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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.
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| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Otilimab 90 mg | Experimental | Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly. |
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| Otilimab 150 mg | Experimental | Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Otilimab (GSK3196165) | Biological | GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. Protocol defined AESIs were included. | Up to approximately 145 Weeks |
| Change From Baseline in Hematology Parameter of Platelet Count at Week 24 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. | Baseline (Day 01) and Week 24 |
| Change From Baseline in Hematology Parameter of Platelet Count at Week 48 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. | Baseline (Day 01) and Week 48 |
| Change From Baseline in Hematology Parameter of Platelet Count at Week 96 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. | Baseline (Day 01) and Week 96 |
| Change From Baseline in Hematology Parameter of Platelet Count at Week 144 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. | Baseline (Day 01) and Week 144 |
| Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. Percentage values are rounded off. |
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Inclusion Criteria:
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
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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Anniston | Alabama | 36207 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40044198 | Derived | Weinblatt ME, Taylor PC, McInnes IB, Atsumi T, Strand V, Takeuchi T, Bracher M, Brooks D, Curtis P, Gupta A, Nijhawan R, O'Shea C, Rayner K, Saurigny D, Shelton C, Wang M, Wang R, Fleischmann RM. Long-term safety and efficacy of anti-GM-CSF otilimab in patients with rheumatoid arthritis: long-term extension of three phase 3 randomised trials (contRAst X). BMJ Open. 2025 Mar 5;15(3):e088869. doi: 10.1136/bmjopen-2024-088869. |
| Label | URL |
|---|---|
| 201790 contRAst 1 NCT03980483 | View source |
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IPD for this study will be made available via the Clinical Study Data Request site.
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 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.
The participants in this study 209564 (ContRAst X) were adults with Rheumatoid Arthritis (RA) who completed the treatment phase of a qualifying Otilimab clinical study (Phase 3 studies 201790 [ContRAst 1], 201791 [ContRAst 2] or 202018 [ContRAst 3]) and who, in the investigator's and participant's judgement would have benefited from extended treatment with Otilimab. One participant withdrew from 150mg GSK3196165 before receiving intervention due to Physician Decision (N=1459).
Participants who consented, were enrolled and assigned to receive Otilimab 90 milligram (mg) or 150 mg weekly. Participants who received Otilimab in their qualifying study (202018, 201790 and 201791) were enrolled into this study on the same dose. Participants who received an active comparator in their qualifying study were centrally randomized using Interactive Response Technology (IRT) in a ratio of 1:1 to receive either Otilimab 90 mg or 150 mg weekly.
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| ID | Title | Description |
|---|---|---|
| FG000 | Otilimab 90 mg | Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 14, 2019 | Nov 28, 2023 |
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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.
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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.
| csDMARD(s) | Drug | Stable dose of csDMARD(s) as standard of care (SoC). |
|
Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. |
| Baseline (Day 01) and Week 24 |
| Change From Baseline in Hematology Parameter of Hemoglobin at Week 48 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. | Baseline (Day 01) and Week 48 |
| Change From Baseline in Hematology Parameter of Hemoglobin at Week 96 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. | Baseline (Day 01) and Week 96 |
| Change From Baseline in Hematology Parameter of Hemoglobin at Week 144 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. | Baseline (Day 01) and Week 144 |
| Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. | Baseline (Day 01) and Week 24 |
| Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. | Baseline (Day 01) and Week 48 |
| Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. | Baseline (Day 01) and Week 96 |
| Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. | Baseline (Day 01) and Week 144 |
| Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK. | Baseline (Day 01) and Week 24 |
| Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK. | Baseline (Day 01) and Week 48 |
| Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK. | Baseline (Day 01) and Week 96 |
| Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK. | Baseline (Day 01) and Week 144 |
| Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 | Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides | Baseline (Day 01) and Week 24 |
| Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 | Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides | Baseline (Day 01) and Week 48 |
| Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 | Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides | Baseline (Day 01) and Week 96 |
| Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 | Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides | Baseline (Day 01) and Week 144 |
| Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Number of participants with NCI-CTCAE >=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case >=Grade 3 shifts from Baseline. | Up to approximately 145 Weeks |
| Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin. | Baseline (Day 01) and Week 24 |
| Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin. | Baseline (Day 01) and Week 48 |
| Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin. | Baseline (Day 01) and Week 96 |
| Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin. | Baseline (Day 01) and Week 144 |
| Week 24, 48, 96 and 144 |
| Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score <=2.8. Percentage values are rounded off. | Week 24, 48, 96 and 144 |
| Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 | The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off. | Week 24, 48, 96 and 144 |
| Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 | The DAS28-ESR is a measure of RA disease activity calculated using TJC28,SJC28, ESR (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off. | Week 24, 48, 96 and 132 |
| Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 | Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) <= 1, Swollen Joint Count 66 (SJC66) <= 1, high sensitivity C-reactive Protein (hsCRP) <= 1mg/dl and patient's global assessment of disease activity (PtGA) <= 10. Simple Disease Activity Index based ACR/EULAR remission is achieved if a has SDAI <= 3.3. The SDAI is the sum of the tender/painful joint count and swollen joint count, employing 28 joints; PtGA and PhGA (on a scale of 0-10); and hsCRP (mg/L). Percentage values are rounded off. | Week 24, 48, 96 and 144 |
| Absolute Values for Clinical Disease Activity Index (CDAI) Total Score | CDAI total score is a composite score consisting of the sum of TJC28, TJC28, PtGA (visual analogue scale with values from 0=best to 100=worst) and PhGA (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. | Week 24, 48, 96 and 144 |
| Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) | The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- PtGA is transformed to a 0-10 scale before computing the total score. CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. | Week 24, 48, 96 and 144 |
| Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter [mm]/hour[hr]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. | Week 24, 48, 96 and 132 |
| Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS) | Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score ranges from 0 to 448 for mTSS with higher values representing higher disease activity. | Week 24 and 48 |
| Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) | The HAQ-DI includes 20 questions which assesses difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming, Hygiene, Arising, Reach, Eating, Grip, Walking, Common Daily Activities. The questions assess domain scores ranging from 0 "without any difficulty" to 3 "unable to do." Scores on each domain were summed and averaged to provide an overall score ranging from 0 to 3, where higher score reflected worse status and a lower score indicates better quality of life. | Week 24, 48, 96 and 144 |
| Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) | For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. | Week 24, 48, 96 and 144 |
| Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) | SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health. Quality Metric software was used for scoring. | Week 24, 48, 96 and 144 |
| Absolute Values SF-36 Domain Scores | Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. Quality Metric software was used for scoring for SF-36. | Week 24, 48, 96 and 144 |
| Absolute Values SF-36 Physical Component Scores (PCS) | SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health. Quality Metric software was used for scoring. | Week 24, 48, 96 and 144 |
| Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue | The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. | Week 24, 48, 96 and 144 |
| Number of Participants With Anti-GSK3196165 Antibodies | Serum samples were collected for the determination of anti- GSK3196165 antibodies (ADA) using a validated electrochemiluminescence (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA | Week 120 |
| Flagstaff |
| Arizona |
| 86001 |
| United States |
| GSK Investigational Site | Gilbert | Arizona | 85297 | United States |
| GSK Investigational Site | Glendale | Arizona | 85306 | United States |
| GSK Investigational Site | Mesa | Arizona | 85210 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85032 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85037 | United States |
| GSK Investigational Site | Tucson | Arizona | 85704 | United States |
| GSK Investigational Site | Covina | California | 91722 | United States |
| GSK Investigational Site | Poway | California | 92064 | United States |
| GSK Investigational Site | San Diego | California | 92108 | United States |
| GSK Investigational Site | San Diego | California | 92128 | United States |
| GSK Investigational Site | Upland | California | 91786 | United States |
| GSK Investigational Site | Van Nuys | California | 91405 | United States |
| GSK Investigational Site | Whittier | California | 90602 | United States |
| GSK Investigational Site | Denver | Colorado | 80230 | United States |
| GSK Investigational Site | Fort Collins | Colorado | 80528 | United States |
| GSK Investigational Site | Aventura | Florida | 33180 | United States |
| GSK Investigational Site | Brandon | Florida | 33511 | United States |
| GSK Investigational Site | Clearwater | Florida | 33765 | United States |
| GSK Investigational Site | Daytona Beach | Florida | 32117 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32207 | United States |
| GSK Investigational Site | Miami | Florida | 33134 | United States |
| GSK Investigational Site | Miami | Florida | 33155 | United States |
| GSK Investigational Site | Miami | Florida | 33165 | United States |
| GSK Investigational Site | Miami | Florida | 33173 | United States |
| GSK Investigational Site | Miami Lakes | Florida | 33014 | United States |
| GSK Investigational Site | Miami Lakes | Florida | 33016 | United States |
| GSK Investigational Site | New Port Richey | Florida | 34652 | United States |
| GSK Investigational Site | Orlando | Florida | 32835 | United States |
| GSK Investigational Site | Palmetto Bay | Florida | 33157 | United States |
| GSK Investigational Site | Tamarac | Florida | 33321 | United States |
| GSK Investigational Site | Tampa | Florida | 33603 | United States |
| GSK Investigational Site | Tampa | Florida | 33614 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30318 | United States |
| GSK Investigational Site | Marietta | Georgia | 30060 | United States |
| GSK Investigational Site | Idaho Falls | Idaho | 83404 | United States |
| GSK Investigational Site | Skokie | Illinois | 60076 | United States |
| GSK Investigational Site | Evansville | Indiana | 47715 | United States |
| GSK Investigational Site | Wichita | Kansas | 67207 | United States |
| GSK Investigational Site | Bowling Green | Kentucky | 42101 | United States |
| GSK Investigational Site | Lake Charles | Louisiana | 70601 | United States |
| GSK Investigational Site | Monroe | Louisiana | 71203 | United States |
| GSK Investigational Site | Wheaton | Maryland | 20902 | United States |
| GSK Investigational Site | Grand Blanc | Michigan | 48439 | United States |
| GSK Investigational Site | Lansing | Michigan | 48910 | United States |
| GSK Investigational Site | Novi | Michigan | 48375 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Lincoln | Nebraska | 68516 | United States |
| GSK Investigational Site | Lebanon | New Hampshire | 03756 | United States |
| GSK Investigational Site | Freehold | New Jersey | 07728 | United States |
| GSK Investigational Site | Brooklyn | New York | 11201 | United States |
| GSK Investigational Site | Fayetteville | North Carolina | 30214 | United States |
| GSK Investigational Site | Greensboro | North Carolina | 27408 | United States |
| GSK Investigational Site | Minot | North Dakota | 58701 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45242 | United States |
| GSK Investigational Site | Vandalia | Ohio | 45377 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | United States |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| GSK Investigational Site | Yukon | Oklahoma | 73099 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29601 | United States |
| GSK Investigational Site | Summerville | South Carolina | 29486 | United States |
| GSK Investigational Site | Amarillo | Texas | 79124 | United States |
| GSK Investigational Site | Austin | Texas | 78731 | United States |
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| GSK Investigational Site | Adazi | LV2164 | Latvia |
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| GSK Investigational Site | Orpington | Kent | BR5 3QG | United Kingdom |
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| 201791 contRAst 2 NCT03970837 | View source |
| 202018 contRAst 3 NCT04134728 | View source |
| FG001 | Otilimab 150 mg | Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
One participant withdrew from 150mg GSK3196165 before receiving intervention due to Physician Decision. Hence the participant was removed from intent-to-treat (ITT) and safety population (N=1459).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Otilimab 90 mg | Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly. |
| BG001 | Otilimab 150 mg | Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | YEARS |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. Protocol defined AESIs were included. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 145 Weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Hematology Parameter of Platelet Count at Week 24 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Giga cells per liter (10^9 cells/L) | Baseline (Day 01) and Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Hematology Parameter of Platelet Count at Week 48 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Giga cells per liter (10^9 cells/L) | Baseline (Day 01) and Week 48 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Hematology Parameter of Platelet Count at Week 96 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Giga cells per liter (10^9 cells/L) | Baseline (Day 01) and Week 96 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Hematology Parameter of Platelet Count at Week 144 | Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Giga cells per liter (10^9 cells/L) | Baseline (Day 01) and Week 144 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Hematology Parameter of Hemoglobin at Week 24 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Gram Per Liter (g/L) | Baseline (Day 01) and Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Hematology Parameter of Hemoglobin at Week 48 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Gram Per Liter (g/L) | Baseline (Day 01) and Week 48 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Hematology Parameter of Hemoglobin at Week 96 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Gram Per Liter (g/L) | Baseline (Day 01) and Week 96 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Hematology Parameter of Hemoglobin at Week 144 | Blood samples were collected for the assessment of change from baseline in hematology parameter hemoglobin. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Gram Per Liter (g/L) | Baseline (Day 01) and Week 144 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 24 | Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Giga cells per liter (10^9 cells/L) | Baseline (Day 01) and Week 24 |
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| Primary | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 48 | Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Giga cells per liter (10^9 cells/L) | Baseline (Day 01) and Week 48 |
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| Primary | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 96 | Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Giga cells per liter (10^9 cells/L) | Baseline (Day 01) and Week 96 |
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| Primary | Change From Baseline in White Blood Cell (WBC) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils at Week 144 | Blood samples were collected for the assessment of change from baseline in hematology parameters including White Blood Cell (WBC) Count with Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Giga cells per liter (10^9 cells/L) | Baseline (Day 01) and Week 144 |
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| Primary | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 24 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | International units per liter (IU/L) | Baseline (Day 01) and Week 24 |
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| Primary | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 48 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | International units per liter (IU/L) | Baseline (Day 01) and Week 48 |
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| Primary | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 96 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | International units per liter (IU/L) | Baseline (Day 01) and Week 96 |
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| Primary | Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP), Gamma Glutamyl Transferase (GGT), Creatine Kinase (CPK) at Week 144 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including AST, ALT, AP, GGT, CPK. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | International units per liter (IU/L) | Baseline (Day 01) and Week 144 |
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| Primary | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 24 | Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Baseline (Day 01) and Week 24 |
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| Primary | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 48 | Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Baseline (Day 01) and Week 48 |
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| Primary | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 96 | Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Baseline (Day 01) and Week 96 |
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| Primary | Change From Baseline in Lipid Profile Parameter of Cholesterol, Low-Density Lipoprotein (LDL) Cholesterol, High-Density Lipoprotein-Cholesterol (HDL), Triglycerides at Week 144 | Blood samples was collected for the assessment of clinical chemistry parameters including Cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein-cholesterol (HDL), Triglycerides | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Millimoles per liter (mmol/L) | Baseline (Day 01) and Week 144 |
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| Primary | Number of Participants With National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE)>=Grade 3 Hematological/Clinical Chemistry Abnormalities | Number of participants with NCI-CTCAE >=Grade 3 hematological/clinical chemistry abnormalities were summarized. Hematological and Clinical chemistry parameters were summarized according to the NCI-CTCAE, version 5.0: Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening or disabling. Higher grade indicates more severity. Data is presented for only those parameters for which participants had worst case >=Grade 3 shifts from Baseline. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Up to approximately 145 Weeks |
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| Secondary | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score Lesser Than or Equal to (<=)10 (CDAI) Low Disease Activity (LDA) at Week 24, 48, 96 and 144 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. Low disease activity (LDA) is achieved when CDAI total score <=10. Percentage values are rounded off. | The analysis was performed on the intent to treat (ITT) set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 24, 48, 96 and 144 |
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| Secondary | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Total Score <=2.8 (CDAI Remission) at Week 24, 48, 96 and 144 | Clinical Disease Activity Index (CDAI) total score is a composite score consisting of the sum of Swollen Joint Count 28 (SJC28), Tender Joint Count 28 (TJC28), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst) and Physician Global Assessment of Arthritis Disease Activity (PhGA) (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. CDAI remission is achieved when CDAI total score <=2.8. Percentage values are rounded off. | The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 24, 48, 96 and 144 |
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| Secondary | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) <2.6 at Week 24, 48, 96 and 144 | The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28- CRP scores range from 1.0 to 9.4, where lower scores indicates less disease activity. Low disease activity (LDA) is achieved when DAS28-CRP greater than or equal to (<=)3.2. A negative change from baseline in DAS28-CRP indicates an improvement. Percentage values are rounded off. | The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 24, 48, 96 and 144 |
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| Secondary | Percentage of Participants Achieving Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (ESR) <2.6 (DAS28-ESR Remission) at Week 24, 48, 96 and 132 | The DAS28-ESR is a measure of RA disease activity calculated using TJC28,SJC28, ESR (in mm/hr), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. Remission is achieved when DAS28-ESR <2.6. A negative change from baseline in DAS28-ESR indicates an improvement. Percentage values are rounded off. | The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 24, 48, 96 and 132 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) Remission at Week 24, 48, 96 and 144 | Boolean-based ACR/EULAR remission is achieved if all of the following requirements are met at the same timepoint: Tender Joint Count 68 (TJC68) <= 1, Swollen Joint Count 66 (SJC66) <= 1, high sensitivity C-reactive Protein (hsCRP) <= 1mg/dl and patient's global assessment of disease activity (PtGA) <= 10. Simple Disease Activity Index based ACR/EULAR remission is achieved if a has SDAI <= 3.3. The SDAI is the sum of the tender/painful joint count and swollen joint count, employing 28 joints; PtGA and PhGA (on a scale of 0-10); and hsCRP (mg/L). Percentage values are rounded off. | The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Week 24, 48, 96 and 144 |
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| Secondary | Absolute Values for Clinical Disease Activity Index (CDAI) Total Score | CDAI total score is a composite score consisting of the sum of TJC28, TJC28, PtGA (visual analogue scale with values from 0=best to 100=worst) and PhGA (visual analogue scale with values from 0=best to 100=worst). PtGA and PhGA are transformed to a 0-10 scale before computing the CDAI total score. CDAI total score ranges from 0 to 76 with higher values representing higher disease activity. | The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | Week 24, 48, 96 and 144 |
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| Secondary | Absolute Values for Disease Activity Score Using 28 Joint Count and C-Reactive Protein (DAS28-CRP) | The DAS28-CRP is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), C-reactive protein (CRP) (in mg/L), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). DAS28- PtGA is transformed to a 0-10 scale before computing the total score. CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. | The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | Week 24, 48, 96 and 144 |
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| Secondary | Absolute Values for Disease Activity Score Using 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | The DAS28-ESR is a measure of RA disease activity calculated using Tender Joint Count 28 (TJC28), Swollen Joint Count 28 (SJC28), Erythrocyte sedimentation rate (ESR) (in millimeter [mm]/hour[hr]), Patient's Global Assessment of Arthritis Disease Activity (PtGA) (visual analogue scale with values from 0=best to 100=worst). PtGA is transformed to a 0-10 scale before computing the total score. DAS28-ESR scores range from 1.0 to 9.4, where lower scores indicate less disease activity. | The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | Week 24, 48, 96 and 132 |
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| Secondary | Absolute Values of Van Der Heijde Modified Total Sharp Scores (mTSS) | Van der Heijde mTSS is utilized for scoring radiographs of hands and feet in rheumatoid arthritis. This method includes 16 areas of erosions, and 15 areas for joint space narrowing (JSN) in each hand, and 6 areas for erosions and 6 areas JSN in each foot. The total mTSS score is the sum of erosion (maximum of 280) and JSN (maximum of 168) scores. The score ranges from 0 to 448 for mTSS with higher values representing higher disease activity. | The analysis was performed on the ITT set that includes participants from qualifying studies 201790 and 201791 only who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | Week 24 and 48 |
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| Secondary | Absolute Values for Health Assessment Questionnaire Disability Index (HAQ-DI) | The HAQ-DI includes 20 questions which assesses difficulty in performing activities of daily living. The questionnaire assesses eight domains of physical functioning: Dressing and Grooming, Hygiene, Arising, Reach, Eating, Grip, Walking, Common Daily Activities. The questions assess domain scores ranging from 0 "without any difficulty" to 3 "unable to do." Scores on each domain were summed and averaged to provide an overall score ranging from 0 to 3, where higher score reflected worse status and a lower score indicates better quality of life. | The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | Week 24, 48, 96 and 144 |
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| Secondary | Absolute Values for Arthritis Pain Visual Analogue Scale (VAS) | For the Arthritis Pain VAS, participants assess the severity of their current arthritis pain using a continuous visual analogue scale (VAS) with anchors at "0" (no pain) and "100" (most severe pain). A negative change from baseline indicates an improvement. | The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | Week 24, 48, 96 and 144 |
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| Secondary | Absolute Values Short Form (SF)-36 Mental Component Scores (MCS) | SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning,bodily pain,role limitations due to physical/emotional problems,general health,mental health(MH),social functioning(SF),vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.MCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health. MCS is primarily derived from 4 domains (SF,vitality,MH,role-emotional) representing overall mental health. Quality Metric software was used for scoring. | The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | T-score | Week 24, 48, 96 and 144 |
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| Secondary | Absolute Values SF-36 Domain Scores | Short-Form 36 (SF-36) is a health-related survey that assesses quality of life covering 8 domains: physical functioning, bodily pain, role limitations due to physical and emotional problems, general health, mental health, social functioning, vitality. The MCS consists of 4 domains (social functioning, vitality, mental health, and role-emotional domains) and PCS consists of 4 domains (physical functioning, role-physical, bodily pain and general health). The individual question items are first summed for each item under the various sections. Then, those domain scores are weighted to a scale between 0 to 100, where higher score represents better health. Quality Metric software was used for scoring for SF-36. | The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | Week 24, 48, 96 and 144 |
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| Secondary | Absolute Values SF-36 Physical Component Scores (PCS) | SF-36 is health-related survey that assesses quality of life covering 8 domains:physical functioning(PF),bodily pain(BP),role limitations due to physical/emotional problems,general health(GH),mental health,social functioning,vitality.Each of 8 domains is scored using average, 0-100; higher score represents better health.PCS was aggregated across the domains and scaled to T-score with mean of 50 and SD of 10; higher score represents better health.PCS is primarily derived from 4 domains(PF,role-physical,BP,GH) representing overall physical health. Quality Metric software was used for scoring. | The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | T-Score | Week 24, 48, 96 and 144 |
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| Secondary | Absolute Values Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue | The Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue is a validated patient-reported measure of 13 statements regarding the feeling of fatigue. The total score ranges from 0 to 52 with higher values representing a lower fatigue and a better quality of life. | The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Scores on a scale | Week 24, 48, 96 and 144 |
