A Study of LY2127399 in Participants With Systemic Lupus Erythematosus
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01196091
Collaborator
(none)
1,164
192
3
54
6.1
0.1
Study Details
Study Description
Brief Summary
The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in participants with active SLE.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1164 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE)
Study Start Date
:
Dec 1, 2010
Actual Primary Completion Date
:
Jul 1, 2014
Actual Study Completion Date
:
Jun 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY2127399 every 2 weeks Administered SC |
Drug: LY2127399
120 mg administered via subcutaneous (SC) injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Drug: Standard of Care
Other Names:
|
| Experimental: LY2127399 every 4 wks During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. |
Drug: LY2127399
120 mg administered via subcutaneous (SC) injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
Drug: Placebo every 4 weeks
Administered via subcutaneous injection for 52 weeks.
Drug: Standard of Care
Other Names:
|
| Placebo Comparator: Placebo Administered SC |
Drug: Placebo every 2 weeks
Administered via subcutaneous injection for 52 weeks. A matching loading dose of corticosteroids, NSAIDs, antimalarials, or immunosuppressants will also be administered at the first dose
Drug: Standard of Care
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving an SLE Responder Index Response at Week 52 [52 weeks]
Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 9 organ domains; range is from severe (A) to no disease (E). Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data.
Secondary Outcome Measures
- Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52 [52 weeks]
A participant achieves corticosteroid sparing effects (quiescent disease) if they have met the following criteria during Weeks 24 through 52; able to decrease their dose of prednisone or equivalent to 7.5 mg/day or less, have quiescent disease (BILAG C score or better in all nine systems), and no BILAG A or B flares in the previous three months, without an increase in either antimalarials or immunosuppressants on or prior to the visit. Only participants receiving a prednisone or equivalent dose of more than 7.5 mg/day at baseline are included.
- Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level [Baseline, 52 weeks]
Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE.
- Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score [Baseline, 52 weeks]
SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
- Time to First Severe SLE Flare (SFI) [Baseline through 52 weeks]
The SFI uses the SELENA-SLEDAI disease activity index score, disease activity scenarios, treatment changes, and PGA to define mild/moderate and severe flares. The index takes into account the absolute change in total scores, new or worsening symptoms, and increases in corticosteroid use or hospitalization due to the disease activity. Time to first severe SLE flare (SFI) (in days) is calculated as: (Start date of first severe SLE flare (SFI) - Date of randomization + 1).
- Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks [52 weeks]
Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100 millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100. No worsening is defined as increase of ≥0.3 points.
- Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores [Baseline, 52 weeks]
A participants-reported scale that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity scores ranged from 0 (no fatigue) to 10 (fatigue as severe as you can imagine).
- Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores [Baseline, 52 weeks]
The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of participants with SLE within 8 domains.Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). A LupusQoL score for each domain is reported on a 0 to 100 scale, with greater values indicating better HRQoL.
- Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares [Baseline through 52 weeks]
The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare. Time to first BILAG A or two BILAG B flares (in days) is calculated as: (Start date of first BILAG A or two BILAG B flares - Date of randomization + 1). The two BILAG B flares must occur in different domains at the same visit.
- Change From Baseline to 52 Week Endpoint in PGA [Baseline, 52 weeks]
Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100-mm visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores range from 0, being worst possible to 100 being very active or best possible.
- Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks [52 weeks]
An increase in corticosteroids at a visit was defined as a change from baseline greater than 2.5 mg/day in dose or prednisone or equivalent using average daily dose of corticosteroids taken since the previous scheduled visit.
- Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score [Baseline, 52 weeks]
Safety of Estrogens in Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) score is a weighted, cumulative index of lupus disease activity. SELENA-SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.
- Percentage of Participants Achieving a Response as Measured by Modified SRI With No BILAG A or No More Than 1 BILAG B Organ Domain Flares at 52 Weeks [52 weeks]
Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A or no more than 1 new BILAG B organ domain flare compared with baseline. (Primary outcome modified to use BILAG flare instead of BILAG disease score) SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG flare is assessed for each of the 9 organ domains; A is a severe flare and B is a moderate flare. Patients who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data.
- Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline [Baseline through 52 weeks]
The BILAG2004 index is a validated global disease activity index designed on the basis of the physician's ITT, focusing on changes in disease manifestations (new, improved, worsening, etc) occurring in the last 4 weeks compared with the previous 4 weeks. The instrument assesses 97 clinical signs, symptoms, and laboratory parameters across 9 organ system domains: constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, opthalmic, renal and hematology.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria
-
Have positive antinuclear antibodies (ANA)
-
Agree not to become pregnant throughout the course of the trial
-
Have a screening SELENA-SLEDAI score ≥6. (The participant must be actively exhibiting all the symptoms scored on the screening SELENA-SLEDAI on the day of screening.)
Exclusion Criteria:
-
Have active severe Lupus kidney disease
-
Have active Central Nervous System or peripheral neurologic disease
-
Have received intravenous immunoglobulin (IVIg) within 180 days of randomization
-
Have active or recent infection within 30 days of screening
-
Have had a serious infection within 90 days of randomization
-
Have evidence or test positive for Hepatitis B
-
Have Hepatitis C
-
Are human immunodeficiency virus (HIV) positive
-
Have evidence of active or latent tuberculosis (TB)
-
Presence of significant laboratory abnormalities at screening
-
Have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization
-
Have received greater than 40 mgs of prednisone or equivalent in the past 30 days
-
Have changed your dose of antimalarial drug in the past 30 days
-
Have changed your dose of immunosuppressive drug in the past 90 days
-
Have previously received rituximab
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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. | Birmingham | Alabama | United States | 35294 |
| 2 | 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. | Glendale | Arizona | United States | 85304 |
| 3 | 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. | Mesa | Arizona | United States | 85202 |
| 4 | 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. | Paradise Valley | Arizona | United States | 85253 |
| 5 | 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. | Peoria | Arizona | United States | 85381 |
| 6 | 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. | Phoenix | Arizona | United States | 85037 |
| 7 | 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. | Little Rock | Arkansas | United States | 72205 |
| 8 | 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. | Anaheim | California | United States | 92805 |
| 9 | 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. | Glendale | California | United States | 91204 |
| 10 | 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. | Lakewood | California | United States | 90712 |
| 11 | 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. | Long Beach | California | United States | 90808 |
| 12 | 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. | Los Angeles | California | United States | 90048 |
| 13 | 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. | Sacramento | California | United States | 95825 |
| 14 | 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. | San Leandro | California | United States | 94578 |
| 15 | 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. | Upland | California | United States | 91786 |
| 16 | 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. | Danbury | Connecticut | United States | 06810 |
| 17 | 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. | Farmington | Connecticut | United States | 06030 |
| 18 | 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. | Norwich | Connecticut | United States | 06360 |
| 19 | 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. | Trumbull | Connecticut | United States | 06611 |
| 20 | 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. | Boca Raton | Florida | United States | 33486 |
| 21 | 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. | Clearwater | Florida | United States | 33765 |
| 22 | 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. | Doral | Florida | United States | 33166 |
| 23 | 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. | Fort Lauderdale | Florida | United States | 33334 |
| 24 | 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. | Jacksonville | Florida | United States | 32216 |
| 25 | 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. | Lake Mary | Florida | United States | 32746 |
| 26 | 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. | Miami | Florida | United States | 33169 |
| 27 | 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. | Orange Park | Florida | United States | 32073 |
| 28 | 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. | Palm Harbor | Florida | United States | 34684 |
| 29 | 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. | Saint Petersburg | Florida | United States | 33710 |
| 30 | 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. | Tamarac | Florida | United States | 33321 |
| 31 | 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. | Tampa | Florida | United States | 33612 |
| 32 | 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. | Atlanta | Georgia | United States | 30342 |
| 33 | 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. | Decatur | Georgia | United States | 30033 |
| 34 | 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. | Marietta | Georgia | United States | 30060 |
| 35 | 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. | Boise | Idaho | United States | 83702 |
| 36 | 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. | Chicago | Illinois | United States | 60612 |
| 37 | 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. | Peoria | Illinois | United States | 61636 |
| 38 | 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. | Muncie | Indiana | United States | 47304 |
| 39 | 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. | Kansas City | Kansas | United States | 66160 |
| 40 | 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. | Bowling Green | Kentucky | United States | 42101 |
| 41 | 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. | Lexington | Kentucky | United States | 40504 |
| 42 | 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. | Baltimore | Maryland | United States | 21239 |
| 43 | 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. | Hagerstown | Maryland | United States | 21742 |
| 44 | 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. | Wheaton | Maryland | United States | 20902 |
| 45 | 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. | Grand Rapids | Michigan | United States | 49546 |
| 46 | 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. | Eagan | Minnesota | United States | 55121 |
| 47 | 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. | Florissant | Missouri | United States | 63031 |
| 48 | 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. | Lincoln | Nebraska | United States | 68516 |
| 49 | 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. | Omaha | Nebraska | United States | 68134 |
| 50 | 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. | Clifton | New Jersey | United States | 07012 |
| 51 | 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. | Teaneck | New Jersey | United States | 07666 |
| 52 | 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. | Toms River | New Jersey | United States | 08755 |
| 53 | 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. | Albuquerque | New Mexico | United States | 87102 |
| 54 | 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. | Bronx | New York | United States | 10457 |
| 55 | 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. | Endwell | New York | United States | 13760 |
| 56 | 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. | Manhasset | New York | United States | 11030 |
| 57 | 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. | New York | New York | United States | 10019 |
| 58 | 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. | Rochester | New York | United States | 14618 |
| 59 | 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. | Charlotte | North Carolina | United States | 28210 |
| 60 | 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. | Greenville | North Carolina | United States | 27834 |
| 61 | 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. | Hickory | North Carolina | United States | 28602 |
| 62 | 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. | Cincinnati | Ohio | United States | 45229 |
| 63 | 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. | Middleburg Heights | Ohio | United States | 44130 |
| 64 | 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. | Edmond | Oklahoma | United States | 73013 |
| 65 | 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. | Oklahoma City | Oklahoma | United States | 73103 |
| 66 | 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. | Philadelphia | Pennsylvania | United States | 19107 |
| 67 | 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. | Pittsburgh | Pennsylvania | United States | 15217 |
| 68 | 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. | Willow Grove | Pennsylvania | United States | 19090 |
| 69 | 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. | Columbia | South Carolina | United States | 29204 |
| 70 | 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. | Greenville | South Carolina | United States | 29601 |
| 71 | 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. | North Charleston | South Carolina | United States | 29406 |
| 72 | 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. | Crossville | Tennessee | United States | 38555 |
| 73 | 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. | Hixon | Tennessee | United States | 37343 |
| 74 | 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. | Jackson | Tennessee | United States | 38305 |
| 75 | 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. | Allen | Texas | United States | 75013 |
| 76 | 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. | Dallas | Texas | United States | 75390 |
| 77 | 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. | Houston | Texas | United States | 77034 |
| 78 | 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. | Irving | Texas | United States | 75061 |
| 79 | 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 | United States | 75150 |
| 80 | 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. | San Antonio | Texas | United States | 78229 |
| 81 | 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. | Sugar Land | Texas | United States | 77478 |
| 82 | 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. | Waco | Texas | United States | 76708 |
| 83 | 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. | Chesapeake | Virginia | United States | 23320 |
| 84 | 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. | Danville | Virginia | United States | 24541 |
| 85 | 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. | Richmond | Virginia | United States | 23294 |
| 86 | 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. | Williamsburg | Virginia | United States | 23185 |
| 87 | 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. | Tacoma | Washington | United States | 98405 |
| 88 | 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. | Milwaukee | Wisconsin | United States | 53226 |
| 89 | 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. | Buenos Aires | Argentina | C1417EYG | |
| 90 | 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. | Caba | Argentina | C1181ACH | |
| 91 | 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. | Córdoba | Argentina | X5016KEH | |
| 92 | 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. | Rosario | Argentina | S2000PBJ | |
| 93 | 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. | San Juan | Argentina | 5400 | |
| 94 | 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. | Tucuman | Argentina | 4000 | |
| 95 | 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. | Graz | Austria | 8036 | |
| 96 | 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. | Vienna | Austria | A1090 | |
| 97 | 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. | Brest | Belarus | 224027 | |
| 98 | 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. | Grodno | Belarus | 230017 | |
| 99 | 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. | Minsk | Belarus | 220116 | |
| 100 | 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. | Plovdiv | Bulgaria | 4002 | |
| 101 | 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. | Sofia | Bulgaria | 1612 | |
| 102 | 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. | Stara Zagora | Bulgaria | 6003 | |
| 103 | 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. | Varna | Bulgaria | 9010 | |
| 104 | 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. | Kelowna | British Columbia | Canada | V1Y3G5 |
| 105 | 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. | Markham | Ontario | Canada | L3P1A8 |
| 106 | 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. | Newmarket | Ontario | Canada | L3Y3R7 |
| 107 | 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. | Osorno | Chile | 5290000 | |
| 108 | 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. | Santiago | Chile | 7500000 | |
| 109 | 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. | Valdivia | Chile | ||
| 110 | 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. | Bogota | Colombia | ||
| 111 | 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. | Bucaramanga | Colombia | 681001 | |
| 112 | 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. | Cali | Colombia | ||
| 113 | 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. | Chia | Colombia | ||
| 114 | 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. | Medellín | Colombia | 574 | |
| 115 | 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. | Osijek | Croatia | 31000 | |
| 116 | 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. | Al Minya | Egypt | 61111 | |
| 117 | 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. | Alexandria | Egypt | 21131 | |
| 118 | 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. | Cairo | Egypt | 941400 | |
| 119 | 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. | Bad Nauheim | Germany | 61231 | |
| 120 | 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. | Baden-Baden | Germany | 76530 | |
| 121 | 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. | Berlin | Germany | 14059 | |
| 122 | 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. | Erlangen | Germany | 91054 | |
| 123 | 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. | Freiburg | Germany | 79106 | |
| 124 | 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. | Hildesheim | Germany | 31134 | |
| 125 | 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. | Jena | Germany | 07747 | |
| 126 | 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. | Zerbst | Germany | 39261 | |
| 127 | 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. | Guatemala | Guatemala | 1010 | |
| 128 | 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. | Brescia | Italy | 25123 | |
| 129 | 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. | Genova | Italy | 16132 | |
| 130 | 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. | Milano | Italy | 20122 | |
| 131 | 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. | Napoli | Italy | 80131 | |
| 132 | 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. | Padova | Italy | 35128 | |
| 133 | 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. | Palermo | Italy | 90127 | |
| 134 | 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. | Scafati | Italy | 84018 | |
| 135 | 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. | Torino | Italy | 10128 | |
| 136 | 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. | Aichi | Japan | 4600001 | |
| 137 | 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. | Chiba | Japan | 284-0003 | |
| 138 | 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 | Japan | 807-8556 | |
| 139 | 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. | Hokkaido | Japan | 060-8648 | |
| 140 | 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. | Japan | Japan | 852-8501 | |
| 141 | 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. | Miyagi | Japan | 980-8574 | |
| 142 | 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 | Japan | 856-8562 | |
| 143 | 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. | Osaka | Japan | 530-8480 | |
| 144 | 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 | Japan | 101-0062 | |
| 145 | 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. | Bucheon | Korea, Republic of | 420-717 | |
| 146 | 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. | Daegu | Korea, Republic of | 700-712 | |
| 147 | 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. | Daejeon | Korea, Republic of | 301-721 | |
| 148 | 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. | Gwangju | Korea, Republic of | 501-757 | |
| 149 | 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. | Incheon | Korea, Republic of | 405-760 | |
| 150 | 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. | Jeonju-Si | Korea, Republic of | 561712 | |
| 151 | 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. | Seoul | Korea, Republic of | 143-729 | |
| 152 | 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. | Suwon | Korea, Republic of | 443-721 | |
| 153 | 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. | Bitola | Macedonia, The Former Yugoslav Republic of | 7000 | |
| 154 | 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. | Skopje | Macedonia, The Former Yugoslav Republic of | 1000 | |
| 155 | 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. | Stip | Macedonia, The Former Yugoslav Republic of | 2000 | |
| 156 | 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. | Arequipa | Peru | ||
| 157 | 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. | Lima | Peru | L41 | |
| 158 | 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. | Lince | Peru | Lima14 | |
| 159 | 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. | Piura | Peru | ||
| 160 | 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. | Angeles City | Philippines | 2009 | |
| 161 | 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. | Cebu | Philippines | 6000 | |
| 162 | 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. | Davao City | Philippines | 8000 | |
| 163 | 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. | Ermita | Philippines | 1000 | |
| 164 | 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. | Espana | Philippines | 1008 | |
| 165 | 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. | Iloilo City | Philippines | 5000 | |
| 166 | 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. | Manila | Philippines | 1007 | |
| 167 | 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. | Paranaque | Philippines | ||
| 168 | 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. | Quezon City | Philippines | 1102 | |
| 169 | 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. | ?Ód? | Poland | 94-017 | |
| 170 | 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. | Bytom | Poland | 41-902 | |
| 171 | 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. | Poznan | Poland | 61-397 | |
| 172 | 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. | Sosnowiec | Poland | 41-200 | |
| 173 | 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. | Warsaw | Poland | 02-507 | |
| 174 | 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. | Wroc?Aw | Poland | 50-368 | |
| 175 | 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. | San Juan | Puerto Rico | 00918 | |
| 176 | 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. | Santurce | Puerto Rico | 00909 | |
| 177 | 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. | Singapore | Singapore | 258499 | |
| 178 | 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. | Bangkok | Thailand | 10700 | |
| 179 | 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. | Chiang Mai | Thailand | 50200 | |
| 180 | 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. | Donetsk | Ukraine | 83001 | |
| 181 | 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. | Ivano-Frankivsk | Ukraine | 76008 | |
| 182 | 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. | Kharkiv | Ukraine | 61029 | |
| 183 | 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. | Kryvyi Rih | Ukraine | 50056 | |
| 184 | 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. | Kyiv | Ukraine | 1601 | |
| 185 | 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. | Lviv | Ukraine | 79011 | |
| 186 | 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. | Odesa | Ukraine | 65025 | |
| 187 | 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. | Simferopol | Ukraine | 95017 | |
| 188 | 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. | Ternopil | Ukraine | 46002 | |
| 189 | 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. | Uzhorod | Ukraine | 88018 | |
| 190 | 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. | Vinnytsya | Ukraine | 21018 | |
| 191 | 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. | Zaporizhzhia | Ukraine | 69600 | |
| 192 | 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. | Zhytomyr | Ukraine | 10002 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT -5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01196091
Other Study ID Numbers:
- 13656
- H9B-MC -BCDS
First Posted:
Sep 8, 2010
Last Update Posted:
Jun 12, 2018
Last Verified:
Jun 1, 2018
Keywords provided by Eli Lilly and Company
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Intent to Treat population (ITT) is all randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues. |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose |
| Period Title: Overall Study | |||
| STARTED | 387 | 389 | 388 |
| Received at Least 1 Dose of Study Drug | 386 | 389 | 387 |
| ITT-Received Drug and Excluded Sites | 381 | 378 | 379 |
| Follow-Up | 103 | 105 | 128 |
| COMPLETED | 299 | 291 | 284 |
| NOT COMPLETED | 88 | 98 | 104 |
Baseline Characteristics
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo | Total |
|---|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose | Total of all reporting groups |
| Overall Participants | 381 | 378 | 379 | 1138 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
39.8
(12.51)
|
40.2
(11.21)
|
39.1
(11.69)
|
39.7
(11.82)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
354
92.9%
|
352
93.1%
|
360
95%
|
1066
93.7%
|
| Male |
27
7.1%
|
26
6.9%
|
19
5%
|
72
6.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
119
31.2%
|
116
30.7%
|
122
32.2%
|
357
31.4%
|
| Not Hispanic or Latino |
233
61.2%
|
225
59.5%
|
229
60.4%
|
687
60.4%
|
| Unknown or Not Reported |
29
7.6%
|
37
9.8%
|
28
7.4%
|
94
8.3%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
65
17.1%
|
55
14.6%
|
67
17.7%
|
187
16.4%
|
| Asian |
68
17.8%
|
61
16.1%
|
66
17.4%
|
195
17.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
0.3%
|
0
0%
|
1
0.1%
|
| Black or African American |
40
10.5%
|
41
10.8%
|
39
10.3%
|
120
10.5%
|
| White |
204
53.5%
|
218
57.7%
|
205
54.1%
|
627
55.1%
|
| More than one race |
4
1%
|
2
0.5%
|
2
0.5%
|
8
0.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | ||||
| Colombia |
16
4.2%
|
10
2.6%
|
18
4.7%
|
44
3.9%
|
| Argentina |
20
5.2%
|
24
6.3%
|
22
5.8%
|
66
5.8%
|
| Puerto Rico |
3
0.8%
|
7
1.9%
|
11
2.9%
|
21
1.8%
|
| Singapore |
0
0%
|
2
0.5%
|
0
0%
|
2
0.2%
|
| United States |
128
33.6%
|
133
35.2%
|
116
30.6%
|
377
33.1%
|
| Philippines |
26
6.8%
|
14
3.7%
|
22
5.8%
|
62
5.4%
|
| Japan |
15
3.9%
|
15
4%
|
15
4%
|
45
4%
|
| Egypt |
19
5%
|
19
5%
|
21
5.5%
|
59
5.2%
|
| Ukraine |
23
6%
|
22
5.8%
|
29
7.7%
|
74
6.5%
|
| Thailand |
14
3.7%
|
9
2.4%
|
11
2.9%
|
34
3%
|
| Belarus |
4
1%
|
6
1.6%
|
2
0.5%
|
12
1.1%
|
| Canada |
2
0.5%
|
0
0%
|
2
0.5%
|
4
0.4%
|
| Austria |
3
0.8%
|
3
0.8%
|
1
0.3%
|
7
0.6%
|
| Macedonia |
3
0.8%
|
6
1.6%
|
3
0.8%
|
12
1.1%
|
| Poland |
19
5%
|
16
4.2%
|
19
5%
|
54
4.7%
|
| Guatemala |
13
3.4%
|
17
4.5%
|
13
3.4%
|
43
3.8%
|
| South Korea |
11
2.9%
|
18
4.8%
|
14
3.7%
|
43
3.8%
|
| Italy |
1
0.3%
|
7
1.9%
|
2
0.5%
|
10
0.9%
|
| Bulgaria |
8
2.1%
|
11
2.9%
|
12
3.2%
|
31
2.7%
|
| Chile |
8
2.1%
|
0
0%
|
5
1.3%
|
13
1.1%
|
| Peru |
32
8.4%
|
33
8.7%
|
34
9%
|
99
8.7%
|
| Germany |
12
3.1%
|
5
1.3%
|
7
1.8%
|
24
2.1%
|
| Croatia |
1
0.3%
|
1
0.3%
|
0
0%
|
2
0.2%
|
| Anti-dsDNA Antibody Level (International Units/Milliliter (IU/mL)) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [International Units/Milliliter (IU/mL)] |
107.2
(113.50)
|
110.4
(111.58)
|
107.1
(112.40)
|
108.2
(112.41)
|
| Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA-SLEDAI) Score (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
10.2
(3.5)
|
10.4
(3.6)
|
10.7
(3.9)
|
10.4
(3.7)
|
| Physician's Global Assessment (PGA) Score (millimeters (mm)) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [millimeters (mm)] |
46.3
(15.7)
|
46.1
(16.2)
|
47.1
(16.10)
|
46.5
(16.0)
|
| Time of Onset of Lupus (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
7.5
(7.4)
|
8.1
(7.9)
|
6.4
(6.8)
|
7.3
(7.4)
|
| At Least One BILAG A or Two BILAG B Disease Activity Scores (Count of Participants) | ||||
| Yes |
360
94.5%
|
340
89.9%
|
347
91.6%
|
1047
92%
|
| No |
21
5.5%
|
38
10.1%
|
31
8.2%
|
90
7.9%
|
| Lupus Quality of Life (lupus QOL) Domain Score (units on a scale) [Mean (Standard Deviation) ] | ||||
| Physical Health |
59.2
(24.98)
|
59.1
(25.13)
|
56.9
(26.17)
|
58.4
(25.43)
|
| Emotional Health |
65.7
(25.19)
|
66.7
(23.99)
|
64.6
(26.22)
|
65.7
(25.14)
|
| Body Image |
61.1
(28.99)
|
63.2
(27.67)
|
61.9
(29.20)
|
62.1
(28.61)
|
| Pain |
56.1
(28.40)
|
56.9
(26.75)
|
53.6
(28.62)
|
55.5
(27.95)
|
| Planning |
61.2
(30.37)
|
62.1
(28.69)
|
59.0
(30.92)
|
60.8
(30.01)
|
| Fatigue |
56.0
(26.39)
|
54.4
(25.54)
|
53.4
(27.14)
|
54.6
(26.36)
|
| Intimate Relationships |
56.2
(33.92)
|
63.3
(31.53)
|
56.8
(34.21)
|
58.8
(33.36)
|
| Burden to Others |
52.8
(30.70)
|
51.9
(30.31)
|
49.3
(32.39)
|
51.3
(31.15)
|
| Brief Fatigue Inventory (BFI) Score (Worst Level of Fatigue in the Last 24 Hours) (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
5.8
(2.57)
|
5.6
(2.81)
|
5.6
(2.81)
|
5.6
(2.73)
|
Outcome Measures
| Title | Percentage of Participants Achieving an SLE Responder Index Response at Week 52 |
|---|---|
| Description | Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 9 organ domains; range is from severe (A) to no disease (E). Participants who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to Treat population (ITT) all randomized participants who received at least 1 dose of study drug and evaluable SLE scores, excluding two sites' participants due to good clinical practice (GCP) issues. |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose |
| Measure Participants | 381 | 378 | 379 |
| Number [percentage of participants] |
31.8
8.3%
|
35.2
9.3%
|
29.3
7.7%
|
| Title | Percentage Participants Able to Decrease Dose of Prednisone or Equivalent With No Increase in Disease Activity at Week 52 |
|---|---|
| Description | A participant achieves corticosteroid sparing effects (quiescent disease) if they have met the following criteria during Weeks 24 through 52; able to decrease their dose of prednisone or equivalent to 7.5 mg/day or less, have quiescent disease (BILAG C score or better in all nine systems), and no BILAG A or B flares in the previous three months, without an increase in either antimalarials or immunosuppressants on or prior to the visit. Only participants receiving a prednisone or equivalent dose of more than 7.5 mg/day at baseline are included. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug, a baseline use of prednisone or equivalent >7.5 mg/day, excluding two sites' participants due to good clinical practice (GCP) issues. |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose |
| Measure Participants | 197 | 200 | 196 |
| Number [percentage of partipants] |
15.5
|
17.0
|
16.4
|
| Title | Change From Baseline to 52 Weeks in Anti-double Stranded Deoxyribonucleic Acid (Anti-dsDNA) Level |
|---|---|
| Description | Anti-double stranded deoxyribonucleic acid (anti-dsDNA) is a lab analyte used to assist in the diagnosis of SLE. |
| Time Frame | Baseline, 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues and a non-missing result at Week 52. |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose |
| Measure Participants | 381 | 378 | 377 |
| Mean (Standard Deviation) [international units] |
107.2
(113.50)
|
110.4
(111.58)
|
107.1
(112.40)
|
| Title | Change From Baseline to 52 Week Endpoint in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI2K) Score |
|---|---|
| Description | SLE Disease Activity Index 2000 (SLEDAI-2K) score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. |
| Time Frame | Baseline, 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period. |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose |
| Measure Participants | 377 | 374 | 376 |
| Mean (Standard Deviation) [units on a scale] |
-4.7
(4.35)
|
-4.9
(4.32)
|
-4.6
(4.54)
|
| Title | Time to First Severe SLE Flare (SFI) |
|---|---|
| Description | The SFI uses the SELENA-SLEDAI disease activity index score, disease activity scenarios, treatment changes, and PGA to define mild/moderate and severe flares. The index takes into account the absolute change in total scores, new or worsening symptoms, and increases in corticosteroid use or hospitalization due to the disease activity. Time to first severe SLE flare (SFI) (in days) is calculated as: (Start date of first severe SLE flare (SFI) - Date of randomization + 1). |
| Time Frame | Baseline through 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Zero participants analyzed. Time to first severe SLE flare data was not collected for analysis. |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at first dose. |
| Measure Participants | 0 | 0 | 0 |
| Title | Percentage of Participants With No Worsening in Physician Global Assessment (PGA) Score at 52 Weeks |
|---|---|
| Description | Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100 millimeter (mm) visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores are presented from 0 to 100. No worsening is defined as increase of ≥0.3 points. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose |
| Measure Participants | 381 | 378 | 379 |
| Number [percentage of participants] |
64.3
16.9%
|
61.4
16.2%
|
58.0
15.3%
|
| Title | Change From Baseline to 52 Week Endpoint in Brief Fatigue Inventory (BFI) Scores |
|---|---|
| Description | A participants-reported scale that measures the severity of fatigue based on the worst fatigue experienced during the past 24-hours. The severity scores ranged from 0 (no fatigue) to 10 (fatigue as severe as you can imagine). |
| Time Frame | Baseline, 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period. |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose |
| Measure Participants | 362 | 363 | 361 |
| Mean (Standard Deviation) [units on a scale] |
-0.9
(3.09)
|
-0.9
(3.14)
|
-0.6
(2.86)
|
| Title | Change From Baseline to 52 Week Endpoint Lupus Quality of Life (LupusQoL) Domain Scores |
|---|---|
| Description | The LupusQoL is a disease-specific, 34-item, self-report questionnaire designed to measure the health-related quality of life (HRQoL) of participants with SLE within 8 domains.Responses are based on a 5-point Likert scale where 0 (all of the time) to 4 (never). A LupusQoL score for each domain is reported on a 0 to 100 scale, with greater values indicating better HRQoL. |
| Time Frame | Baseline, 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and a non-missing result. |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose |
| Measure Participants | 381 | 378 | 361 |
| Physical Health |
73.7
(26.05)
|
72.8
(24.53)
|
72.8
(23.70)
|
| Emotional Health |
75.2
(25.50)
|
72.4
(24.08)
|
73.1
(25.54)
|
| Body Language |
75.1
(26.21)
|
75.0
(24.82)
|
71.9
(28.90)
|
| Pain |
74.0
(27.42)
|
74.1
(24.94)
|
73.2
(27.30)
|
| Planning |
77.3
(26.53)
|
75.0
(29.07)
|
74.5
(28.93)
|
| Fatigue |
70.4
(25.51)
|
68.8
(26.34)
|
64.5
(24.94)
|
| Intimate Relationships |
77.4
(29.01)
|
68.8
(34.06)
|
68.7
(30.08)
|
| Burden to Others |
68.7
(30.43)
|
63.5
(30.34)
|
63.7
(30.21)
|
| Title | Time to First New British Isles Lupus Assessment Group (BILAG A) or 2 New BILAG B SLE Flares |
|---|---|
| Description | The British Isles Lupus Assessment Group (BILAG) instrument assesses global disease activity across 9 organ system domains. BILAG flare is assessed for each of the 9 organ domains using BILAG2004 index flare rules; A is a severe flare and B is a moderate flare. Time to first BILAG A or two BILAG B flares (in days) is calculated as: (Start date of first BILAG A or two BILAG B flares - Date of randomization + 1). The two BILAG B flares must occur in different domains at the same visit. |
| Time Frame | Baseline through 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Zero participants analyzed. Time first new British Isles Lupus Assessment Group (BILAG A) or 2 new BILAG B SLE flares data was not collected for analysis. |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose. |
| Measure Participants | 0 | 0 | 0 |
| Title | Change From Baseline to 52 Week Endpoint in PGA |
|---|---|
| Description | Physician's Global Assessment (PGA) is a single-item clinician rated assessment of the patient's current level of disease activity measured on a continuous 100-mm visual analytic scale with benchmarks of 0, 1, 2, and 3 from left to right corresponding to no, mild, moderate, and severe SLE disease activity. Scores range from 0, being worst possible to 100 being very active or best possible. |
| Time Frame | Baseline, 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period. |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose |
| Measure Participants | 375 | 374 | 375 |
| Mean (Standard Deviation) [millimeters] |
-20.8
(21.97)
|
-20.8
(22.33)
|
-20.2
(22.42)
|
| Title | Percentage of Participants With an Increase in Corticosteroids Dose at 52 Weeks |
|---|---|
| Description | An increase in corticosteroids at a visit was defined as a change from baseline greater than 2.5 mg/day in dose or prednisone or equivalent using average daily dose of corticosteroids taken since the previous scheduled visit. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues. |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose |
| Measure Participants | 381 | 378 | 379 |
| Number [percentage of participants] |
6.7
1.8%
|
9.1
2.4%
|
8.8
2.3%
|
| Title | Change From Baseline to 52 Weeks Endpoint in SELENA-SLEDAI Disease Activity Score |
|---|---|
| Description | Safety of Estrogens in Lupus Erythematosus National Assessment - SLE Disease Activity Index (SELENA-SLEDAI) score is a weighted, cumulative index of lupus disease activity. SELENA-SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. |
| Time Frame | Baseline, 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug, excluding 2 sites' participants due to GCP issues and non-missing results; LOCF, defined as: endpoint is defined as the latest post-baseline response obtained on or prior to the date of Week 52 or the date of early discontinuation from the treatment period. |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose |
| Measure Participants | 381 | 378 | 376 |
| Mean (Standard Deviation) [units on a scale] |
-4.6
(4.19)
|
-4.7
(4.11)
|
-4.8
(4.47)
|
| Title | Percentage of Participants Achieving a Response as Measured by Modified SRI With No BILAG A or No More Than 1 BILAG B Organ Domain Flares at 52 Weeks |
|---|---|
| Description | Percentage of participants with a ≥ 5 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of < 0.30 points from baseline) in PGA, and no new BILAG A or no more than 1 new BILAG B organ domain flare compared with baseline. (Primary outcome modified to use BILAG flare instead of BILAG disease score) SELENA SLEDAI is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105. PGA is a visual analog scale scored from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe). BILAG flare is assessed for each of the 9 organ domains; A is a severe flare and B is a moderate flare. Patients who were unable to comply with allowed concomitant medications requirements were considered non-responders, as were participants who dropped out or were missing Week 52 data. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues. |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose |
| Measure Participants | 381 | 378 | 379 |
| Responder |
31.8
8.3%
|
35.2
9.3%
|
29.6
7.8%
|
| Non-Responder |
68.2
17.9%
|
64.8
17.1%
|
70.4
18.6%
|
| Title | Number of Participants With No New BILAG A and No More Than One New BILAG B Disease Activity Scores Compared to Baseline |
|---|---|
| Description | The BILAG2004 index is a validated global disease activity index designed on the basis of the physician's ITT, focusing on changes in disease manifestations (new, improved, worsening, etc) occurring in the last 4 weeks compared with the previous 4 weeks. The instrument assesses 97 clinical signs, symptoms, and laboratory parameters across 9 organ system domains: constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, opthalmic, renal and hematology. |
| Time Frame | Baseline through 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least 1 dose of study drug, excluding two sites' participants due to good clinical practice (GCP) issues. |
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo |
|---|---|---|---|
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose. |
| Measure Participants | 381 | 378 | 379 |
| Count of Participants [Participants] |
247
64.8%
|
234
61.9%
|
219
57.8%
|
Adverse Events
| Time Frame | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All participants who received at least 1 dose of study drug. | |||||||||||
| Arm/Group Title | LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo | LY2127399 Every 2 Weeks, Follow Up | LY2127399 Every 4 Wks, Follow Up | Placebo, Follow Up | ||||||
| Arm/Group Description | LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. | During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. LY2127399: 120 mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. Placebo every 4 weeks: Administered via subcutaneous injection for 52 weeks. | Placebo every 2 weeks: Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose | 24-48 weeks post last dose | 24-48 weeks post last dose | 24-48 weeks post last dose | ||||||
All Cause Mortality |
||||||||||||
| LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo | LY2127399 Every 2 Weeks, Follow Up | LY2127399 Every 4 Wks, Follow Up | Placebo, Follow Up | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo | LY2127399 Every 2 Weeks, Follow Up | LY2127399 Every 4 Wks, Follow Up | Placebo, Follow Up | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 42/386 (10.9%) | 56/389 (14.4%) | 50/387 (12.9%) | 14/103 (13.6%) | 16/105 (15.2%) | 23/128 (18%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Antiphospholipid syndrome | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Autoimmune haemolytic anaemia | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Febrile neutropenia | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Haemorrhagic anaemia | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Histiocytosis haematophagic | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Leukopenia | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Neutropenia | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Thrombocytopenia | 0/386 (0%) | 0 | 2/389 (0.5%) | 3 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Thrombocytosis | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Cardiac disorders | ||||||||||||
| Acute myocardial infarction | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Atrioventricular block complete | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Cardiac arrest | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Cardiac failure | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Cardiac failure congestive | 2/386 (0.5%) | 2 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Coronary artery disease | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 2/387 (0.5%) | 2 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Lupus endocarditis | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Mitral valve prolapse | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Myocarditis | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 2 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Pericarditis | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Supraventricular tachycardia | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Ventricular fibrillation | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||||||||||
| Sickle cell anaemia with crisis | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| Abdominal hernia | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Constipation | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Enterocolitis | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Gastric ulcer | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Gastritis | 2/386 (0.5%) | 2 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Gastritis atrophic | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Gastrointestinal haemorrhage | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Gastrointestinal inflammation | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Gastrooesophageal reflux disease | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Obstruction gastric | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Pancreatitis | 1/386 (0.3%) | 1 | 1/389 (0.3%) | 1 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Pancreatitis acute | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Rectal ulcer | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Varices oesophageal | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Vasculitis gastrointestinal | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Vomiting | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| General disorders | ||||||||||||
| Death | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Generalised oedema | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Non-cardiac chest pain | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 2/387 (0.5%) | 2 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Pyrexia | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Hepatobiliary disorders | ||||||||||||
| Cholecystitis acute | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Cholelithiasis | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Hepatic steatosis | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Immune system disorders | ||||||||||||
| Type III immune complex mediated reaction | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Infections and infestations | ||||||||||||
| Abscess limb | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Appendicitis | 2/386 (0.5%) | 2 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Arthritis bacterial | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Bronchitis | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 2/387 (0.5%) | 2 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Cellulitis | 1/386 (0.3%) | 1 | 2/389 (0.5%) | 2 | 1/387 (0.3%) | 2 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Device related infection | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Disseminated tuberculosis | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Diverticulitis | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Gastroenteritis | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Gastroenteritis norovirus | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Gastroenteritis viral | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Haematoma infection | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Herpes zoster | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Infected skin ulcer | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Klebsiella bacteraemia | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Lung infection | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Mycobacterial infection | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Oral candidiasis | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Osteomyelitis | 1/386 (0.3%) | 1 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Pancreas infection | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Parotitis | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Pharyngotonsillitis | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Pneumonia | 5/386 (1.3%) | 5 | 8/389 (2.1%) | 9 | 4/387 (1%) | 4 | 0/103 (0%) | 0 | 2/105 (1.9%) | 2 | 1/128 (0.8%) | 1 |
| Pneumonia viral | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Post procedural infection | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Pyelonephritis | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Pyelonephritis acute | 1/386 (0.3%) | 1 | 1/389 (0.3%) | 1 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Respiratory tract infection | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Salpingo-oophoritis | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Sepsis | 1/386 (0.3%) | 2 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Sinusitis | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Sinusitis bacterial | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Staphylococcal bacteraemia | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Staphylococcal infection | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Staphylococcal skin infection | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Superinfection bacterial | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Tracheobronchitis | 2/386 (0.5%) | 2 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Upper respiratory tract infection | 3/386 (0.8%) | 3 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Urinary tract infection | 7/386 (1.8%) | 7 | 2/389 (0.5%) | 2 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Viral infection | 1/386 (0.3%) | 1 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||||
| Compression fracture | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Fall | 0/386 (0%) | 0 | 3/389 (0.8%) | 3 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Foot fracture | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Humerus fracture | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Incisional hernia | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Medication error | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Overdose | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Radius fracture | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Spinal fracture | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Tendon rupture | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Thoracic vertebral fracture | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Toxicity to various agents | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Wrist fracture | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Investigations | ||||||||||||
| Haemoglobin decreased | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Weight increased | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| Diabetes mellitus inadequate control | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Fluid overload | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Hyponatraemia | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Arthritis | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Cervical spinal stenosis | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Intervertebral disc degeneration | 0/386 (0%) | 0 | 2/389 (0.5%) | 2 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Intervertebral disc protrusion | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Musculoskeletal chest pain | 0/386 (0%) | 0 | 2/389 (0.5%) | 2 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Osteoarthritis | 1/386 (0.3%) | 1 | 1/389 (0.3%) | 1 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Osteonecrosis | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Pain in extremity | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Polyarthritis | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| SLE arthritis | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Systemic lupus erythematosus | 2/386 (0.5%) | 2 | 4/389 (1%) | 4 | 5/387 (1.3%) | 5 | 4/103 (3.9%) | 4 | 1/105 (1%) | 1 | 2/128 (1.6%) | 3 |
| Tendon disorder | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Breast cancer | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Brenner tumour | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Haemangioma | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Intestinal adenocarcinoma | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Uterine leiomyoma | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| Central nervous system inflammation | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Cerebral venous thrombosis | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Cerebrovascular accident | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 1/103 (1%) | 1 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Convulsion | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Headache | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Ischaemic stroke | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Migraine | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Neuropsychiatric lupus | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Radiculopathy | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Syncope | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Vasculitis cerebral | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Vertebrobasilar insufficiency | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||||||||||
| Abortion spontaneous | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Pre-eclampsia | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Psychiatric disorders | ||||||||||||
| Affect lability | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Affective disorder | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Anxiety | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Depression | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Generalised anxiety disorder | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Major depression | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Mental disorder due to a general medical condition | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Psychotic disorder | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Suicidal ideation | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Suicide attempt | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Renal and urinary disorders | ||||||||||||
| Calculus ureteric | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Glomerulonephritis proliferative | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Lupus cystitis | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Lupus nephritis | 2/386 (0.5%) | 2 | 1/389 (0.3%) | 1 | 4/387 (1%) | 4 | 3/103 (2.9%) | 3 | 0/105 (0%) | 0 | 7/128 (5.5%) | 7 |
| Mesangioproliferative glomerulonephritis | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Nephrolithiasis | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Nephrotic syndrome | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Renal failure | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Renal failure acute | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Renal failure chronic | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||||||
| Adenomyosis | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Ovarian cyst | 1/386 (0.3%) | 1 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 1/105 (1%) | 1 | 0/128 (0%) | 0 |
| Ovarian cyst ruptured | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Pelvic pain | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Asthma | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Atelectasis | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Chronic obstructive pulmonary disease | 1/386 (0.3%) | 1 | 1/389 (0.3%) | 1 | 2/387 (0.5%) | 2 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Pleural effusion | 1/386 (0.3%) | 2 | 1/389 (0.3%) | 1 | 2/387 (0.5%) | 2 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Pleuritic pain | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Pneumonitis | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Pulmonary embolism | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Respiratory failure | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||
| Cutaneous lupus erythematosus | 1/386 (0.3%) | 1 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Erythema multiforme | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Hypersensitivity vasculitis | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Systemic lupus erythematosus rash | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 1/103 (1%) | 1 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Surgical and medical procedures | ||||||||||||
| Female sterilisation | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Vascular disorders | ||||||||||||
| Deep vein thrombosis | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Femoral artery occlusion | 0/386 (0%) | 0 | 1/389 (0.3%) | 1 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Haematoma | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Hypertension | 2/386 (0.5%) | 2 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Thrombosis | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||||||
| LY2127399 Every 2 Weeks | LY2127399 Every 4 Wks | Placebo | LY2127399 Every 2 Weeks, Follow Up | LY2127399 Every 4 Wks, Follow Up | Placebo, Follow Up | |||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 250/386 (64.8%) | 243/389 (62.5%) | 246/387 (63.6%) | 13/103 (12.6%) | 11/105 (10.5%) | 13/128 (10.2%) | ||||||
| Eye disorders | ||||||||||||
| Dry eye | 8/386 (2.1%) | 8 | 3/389 (0.8%) | 3 | 1/387 (0.3%) | 1 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||
| Abdominal pain | 8/386 (2.1%) | 8 | 12/389 (3.1%) | 14 | 12/387 (3.1%) | 12 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Abdominal pain upper | 10/386 (2.6%) | 11 | 11/389 (2.8%) | 12 | 11/387 (2.8%) | 11 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Constipation | 11/386 (2.8%) | 11 | 7/389 (1.8%) | 7 | 11/387 (2.8%) | 11 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Diarrhoea | 22/386 (5.7%) | 26 | 29/389 (7.5%) | 33 | 23/387 (5.9%) | 30 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Dyspepsia | 8/386 (2.1%) | 9 | 8/389 (2.1%) | 8 | 10/387 (2.6%) | 17 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Gastritis | 12/386 (3.1%) | 13 | 6/389 (1.5%) | 6 | 7/387 (1.8%) | 7 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Gastrooesophageal reflux disease | 11/386 (2.8%) | 11 | 7/389 (1.8%) | 7 | 7/387 (1.8%) | 9 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Nausea | 17/386 (4.4%) | 19 | 31/389 (8%) | 42 | 21/387 (5.4%) | 24 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Vomiting | 16/386 (4.1%) | 19 | 14/389 (3.6%) | 17 | 11/387 (2.8%) | 12 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| General disorders | ||||||||||||
| Fatigue | 10/386 (2.6%) | 12 | 15/389 (3.9%) | 16 | 10/387 (2.6%) | 11 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Injection site reaction | 11/386 (2.8%) | 17 | 7/389 (1.8%) | 10 | 6/387 (1.6%) | 8 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Oedema peripheral | 11/386 (2.8%) | 11 | 8/389 (2.1%) | 9 | 10/387 (2.6%) | 11 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Pyrexia | 8/386 (2.1%) | 9 | 10/389 (2.6%) | 14 | 8/387 (2.1%) | 16 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Infections and infestations | ||||||||||||
| Bronchitis | 15/386 (3.9%) | 18 | 19/389 (4.9%) | 19 | 17/387 (4.4%) | 19 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Conjunctivitis | 9/386 (2.3%) | 11 | 8/389 (2.1%) | 10 | 6/387 (1.6%) | 6 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Cystitis | 4/386 (1%) | 5 | 8/389 (2.1%) | 8 | 9/387 (2.3%) | 10 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Gastroenteritis | 10/386 (2.6%) | 11 | 9/389 (2.3%) | 10 | 11/387 (2.8%) | 12 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Herpes zoster | 13/386 (3.4%) | 13 | 4/389 (1%) | 5 | 9/387 (2.3%) | 9 | 1/103 (1%) | 1 | 2/105 (1.9%) | 2 | 3/128 (2.3%) | 3 |
| Influenza | 9/386 (2.3%) | 10 | 5/389 (1.3%) | 5 | 6/387 (1.6%) | 6 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Nasopharyngitis | 29/386 (7.5%) | 46 | 33/389 (8.5%) | 35 | 37/387 (9.6%) | 48 | 3/103 (2.9%) | 3 | 0/105 (0%) | 0 | 1/128 (0.8%) | 1 |
| Oral candidiasis | 6/386 (1.6%) | 7 | 3/389 (0.8%) | 3 | 8/387 (2.1%) | 9 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Pharyngitis | 13/386 (3.4%) | 17 | 18/389 (4.6%) | 19 | 14/387 (3.6%) | 18 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Sinusitis | 16/386 (4.1%) | 22 | 15/389 (3.9%) | 16 | 11/387 (2.8%) | 11 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Upper respiratory tract infection | 55/386 (14.2%) | 86 | 41/389 (10.5%) | 55 | 51/387 (13.2%) | 72 | 3/103 (2.9%) | 3 | 3/105 (2.9%) | 3 | 4/128 (3.1%) | 4 |
| Urinary tract infection | 68/386 (17.6%) | 100 | 52/389 (13.4%) | 76 | 51/387 (13.2%) | 77 | 6/103 (5.8%) | 6 | 2/105 (1.9%) | 2 | 4/128 (3.1%) | 4 |
| Vulvovaginal mycotic infection | 7/386 (1.8%) | 7 | 9/389 (2.3%) | 12 | 8/387 (2.1%) | 11 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||
| Hypertriglyceridaemia | 8/386 (2.1%) | 9 | 4/389 (1%) | 5 | 2/387 (0.5%) | 2 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Hypokalaemia | 9/386 (2.3%) | 11 | 1/389 (0.3%) | 1 | 3/387 (0.8%) | 4 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Arthralgia | 14/386 (3.6%) | 15 | 15/389 (3.9%) | 17 | 11/387 (2.8%) | 14 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Back pain | 15/386 (3.9%) | 15 | 28/389 (7.2%) | 30 | 19/387 (4.9%) | 24 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Muscle spasms | 4/386 (1%) | 5 | 8/389 (2.1%) | 8 | 7/387 (1.8%) | 7 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Musculoskeletal chest pain | 2/386 (0.5%) | 2 | 8/389 (2.1%) | 8 | 8/387 (2.1%) | 8 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Musculoskeletal pain | 1/386 (0.3%) | 1 | 6/389 (1.5%) | 6 | 10/387 (2.6%) | 12 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Myalgia | 9/386 (2.3%) | 11 | 6/389 (1.5%) | 6 | 9/387 (2.3%) | 9 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Pain in extremity | 7/386 (1.8%) | 8 | 5/389 (1.3%) | 7 | 8/387 (2.1%) | 9 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Nervous system disorders | ||||||||||||
| Dizziness | 6/386 (1.6%) | 6 | 19/389 (4.9%) | 31 | 15/387 (3.9%) | 15 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Headache | 34/386 (8.8%) | 48 | 35/389 (9%) | 56 | 45/387 (11.6%) | 54 | 0/103 (0%) | 0 | 3/105 (2.9%) | 3 | 0/128 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||||||||||
| Pregnancy | 0/386 (0%) | 0 | 0/389 (0%) | 0 | 0/387 (0%) | 0 | 0/103 (0%) | 0 | 2/105 (1.9%) | 2 | 1/128 (0.8%) | 1 |
| Psychiatric disorders | ||||||||||||
| Anxiety | 6/386 (1.6%) | 7 | 8/389 (2.1%) | 8 | 6/387 (1.6%) | 7 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Depression | 7/386 (1.8%) | 7 | 12/389 (3.1%) | 13 | 12/387 (3.1%) | 12 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Insomnia | 22/386 (5.7%) | 22 | 17/389 (4.4%) | 17 | 16/387 (4.1%) | 17 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Cough | 10/386 (2.6%) | 11 | 12/389 (3.1%) | 13 | 18/387 (4.7%) | 18 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||||||
| Rash | 5/386 (1.3%) | 5 | 6/389 (1.5%) | 6 | 10/387 (2.6%) | 11 | 0/103 (0%) | 0 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
| Vascular disorders | ||||||||||||
| Hypertension | 14/386 (3.6%) | 14 | 13/389 (3.3%) | 13 | 20/387 (5.2%) | 21 | 4/103 (3.9%) | 4 | 0/105 (0%) | 0 | 0/128 (0%) | 0 |
Limitations/Caveats
Due to product program termination, not all analyses were completed.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01196091
Other Study ID Numbers:
- 13656
- H9B-MC -BCDS
First Posted:
Sep 8, 2010
Last Update Posted:
Jun 12, 2018
Last Verified:
Jun 1, 2018