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| ID | Type | Description | Link |
|---|---|---|---|
| H9B-MC-BCDF | Other Identifier | Eli Lilly and Company |
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This study is a multicenter, double-blind, study to evaluate the safety and effectiveness of treatment with LY2127399 (in addition to the standard of care treatment, methotrexate) for participants with Rheumatoid Arthritis. Participants will receive three intravenous doses of LY2127399 or placebo. Participants will participate in 10 or more visits to the study site, over 6 months. Evaluation of safety and efficacy will be conducted throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2127399 | Drug | 30 mg, 60 mg or 160 mg, IV (in the vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 20% Response (ACR20) (Effectiveness of LY2127399 in Treating Rheumatoid Arthritis Using the ACR20 Scale) | ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), visual analog pain scale, and erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAE) (Safety of Repeat Doses (3) of LY2127399 Through Evaluation of Laboratory Tests, Vital Signs and Electrocardiograms) | Treatment-emergent adverse events (TEAEs) were defined as those AEs with start date and time equal to or after the start of study medication infusion. In the case of a missing onset time for an AE, an AE with a start date equal to or greater than the dosing date was considered treatment-emergent. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. All participants who received at least one dose of study drug. Due to dosing errors (a participant received 60 mg LY2127399 in the placebo group), the safety population was adjusted to account for actual treatment received. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bacau | 600114 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23359344 | Derived | Genovese MC, Bojin S, Biagini IM, Mociran E, Cristei D, Mirea G, Georgescu L, Sloan-Lancaster J. Tabalumab in rheumatoid arthritis patients with an inadequate response to methotrexate and naive to biologic therapy: a phase II, randomized, placebo-controlled trial. Arthritis Rheum. 2013 Apr;65(4):880-9. doi: 10.1002/art.37820. |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Completers were defined as having completed 3 infusions and required follow-up visits.
Study populations are based on randomized treatment groups. Safety and Pharmacokinetic (PK) populations were adjusted due to dosing errors and account for actual treatment received.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo administered IV in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
| FG001 | 30 mg LY2127399 | 30 milligram (mg) LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | IV (in vein) in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
|
| Baseline through Study Completion (Up to 19 Months) |
| Evaluation of the Pharmacokinetics of LY2127399: Clearance | Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum. | 2 hours pre-dose, pre-dose, 1 hour and 4 hour(s) post dose |
| Percentage of Participants Achieving ACR 50 and ACR70 | ACR Responder Index: composite of clinical, laboratory, and functional measures of Rheumatoid Arthritis (RA). ACR50 and ACR70 Responder: had either a ≥50% or ≥70% improvement from baseline in both tender and swollen joint counts and either a ≥50% or ≥70% improvement in at least 3 of 5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP (respectively). | Baseline through Week 24 |
| Change From Baseline in the Disease Activity Score 28 Joint Count (DAS28-CRP) | Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP [milligrams per liter (mg/L)], and participant's global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A negative change indicated an improvement. | Baseline, Week 24 |
| European League Against Rheumatism (EULAR28) Response: Percentage of Participants With Combined Good and Moderate Responses | EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or non-responders (NR) based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response =(number of participants with specific response) / (number of participants analyzed in the group) * 100. | Baseline, Week 24 |
| Change From Baseline (CFB) in Serum Immunoglobulins IgG, IgA and IgM | Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. A negative change indicates a decrease in Ig levels. | Baseline, Week 24 |
| Change From Baseline in CD20+ B Cell Number Count | CD20+ B-cells are a disease-related peripheral blood biomarker used to assess disease progression of Rheumatoid Arthritis (RA). A reduction in CD20+ B-cell values may indicate an improvement in RA symptoms. | Baseline, Week 24 |
| Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Baia Mare | 430031 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brasov | 500365 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brăila | 810217 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bucharest | 024092 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cluj-Napoca | 400006 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Constanța | 900607 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Craiova | 200322 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Iași | 707061 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sf. Gheorghe | 520064 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sibiu | 550245 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Targoviste | 130083 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Târgu Mureş | 540136 | Romania |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Timișoara | 300002 | Romania |
| FG002 | 60 mg LY2127399 | 60 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
| FG003 | 160 mg LY2127399 | 160 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo administered IV in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
| BG001 | 30 mg LY2127399 | 30 milligram (mg) LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
| BG002 | 60 mg LY2127399 | 60 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
| BG003 | 160 mg LY2127399 | 160 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
| BG004 | 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, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| ACR functional class | ACR American College of Rheumatology. Class I: Completely able to perform usual activities of daily living (self-care, vocational, and avocational). Class II: Able to perform usual self-care and vocational activities (work, school, homemaking), but limited in avocational activities (recreation and/or leisure). Class III: Able to perform usual self-care activities, but limited in vocational and avocational activities. Class IV: Limited in availability to perform usual self-care, vocational, and avocational activities. | Count of Participants | Participants | No |
|
