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| ID | Type | Description | Link |
|---|---|---|---|
| H9B-MC-BCEE | Other Identifier | Eli Lilly and Company |
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Insufficient efficacy observed in study BCDM(NCT01198002) and BCDV(NCT01202773).
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This study will investigate how LY2127399 works in participants with rheumatoid arthritis (RA) who are not adequately responding to methotrexate. Participants will receive LY2127399 via an injection(s) under the skin at 4 week intervals for up to 52 weeks. Key study procedures include biopsies of the lining of an inflamed joint and blood tests to measure RA activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY2127399 | Experimental | LY2127399 given subcutaneously (SC) at 240 milligrams (mg) as a loading dose in the first week followed by 120 mg SC every 4 weeks for up to 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY2127399 | Drug | Administered subcutaneously |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Synovitis Scores From Baseline up to Week 16 | Primary and secondary analyses were not conducted given insufficient data due to termination of the trial. | Baseline up to Week 16 |
| Percent Change in Synovial B Cell Mass From Baseline up to Week 16 | Primary and secondary analyses were not conducted given insufficient data due to termination of the trial. | Baseline up to Week 16 |
| Percent Change in Synovial Immunoglobulin (Ig) Synthesis From Baseline up to Week 16 | Primary and secondary analyses were not conducted given insufficient data due to termination of the trial. | Baseline up to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Various Cell Types in the Blood From Baseline up to Week 24 | Primary and secondary analyses were not conducted given insufficient data due to termination of the trial. | Baseline up to Week 24 |
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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. | Frederick | Maryland | 21702 |
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| ID | Title | Description |
|---|---|---|
| FG000 | LY2127399 | Participants received 240 milligrams (mg) LY2127399 administered subcutaneously (SC) (2 SC injections of 120 mg) as a loading dose on Day 1. Follow-up visits occurred up to 24 weeks after the final injection of study drug. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who received at least one dose of study drug (LY2127399).
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| ID | Title | Description |
|---|---|---|
| BG000 | LY2127399 | Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1. |
| 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 | Percent Change in Synovitis Scores From Baseline up to Week 16 | Primary and secondary analyses were not conducted given insufficient data due to termination of the trial. | No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection. | Posted | Baseline up to Week 16 |
|
|
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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 | LY2127399 - Treatment Period | Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
Due to early termination of the trial (February 2013 in conjunction with the FLEX RA program), no participant had outcome measure data analyzed. Participants who received study treatment had disposition, demographic, and adverse event data reported.
| 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 |
|---|---|
| C575974 | tabalumab |
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| United States |
| 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. | Battle Creek | Michigan | 49015 | United States |
| 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. | Mayfield | Ohio | 44143 | United States |
| 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. | Mesquite | Texas | 75150 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Primary | Percent Change in Synovial B Cell Mass From Baseline up to Week 16 | Primary and secondary analyses were not conducted given insufficient data due to termination of the trial. | No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection. | Posted | Baseline up to Week 16 |
|
|
| Primary | Percent Change in Synovial Immunoglobulin (Ig) Synthesis From Baseline up to Week 16 | Primary and secondary analyses were not conducted given insufficient data due to termination of the trial. | No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection. | Posted | Baseline up to Week 16 |
|
|
| Secondary | Percent Change in Various Cell Types in the Blood From Baseline up to Week 24 | Primary and secondary analyses were not conducted given insufficient data due to termination of the trial. | No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection. | Posted | Baseline up to Week 24 |
|
|
| 1 |
| 2 |
| 2 |
| 2 |
| EG001 | LY2127399 - Follow-up Period | Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1. Participants then discontinued dosing as a result of study closure, but completed the Post-Treatment Follow-Up Period for up to 24 weeks after the final injection of study drug. | 1 | 2 | 1 | 2 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
|
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |