Trial · NCT02265744
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 34
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169 | 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. |
| Secondary | Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169 | 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) |
| Secondary | Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85 | 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) |
| Secondary | Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85 | 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. |
| Secondary | Mean Change From Baseline in CLASI Score at Day 85 and Day 169 | 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. |
| 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 | 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. |
| 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 | At baseline, 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) |
| Secondary | Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169 | At baseline, 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. |
| Secondary | Cumulative Corticosteroid and Immunosuppressant Use | 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 | Percent of participants requiring use of corticosteroids and mmunosuppressants use over time |
| Secondary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest | 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 | 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 |
| Secondary | Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate | At Day 85 and Day 169 | HEART RATE (HR) Beats per min (BPM): HR \> 100 AND CHANGE FROM BASELINE \> 30 OR HR \< 55 AND CHANGE FROM BASELINE \< -15 |
| Secondary | Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure | At Day 85 and Day 169 | 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; |
| Secondary | Percentage of Participants With Clinically Significant Changes in Vital Signs: Respiration Rate | At Day 85 and Day 169 | RESPIRATION RATE (RESP) (PER MIN) RESP \> 16 OR RESP CHANGE FROM BASELINE \> 10 |
| Secondary | Percentage of Participants With Clinically Significant Changes in Vital Signs: Temperature | At Day 85 and Day 169 | TEMPERATURE (TEMP) (C) TEMP \> 38.3 OR TEMP CHANGE FROM BASELINE \> 1.6 |
| Secondary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | 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. | QTc (corrected QT) Fridericia, PR Interval, QRS Interval and Change from baseline in QTCF |
| Secondary | Ctrough: Trough Level Serum Concentration of BMS-931699 at Time Point Specified | Day 169 | 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. |
| Secondary | Serum Biomarkers C3, C4 | At Day 85 and Day 169 | 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 |
| Secondary | Serum Biomarkers: Anti-Nuclear Antibodies (ANA) | At Day 85 and Day 169 | 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 |
| Secondary | Short Term: Receptor Occupancy Over Time | At Day 85 and Day 169 | Percent CD4+ Receptor Occupancy and percent CD8+ Receptor Occupancy |
| Secondary | Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified | Day 169 | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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