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| ID | Type | Description | Link |
|---|---|---|---|
| I1F-JE-RHAM | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to evaluate the safety and tolerability of LY2439821 subcutaneously administered for 48 weeks in Japanese participants with rheumatoid arthritis who have completed Study I1F-JE-RHAL (NCT01253265).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 milligrams (mg) LY2439821 | Experimental | Participants will start receiving LY2439821 30 mg once every week for the first 3 doses and then once every 2 weeks until week 44. Investigators or its designees will increase the LY2439821 dose to 160 mg at any visit once the safety of LY2439821 180 mg is confirmed by the Data Review Meeting in Study I1F-JE-RHAL (NCT01253265). |
|
| 80 mg LY2439821 | Experimental | Participants will start receiving LY2439821 80 mg once every week for the first 3 doses and then once every 2 weeks until week 44. Investigators or its designees will increase the LY2439821 dose to 160 mg at any visit once the safety of LY2439821 180 mg is confirmed by the Data Review Meeting in Study I1F-JE-RHAL (NCT01253265). |
|
| 160 mg LY2439821 | Experimental | Participants will start receiving LY2439821 160 mg once every 2 weeks for the first 3 doses and then once every 4 weeks until Week 44. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2439821 | Drug | Administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) [Clinically Significant Events] | Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report. | Baseline through study completion (up to Week 56) |
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Inclusion Criteria:
Participants who have received 7 injections of LY2439821 subcutaneously in the 30-, 80-, or 180-mg dose cohorts, or 11 injections in the 240-mg loading dose/120-mg once-a-week maintenance dose group, and completed the follow-up period (14 weeks) in Study I1F-JE-RHAL ((NCT01253265).
Ambulatory male or female participants.
Participants who have been treated with methotrexate (MTX) throughout Study I1F-JE-RHAL (NCT01253265). Bucillamine, sulfasalazine and/or hydroxychloroquine are allowed to be administered in addition to MTX. In such a case, the participant needs to have been on a stable dose of the drug(s) throughout Study I1F-JE-RHAL (NCT01253265) and I1F-JE-RHAM.
Participants who have given written informed consent approved by the Sponsor and the Institutional Review Board (IRB) governing the investigational site.
Exclusion Criteria:
Participants who have had, during Study I1F-JE-RHAL (NCT01253265), any safety event including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (AE) that caused discontinuation from treatment , that in the opinion of the investigator poses an unacceptable risk to participation in this study.
Participants who have any of the following abnormalities of clinical laboratory test results by Week 26 of Study I1F-JE-RHAL (NCT01253265):
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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 |
Eligible participants must have completed Study I1F-JE-RHAL (NCT01253265) to meet the enrollment criteria of this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 30 mg LY2439821 | Included participants from 30 milligrams (mg) group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection once every week (Q1W) for the first 3 doses and once every 2 weeks (Q2W) until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection once every 4 weeks (Q4W) until Week 44. |
| FG001 | 80 mg LY2439821 | Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. |
| FG002 | 160 mg LY2439821 | Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 30 mg LY2439821 | Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. |
| 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 Adverse Events (AEs) [Clinically Significant Events] | Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs). A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report. | All enrolled participants. | Posted | Number | participants | Baseline through study completion (up to Week 56) |
|
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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 | Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | 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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| 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. | Nagasaki | 857 | 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. | Tokyo | 152-8902 | Japan |
| Withdrawal by Subject |
|
| BG001 | 80 mg LY2439821 | Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and then Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. |
| BG002 | 160 mg LY2439821 | Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 Q2W subcutaneous injection for the first 3 doses then Q4W until Week 44. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
| Height | Mean | Standard Deviation | centimeters (cm) |
|
| Body Mass Index (BMI) | BMI is an estimate of body fat based on body weight in kilograms divided by height squared in meters. | Mean | Standard Deviation | kilograms per square meter (kg/m^2) |
|
| Weekly Dose of Methotrexate (MTX) | Mean | Standard Deviation | milligrams per week (mg/week) |
|
| Number of Participants Given Doses in Study I1F-JE-RHAL (NCT01253265) | Number | participants |
|
| OG001 | 80 mg LY2439821 | Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. |
| OG002 | 160 mg LY2439821 | Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44. |
|
|
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | 80 mg LY2439821 | Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44. | 0 | 5 | 5 | 5 |
| EG002 | 160 mg LY2439821 | Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44. | 2 | 17 | 16 | 17 |
| Cellulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Eczema infected | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gastritis atrophic | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Administration site reaction | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Systemic mycosis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
|
| Chillblains | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Hepatitis b dna assay positive | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 13.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hand deformity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hyperkeratosis palmaris and plantaris | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| Cardioversion | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
|
| Percutaneous coronary intervention | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
|
| Skin operation | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 13.0 | Systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |