

South Africa

Facility Name

GSK Investigational Site

City

Johannesburg

ZIP/Postal Code

2193

Country

South Africa

Facility Name

GSK Investigational Site

City

Kempton Park

ZIP/Postal Code

1619

Country

South Africa

Facility Name

GSK Investigational Site

City

Pretoria

ZIP/Postal Code

0002

Country

South Africa

Facility Name

GSK Investigational Site

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

GSK Investigational Site

City

Stellenbosch

ZIP/Postal Code

7600

Country

South Africa

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

GSK Investigational Site

City

Cordoba

ZIP/Postal Code

140044

Country

Spain

Facility Name

GSK Investigational Site

City

Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

GSK Investigational Site

City

Elche

ZIP/Postal Code

?03203

Country

Spain

Facility Name

GSK Investigational Site

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

GSK Investigational Site

City

Santiago De Compostela. La Coruña.

ZIP/Postal Code

15706

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

GSK Investigational Site

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

GSK Investigational Site

City

Rajathevee

ZIP/Postal Code

10400

Country

Thailand

Facility Name

GSK Investigational Site

City

Cherkasy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

GSK Investigational Site

City

Ivano-Frankivsk

ZIP/Postal Code

76008

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kharkiv

ZIP/Postal Code

61124

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kharkiv

ZIP/Postal Code

61176

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

02125

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

03037

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

03049

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

04054

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

1023

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

2002

Country

Ukraine

Facility Name

GSK Investigational Site

City

Lutsk

ZIP/Postal Code

43005

Country

Ukraine

Facility Name

GSK Investigational Site

City

Lutsk

ZIP/Postal Code

43024

Country

Ukraine

Facility Name

GSK Investigational Site

City

Odessa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

GSK Investigational Site

City

Poltava

ZIP/Postal Code

36011

Country

Ukraine

Facility Name

GSK Investigational Site

City

Vinnytsia

ZIP/Postal Code

21001

Country

Ukraine

Facility Name

GSK Investigational Site

City

Vinnytsia

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

GSK Investigational Site

City

Vinnytsia

ZIP/Postal Code

21029

Country

Ukraine

Facility Name

GSK Investigational Site

City

Vinnytsia

ZIP/Postal Code

21050

Country

Ukraine

Facility Name

GSK Investigational Site

City

Vinnytsya

ZIP/Postal Code

21029

Country

Ukraine

Facility Name

GSK Investigational Site

City

Zaporizhzhia

ZIP/Postal Code

69014

Country

Ukraine

Facility Name

GSK Investigational Site

City

Zaporizhzia

ZIP/Postal Code

69065

Country

Ukraine

Facility Name

GSK Investigational Site

City

Zhytomyr

ZIP/Postal Code

10002

Country

Ukraine

Facility Name

GSK Investigational Site

City

Orpington

State/Province

Kent

ZIP/Postal Code

BR5 3QG

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Northwood

State/Province

Middlesex

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Coventry

ZIP/Postal Code

CV3 4FJ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

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.

IPD Sharing Access Criteria

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.

IPD Sharing URL

http://clinicalstudydatarequest.com

Links:

URL

https://clinicaltrials.gov/ct2/show/NCT03980483?term=201790&draw=2&rank=2

Description

201790 contRAst 1 NCT03980483

URL

https://clinicaltrials.gov/ct2/show/NCT03970837?term=201791&draw=2&rank=2

Description

201791 contRAst 2 NCT03970837

URL

https://clinicaltrials.gov/ct2/show/NCT04134728?term=202018&draw=2&rank=1

Description

202018 contRAst 3 NCT04134728

Learn more about this trial

Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA)

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Long-term Safety and Efficacy of GSK3196165 (Otilimab) in the Treatment of Rheumatoid Arthritis (RA) (contRAst X)

Arthritis, Rheumatoid

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial