Trial · NCT00866359
A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease
NCT00866359, Phase 2, Completed, Amgen; results first posted 2014-08-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease. Trials, record NCT00866359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00866359
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease
- NCT number
- NCT00866359
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 111 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Behcet Syndrome
- Interventions
- Apremilast (CC-10004), Placebo
- First posted
- 2009-03-20
- Last updated
- 2020-06-19
- Other registries' IDs
- eudract:2008-002722-11
- Results first posted
- 2014-08-27
- Limitations and caveats
- Planned sample size not reached; slow enrollment
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Oral Ulcers at Day 85 | Day 85 | The number of oral ulcers were counted at each visit and at the end of the treatment period (starting point was at baseline). |
| Secondary | Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85 | Day 85 | A 100-mm VAS pain scale for oral ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. |
| Secondary | Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) Scores at Day 85 | Baseline to Day 85 | A 100-mm VAS pain scale for genital ulcers was completed by the participant at timepoints specified in the protocol. Each 100-mm VAS was presented to the participant on a single sheet of bond paper. The participant was asked to draw a single line perpendicular to the VAS line at the point that represented the severity of their pain during the previous week, with 0 mm (the left-hand end of the scale) representing no pain and 100 mm (the right-hand end of the scale) representing the worst pain imaginable. The distance of the perpendicular line from the left-hand end of the scale was measured by ruler and recorded. When responding to a VAS item, participants specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. |
| Secondary | Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85 | Day 1 to Day 85 | Area under curve (AUC\^85) from Day 1 to Day 85 for the number of oral ulcers per day was determined using the trapezoidal rule and divided by the days between the date of the last observation and baseline. The AUC was determined using the LOCF approach to impute missing values. |
| Secondary | Area Under the Curve for the Number of Genital Ulcers From Day 1 to 85 | Day 1 to Day 85 | Area under curve (AUC\^85) from Day 1 to Day 85 for the number of genital ulcers per day was not analyzed. |
| Secondary | Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85 | Day 1 to Day 85 | Area under curve (AUC) from Day 1 to Day 85 (AUC\^85) for the number of oral plus genital ulcers per day was determined using the trapezoidal rule and divided by the days between the date of the last observation and baseline. The AUC was determined using the LOCF approach to impute missing values. |
| Secondary | Sum of the Number Oral Ulcers, Genital Ulcers or Oral Plus Genital Ulcers at Day 85 | Day 85 | Sum of the number oral ulcers, genital ulcers or oral plus genital ulcers at Day 85 |
| Secondary | Percentage of Participants Who Were Oral Ulcer-free (Complete Response), or Whose Oral Ulcers Were Reduced by ≥ 50%, (Partial Response) | Baseline and Day 85 | Comparison of the percentage of participants who were oral ulcer-free (complete response: free from active oral ulcers), or whose oral ulcers were reduced by ≥ 50%, (partial response) between the apremilast-treated and the placebo-treated groups. In this case, partial response also includes complete response. |
| Secondary | Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 85 | Day 1 to Day 85 or to early termination visit | The Behçet's Disease Current Activity Index consists of three component scores, a participant's perception of disease activity, a clinician's overall perception of disease activity and a Behçet's Disease Current Activity Index Score. The score ranges from 0 to 12. A higher score indicates higher level of disease activity (worsening) and a negative change from baseline indicates improvement. |
| Secondary | Number of Treatment Emergent Adverse Events (TEAE) During the Placebo Controlled Treatment Phase | Day 1 to Day 85; maximum exposure to study drug was 13 weeks during treatment phase | A Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring or worsening on or after the first treatment of any study drug, and within 28 days after the last dose of the last study drug. A treatment related toxicity was considered by the investigator to be not suspected or suspected. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Oral Ulcers at Day 85 | Day 85 | Intent to Treat (ITT) = all randomized participants with at least one oral ulcer evaluation (including the baseline visit). A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation. | ulcers/participants | LEAST_SQUARES_MEAN |
| SECONDARY | Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85 | Day 85 | The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation. | units on a scale | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 85 | Baseline to Day 85 | Intent to Treat (ITT) = all randomized participants with at least one genital ulcer at baseline. A Last Observation Carried Forward (LOCF) approach was applied for participants terminated early. If a participant had no post-baseline genital ulcer assessment, the baseline value was carried forward for calculation. | percentage of participants | NUMBER |
| SECONDARY | Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) Scores at Day 85 | Baseline to Day 85 | Not analyzed due to low numbers of genital ulcers; not considered meaningful. | ||
| SECONDARY | Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85 | Day 1 to Day 85 | The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation. | total AUC (#ulcers*days) | LEAST_SQUARES_MEAN |
| SECONDARY | Area Under the Curve for the Number of Genital Ulcers From Day 1 to 85 | Day 1 to Day 85 | No population analyzed due to small number of participants with genital ulcers; not considered meaningful. | ||
| SECONDARY | Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85 | Day 1 to Day 85 | The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation. | total AUC (#ulcers*days) | MEAN |
| SECONDARY | Sum of the Number Oral Ulcers, Genital Ulcers or Oral Plus Genital Ulcers at Day 85 | Day 85 | The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation. | Ulcers/participants | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Were Oral Ulcer-free (Complete Response), or Whose Oral Ulcers Were Reduced by ≥ 50%, (Partial Response) | Baseline and Day 85 | The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 85 | Day 1 to Day 85 or to early termination visit | The ITT population included all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation). A LOCF approach was applied for participants terminated early from the study. If a participant had no post-baseline oral ulcer assessment, the baseline value was carried forward for calculation. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Oral Ulcers at Day 85 | Placebo (Oral) BID | 2.0 | Standard Error 0.28 | ulcers/participants | |
| Number of Oral Ulcers at Day 85 | Apremilast 30mg (Oral) BID | 0.4 | Standard Error 0.28 | ulcers/participants | |
| Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85 | Placebo (Oral) BID | 36.7 | Standard Error 3.23 | units on a scale | |
| Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85 | Apremilast 30mg (Oral) BID | 9.9 | Standard Error 3.30 | units on a scale | |
| Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 85 | Placebo (Oral) BID | 50 | percentage of participants | ||
| Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 85 | Apremilast 30mg (Oral) BID | 100 | percentage of participants | ||
| Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85 | Placebo (Oral) BID | 157.82 | Standard Error 12.890 | total AUC (#ulcers*days) | |
| Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85 | Apremilast 30mg (Oral) BID | 67.74 | Standard Error 13.267 | total AUC (#ulcers*days) | |
| Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85 | Placebo (Oral) BID | 193.95 | Standard Deviation 161.492 | total AUC (#ulcers*days) | |
| Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85 | Apremilast 30mg (Oral) BID | 65.79 | Standard Deviation 108.037 | total AUC (#ulcers*days) |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase (Days 1 to 85) | STARTED | Placebo (Oral) BID | 56 | |
| Treatment Phase (Days 1 to 85) | STARTED | Apremilast 30mg (Oral) BID | 55 | |
| Treatment Phase (Days 1 to 85) | STARTED | Placebo/Apremilast 30 mg | 0 | |
| Treatment Phase (Days 1 to 85) | STARTED | Apremilast 30mg/Apremilast 30mg | 0 | |
| Treatment Phase (Days 1 to 85) | COMPLETED | Placebo (Oral) BID | 45 | |
| Treatment Phase (Days 1 to 85) | COMPLETED | Apremilast 30mg (Oral) BID | 50 | |
| Treatment Phase (Days 1 to 85) | COMPLETED | Placebo/Apremilast 30 mg | 0 | |
| Treatment Phase (Days 1 to 85) | COMPLETED | Apremilast 30mg/Apremilast 30mg | 0 | |
| Treatment Phase (Days 1 to 85) | NOT COMPLETED | Placebo (Oral) BID | 11 | |
| Treatment Phase (Days 1 to 85) | NOT COMPLETED | Apremilast 30mg (Oral) BID | 5 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events93
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Influenza | Infections and infestations | Week 12: Placebo BID | 1 | 56 | |
| other | Influenza | Infections and infestations | Week 12: Apremilast 30 mg BID | 3 | 55 | |
| other | Influenza | Infections and infestations | Week 24: Apremilast 30 mg BID | 13 | 100 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Week 12: Placebo BID | 4 | 56 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Week 12: Apremilast 30 mg BID | 2 | 55 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Week 24: Apremilast 30 mg BID | 6 | 100 | |
| other | Oral Herpes | Infections and infestations | Week 12: Placebo BID | 4 | 56 | |
| other | Oral Herpes | Infections and infestations | Week 12: Apremilast 30 mg BID | 2 | 55 | |
| other | Oral Herpes | Infections and infestations | Week 24: Apremilast 30 mg BID | 4 | 100 | |
| other | Urinary Tract Infection | Infections and infestations | Week 12: Placebo BID | 3 | 56 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Week 12: Placebo BID | ||
| Total, all-cause mortality | Week 12: Apremilast 30 mg BID | ||
| Total, all-cause mortality | Week 24: Apremilast 30 mg BID | ||
| Total, other adverse events | Week 12: Placebo BID | 48 | 56 |
| Total, other adverse events | Week 12: Apremilast 30 mg BID | 47 | 55 |
| Total, other adverse events | Week 24: Apremilast 30 mg BID | 82 | 100 |
| Total, serious adverse events | Week 12: Placebo BID | 3 | 56 |
| Total, serious adverse events | Week 12: Apremilast 30 mg BID | 2 | 55 |
| Total, serious adverse events | Week 24: Apremilast 30 mg BID | 6 | 100 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00866359
GET https://conductscience.org/api/trials/v1/NCT00866359/registered?page=2