Trial · NCT02847598
Outcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24 | Baseline to Week 24 | MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure. | joints | MEAN |
| PRIMARY | Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16 | Baseline to Week 16 | MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure. | percent change | MEAN |
| SECONDARY | Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24 | Week 24 | MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies those with baseline CLASI-A \>=8 following protocol amendment. | percentage of participants | NUMBER |
| SECONDARY | Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16 | Week 12, Week 16 | MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number analyzed signifies number of participants analyzed at specific timepoint. | percentage of participants | NUMBER |
| SECONDARY | Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24 | Baseline, Week 12, 16 and 24 | MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure and number analyzed signifies number of participants analyzed at specific timepoint. | percent change | MEAN |
| SECONDARY | Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 | Baseline, Week 12 | MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participant analyzed in this outcome measure. | percent change | MEAN |
| SECONDARY | Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24 | Week 24 | MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 12, Week 16 | MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of analyzed signifies number of participants analyzed at specific timepoint. | percentage of participants | NUMBER |
| SECONDARY | Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24 | Week 24 | MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16 | Week 12, Week 16 | MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number analyzed signifies number of participants analyzed at specific timepoint. | percentage of participants | NUMBER |
| SECONDARY | Part A: Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index >=4 (SRI-4) at Week 24 | Week 24 | MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). | percentage of participants | NUMBER |
| SECONDARY | Part A: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24 | Baseline to Week 24 | MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure. | score on a scale | MEAN |
| SECONDARY | Part A: Percentage of Participants With no New Organ System Affected at Week 24 | Week 24 | MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). | percentage of participants | NUMBER |
| SECONDARY | Part A: Change From Baseline in Physician's Global Assessment (PGA) of SLE Visual Analog Scale (VAS) Score at Week 24 | Baseline to Week 24 | MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, number of participants analyzed signifies number of participants analyzed in this outcome measure. | score on a scale | MEAN |
| SECONDARY | Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 36 | Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Week 28 | Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | Baseline up to Week 36 | Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part B: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | Baseline up to Week 28 | Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Number of Participants With Clinically Significant Vital Sign Abnormalities | Baseline up to Week 36 | Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities | Baseline up to Week 28 | Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment 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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GET https://conductscience.org/api/trials/v1/NCT02847598/outcomes