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| Secondary | Number of Participants With Anti-GSK3196165 Antibodies | Serum samples were collected for the determination of anti- GSK3196165 antibodies (ADA) using a validated electrochemiluminescence (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA | The analysis was performed on the ITT set that includes all randomized participants who received at least one dose of study treatment. This population was based on the treatment the subject was randomized to. | Posted | Count of Participants | Participants | Week 120 |
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| Primary | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 24 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Micromoles per liter (umol/L) | Baseline (Day 01) and Week 24 |
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| Primary | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 48 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Micromoles per liter (umol/L) | Baseline (Day 01) and Week 48 |
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| Primary | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 96 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Micromoles per liter (umol/L) | Baseline (Day 01) and Week 96 |
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| Primary | Change From Baseline in Clinical Chemistry Parameter Total Bilirubin, Direct Bilirubin at Week 144 | Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters including total bilirubin, direct bilirubin. | The analysis was performed on the Safety Set that includes all randomized participants who received at least one dose of study treatment. Number of participants analyzed signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Micromoles per liter (umol/L) | Baseline (Day 01) and Week 144 |
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All AE and SAE were collected from the start of the study intervention. Initially the study was planned for 4 years approx. 208 weeks however due to early termination by sponsor; data for all Adverse event was collected up to approximately 145 Weeks only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Otilimab 90 mg | Participants who received Otilimab 90mg in a qualifying study and continued on Otilimab 90mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 90mg in study 209564. Otilimab 90mg was administered through subcutaneous (SC) injection once weekly. | 10 | 1,456 | 123 | 1,456 | 279 | 1,456 |
| EG001 | Otilimab 150 mg | Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly. | 9 | 1,459 | 114 | 1,459 | 308 | 1,459 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia vitamin B12 deficiency | Blood and lymphatic system disorders | v25.0 | Systematic Assessment |
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| Eosinophilia | Blood and lymphatic system disorders | v25.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | v25.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | v25.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | v25.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | v25.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | v25.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | v25.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | v25.0 | Systematic Assessment |
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| Meniere's disease | Ear and labyrinth disorders | v25.0 | Systematic Assessment |
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| Tympanic membrane perforation | Ear and labyrinth disorders | v25.0 | Systematic Assessment |
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| Vestibular disorder | Ear and labyrinth disorders | v25.0 | Systematic Assessment |
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| Retinal artery occlusion | Eye disorders | v25.0 | Systematic Assessment |
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| Abdominal incarcerated hernia | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Diverticulum | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Diverticulum intestinal | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Enterovesical fistula | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Gastritis haemorrhagic | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Jejunal perforation | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Large intestinal obstruction | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Large intestine polyp | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Oesophageal rupture | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Omental haemorrhage | Gastrointestinal disorders | v25.0 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | v25.0 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | v25.0 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | v25.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | v25.0 | Systematic Assessment |
| |
| Asthenia | General disorders | v25.0 | Systematic Assessment |
| |
| Hyperthermia | General disorders | v25.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | v25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | v25.0 | Systematic Assessment |
| |
| Sudden death | General disorders | v25.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | v25.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | v25.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | v25.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | v25.0 | Systematic Assessment |
| |
