| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01202760 | A Rheumatoid Arthritis Study in Participants | PHASE3 | COMPLETED | 1,004 | — | — | Jan 1, 2011 | Jul 1, 2013 | Apr 25, 2018 | 213 | United States, Argentina +20 |
| NCT00837811 | An Open Label Extension Study in Participants With Rheumatoid Arthritis | PHASE2 | COMPLETED | 182 | — | — | Feb 1, 2009 | Jan 1, 2012 | Apr 25, 2018 | 62 | United States, Australia +12 |
| NCT00785928 | A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy | PHASE2 | COMPLETED | 158 | — | — | Oct 1, 2008 | Dec 1, 2010 | Jul 10, 2018 | 48 | United States, Argentina +10 |
| NCT01253291 | A Study of Japanese Rheumatoid Arthritis Participants | PHASE1 | COMPLETED | 26 | — | — | May 1, 2010 | Mar 1, 2014 | Mar 1, 2019 | 9 | Japan |
| NCT01253226 | A Study for Japanese Participants With Rheumatoid Arthritis (RA) | PHASE1 | COMPLETED | 32 | — | — | Sep 1, 2009 | Aug 1, 2011 | Oct 23, 2018 | 10 | Japan |
ACR20 Responder Index: Composite of clinical, laboratory, and functional measures of rheumatoid arthritis. ACR20 Responder: had \>=20% improvement from baseline in both 68 tender and 66 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), joint pain, and C-reactive protein (CRP). Percentage of participants achieving ACR20 response=(number of ACR20 responders/number of participants treated)\*100. All non-responders at Week 16 as well as all participants who discontinued study treatment at any time, for any reason, were defined as non-responders starting at that timepoint and going forward, including Week 24 endpoint.
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module. Participants were on treatment up to 48 weeks. If a participant completed 48 weeks of treatment, the post-study treatment follow-up started at the next visit, 4 weeks later (Week 52). If a participant discontinued treatment early \[early discontinuation (ED)\], the post-study treatment follow-up started immediately afterwards. Baseline was defined as Week 0 in this study \[which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)\].
For each planned laboratory evaluation, the range of values to be reported as AEs, regardless of causality, was pre-specified. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. Baseline was defined as Week 0 in this study \[which is equivalent to Week 24 of the participant's prior study: Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)\].
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR50 Responder is defined as a participant with \>50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.
Included are the number of participants who experienced SAEs and treatment-emergent other non-SAEs. A summary of SAEs and other non-SAEs, regardless of causality, is located in the Reported Adverse Events (AEs) module.
Clinically significant effects are defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| 120 mg LY2127399 | EXPERIMENTAL | LY2127399: 120 milligrams (mg), subcutaneous (SC) injection, every 4 weeks for 24 weeks. Participants received a 240-mg (2 SC injections of 120 mg each) loading dose of LY2127399 when initiating treatment. During the Treatment Period, for blinding purposes, participants alternated injections of LY2127399 and injections of Placebo every 2 weeks. After 16 weeks, non-responders received 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period. |
| 90 mg LY2127399 | EXPERIMENTAL | LY2127399: 90 milligrams (mg), subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a 180-mg (2 SC injections of 90 mg each) loading dose of LY2127399 when initiating treatment. After 16 weeks, non-responders continued to receive 90 mg of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period. |
| Placebo | PLACEBO_COMPARATOR | Placebo: subcutaneous (SC) injection, every 2 weeks for 24 weeks. Participants received a loading dose of 2 SC injections of Placebo when initiating treatment. After 16 weeks, non-responders received 90 milligrams (mg) of LY2127399 every 2 weeks for the rest of the 24-week Treatment Period. |
| LY2127399 | EXPERIMENTAL | - |
| 1 mg LY2127399 | EXPERIMENTAL | - |
| 3 mg LY2127399 | EXPERIMENTAL | - |
| 10 mg LY2127399 | EXPERIMENTAL | - |
| 30 mg LY2127399 | EXPERIMENTAL | - |
| 60 mg LY2127399 | EXPERIMENTAL | - |
| 30mg/120 mg LY2127399 | EXPERIMENTAL | Participants in the 30 milligrams (mg) every 4 weeks arm of the lead-in study will receive 30 mg every 4 weeks until the safety of the 120 mg every 4 weeks dose is confirmed in the lead-in study. |
| 30 milligrams (mg) Tabalumab | EXPERIMENTAL | 30 mg tabalumab every 4 weeks (Q4W) for 20 weeks (6 doses of study drug) |
| 60 mg Tabalumab | EXPERIMENTAL | 60 mg tabalumab Q4W for 20 weeks (6 doses of study drug) |
| 120 mg Tabalumab | EXPERIMENTAL | 120 mg tabalumab Q4W for 20 weeks (6 doses of study drug) |
| Placebo Q4W | PLACEBO_COMPARATOR | Q4W for 20 weeks |
| 120 mg once every 2 weeks (Q2W) Tabalumab | EXPERIMENTAL | Initial loading dose of 240 mg tabalumab followed by 120 mg Q2W for 20 weeks (10 doses of study drug) |
| Placebo Q2W | PLACEBO_COMPARATOR | Q2W for 20 weeks |
| Name | Type | Description |
|---|---|---|
| LY2127399 | DRUG | - |
| Placebo | DRUG | - |
| LY2127399 (Tabalumab) | DRUG | Administered subcutaneously |
Inclusion Criteria: * Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years * Global Assessment of Disease Activity visual analog scale (VAS) greater than or equal to 20/100 millimeters (mm) * If on one or more conventional disease-modifying anti-rheumatic Drugs (DMARD...