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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00866359
First Posted: March 20, 2009
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Celgene
Results First Submitted: April 22, 2014  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Placebo (Oral) BID Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
Apremilast 30mg (Oral) BID Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Placebo/Apremilast 30 mg 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.
Apremilast 30mg/Apremilast 30mg 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.

Participant Flow for 3 periods

Period 1:   Treatment Phase (Days 1 to 85)
    Placebo (Oral) BID   Apremilast 30mg (Oral) BID   Placebo/Apremilast 30 mg   Apremilast 30mg/Apremilast 30mg
STARTED   56   55   0   0 
COMPLETED   45   50   0   0 
NOT COMPLETED   11   5   0   0 
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 2:   Extension Phase (Day 86 to 169)
    Placebo (Oral) BID   Apremilast 30mg (Oral) BID   Placebo/Apremilast 30 mg   Apremilast 30mg/Apremilast 30mg
STARTED   0   0   45   50 
COMPLETED   0   0   44   47 
NOT COMPLETED   0   0   1   3 
Adverse Event                0                0                1                3 

Period 3:   Observational Follow-Up Phase
    Placebo (Oral) BID   Apremilast 30mg (Oral) BID   Placebo/Apremilast 30 mg   Apremilast 30mg/Apremilast 30mg
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.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The intent to treat (ITT) population was defined as all randomized participants with at least one oral ulcer evaluation (including the baseline evaluation)

Reporting Groups
  Description
Placebo (Oral) BID Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
Apremilast 30mg (Oral) BID Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
Total Total of all reporting groups

Baseline Measures
   Placebo (Oral) BID   Apremilast 30mg (Oral) BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   55   111 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.7  (10.97)   34.3  (9.11)   34.5  (10.05) 
Sex: Female, Male 
[Units: Participants]
Count of 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] 
[Units: Years]
Mean (Standard Deviation)
 5.72  (6.084)   4.92  (3.982)   5.33  (5.143) 
[1] 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.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Oral Ulcers at Day 85   [ Time Frame: Day 85 ]

2.  Secondary:   Pain of Oral Ulcers as Measured by Visual Analog Scale (VAS) at Day 85   [ Time Frame: Day 85 ]

3.  Secondary:   Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) Scores at Day 85   [ Time Frame: Baseline to Day 85 ]

4.  Secondary:   Area Under the Curve (AUC) for the Number of Oral Ulcers From Day 1 to 85   [ Time Frame: Day 1 to Day 85 ]

5.  Secondary:   Area Under the Curve for the Number of Genital Ulcers From Day 1 to 85   [ Time Frame: Day 1 to Day 85 ]

6.  Secondary:   Area Under the Curve (AUC) for the Number of Oral Plus Genital Ulcers From Day 1 to 85   [ Time Frame: Day 1 to Day 85 ]

7.  Secondary:   Sum of the Number Oral Ulcers, Genital Ulcers or Oral Plus Genital Ulcers at Day 85   [ Time Frame: Day 85 ]

8.  Secondary:   Percentage of Participants Who Were Oral Ulcer-free (Complete Response), or Whose Oral Ulcers Were Reduced by ≥ 50%, (Partial Response)   [ Time Frame: Baseline and Day 85 ]

9.  Secondary:   Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 85   [ Time Frame: Day 1 to Day 85 or to early termination visit ]

10.  Secondary:   Number of Treatment Emergent Adverse Events (TEAE) During the Placebo Controlled Treatment Phase   [ Time Frame: Day 1 to Day 85; maximum exposure to study drug was 13 weeks during treatment phase ]

11.  Secondary:   Number of New Manifestations of Behçet’s Disease or Flare During the Placebo Controlled Treatment Phase   [ Time Frame: Day 1 to Day 85 ]

12.  Secondary:   Number of Oral Ulcers at Day 169   [ Time Frame: Day 169 ]

13.  Secondary:   Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 169   [ Time Frame: Day 169 ]

14.  Secondary:   Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 169   [ Time Frame: Day 1 to Day 169 ]

15.  Secondary:   Behçet's Disease (BD) Current Activity Index Form Score at Day 169   [ Time Frame: Day 169 ]

16.  Secondary:   Number of New Manifestations of Behçet’s Disease or Flare That Were Not Present at Day 1   [ Time Frame: Day 1 to Day 169 ]

17.  Secondary:   Number of Oral Ulcers at Day 197   [ Time Frame: Day 197 ]

18.  Secondary:   Pain of Oral Ulcers as Measured by VAS (VAS Score) at Day 197   [ Time Frame: Day 197 ]

19.  Secondary:   Pain of Genital Ulcers as Measured by Visual Analog Scale (VAS) at Day 197   [ Time Frame: Day 1 to Day 197 ]

20.  Secondary:   Change From Baseline in the Disease Activity as Measured by BD Current Activity Form/Index Score on Day 197   [ Time Frame: Day 1 to Day 197 ]

21.  Secondary:   Summary of Treatment Emergent Adverse Events During the Active Treatment-Extension Phase   [ Time Frame: Day 1 to Day 197; maximum exposure was 25.1 weeks ]

22.  Other Pre-specified:   Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 85   [ Time Frame: Baseline to Day 85 ]

23.  Other Pre-specified:   Percentage of Participants Who Were Genital Ulcer-free (Complete Response) at Day 169   [ Time Frame: Day 1 to Day 169 ]

24.  Other Pre-specified:   Percentage of Participants Who Were Genital Ulcer-free (Complete Response)   [ Time Frame: Day 1 to Day 197 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Planned sample size not reached; slow enrollment


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Anne McClain
Organization: Celgene Corporation
phone: 888-260-1599
e-mail: ClinicalTrialDisclosure@Celgene.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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