Trial · NCT02070978
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With at Least One Serious Adverse Event (SAE) During the Treatment Period | Baseline (LTE Day 1) up to maximum treatment duration of 143.7 weeks | The safety analyses set included all participants enrolled into the LTE study and who received at least 1 dose of planned study treatment. Participants were analyzed according to the actual treatment they received. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Prematurely Discontinued the Treatment Due to Adverse Event (AE) | Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks | The safety analyses set included all participants enrolled into the LTE study and who received at least 1 dose of planned study treatment. Participants were analyzed according to the actual treatment they received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores | Baseline: Day 1 (Core Study), Day 1 (LTE Study), Week 24, Week 48, Week 72 and Week 96 | Modified intent-to-treat (mITT) analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Disease Activity as Measured by British Isles Lupus Assessment Group (BILAG) 2004 Score | Baseline: Core study Screening, LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Disease Activity as Measured by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score | Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here, Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Disease Activity as Measured by SLEDAI-2K Responder Index-50 (SRI-50) Score | Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | Data was not collected for this endpoint as the results from ADDRESS II core study (700461-023; NCT01972568) for SRI-50 were not significant. Therefore, data collection for the SRI-50 for current study (700461-024; NCT02070978) was halted and no analysis was conducted for endpoint. | ||
| SECONDARY | Change From Baseline in Disease Activity as Measured by Physician's Global Assessment (PGA) Score | Baseline: Screening Visit (Core Study); LTE Day1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Units on a scale | MEAN |
| SECONDARY | Number of Participants Who Achieved SLE Responder Index (SRI-4) Response (a Disease Activity Composite Index) | Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was used. For this outcome measure, baseline was measured as reference timepoint for response in the screening visit from core study. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Achieved BILAG-based Combined Lupus Assessment (BICLA) Response (a Disease Activity Composite Index) | Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT BILAG analysis set included mITT population with at least one BILAG A and/or B at screening visit. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change From Baseline in Prednisone-equivalent Corticosteroid Dose | Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Percent change | MEAN |
| SECONDARY | Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score | Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score | Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72, and Week 96 | mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Units on a scale | MEAN |
| SECONDARY | Number of Participants With Patient Global Impression of Change (PGIC) | Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in EuroQoL 5 Dimension Instrument (EQ-5D) Score | Baseline: Day 1 (Core Study), LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores | Baseline: Day 1 (Core Study), LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | mm | MEAN |
| SECONDARY | Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score | Baseline: Day 1 (Core study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96 | mITT analysis set was defined as all enrolled participants in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here Number Analyzed signifies those participants who were evaluable for this outcome measure at specified categories. | Units on a scale | MEAN |
| SECONDARY | Number of Participants With at Least One Adverse Event | Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks | The safety analyses set included all participants enrolled into the LTE study and who received at least 1 dose of planned study treatment. Participants were analyzed according to the actual treatment they received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Score | LTE Day 1, Week 24, Week 48, Week 72 and Week 98 | The safety analyses set included all participants enrolled into the LTE study and who received at least 1 dose of planned study treatment. Participants were analyzed according to the actual treatment they received. | Participants | COUNT_OF_PARTICIPANTS |
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.
For software
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