Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00966875 | A Study in Patients With Rheumatoid Arthritis | PHASE2 | COMPLETED | 448 | — | — | Aug 1, 2009 | Jun 1, 2012 | May 26, 2016 | 75 | United States, Argentina +9 |
| NCT01236118 | A Study of LY2439821 in Rheumatoid Arthritis | PHASE1 | COMPLETED | 28 | — | — | Dec 1, 2010 | Jan 1, 2013 | May 26, 2016 | 6 | Japan |
| NCT01253265 | A Study in Rheumatoid Arthritis | PHASE1 | COMPLETED | 32 | — | — | May 1, 2010 | Dec 1, 2011 | May 26, 2016 | 8 | Japan |
ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), Patient's Global Assessment of Disease Activity-VAS(PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI). Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) \* 100.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 3 mg LY2439821 (bDMARD-naive population) | EXPERIMENTAL | 3 milligrams (mg) LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. \[Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)\] |
| 10 mg LY2439821 (bDMARD-naive population) | EXPERIMENTAL | 10 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| 30 mg LY2439821 (bDMARD-naive population) | EXPERIMENTAL | 30 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| 80 mg LY2439821 (bDMARD-naive population) | EXPERIMENTAL | 80 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| 180 mg LY2439821 (bDMARD-naive population) | EXPERIMENTAL | 180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| 80 mg LY2439821 (TNFa-IR population) | EXPERIMENTAL | 80 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. \[Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)\] |
| 180 mg LY2439821 (TNFa-IR population) | EXPERIMENTAL | 180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| Placebo (bDMARD-naive population) | PLACEBO_COMPARATOR | Placebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| Placebo (TNFa-IR population) | PLACEBO_COMPARATOR | Placebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. |
| 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. |
| 30 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 |
|---|---|---|
| LY2439821 | BIOLOGICAL | Subcutaneous |
| Placebo | DRUG | Subcutaneous |
Inclusion Criteria: * You must be between the ages of 18 and 75 * You must have active RA Qualifications Specific to the bDMARD-naive Population: You must be regularly using methotrexate (MTX) for at least 12 weeks before your participation in this study Qualifications Specific to the TNFα-IR Po...