| Abscess bacterial | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Anastomotic infection | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Bursitis infective | Infections and infestations | v25.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | v25.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Diabetic gangrene | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Enterobacter bacteraemia | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Escherichia pyelonephritis | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Viral sinusitis | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Accidental poisoning | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Acetabulum fracture | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Burns first degree | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Dislocation of vertebra | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Periprosthetic osteolysis | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | v25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | v25.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | v25.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | v25.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | v25.0 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
| |
| Joint destruction | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
| |
| Adenocarcinoma of appendix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Anogenital warts | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Intraductal papillary-mucinous carcinoma of pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Lymphoproliferative disorder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Ovarian cancer stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Pancreatic neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v25.0 | Systematic Assessment |
| |
| Carotid artery disease | Nervous system disorders | v25.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | v25.0 | Systematic Assessment |
| |
| Cervical radiculopathy | Nervous system disorders | v25.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | v25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | v25.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | v25.0 | Systematic Assessment |
| |
| Lumbosacral radiculopathy | Nervous system disorders | v25.0 | Systematic Assessment |
| |
| Myelopathy | Nervous system disorders | v25.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | v25.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | v25.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | v25.0 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | v25.0 | Systematic Assessment |
| |
| Device physical property issue | Product Issues | v25.0 | Systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | v25.0 | Systematic Assessment |
| |
| Transient psychosis | Psychiatric disorders | v25.0 | Systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | v25.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | v25.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | v25.0 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | v25.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | v25.0 | Systematic Assessment |
| |
| Adnexal torsion | Reproductive system and breast disorders | v25.0 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | v25.0 | Systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | v25.0 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | v25.0 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | v25.0 | Systematic Assessment |
| |
| Menstrual disorder | Reproductive system and breast disorders | v25.0 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | v25.0 | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | v25.0 | Systematic Assessment |
| |
| Rectocele | Reproductive system and breast disorders | v25.0 | Systematic Assessment |
| |
| Uterine cyst | Reproductive system and breast disorders | v25.0 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | v25.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | v25.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | v25.0 | Systematic Assessment |
| |
| Laryngeal ulceration | Respiratory, thoracic and mediastinal disorders | v25.0 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | v25.0 | Systematic Assessment |
| |
| Nasal turbinate hypertrophy | Respiratory, thoracic and mediastinal disorders | v25.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | v25.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | v25.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | v25.0 | Systematic Assessment |
| |
| Brachiocephalic vein thrombosis | Vascular disorders | v25.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | v25.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | v25.0 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | v25.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | v25.0 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | v25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | v25.0 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | v25.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 12, 2023 | Nov 28, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000599766 | Otilimab |
Not provided
Not provided
Not provided
| Male |
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| ASIAN |
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| BLACK OR AFRICAN AMERICAN |
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| MULTIPLE |
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| OG001 | Otilimab 150 mg | Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly. |
|
|
| OG001 |
| Otilimab 150 mg |
Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly. |
|
|
| OG001 |
| Otilimab 150 mg |
Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly. |
|
|
Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly. |
|
|
| Otilimab 150 mg |
Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly. |
|
|
|
|
|
|
Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
|
|
|
|
Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
|
|
|
|
Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
|
|
| Otilimab 150 mg |
Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly. |
|
|
Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly.
|
|
|
|
Participants who received Otilimab 150mg in a qualifying study and continued on Otilimab 150mg in study 209564 or participants who received either tofacitinib 5mg (study 201790 or 201791) or sarilumab 200mg (study 202018) in a qualifying study and were exposed for the first time to Otilimab 150mg in study 209564. Otilimab 150mg was administered through subcutaneous (SC) injection once weekly. |
|
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