ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis

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.
ClinicalTrials.gov Identifier: NCT01925768
Recruitment Status : Completed
First Posted : August 20, 2013
Results First Posted : June 13, 2016
Last Update Posted : April 6, 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: Psoriatic Arthritis
Interventions: Drug: Apremilast 30 mg
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This is an ongoing study consisting of a 24-week randomized, double-blind, placebo-controlled treatment phase, followed by a 28-week active treatment phase and a 52-week open-label extension phase, for an overall study duration of 113 weeks.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Randomized participants were stratified by their baseline prednisone use (yes or no) and by their previous disease modifying antirheumatic drug (DMARD) use (excluding biologics). Participants were allowed to take non-steroidal anti-inflammatory agents and/or low dose corticosteroids during the study.

Reporting Groups
  Description
Placebo (PBO) Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
Apremilast (APR) 30 mg Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.

Participant Flow:   Overall Study
    Placebo (PBO)   Apremilast (APR) 30 mg
STARTED   109   110 
Received Treatment   109   109 
Safety Population   109 [1]   109 [1] 
Completed Week 16   101   91 
Escaped Early (EE)   35 [2]   13 [2] 
COMPLETED   98 [3]   87 [3] 
NOT COMPLETED   11   23 
Lost to Follow-up                1                0 
Protocol Violation                1                2 
Adverse Event                5                10 
Lack of Efficacy                3                6 
Withdrawal by Subject                1                4 
Non-compliance with study drug                0                1 
[1] Safety population = participants who were randomized and received at least one dose of study drug.
[2] EE= investigator’s discretion plus <10% improvement in both swollen & tender joint counts at Week16
[3] Completed = participants who completed week 24



  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.
Full analysis set consisting of all participants who were randomized as specified in the protocol.

Reporting Groups
  Description
Placebo (PBO) Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
Apremilast (APR) 30 mg Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
Total Total of all reporting groups

Baseline Measures
   Placebo (PBO)   Apremilast (APR) 30 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 109   110   219 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.0  (13.75)   50.7  (12.22)   49.3  (13.04) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      65  59.6%      58  52.7%      123  56.2% 
Male      44  40.4%      52  47.3%      96  43.8% 
Duration of Psoriatic Arthritis [1] 
[Units: Years]
Mean (Standard Deviation)
 3.59  (5.497)   4.04  (4.482)   3.82  (5.007) 
[1] Duration of Psoriatic Arthritis is reported as the time since diagnosis


  Outcome Measures

1.  Primary:   Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16   [ Time Frame: Baseline and Week 16 ]

2.  Secondary:   Number of Participants With Treatment Emergent Adverse Events (TEAE) During the 24 Week Placebo Controlled Phase   [ Time Frame: Start of the lst dose of IP to the end of the PBO controlled phase; Weeks 0-24 for those randomized to APR 30 mg; Weeks 0-24 for those randomized to PBO who did not enter EE at Week 16; Weeks 0-16 for those randomized to PBO who entered EE at Week 16 ]

3.  Secondary:   Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24   [ Time Frame: Baseline and Week 24 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

4.  Secondary:   Percentage of Participants Who Achieve an ACR 20 Response at Week 24   [ Time Frame: Baseline and Week 24 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

5.  Secondary:   Change From Baseline in the 28-joint Disease Activity Score Using C-reactive Protein as the Acute-phase Reactant (DAS28 [CRP]) at Week 24   [ Time Frame: Baseline and Week 24 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

6.  Secondary:   Change From Baseline in the Medical Outcomes Short Form Health Survey (SF-36) V2 Physical Function Domain Score Change at Week 24   [ Time Frame: Baseline and Week 24 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

7.  Secondary:   Change From Baseline in the SF-36V2 Physical Component Summary Score at Week 24   [ Time Frame: Baseline and Week 24 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

8.  Secondary:   Change From Baseline in the Duration of Morning Stiffness at Week 24   [ Time Frame: Baseline and Week 24 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

9.  Secondary:   Percentage of Participants Whose Severity of Morning Stiffness at Week 24 Improved From Baseline   [ Time Frame: Baseline and Week 24 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

10.  Secondary:   Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16   [ Time Frame: Baseline and Week 16 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

11.  Secondary:   Change From Baseline in the Disease Activity Score DAS28 (CRP) at Week 16   [ Time Frame: Baseline and Week 16 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

12.  Secondary:   Change From Baseline in 36-item Short Form Health Survey (SF-36) V 2.0 Physical Functioning Domain at Week 16   [ Time Frame: Baseline and Week 16 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

13.  Secondary:   Change From Baseline in the Duration of Morning Stiffness at Week 16   [ Time Frame: Baseline and Week 16 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

14.  Secondary:   Percentage of Participants Whose Severity of Morning Stiffness at Week 16 Improved From Baseline   [ Time Frame: Baseline and Week 16 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

15.  Secondary:   Percentage of Participants Who Achieve an ACR 20 Response at Weeks 2, 4, 6, 8, 12 and 20   [ Time Frame: Baseline and at Weeks 2, 4, 6, 8, 12 and 20 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

16.  Secondary:   Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Weeks 52 and 104   [ Time Frame: Baseline and Weeks 52 and 104 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

17.  Secondary:   Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Weeks 52 and 104   [ Time Frame: Baseline and Weeks 52 and 104 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

18.  Secondary:   Change From Baseline in the Disease Activity Score (DAS28) at Week 52 and 104   [ Time Frame: Baseline and Weeks 52 and 104 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

19.  Secondary:   Change From Baseline in 36-item SF-36 (V2.0) Physical Functioning Component Scores and Summary Score at Weeks 52 and 104   [ Time Frame: Baseline and Weeks 52 and 104 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

20.  Secondary:   Change From Baseline in the Duration of Morning Stiffness at Weeks 52 and 104   [ Time Frame: Baseline and Weeks 52 and 104 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  

21.  Secondary:   Change From Baseline in the Severity of Morning Stiffness at Weeks 52 and 104   [ Time Frame: Baseline and Weeks 52 and 104 ]
Results not yet reported.   Anticipated Reporting Date:   11/2017  


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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, Senior Manager
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: NCT01925768     History of Changes
Other Study ID Numbers: CC-10004-PSA-006
First Submitted: August 15, 2013
First Posted: August 20, 2013
Results First Submitted: February 25, 2016
Results First Posted: June 13, 2016
Last Update Posted: April 6, 2017