| 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 | Percentage of Participants Achieving American College of Rheumatology 20% Response (ACR20) (Effectiveness of LY2127399 in Treating Rheumatoid Arthritis Using the ACR20 Scale) | ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), visual analog pain scale, and erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). | All participants who received at least 1 dose of study drug who had a baseline and at least 1 post-baseline ACR value. | Posted | Number | percentage of participants | Week 16 |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAE) (Safety of Repeat Doses (3) of LY2127399 Through Evaluation of Laboratory Tests, Vital Signs and Electrocardiograms) | Treatment-emergent adverse events (TEAEs) were defined as those AEs with start date and time equal to or after the start of study medication infusion. In the case of a missing onset time for an AE, an AE with a start date equal to or greater than the dosing date was considered treatment-emergent. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. All participants who received at least one dose of study drug. Due to dosing errors (a participant received 60 mg LY2127399 in the placebo group), the safety population was adjusted to account for actual treatment received. | All participants who received at least one dose of study drug. Due to dosing errors (a participant received 60 mg LY2127399 in the placebo group), the safety population was adjusted to account for actual treatment received. | Posted | Count of Participants | Participants | No | Baseline through Study Completion (Up to 19 Months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Evaluation of the Pharmacokinetics of LY2127399: Clearance | Population estimate of constant clearance as determined by population PK analysis. A 2-compartment model was used in PK modeling. Constant clearance is the PK parameter which describes the linear elimination of LY2127399 from serum. | All participants who received at least one dose of LY2127399 and had evaluable PK data. | Posted | Mean | Standard Deviation | Liters per Hour (L/Hr) | 2 hours pre-dose, pre-dose, 1 hour and 4 hour(s) post dose |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving ACR 50 and ACR70 | ACR Responder Index: composite of clinical, laboratory, and functional measures of Rheumatoid Arthritis (RA). ACR50 and ACR70 Responder: had either a ≥50% or ≥70% improvement from baseline in both tender and swollen joint counts and either a ≥50% or ≥70% improvement in at least 3 of 5 criteria: participant's (Pt's) and physician's global assessment of disease activity, HAQ-DI (measured Pts' perceived degree of difficulty performing daily activities), joint pain, and CRP (respectively). | All participants who received at least 1 dose of study drug who had a baseline and at least 1 post-baseline ACR value. | Posted | Number | percentage of participants | Baseline through Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Disease Activity Score 28 Joint Count (DAS28-CRP) | Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP [milligrams per liter (mg/L)], and participant's global assessment of disease activity using visual analog scale (VAS) (participant global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*participant global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A negative change indicated an improvement. | All participants who received at least 1 dose of study drug who had a baseline and at least 1 post-baseline ACR value. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | European League Against Rheumatism (EULAR28) Response: Percentage of Participants With Combined Good and Moderate Responses | EULAR Responder index based on 28 joint counts categorizes clinical response based on improvement since baseline in DAS28-CRP. DAS28-CRP scores range from 1.0-9.4, where lower scores indicated less disease activity. High disease activity: DAS28-CRP >5.1, low disease activity: DAS28-CRP <3.2, and remission: DAS28-CRP <2.6. Participants are categorized as EULAR responders or non-responders (NR) based on improvement of DAS28-CRP scores from baseline. EULAR DAS28-CRP responder index defines a good (absolute: <3.2 or >1.2 improvement from baseline), moderate (absolute: 3.2-5.1 or 0.6-1.2 improvement from baseline), or no response (absolute: >5.1 or <0.6 improvement from baseline). Percentage of participants with DAS28-CRP based EULAR response =(number of participants with specific response) / (number of participants analyzed in the group) * 100. | All participants who received at least 1 dose of study drug who had a baseline and at least 1 post-baseline ACR value. | Posted | Number | percentage of participants | Baseline, Week 24 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (CFB) in Serum Immunoglobulins IgG, IgA and IgM | Immunoglobulins (Ig), or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. A negative change indicates a decrease in Ig levels. | All participants who received one dose of study drug and had post baseline serum immunoglobulin data. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Baseline, Week 24 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in CD20+ B Cell Number Count | CD20+ B-cells are a disease-related peripheral blood biomarker used to assess disease progression of Rheumatoid Arthritis (RA). A reduction in CD20+ B-cell values may indicate an improvement in RA symptoms. | All participants who received one dose of study drug and had post baseline CD20+ cell data. | Posted | Mean | Standard Deviation | Cells per microLiter | Baseline, Week 24 |
|
Not provided
All participants who received at least one dose of study drug. Due to dosing errors (a participant received 60 mg LY2127399 in the placebo group), the safety population was adjusted to account for actual treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo administered IV in weeks 0, 3 and 6. Treatment duration: 6 weeks. | 3 | 33 | 15 | 33 | ||
| EG001 | 30 mg LY2127399 | 30 milligram (mg) LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. | 2 | 34 | 14 | 34 | ||
| EG002 | 60 mg LY2127399 | 60 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. | 0 | 35 | 15 | 35 | ||
| EG003 | 160 mg LY2127399 | 160 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. | 3 | 34 | 15 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Gastritis Haemorrhagic | Gastrointestinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Bile Duct Stone | Hepatobiliary disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Necrotising Fasciitis | Infections and infestations | MedDRA Version 8.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 8.1 | Systematic Assessment |
| |
| Rheumatoid Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Endometrial Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 8.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| Blood Pressure Increased | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| Gamma Glutamyl Transferase Increased | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA Version 8.1 | Systematic Assessment |
| |
| Upper respiratory tract infections | Infections and infestations | MedDRA Version 8.1 | Systematic Assessment |
| |
| Ventricular Extrasystoles | Cardiac disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Myocardial Ischemia | Cardiac disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Injection Site Irritation | General disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 8.1 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA Version 8.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
| 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 |
|---|---|
| C575974 | tabalumab |
Not provided
Not provided
Not provided
| Between 18 and 73 years |
|
| >=73 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Class II |
|
| Class III |
|
| OG002 | 60 mg LY2127399 | 60 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
| OG003 | 160 mg LY2127399 | 160 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
|
|
| Participants |
|
|
| OG003 |
| 160 mg LY2127399 |
160 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
|
|
| OG003 | 160 mg LY2127399 | 160 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
|
|
| OG002 | 60 mg LY2127399 | 60 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
| OG003 | 160 mg LY2127399 | 160 mg LY2127399 administered Intravenously (IV) in weeks 0, 3 and 6. Treatment duration: 6 weeks. |
|
|
|
|
|
|