Trial · NCT02307513
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 | Area Under the Curve (AUC) for the Number of Oral Ulcers From Baseline Through Week 12 (AUC W0-12) | Oral ulcers were assessed at weeks 0 (baseline), 1, 2, 4, 6, 8, 10, and 12 during the placebo-controlled period. | The intent to treat (ITT) population included all randomized participants who received at least 1 dose of study drug. Multiple imputation (MI) was used to impute missing oral ulcer counts. | Ulcers*days | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Oral Ulcer Pain as Measured by Visual Analog Scale (VAS) at Week 12 | Baseline to week 12 | The ITT population with available baseline data. Last observation carried forward (LOCF) imputation was used. LOCF is the last observation (baseline value if no post-baseline assessment) is carried forward for missing values at week 12. | mm | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Activity as Measured by Behçet's Syndrome Activity Score (BSAS) at Week 12 | Baseline to week 12 | The intent to treat population with available baseline data. LOCF imputation was used for missing values at week 12. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Behçet's Disease Current Activity Index (BDCAI) at Week 12 | Baseline to week 12 | The intent to treat population with available baseline data. LOCF imputation was used for missing values at week 12. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Patient's Perception of Disease Activity at Week 12 | Baseline to week 12 | The intent to treat population with available data. LOCF imputation was used for missing values at week 12. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Disease Activity as Measured by Behçet's Disease Current Activity Form (BDCAF): Clinician's Overall Perception of Disease Activity at Week 12 | Baseline to week 12 | The intent to treat population with available baseline data. LOCF imputation was used for missing values at week 12. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved an Oral Ulcer Complete Response (Oral Ulcer-Free) by Week 6 and Remained Oral Ulcer-Free for at Least 6 Additional Weeks | Baseline to week 12 | The intent to treat population | Percentage of participants | NUMBER |
| SECONDARY | Time to Oral Ulcer Resolution (Complete Response) | Baseline to week 12 | The intent to treat population | Weeks | MEDIAN |
| SECONDARY | Percentage of Participants Who Experienced an Oral Ulcer Complete Response at Week 12 | Week 12 | The intent to treat population; participants with missing data at week 12 were classified as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Behçet's Disease Quality of Life (BD Qol) Scores at Week 12 | Baseline to week 12 | The intent to treat population. LOCF was used for missing values at week 12. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Experienced a Complete Response For Genital Ulcers at Week 12 | Week 12 | The intent to treat population who had genital ulcers at baseline. Participants with missing data at week 12 were classified as non-responders. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With no Oral Ulcers Following a Complete Response | Baseline to week 12 | The intent to treat population who had a complete response prior to week 12. | Percentage of participants | NUMBER |
| SECONDARY | Time to Recurrence of Oral Ulcers Following Loss of Complete Response | Baseline through week 12 | The intent to treat population who had a complete response prior to week 12. | Weeks | MEDIAN |
| SECONDARY | Number of Oral Ulcers Following Loss of Complete Response Through Week 12 | Baseline to week 12 | The intent to treat population who had a complete response prior to week 12. | oral ulcers | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Total Score of the Static Physician's Global Assessment (PGA) of Skin Lesions of BD at Week 12 | Baseline to week 12 | The intent to treat population who had BD skin lesions at baseline. LOCF imputation was used for missing values at week 12. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Genital Ulcer Pain as Measured by VAS Score at Week 12 | Baseline to week 12 | The intent to treat population who had genital ulcers at baseline. The last observation (baseline value if no post-baseline assessment) was carried forward for missing values at week 12. | mm | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo-controlled Treatment Period | From first dose of study drug in the placebo-controlled phase to the first dose of apremilast in the active treatment phase (12 weeks) or up to 28 days after last dose for participants who did not receive study drug at week 12, whichever was earlier. | The safety population included all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs During the Apremilast-Exposure Period | From first dose of apremilast (week 0 for those assigned to apremilast or week 12 for those assigned to placebo) up to 28 days after last dose; up to 56 weeks and 68 weeks in each arm respectively. | The apremilast as treated (AAT) population includes participants who received at least 1 dose of apremilast at any time during the study. | 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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02307513/outcomes