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| ID | Type | Description | Link |
|---|---|---|---|
| I1F-JE-RHAL | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the safety and tolerability of multiple doses of LY2439821 in Japanese patients with rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 mg LY2439821 | Experimental | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
|
| 80 mg LY2439821 | Experimental | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
|
| 180 mg LY2439821 | Experimental | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
|
| Placebo | Placebo Comparator | Placebo is administered subcutaneously in the same manner as active drug in each dose group |
|
| 120 mg LY2439821 | Experimental | Administered subcutaneously at 240 mg as a single loading dose followed by 120 mg every week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2439821 | Drug | Administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Effects | Clinically significant events were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module. | Baseline up to 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline to 16 Week Endpoint in C-Reactive Protein | C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter. | Baseline, 16 weeks |
| Percentage Change From Baseline to 16 Week Endpoint in Erythrocyte Sedimentation Rate (ESR) |
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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. | Fukuoka | 820-8505 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 30 Milligram (mg) LY2439821 | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
| FG001 | 80 mg LY2439821 | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
| FG002 | 180 mg LY2439821 | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
| FG003 | 120 mg LY2439821 | 240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10 |
| FG004 | Placebo | Placebo is administered subcutaneously in the same manner as active drug in each dose group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 30 mg LY2439821 | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
| BG001 | 80 mg LY2439821 | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Clinically Significant Effects | Clinically significant events were defined as serious and other non-serious adverse events. A summary of serious and all other non-serious adverse events is located in the Reported Adverse Event module. | All randomized participants. | Posted | Number | participants | Baseline up to 26 weeks |
|
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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 | 30 mg LY2439821 | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eyelid oedema | Eye disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C549079 | ixekizumab |
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| Placebo | Drug | Administered subcutaneously |
|
Erythrocyte Sedimentation Rate (ESR) is a disease related biomarker and measured in millimeters per hour (mm/h). |
| Baseline, 16 weeks |
| Change From Baseline to 26 Week Endpoint in Neutrophil Counts | Baseline, 26 weeks |
| Change From Baseline to 26 Week Endpoint in Lymphocyte Counts | Baseline, 26 weeks |
| Pharmacokinetics - Area Under the Concentration-time Curve (AUC) at Steady State (ss) | AUCτ,ss= area under the concentration versus time curve (τ) at steady state (ss) | Week 10 pre-dose up to 2 weeks post-dose (Week 12) |
| Pharmacokinetics - Maximum Plasma Drug Concentration (Cmax) at Steady State (ss) | Cmax,ss = maximum observed drug concentration (Cmax) at steady state (ss) | Week 10 pre-dose up to 2 weeks post-dose (Week 12) |
| Pharmacokinetics - Time of Maximum Observed Drug Concentration (Tmax) at Steady State (ss) | tmax,ss = time of maximum observed drug concentration (tmax) at steady state (ss) | Week 10 pre-dose up to 2 weeks post-dose (Week 12) |
| Japan |
| 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. | Hyōgo | 673-1462 | Japan |
| 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. | Ibaraki | 316-0035 | Japan |
| 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. | Nagasaki | 857-1165 | Japan |
| 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. | Niigata | 940-2085 | Japan |
| 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. | Okayama | 712-8044 | Japan |
| 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. | Shimane | 699-0293 | Japan |
| 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. | Tokyo | 164-8541 | Japan |
| Withdrawal by Subject |
|
| BG002 | 180 mg LY2439821 | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
| BG003 | 120 mg LY2439821 | 240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10 |
| BG004 | Placebo | Placebo is administered subcutaneously in the same manner as active drug in each dose group |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| C-Reactive Protein (CRP) | Median | Full Range | milligrams per liter (mg/L) |
|
| Erythrocyte Sedimentation Rate (ESR) | Median | Full Range | millimeters per hour (mm/h) |
|
| Neutrophils | Median | Full Range | 10^9 cells per liter (GI/L) |
|
| Lymphocytes | Median | Full Range | 10^9 cells per liter (GI/L) |
|
| Duration of Rheumatoid Arthritis (RA) | Mean | Standard Deviation | years |
|
| Weekly dose of Methotrexate (MTX) | Mean | Standard Deviation | milligrams per week (mg/wk) |
|
| 180 mg LY2439821 |
Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 |
| OG003 | 120 mg LY2439821 | 240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10 |
| OG004 | Placebo | Placebo is administered subcutaneously in the same manner as active drug in each dose group |
|
|
| Secondary | Percentage Change From Baseline to 16 Week Endpoint in C-Reactive Protein | C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter. | All randomized participants. | Posted | Median | Full Range | percentage change in C-Reactive Protein | Baseline, 16 weeks |
|
|
|
| Secondary | Percentage Change From Baseline to 16 Week Endpoint in Erythrocyte Sedimentation Rate (ESR) | Erythrocyte Sedimentation Rate (ESR) is a disease related biomarker and measured in millimeters per hour (mm/h). | All randomized participants. | Posted | Median | Full Range | percentage change in ESR | Baseline, 16 weeks |
|
|
|
| Secondary | Change From Baseline to 26 Week Endpoint in Neutrophil Counts | All randomized participants. | Posted | Median | Full Range | 10^9 cells per liter (GI/L) | Baseline, 26 weeks |
|
|
|
| Secondary | Change From Baseline to 26 Week Endpoint in Lymphocyte Counts | All randomized participants. | Posted | Median | Full Range | 10^9 cells per liter (GI/L) | Baseline, 26 weeks |
|
|
|
| Secondary | Pharmacokinetics - Area Under the Concentration-time Curve (AUC) at Steady State (ss) | AUCτ,ss= area under the concentration versus time curve (τ) at steady state (ss) | All randomized participants with analyzable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms•day per milliliter(μg•day/mL) | Week 10 pre-dose up to 2 weeks post-dose (Week 12) |
|
|
|
| Secondary | Pharmacokinetics - Maximum Plasma Drug Concentration (Cmax) at Steady State (ss) | Cmax,ss = maximum observed drug concentration (Cmax) at steady state (ss) | All randomized participants with analyzable pharmacokinetic data. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (μg/mL) | Week 10 pre-dose up to 2 weeks post-dose (Week 12) |
|
|
|
| Secondary | Pharmacokinetics - Time of Maximum Observed Drug Concentration (Tmax) at Steady State (ss) | tmax,ss = time of maximum observed drug concentration (tmax) at steady state (ss) | All randomized participants with analyzable pharmacokinetic data. | Posted | Median | Full Range | days | Week 10 pre-dose up to 2 weeks post-dose (Week 12) |
|
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | 80 mg LY2439821 | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 | 0 | 6 | 5 | 6 |
| EG002 | 180 mg LY2439821 | Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10 | 0 | 6 | 3 | 6 |
| EG003 | 120 mg LY2439821 | 240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10 | 0 | 6 | 3 | 6 |
| EG004 | Placebo | Placebo is administered subcutaneously in the same manner as active drug in each dose group | 0 | 8 | 6 | 8 |
| Ocular hyperaemia | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Administration site reaction | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Molluscum contagiosum | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Bite | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Pain prophylaxis | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |