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A Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in the Treatment of Behçet Disease

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ClinicalTrials.gov Identifier: NCT00866359
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : August 27, 2014
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Behcet Syndrome
Interventions Drug: Apremilast (CC-10004)
Drug: Placebo
Enrollment 111

Recruitment Details The study was conducted at 3 study sites in Turkey and 3 sites in the United States. The first participant enrolled was enrolled on October 23, 2009 and the last participant enrolled was enrolled on May 08, 2012.
Pre-assignment Details Eligible participants were randomized 1:1 to receive study drug (apremilast or placebo). Since the incidence and severity of Behçet’s Disease differ between males and females, randomization was stratified by gender.
Arm/Group Title Placebo (Oral) BID Apremilast 30mg (Oral) BID Placebo/Apremilast 30 mg Apremilast 30mg/Apremilast 30mg
Hide Arm/Group Description Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase. Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase. Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase. Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast BID tablets in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets BID up to Day 169 in the active treatment extension phase.
Period Title: Treatment Phase (Days 1 to 85)
Started 56 55 0 0
Completed 45 50 0 0
Not Completed 11 5 0 0
Reason Not Completed
Adverse Event             5             4             0             0
Lack of Efficacy             3             0             0             0
Withdrawal by Subject             1             0             0             0
Protocol Violation             1             1             0             0
Other             1             0             0             0
Period Title: Extension Phase (Day 86 to 169)
Started 0 0 45 50
Completed 0 0 44 47
Not Completed 0 0 1 3
Reason Not Completed
Adverse Event             0             0             1             3
Period Title: Observational Follow-Up Phase
Started 0 0 54 [1] 54 [1]
Completed 0 0 54 54
Not Completed 0 0 0 0
[1]
Includes those who entered the follow-up phase from both the placebo controlled or extension phase.
Arm/Group Title Placebo (Oral) BID Apremilast 30mg (Oral) BID Total
Hide Arm/Group Description Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase. Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase. Total of all reporting groups
Overall Number of Baseline Participants 56 55 111
Hide Baseline Analysis Population Description
The intent to treat (ITT) population was defined as all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 55 participants 111 participants
34.7  (10.97) 34.3  (9.11) 34.5  (10.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 55 participants 111 participants
Female
38
  67.9%
39
  70.9%
77
  69.4%
Male
18
  32.1%
16
  29.1%
34
  30.6%
Duration of Behçet’s disease   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 55 participants 111 participants
5.72  (6.084) 4.92  (3.982) 5.33  (5.143)
[1]
Measure Description: At the time of diagnosis, participants must meet the 1990 International Study Group criteria for Behçet’s Disease. In the absence of other clinical explanations, participants must have: recurrent oral ulceration (apthous or herpetiform) recurring at least 3 times in a 12-month period, plus at least two of the following criteria: 1. Recurrent Genital Ulceration, 2. Eye Lesions, 3. Skin Lesions, 4. Positive Result on Pathergy Testing.
1.Primary Outcome
Title Number of Oral Ulcers at Day 85
Hide Description The number of oral ulcers were counted at each visit and at the end of the treatment period (starting point was at baseline).
Time Frame Day 85
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (Oral) BID Apremilast 30mg (Oral) BID
Hide Arm/Group Description:
Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Overall Number of Participants Analyzed 56 55
Least Squares Mean (Standard Error)
Unit of Measure: ulcers/participants
2.0  (0.28) 0.4  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Oral) BID, Apremilast 30mg (Oral) BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-2.4 to -0.9
Estimation Comments Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group and gender as factors and the baseline ulcer number as a covariate.
2.Secondary Outcome
Title Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85
Hide Description 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.
Time Frame Day 85
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (Oral) BID Apremilast 30mg (Oral) BID
Hide Arm/Group Description:
Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Overall Number of Participants Analyzed 56 55
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
36.7  (3.23) 9.9  (3.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Oral) BID, Apremilast 30mg (Oral) BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares mean difference
Estimated Value -26.8
Confidence Interval (2-Sided) 95%
-35.5 to -18.0
Estimation Comments Based on an analysis of covariance model for the oral ulcer pain VAS at Day 85, with treatment group and gender as factors and the baseline oral ulcer pain VAS as a covariate.
3.Secondary Outcome
Title Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) Scores at Day 85
Hide Description 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.
Time Frame Baseline to Day 85
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to low numbers of genital ulcers; not considered meaningful.
Arm/Group Title Placebo (Oral) BID Apremilast 30mg (Oral) BID
Hide Arm/Group Description:
Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85
Hide Description 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.
Time Frame Day 1 to Day 85
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (Oral) BID Apremilast 30mg (Oral) BID
Hide Arm/Group Description:
Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Overall Number of Participants Analyzed 56 55
Least Squares Mean (Standard Error)
Unit of Measure: total AUC (#ulcers*days)
157.82  (12.890) 67.74  (13.267)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Oral) BID, Apremilast 30mg (Oral) BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The last post-baseline observation was carried forward to Day 85 for participants who discontinued the study before Day 85. For participants who did not have Day 85 visit on the targeted date, the total AUC was adjusted by the actual study days.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -90.07
Confidence Interval (2-Sided) 95%
-125.32 to -54.82
Estimation Comments Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group, gender, and interaction of treatment group and gender as factors and the baseline ulcer number as a covariate.
5.Secondary Outcome
Title Area Under the Curve for the Number of Genital Ulcers From Day 1 to 85
Hide Description Area under curve (AUC^85) from Day 1 to Day 85 for the number of genital ulcers per day was not analyzed.
Time Frame Day 1 to Day 85
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No population analyzed due to small number of participants with genital ulcers; not considered meaningful.
Arm/Group Title Placebo (Oral) BID Apremilast 30mg (Oral) BID
Hide Arm/Group Description:
Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85
Hide Description 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.
Time Frame Day 1 to Day 85
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (Oral) BID Apremilast 30mg (Oral) BID
Hide Arm/Group Description:
Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Overall Number of Participants Analyzed 56 55
Mean (Standard Deviation)
Unit of Measure: total AUC (#ulcers*days)
193.95  (161.492) 65.79  (108.037)
7.Secondary Outcome
Title Sum of the Number Oral Ulcers, Genital Ulcers or Oral Plus Genital Ulcers at Day 85
Hide Description Sum of the number oral ulcers, genital ulcers or oral plus genital ulcers at Day 85
Time Frame Day 85
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (Oral) BID Apremilast 30mg (Oral) BID
Hide Arm/Group Description:
Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Overall Number of Participants Analyzed 56 55
Least Squares Mean (Standard Error)
Unit of Measure: Ulcers/participants
2.3  (0.35) 0.6  (0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Oral) BID, Apremilast 30mg (Oral) BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-2.7 to -0.8
Estimation Comments Based on an analysis of covariance model for the number of ulcers at Day 85, with treatment group, gender, and interaction of treatment group and gender as factors and the baseline ulcer number as a covariate.
8.Secondary Outcome
Title Percentage of Participants Who Were Oral Ulcer-free (Complete Response), or Whose Oral Ulcers Were Reduced by ≥ 50%, (Partial Response)
Hide Description 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.
Time Frame Baseline and Day 85
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (Oral) BID Apremilast 30mg (Oral) BID
Hide Arm/Group Description:
Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Unit of Measure: percentage of participants
Complete Response 28.6 70.9
Partial Response 50.0 89.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Oral) BID, Apremilast 30mg (Oral) BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Two-sided p-value was based on the CMH test adjusting for gender.
Method of Estimation Estimation Parameter adjusted difference (percentage)
Estimated Value 39.1
Confidence Interval (2-Sided) 95%
23.6 to 54.5
Estimation Comments Adjusted difference in proportions = weighted average of treatment differences across gender with the CMH weights.
9.Secondary Outcome
Title Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 85
Hide Description 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.
Time Frame Day 1 to Day 85 or to early termination visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Apremilast 30mg (Oral) BID
Hide Arm/Group Description:
Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Overall Number of Participants Analyzed 55 54
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.1  (0.22) -1.2  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Apremilast 30mg (Oral) BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-1.7 to -0.5
Estimation Comments Based on an Ancova model for change from baseline with treatment group, gender and interaction of treatment group and gender as factors and the baseline value as a covariate.
10.Secondary Outcome
Title Number of Treatment Emergent Adverse Events (TEAE) During the Placebo Controlled Treatment Phase
Hide Description 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.
Time Frame Day 1 to Day 85; maximum exposure to study drug was 13 weeks during treatment phase
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population defined as all participants who were randomized and received at least 1 dose of Investigational Product.
Arm/Group Title Placebo (Oral) BID Apremilast 30mg (Oral) BID
Hide Arm/Group Description:
Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
Treatment Phase (Days 1 to 85): Participants randomized to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Unit of Measure: participants
Any TEAE 50 49
Any drug related TEAE 24 30
Any severe TEAE 5 5
Any serious TEAE 3 2
Any serious drug related TEAE 1 0
Any TEAE leading to drug interruption 0 1
Any TEAE leading to drug withdrawal 5 4
11.Secondary Outcome
Title Number of New Manifestations of Behçet’s Disease or Flare During the Placebo Controlled Treatment Phase
Hide Description

A flare was defined as the development of new manifestations of BD or worsening of existing disease, meeting the following criteria:

  1. Organ involvement: any major organ involvement (eg, central nervous system, gastrointestinal tract);
  2. Oral/genital ulcers: ≥ 100% increase in the number of oral or genital ulcers from Day 1 or a minimum increase of 3 in the number of oral or genital ulcers, whichever is greater;
  3. Arthritis: ≥ 50% increase in the number of swollen joints, or a minimum increase of 3 swollen joints, whichever is greater;
  4. Skin lesions (non-oral/genital ulcers): ≥ 50% increase in the total score of the Physician’s Global Assessment of Skin Lesions, or a minimum increase of 2 in the total score of the Physician’s Global Assessment of Skin Lesions, whichever is greater'
  5. New onset or worsening of existing Behçet Disease-related inflammatory eye disease requiring initiation of immunosuppressive therapy (uveitis).
Time Frame Day 1 to Day 85
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who were randomized and received at least 1 dose of Investigational Product.
Arm/Group Title Placebo (Oral) BID Apremilast 30mg (Oral) BID
Hide Arm/Group Description:
Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Overall Number of Participants Analyzed 56 55
Measure Type: Number
Unit of Measure: participants
Participants who had disease flare 27 12
Participants with new onset or worsening uveitis 3 0
12.Secondary Outcome
Title Number of Oral Ulcers at Day 169
Hide Description The number of oral ulcers were counted at Day 169 in reference to the participants’ first day of active treatment (Day 1 or Day 85).
Time Frame Day 169
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo/Apremilast 30 mg Apremilast 30 mg /Apremilast 30mg BID (Oral)
Hide Arm/Group Description:
Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase
Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets BID in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast BID up to Day 169 in the active treatment extension phase.
Overall Number of Participants Analyzed 45 49
Mean (Standard Deviation)
Unit of Measure: ulcers/participant
0.4  (1.31) 0.6  (1.27)
13.Secondary Outcome
Title Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 169
Hide Description 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.
Time Frame Day 169
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo/Apremilast 30 mg Apremilast 30 mg /Apremilast 30mg BID (Oral)
Hide Arm/Group Description:
Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
Extension Phase (Days 86 to 169): Participants initially administered to receive 30 mg apremilast tablets BID in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast BID up to Day 169 in the active treatment extension phase.
Overall Number of Participants Analyzed 45 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
9.6  (21.13) 9.7  (20.33)
14.Secondary Outcome
Title Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 169
Hide Description 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.
Time Frame Day 1 to Day 169
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to low numbers of genital ulcers; not considered meaningful.
Arm/Group Title Placebo BID/Apremilast 30 BID (Oral) Apremilast 30 mg BID/Apremilast 30mg BID (Oral)
Hide Arm/Group Description:
Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase .
Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Behçet's Disease (BD) Current Activity Index Form Score at Day 169
Hide Description 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.
Time Frame Day 169
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo/Apremilast 30 mg Apremilast 30mg/Apremilast 30mg
Hide Arm/Group Description:
Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID were titrated to 30 mg apremilast tablets BID up to Day 169 in the active treatment extension phase.
Overall Number of Participants Analyzed 45 49
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.4  (1.18) 1.6  (1.62)
16.Secondary Outcome
Title Number of New Manifestations of Behçet’s Disease or Flare That Were Not Present at Day 1
Hide Description

A flare was defined as the development of new manifestations of BD or worsening of existing disease, meeting the following criteria:

  1. Organ involvement: any major organ involvement (eg, central nervous system, gastrointestinal tract);
  2. Oral/genital ulcers: ≥ 100% increase in the number of oral or genital ulcers from Day 1 or a minimum increase of 3 in the number of oral or genital ulcers, whichever is greater;
  3. Arthritis: ≥ 50% increase in the number of swollen joints, or a minimum increase of 3 swollen joints, whichever is greater;
  4. Skin lesions (non-oral/genital ulcers): ≥ 50% increase in the total score of the Physician’s Global Assessment of Skin Lesions, or a minimum increase of 2 in the total score of the Physician’s Global Assessment of Skin Lesions, whichever is greater;
  5. New onset or worsening of existing Behçet Disease-related inflammatory eye disease requiring initiation of immunosuppressive therapy (uveitis).
Time Frame Day 1 to Day 169
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo/Apremilast 30 mg Apremilast 30mg/Apremilast 30mg
Hide Arm/Group Description:
Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase
Treatment and Extension Phases (Days 1 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
Overall Number of Participants Analyzed 45 55
Measure Type: Number
Unit of Measure: participants
Participants who experienced a disease flare 15 19
Participants with new onset or worsening uveitis 1 2
17.Secondary Outcome
Title Number of Oral Ulcers at Day 197
Hide Description The number of oral ulcers were counted at each visit and at the end of the treatment period (starting point was at baseline).
Time Frame Day 197
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase
Arm/Group Title Placebo/Apremilast 30 mg Apremilast 30 mg /Apremilast 30mg BID (Oral)
Hide Arm/Group Description:

Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.

Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.

Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase.

Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.

Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.

Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase.

Overall Number of Participants Analyzed 54 54
Mean (Standard Deviation)
Unit of Measure: ulcers/participants
1.6  (1.78) 1.7  (2.06)
18.Secondary Outcome
Title Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 197
Hide Description 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.
Time Frame Day 197
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase.
Arm/Group Title Placebo/Apremilast 30 mg Apremilast 30 mg /Apremilast 30mg BID (Oral)
Hide Arm/Group Description:

Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.

Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.

Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase.

Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.

Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.

Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase.

Overall Number of Participants Analyzed 54 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
21.0  (22.26) 27.2  (28.71)
19.Secondary Outcome
Title Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 197
Hide Description 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.
Time Frame Day 1 to Day 197
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not analyzed due to low numbers of genital ulcers; not considered meaningful.
Arm/Group Title Placebo BID/Apremilast 30 BID (Oral) Apremilast 30 mg BID/Apremilast 30mg BID (Oral)
Hide Arm/Group Description:

Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.

Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.

Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase.

Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.

Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.

Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 197
Hide Description 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.
Time Frame Day 1 to Day 197
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Includes participants who entered the Observational Follow-up Phase from either the Treatment Phase or the Extension Phase
Arm/Group Title Placebo/Apremilast 30 mg Apremilast 30 mg/Apremilast 30mg BID
Hide Arm/Group Description:

Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.

Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.

Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase.

Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.

Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.

Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase.

Overall Number of Participants Analyzed 53 53
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.6  (1.28) -1.2  (1.65)
21.Secondary Outcome
Title Summary of Treatment Emergent Adverse Events During the Active Treatment-Extension Phase
Hide Description A Treatment Emergent Adverse Event (TEAE) is 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.
Time Frame Day 1 to Day 197; maximum exposure was 25.1 weeks
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Hide Analysis Population Description
Safety analyses for the apremilast-exposure period was based on the apremilast participants as treated (AAT) Population, and included those who were randomized (at the randomization visit) or switched (at the Day 85 visit) to apremilast 30 mg BID, and received at least one dose of apremilast after the initial randomization or switch to 30 mg BID.
Arm/Group Title Placebo BID/Apremilast 30 BID (Oral) Apremilast 30 mg BID/Apremilast 30mg BID (Oral)
Hide Arm/Group Description:

Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.

Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase.

Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.

Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.

Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase.

Overall Number of Participants Analyzed 45 55
Measure Type: Number
Unit of Measure: particpants
Any TEAE 39 50
Any drug related TEAE 20 33
Any severe TEAE 1 11
Any serious TEAE 1 5
Any serious drug related TEAE 0 1
TEAE leading to drug interuption 0 1
TEAE leading to drug withdrawal 1 7
22.Other Pre-specified Outcome
Title Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 85
Hide Description The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)
Time Frame Baseline to Day 85
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo (Oral) BID Apremilast 30mg (Oral) BID
Hide Arm/Group Description:
Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Overall Number of Participants Analyzed 6 10
Measure Type: Number
Unit of Measure: percentage of participants
50 100
23.Other Pre-specified Outcome
Title Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 169
Hide Description The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)
Time Frame Day 1 to Day 169
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) = all randomized participants with at least one genital ulcer at baseline visit. 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.
Arm/Group Title Placebo/Apremilast 30 mg Apremilast 30mg/Apremilast 30mg
Hide Arm/Group Description:
Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
Overall Number of Participants Analyzed 6 10
Measure Type: Number
Unit of Measure: percentage of participants
66.7 100
24.Other Pre-specified Outcome
Title Percentage of Participants Who Were Genital Ulcer-free (Complete Response)
Hide Description The percentage of participants who were genital ulcer-free (complete response: free from active genital ulcers)
Time Frame Day 1 to Day 197
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo/Apremilast 30 mg Apremilast 30mg/Apremilast 30mg
Hide Arm/Group Description:

Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.

Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.

Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase.

Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.

Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.

Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase.

Overall Number of Participants Analyzed 6 10
Measure Type: Number
Unit of Measure: percentage of participants
100 100
Time Frame Days 1 to Day 197 visit; maximum exposure to study drug was 25.1 weeks. From Day 1 (first dose) through the end of the follow up period up to 28 days after the last dose of study drug.
Adverse Event Reporting Description 108 participants were part of the follow-up phase (had prematurely discontinued therapy during the placebo (PBO)-controlled phase but had completed PBO-controlled phase and prematurely discontinued therapy during the extension phase. Those who prematurely discontinued therapy during the PBO-controlled phase did not participate the extension phase
 
Arm/Group Title Week 12: Placebo BID Week 12: Apremilast 30 mg BID Week 24: Apremilast 30 mg BID
Hide Arm/Group Description Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 12 for all participants randomized to placebo. Participants randomized to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase. Includes data through Week 12 for all participants randomized to 30mg Apremilast BID. Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, or 12), up until Week 24. Includes data through Week 24 for participants who were treated with Apremilast started at Week 0 and data from Week 12 through Week 24 for participants who were treated with Apremilast started at Week 12.
All-Cause Mortality
Week 12: Placebo BID Week 12: Apremilast 30 mg BID Week 24: Apremilast 30 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Week 12: Placebo BID Week 12: Apremilast 30 mg BID Week 24: Apremilast 30 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/56 (5.36%)   2/55 (3.64%)   6/100 (6.00%) 
Gastrointestinal disorders       
Anal Fissure  1  0/56 (0.00%)  1/55 (1.82%)  1/100 (1.00%) 
Haemorrhoids  1  0/56 (0.00%)  1/55 (1.82%)  1/100 (1.00%) 
Pyrexia  1  1/56 (1.79%)  0/55 (0.00%)  0/100 (0.00%) 
Immune system disorders       
Behçet’s Syndrome  1  2/56 (3.57%)  0/55 (0.00%)  3/100 (3.00%) 
Infections and infestations       
Influenza  1  0/56 (0.00%)  0/55 (0.00%)  1/100 (1.00%) 
Nervous system disorders       
Diplegia  1  0/56 (0.00%)  1/55 (1.82%)  1/100 (1.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Week 12: Placebo BID Week 12: Apremilast 30 mg BID Week 24: Apremilast 30 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   48/56 (85.71%)   47/55 (85.45%)   82/100 (82.00%) 
Blood and lymphatic system disorders       
Iron Deficiency Anaemia  1  3/56 (5.36%)  2/55 (3.64%)  6/100 (6.00%) 
Gastrointestinal disorders       
Nausea  1  10/56 (17.86%)  22/55 (40.00%)  36/100 (36.00%) 
Diarrhoea  1  2/56 (3.57%)  12/55 (21.82%)  20/100 (20.00%) 
Abdominal Pain  1  7/56 (12.50%)  8/55 (14.55%)  11/100 (11.00%) 
Vomiting  1  1/56 (1.79%)  9/55 (16.36%)  12/100 (12.00%) 
Abdominal Pain Upper  1  3/56 (5.36%)  3/55 (5.45%)  5/100 (5.00%) 
Dyspepsia  1  0/56 (0.00%)  4/55 (7.27%)  9/100 (9.00%) 
General disorders       
Asthenia  1  2/56 (3.57%)  5/55 (9.09%)  7/100 (7.00%) 
Immune system disorders       
Behçet’s Syndrome  1  25/56 (44.64%)  12/55 (21.82%)  35/100 (35.00%) 
Infections and infestations       
Influenza  1  1/56 (1.79%)  3/55 (5.45%)  13/100 (13.00%) 
Upper Respiratory Tract Infection  1  4/56 (7.14%)  2/55 (3.64%)  6/100 (6.00%) 
Oral Herpes  1  4/56 (7.14%)  2/55 (3.64%)  4/100 (4.00%) 
Urinary Tract Infection  1  3/56 (5.36%)  0/55 (0.00%)  0/100 (0.00%) 
Metabolism and nutrition disorders       
Decreased Appetite  1  1/56 (1.79%)  5/55 (9.09%)  5/100 (5.00%) 
Musculoskeletal and connective tissue disorders       
Pain in Extremity  1  5/56 (8.93%)  6/55 (10.91%)  13/100 (13.00%) 
Arthralgia  1  3/56 (5.36%)  3/55 (5.45%)  11/100 (11.00%) 
Back Pain  1  0/56 (0.00%)  3/55 (5.45%)  5/100 (5.00%) 
Myalgia  1  0/56 (0.00%)  3/55 (5.45%)  5/100 (5.00%) 
Fibromyalgia  1  0/56 (0.00%)  0/55 (0.00%)  6/100 (6.00%) 
Nervous system disorders       
Headache  1  25/56 (44.64%)  26/55 (47.27%)  41/100 (41.00%) 
Hypoaesthesia  1  1/56 (1.79%)  4/55 (7.27%)  4/100 (4.00%) 
Dizziness  1  1/56 (1.79%)  3/55 (5.45%)  4/100 (4.00%) 
Psychiatric disorders       
Insomnia  1  0/56 (0.00%)  0/55 (0.00%)  5/100 (5.00%) 
Depression  1  0/56 (0.00%)  0/55 (0.00%)  5/100 (5.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/56 (1.79%)  2/55 (3.64%)  6/100 (6.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 14.0
Planned sample size not reached; slow enrollment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 45 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential data before submission or defer publication to permit patent applications.
Results Point of Contact
Name/Title: Anne McClain
Organization: Celgene Corporation
Phone: 888-260-1599
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT00866359     History of Changes
Other Study ID Numbers: CC-10004-BCT-001
EudraCT#: 2008-002722-11
First Submitted: March 18, 2009
First Posted: March 20, 2009
Results First Submitted: April 22, 2014
Results First Posted: August 27, 2014
Last Update Posted: November 17, 2017