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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333147
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : January 21, 2022
Sponsor:
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Biological: Otilimab (GSK3196165) Drug: csDMARD(s) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
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.
Primary Purpose: Treatment
Official Title: A Multi-centre Long-term Extension Study to Assess the Safety and Efficacy of GSK3196165 in the Treatment of Rheumatoid Arthritis
Actual Study Start Date : May 12, 2020
Estimated Primary Completion Date : April 17, 2024
Estimated Study Completion Date : April 17, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Participants receiving GSK3196165 in qualifying study
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.
 Biological: Otilimab (GSK3196165)
GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.

Drug: csDMARD(s)
Stable dose of csDMARD(s) as standard of care (SoC).
Experimental: Participants receiving comparator in qualifying 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.
 Biological: Otilimab (GSK3196165)
GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.

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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AEs) , serious adverse events (SAEs) and adverse events of special interests (AESI) [ Time Frame: Up to 4 years ]
    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.

  2. Change from Baseline in platelet count, neutrophils lymphocytes, monocytes, eosinophils, and basophils (Giga cells per liter [giga cells/L]) [ Time Frame: Baseline (Day 1) and up to 4 years ]
    Blood samples will be collected for the assessment of hematology parameters.

  3. Change from Baseline in hemoglobin level (Grams per liter) [ Time Frame: Baseline (Day 1) and up to 4 years ]
    Blood samples will be collected for the assessment of hemoglobin.

  4. 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) [ Time Frame: Baseline (Day 1) and up to 4 years ]
    Blood samples will be collected for the assessment of clinical chemistry parameters

  5. 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) [ Time Frame: Baseline (Day 1) and up to 4 years ]
    Blood samples will be collected for the assessment of clinical chemistry parameters.

  6. Change from Baseline in total and direct bilirubin (Micromoles per liter) [ Time Frame: Baseline (Day 1) and up to 4 years ]
    Blood samples will be collected for the assessment of clinical chemistry parameters

  7. Change from Baseline in albumin level (Grams per Liter) [ Time Frame: Baseline (Day 1) and up to 4 years ]
    Blood samples will be collected for the assessment of clinical chemistry parameters

  8. 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 [ Time Frame: Up to 4 years ]
    Hematological/clinical chemistry abnormalities will be evaluated using NCI-CTCAE grading.


Secondary Outcome Measures :
  1. 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 [ Time Frame: 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.

  2. Proportion of participants achieving CDAI total score <=10 (CDAI LDA) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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.

  3. Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 24 [ Time Frame: 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), PtGA and PhGA. Proportion of participants achieving CDAI total score <=2.8 will be summarized.

  4. Proportion of participants achieving CDAI total score <=2.8 (CDAI Remission) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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. Proportion of participants achieving CDAI total score <=2.8 will be summarized.

  5. Proportion of participants achieving Disease Activity Score using 28 joint count (DAS28)-C-reactive protein (CRP) <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), 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.

  6. Proportion of participants achieving DAS28-CRP <2.6 (DAS28-CRP Remission) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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.

  7. Proportion of participants with DAS28- Erythrocyte sedimentation rate (ESR)<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 (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.

  8. Proportion of participants with DAS28-ESR<2.6 (DAS28-ESR Remission) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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.

  9. 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 [ Time Frame: 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.

  10. Proportion of participants achieving ACR and EULAR remission (Boolean and SDAI) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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.

  11. Absolute values of CDAI total score at Week 24 [ Time Frame: 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.

  12. Absolute values of CDAI total score at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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.

  13. Absolute values of DAS28-CRP at Week 24 [ Time Frame: 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.

  14. Absolute values of DAS28-CRP at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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.

  15. Absolute values of DAS28-ESR at Week 24 [ Time Frame: 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.

  16. Absolute values of DAS28-ESR at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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.

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

  18. Absolute values of van der Heijde mTSS (in participants from 201790 [NCT03980483] and 201791 [NCT03970837] only) at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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]).

  19. Absolute values of Health assessment questionnaire-disability index (HAQ-DI) at Week 24 [ Time Frame: 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.

  20. Absolute values of HAQ-DI at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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.

  21. Absolute values of Arthritis pain visual analogue scale (VAS) at Week 24 [ Time Frame: 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).

  22. Absolute values of Arthritis pain VAS at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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).

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

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

  25. Absolute values of domain scores of SF-36 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. Scores on each item will be summed and averaged (range = 0 [poorer health] to 100 [better health]).

  26. Absolute values of the physical component scores of SF-36 at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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]).

  27. Absolute values of the mental component scores of SF-36 at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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]).

  28. Absolute values of domain scores of SF-36 at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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]).

  29. Absolute values of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue at Week 24 [ Time Frame: 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.

  30. Absolute values of FACIT-Fatigue at Week 48 and every 48 weeks thereafter [ Time Frame: Week 48 and every 48 weeks thereafter, up to 4 years ]
    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.

  31. Proportion of participants with anti-GSK3196165 antibodies [ Time Frame: Up to 4 years ]
    Presence of anti-GSK3196165 antibodies will be determined.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333147


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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Sponsors and Collaborators
GlaxoSmithKline
Iqvia Pty Ltd
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Additional Information:

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT04333147    
Other Study ID Numbers: 209564
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Rheumatoid arthritis
GSK3196165
Otilimab
Long-term safety
Long-term efficacy
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases