| Primary | Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169 | The British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) is a measure of systemic lupus erythematosus (SLE) response. BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline. | All Randomized and Treated participants | Posted | | Number | 90% Confidence Interval | Percentage of participants | | At Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | Subjects received 1.25 mg lulizumab pegol SC injection EOW | | OG004 | Placebo Comparator: 0mg SC Weekly BMS-931699 | Subjects received 0 milligram (mg) subcutaneous (SC) injection of matching placebo weekly. |
| | Units | Counts |
|---|
| Participants | - OG00069
- OG00168
- OG00268
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00059.4(49.7 to 69.1)
- OG00163.2(53.6 to 72.9)
- OG00257.4(47.5 to 67.2)
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Chi-squared | Nominal p-values that are not adjusted for multiplicity. | 0.9745 | | | | | | | | | | | | | | Superiority | | | | | Chi-squared | Nominal p-values that are not adjusted for multiplicity. |
|
| Secondary | Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169 | SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(4) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 4 points AND (a)no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline) AND (b) no new BILAG-2004 Index A organ system score AND (c)no more than one new or worsening BILAG-2004 Index B organ system scores. An SRI(5) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 5 points AND (a) AND (b) AND (c). An SRI(6) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 6 points AND (a) AND (b) AND (c) The outcomes are better in increasing order from SRI(4) to SRI(5) to SRI(6) | All randomized and treated participants | Posted | | Number | 90% Confidence Interval | Percentage of participants | | At Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 |
|
| Secondary | Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85 | SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(4) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 4 points AND (a)no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline) AND (b) no new BILAG-2004 Index A organ system score AND (c)no more than one new or worsening BILAG-2004 Index B organ system scores. An SRI(5) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 5 points AND (a) AND (b) AND (c). An SRI(6) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 6 points AND (a) AND (b) AND (c) The outcomes are better in increasing order from SRI(4) to SRI(5) to SRI(6) | All Randomized and Treated participants | Posted | | Number | 90% Confidence Interval | Percentage of participants | | At Day 85 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 |
|
| Secondary | Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85 | BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale [VAS]) compared to Baseline; No changes in concomitant medications according to the following criteria: No increase of or addition of a new immunosuppressant agent (azathioprine,mycophenolic acid/mycophenolate mofetil, methotrexate, anti-malarial, leflunomide) over baseline levels; No increase in corticosteroid dose above baseline level outside of those allowed per protocol. | All Randomized and Treated Participants | Posted | | Number | 90% Confidence Interval | Percentage of participants | | At Day 85 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. |
|
| Secondary | Mean Change From Baseline in CLASI Score at Day 85 and Day 169 | Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 with higher scores denoting greater disease activity or damage. | All Randomized and Treated Subjects | Posted | | Mean | Standard Deviation | Scores on a scale | | At Day 85 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | Subjects received 1.25 mg lulizumab pegol SC injection EOW | |
|
| Secondary | Percentage of Participants With an Improvement of >4 or a Decrease of >50% From Baseline in Their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Score | Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 with higher scores denoting greater disease activity or damage. | All randomized and treated participants | Posted | | Number | 90% Confidence Interval | Percentage of participants | | At Day 85 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | |
|
| Secondary | Change From Baseline in Arthritis, as Assessed by American College of Rheumatology (ACR) 28-joint Count of Tender and Swollen Joints on Day 85 and Day 169 | Mean Change from Baseline Over Time; Measured by Disease Activity Score 28: A single score on a continuous scale (0-9.4). The level of RA disease activity can be interpreted as low (DAS28 <=3.2),moderate (3.2 < DAS28 <=5.1), or as high disease activity (DAS28 > 5.1) | All Randomized and Treated Participants | Posted | | Mean | Standard Deviation | Scores on a scale | | At baseline, Day 85 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week |
|
| Secondary | Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169 | Overall British Isles Lupus Assessment Group-2004 score, BILAG Scores: A=Severe disease activity, B=Moderate disease activity, C=Mild disease, D=Inactive disease but previously affected, E=System never involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity. | All randomized and treated participants | Posted | | Mean | Standard Deviation | Score | | At baseline, Day 85 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week |
|
| Secondary | Cumulative Corticosteroid and Immunosuppressant Use | Percent of participants requiring use of corticosteroids and mmunosuppressants use over time | All randomized and treated participants | Posted | | Number | | Percentage of participants | | Up to one day prior to the first dose of long-term extension period or up to 42 days post last short-term dose date, which ever is earlier | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | Subjects received 1.25 mg lulizumab pegol SC injection EOW |
|
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest | Although there are no identified risks for BMS-931699, BMS has developed a list of events of special interest for the BMS-931699 program based on the known biologic class effects, the mechanism of action of BMS-931699, overall potential consequences of mmunosuppression, and preliminary data from unblinded clinical trials. Event categories of special interest for this study may include, but are not limited to: Infections, Autoimmunity, Malignancies, Injection-related reactions | | Posted | | Count of Participants | | Participants | | On or after the first dose date of short-term study medication and up to 42 days post last short-term dose date or up to the day prior to the first dose of long-term extension period, whichever is earlier | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | |
|
| Secondary | Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate | HEART RATE (HR) Beats per min (BPM): HR > 100 AND CHANGE FROM BASELINE > 30 OR HR < 55 AND CHANGE FROM BASELINE < -15 | | Posted | | Number | | Percentage of participants | | At Day 85 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | Subjects received 1.25 mg lulizumab pegol SC injection EOW | | OG004 |
|
| Secondary | Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure | SYSTOLIC BLOOD PRESSURE (SYSBP) (MMHG); SYSBP > 140 AND CHANGE FROM BASELINE > 20 OR SYSBP < 90 AND CHANGE FROM BASELINE < -20; DIASTOLIC BLOOD PRESSURE (DIABP) > 90 AND CHANGE FROM BASELINE > 10 OR DIABP < 55 AND CHANGE FROM BASELINE < -10; | | Posted | | Number | | Percentage of participants | | At Day 85 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | Subjects received 1.25 mg lulizumab pegol SC injection EOW |
|
| Secondary | Percentage of Participants With Clinically Significant Changes in Vital Signs: Respiration Rate | RESPIRATION RATE (RESP) (PER MIN) RESP > 16 OR RESP CHANGE FROM BASELINE > 10 | | Posted | | Number | | Percentage of participants | | At Day 85 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | Subjects received 1.25 mg lulizumab pegol SC injection EOW | | OG004 | Placebo Comparator: 0mg SC Weekly BMS-931699 |
|
| Secondary | Percentage of Participants With Clinically Significant Changes in Vital Signs: Temperature | TEMPERATURE (TEMP) (C) TEMP > 38.3 OR TEMP CHANGE FROM BASELINE > 1.6 | | Posted | | Number | | Percentage of participants | | At Day 85 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | Subjects received 1.25 mg lulizumab pegol SC injection EOW | | OG004 | Placebo Comparator: 0mg SC Weekly BMS-931699 |
|
| Secondary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | QTc (corrected QT) Fridericia, PR Interval, QRS Interval and Change from baseline in QTCF | | Posted | | Count of Participants | | Participants | | Up to 42 days post last dose of short-term double-blind study medication or up to the day prior to the start of long-term extension period, whichever is earlier. | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | Subjects received 1.25 mg lulizumab pegol SC injection EOW |
|
| Secondary | Ctrough: Trough Level Serum Concentration of BMS-931699 at Time Point Specified | Pharmacokinetics of BMS-931699 derived from serum concentration versus time data; Ctrough = Trough level serum concentration of BMS-931699 at time point specified Pharmacokinetic Population: defined as all subjects who receive any study medication and have any available concentration-time data. | Pharmacokinetic population | Posted | | Mean | Standard Deviation | ng/mL | | Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | Subjects received 1.25 mg lulizumab pegol SC injection EOW |
|
| Secondary | Serum Biomarkers C3, C4 | Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169 | All Treated participants with at Least One Post-Treatment Biomarker Measurement | Posted | | Mean | Standard Deviation | g/L | | At Day 85 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | Subjects received 1.25 mg lulizumab pegol SC injection EOW |
|
| Secondary | Serum Biomarkers: Anti-Nuclear Antibodies (ANA) | Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169. No anti-dsDNA data was available for this report | All Treated participants with at Least One Post-Treatment Biomarker Measurement | Posted | | Number | | Percentage | | At Day 85 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | Subjects received 1.25 mg lulizumab pegol SC injection EOW |
|
| Secondary | Short Term: Receptor Occupancy Over Time | Percent CD4+ Receptor Occupancy and percent CD8+ Receptor Occupancy | All Treated participants with at Least One Post-Treatment Biomarker Measurement | Posted | | Mean | Standard Deviation | Percentage | | At Day 85 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | Subjects received 1.25 mg lulizumab pegol SC injection EOW | | OG004 | Placebo Comparator: 0mg SC Weekly BMS-931699 |
|
| Secondary | Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified | Immunogenicity defined as positive for anti-drug antibodies post-baseline measurement if baseline missing or negative. If baseline is positive, then immunogenicity is defined as a positive post-baseline measurement with titer value 4 times greater than baseline. (A) all subjects with a laboratory reported positive antibody responses to BMS-931699 during the short-term double-blind treatment period are included. Overall: At least one positive sample relative to baseline during short-term double-blind and follow-up period. | All Treated participants with at Least One Post-Treatment Immunogenicity Assessment Who Developed Laboratory Reported Positive Antibody Responses to BMS-931699 | Posted | | Number | | Percentage of participants | | Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. |
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I | HEMATOLOGY I: ERYTHROCYTE/PLATELET ATTRIBUTES HEMOGLOBIN G/L L < 0.85×PRE-RX; HEMATOCRIT VOL L < 0.85×PRE-RX; PLATELET COUNT X10*9 C/L H > 1.5×ULN (ULN = Upper Limit of Normal) IF PRE-RX IS MISSING OR > 1.5×ULN PLATELET COUNT X10*9 C/L L < 0.85×LLN (LLN = Lower Limit of Normal) IF PRE-RX IS MISSING OR < 0.85×LLN IF PRE-RX >= LLN OR < 0.85×PRE-RX IF PRE-RX < LLN; ERYTHROCYTES RBC X10*12 C/L L < 0.85×PRE-RX HEMATOLOGY II QUANTITATIVE WBC : LEUKOCYTES X10*9 C/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF LLN <= PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; LEUKOCYTES WBC X10*9 C/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF LLN <= PRE-RX <= ULN OR < 0.85×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN | | Posted | | Number | | Participants | | Up to 42 days post last dose of study medication in short-term or long-term extension period | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week |
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II | WBC DIFFERENTIAL COUNT: BASOPHILS (ABSOLUTE) X10*9 C/L H > 0.4; BLASTS (ABSOLUTE) X10*9 C/L H > 0; EOSINOPHILS (ABSOLUTE) EOSA X10*9 C/L H > 0.75; LYMPHOCYTES (ABSOLUTE) X10*9 C/L H > 7.5; LYMPHOCYTES (ABSOLUTE) X10*9 C/L L < 0.75; MONOCYTES (ABSOLUTE) X10*9 C/L H > 2; NEUTROPHILS (ABSOLUTE) X10*9 C/L L < 1.5 IF PRE-RX IS MISSING OR < 1.5 IF PRE-RX >= 1.5 OR < 0.85×PRE-RX IF PRE-RX < 1.5; COAGULATION activated Partial thromboplastin time (APTT) SEC H > 1.5×ULN; INTL NORMALIZED RATIO (INR) INR FRACTION H > 1.5×ULN PROTHROMBIN TIME (PT) PT SEC H > 1.5×ULN | | Posted | | Number | | Participants | | Up to 42 days post last dose of study medication in short-term or long-term extension period | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. |
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS | LIVER FUNCTION TESTS:ALKALINE PHOSPHATASE (ALP) ALP U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; BILIRUBIN, DIRECT UMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN G-GLUTAMYL TRANSFERASE (GGT) GGT U/L H > 1.15×ULN IF PRE-RX IS MISSING OR > 1.15×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN BILIRUBIN, TOTAL UMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN | | Posted | | Number | | Participants | | Up to 42 days post last dose of study medication in short-term or long-term extension period | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | |
|
| Secondary | Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS | KIDNEY FUNCTION TESTS:BLOOD UREA NITROGEN MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN CREATININE UMOL/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 1.33×PRE-RX IF PRE-RX > ULN GLOMERULAR FILTRATION RATE, CALC. ML/S/M*2 L < 0.8×PRE-RX; UREA UREA MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN | | Posted | | Number | | Participants | | Up to 42 days post last dose of study medication in short-term or long-term extension period | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | |
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| Secondary | Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1 | CALCIUM, TOTAL MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; CALCIUM, TOTAL MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; CHLORIDE, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; CHLORIDE, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; | | Posted | | Number | | Participants | | Up to 42 days post last dose of study medication in short-term or long-term extension period | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. |
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| Secondary | Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2 | BICARBONATE MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; BICARBONATE MMOL/L L < 0.8×LLN IF PRE-RX IS MISSING OR < 0.8×LLN IF PRE-RX >= LLN OR < 0.8×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; POTASSIUM, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN; POTASSIUM, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; MAGNESIUM, SERUM MMOL/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN MAGNESIUM, SERUM MMOL/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN | | Posted | | Number | | Participants | | Up to 42 days post last dose of study medication in short-term or long-term extension period | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. |
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| Secondary | Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 3 | SODIUM, SERUM MMOL/L H > 1.05×ULN IF PRE-RX IS MISSING OR > 1.05×ULN IF PRE-RX <= ULN OR > 1.05×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN SODIUM, SERUM MMOL/L L < 0.95×LLN IF PRE-RX IS MISSING OR < 0.95×LLN IF PRE-RX >= LLN OR < 0.95×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN PHOSPHORUS, INORGANIC PHOS MMOL/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN PHOSPHORUS, INORGANIC PHOS MMOL/L L < 0.85×LLN IF PRE-RX IS MISSING OR < 0.85×LLN IF PRE-RX >=LLN OR < 0.85×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN | | Posted | | Number | | Participants | | Up to 42 days post last dose of study medication in short-term or long-term extension period | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | |
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| Secondary | Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1 | GLUCOSE TESTS:GLUCOSE, FASTING SERUM MMOL/L H > 1.3×ULN IF PRE-RX IS MISSING OR > 1.3×ULN IF PRE-RX <= ULN OR > 2×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN GLUCOSE, FASTING SERUM MMOL/L L < 0.8×LLN IF PRE-RX IS MISSING OR < 0.8×LLN IF PRE-RX >= LLN OR < 0.8×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN; PROTEIN TESTS:ALBUMIN G/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN PROTEIN, TOTAL G/L H > 1.1×ULN IF PRE-RX IS MISSING OR > 1.1×ULN IF PRE-RX <= ULN OR > 1.1×PRE-RX IF PRE-RX > ULN OR > ULN IF PRE-RX < LLN PROTEIN, TOTAL G/L L < 0.9×LLN IF PRE-RX IS MISSING OR < 0.9×LLN IF PRE-RX >= LLN OR < 0.9×PRE-RX IF PRE-RX < LLN OR < LLN IF PRE-RX > ULN | | Posted | | Number | | Participants | | Up to 42 days post last dose of study medication in short-term or long-term extension period | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week |
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| Secondary | Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2 | OTHER CHEMISTRY TESTING LIPID TESTS: CHOLESTEROL, TOTAL (TC) MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.2×PRE-RX IF PRE-RX > ULN TRIGLYCERIDES, FASTING MMOL/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN PANCREATIC TESTS: AMYLASE, TOTAL U/L H > 1.5×ULN; LIPASE, TOTAL (TURBIDIMETRIC ASSAY) U/L H > 1.5×ULN; LIPASE, TOTAL (COLORIMETRIC ASSAY) U/L H > 1.5×ULN; ENDOCRINE TESTS:CORTISOL, AM NMOL/L L < 138 THYROID STIMULATING HORMONE (TSH) TSH MU/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 2×PRE-RX IF PRE-RX > ULN | | Posted | | Number | | Participants | | Up to 42 days post last dose of study medication in short-term or long-term extension period | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | |
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| Secondary | Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3 | OTHER CHEMISTRY TESTING CARDIAC TESTS: CREATINE KINASE (CK) CK U/L H > 1.5×ULN IF PRE-RX IS MISSING OR > 1.5×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN; TROPONIN-I, CARDIAC SPECIFIC UG/L H > ULN; METABOLITE TESTS:URIC ACID URIC MMOL/L H > 1.2×ULN IF PRE-RX IS MISSING OR > 1.2×ULN IF PRE-RX <= ULN OR > 1.25×PRE-RX IF PRE-RX > ULN; CHEM TEST, MULTI INDICATIONS : LACTATE DEHYDROGENASE (LD) LD U/L H > 1.25×ULN IF PRE-RX IS MISSING OR > 1.25×ULN IF PRE-RX <= ULN OR > 1.5×PRE-RX IF PRE-RX > ULN | | Posted | | Number | | Participants | | Up to 42 days post last dose of study medication in short-term or long-term extension period | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. |
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| Secondary | Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : IMMUNOLOGY | IMMUNE ACTIVATION MARKERS:C-REACTIVE PROTEIN (CRP) CRP MG/L H > 1.5×ULN; CRP, HIGH SENSITIVITY MG/L H > 1.5×ULN; | | Posted | | Number | | Participants | | Up to 42 days post last dose of study medication in short-term or long-term extension period | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | Subjects received 1.25 mg lulizumab pegol SC injection EOW | |
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| Secondary | Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS | QUALITATIVE URINE CHEMISTRY: BLOOD, URINE N/A H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 GLUCOSE, URINE N/A H >= 1 IF PRE-RX IS MISSING OR >= 1 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 PROTEIN, URINE UNKNOWN H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 1 OR >= 2×PRE-RX IF PRE-RX >= 1 URINALYSIS II URINE WBC + RBC ; RBC, URINE HPF H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 2 OR >= 4 IF PRE-RX >= 2 WBC, URINE HPF H >= 2 IF PRE-RX IS MISSING OR >= 2 IF PRE-RX < 2 OR >= 4 IF PRE-RX >= 2 | | Posted | | Number | | Participants | | Up to 42 days post last dose of study medication in short-term or long-term extension period | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. |
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| Secondary | Change From Baseline in the SLEDAI-2K Score of SLE Activity on Day 85 and Day 169 | Systemic Lupus Erythematosus Disease Activity Index, SLEDAI; Version 2000, also known as SLEDAI-2K. The 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. | All randomized and treated participants | Posted | | Mean | Standard Deviation | Score | | At baseline, Day 85 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | |
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| Secondary | Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) on Day 85 and Day 169 | Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very good and 100 mm = very bad. | All randomized and treated participants | Posted | | Mean | Standard Deviation | Score | | At baseline, Day 85 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | Experimental: 12.5mg SC BMS-931699 Weekly | Subjects received 12.5 mg SC injection of lulizumab pegol weekly. | | OG001 | Experimental: 12.5mg SC BMS-931699 Every Other Week | Subjects received 12.5 mg SC injection of lulizumab pegol EOW. | | OG002 | Experimental: 5mg SC Injection BMS-931699 Every Other Week | Subjects received 5 mg SC injection of lulizumab pegol EOW. | | OG003 | Experimental: 1.25mg SCBMS-931699 Every Other Week | Subjects received 1.25 mg lulizumab pegol SC injection EOW |
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