PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PALACE2)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Celgene

ClinicalTrials.gov Identifier:

NCT01212757

First received: September 29, 2010

Last updated: May 18, 2017

Last verified: May 2017

History of Changes

Results First Received: April 21, 2014

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Participant, Care Provider, Investigator, Outcomes Assessor; Primary Purpose: Treatment
Condition:	Psoriatic Arthritis
Interventions:	Drug: Apremilast 20mg Drug: Apremilast 30mg Drug: Placebo + 20 mg Apremilast Drug: Placebo + 30 mg Apremilast

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This is an ongoing study consisting of a 24-week randomized, double-blind, placebo-controlled phase, a 28-week randomized, double-blind active treatment phase and a 4-year open-label safety phase, for an overall study duration of 5 years. This report includes data up to the end of the active treatment phase (Week 52).

Reporting Groups

	Description
Placebo	Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
Apremilast 20 mg	Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
Apremilast 30 mg	Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
Placebo / Apremilast 20 mg EE	Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years.
Placebo / Apremilast 20 mg XO	Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years.
Placebo / Apremilast 30 mg EE	Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
Placebo / Apremilast 30 mg XO	Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.

Participant Flow for 2 periods

Period 1: Placebo-controlled Phase (Week 0 - 24)

	Placebo	Apremilast 20 mg	Apremilast 30 mg
STARTED	162	163	163
Received Treatment	159	163	162
Completed Week 16	148	151	149
Early Escape at Week 16	88 ^[1]	59 ^[2]	64
COMPLETED	143 ^[3]	143	142
NOT COMPLETED	19	20	21
Adverse Event	4	5	12
Lack of Efficacy	3	2	2
Withdrawal by Subject	7	9	3
Randomization Error	3	0	1
Lost to Follow-up	1	1	2
Protocol Violation	0	1	1
Unspecified	1	2	0

^[1]	Two participants who escaped early did not complete Week 24
^[2]	Three participants who escaped early did not complete Week 24
^[3]	Two participants who completed Week 24 did not enter the active treatment phase

Period 2: Active Treatment Phase (Weeks 25 - 52)

	Apremilast 20 mg	Apremilast 30 mg	Placebo / Apremilast 20 mg EE	Placebo / Apremilast 20 mg XO	Placebo / Apremilast 30 mg EE	Placebo / Apremilast 30 mg XO
STARTED	137 ^[1]	134 ^[2]	43	27	41 ^[3]	28
COMPLETED	125	114	35	25	34	28
NOT COMPLETED	12	20	8	2	7	0
Adverse Event	2	3	1	0	2	0
Lack of Efficacy	5	7	4	0	2	0
Non-compliance with Study Drug	0	2	0	0	0	0
Withdrawal by Subject	3	7	3	1	3	0
Lost to Follow-up	1	0	0	1	0	0
Unspecified	1	1	0	0	0	0

^[1]	Six participants who completed Week 24 did not enter the active treatment phase
^[2]	Eight participants who completed Week 24 did not enter the active treatment phase
^[3]	Two participants who escaped early and completed Week 24 did not enter the active treatment phase

Baseline Characteristics

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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. Four participants who were randomized in error and did not receive any dose of investigational product are excluded.

Reporting Groups

	Description
Placebo	Participants initially randomized to receive placebo tablets twice daily.
Apremilast 20 mg	Participants initially randomized to receive 20 mg apremilast tablets twice daily.
Apremilast 30 mg	Participants initially randomized to receive 30 mg apremilast tablets twice daily.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Apremilast 20 mg	Apremilast 30 mg	Total
Overall Participants Analyzed [Units: Participants]	159	163	162	484

Age [Units: Years] Mean (Standard Deviation)	51.2 (10.97)	50.9 (11.82)	50.5 (11.20)	50.9 (11.32)

Sex: Female, Male [Units: Participants] Count of Participants
Female	85 53.5%	95 58.3%	95 58.6%	275 56.8%
Male	74 46.5%	68 41.7%	67 41.4%	209 43.2%

Duration of Psoriatic Arthritis [Units: Years] Mean (Standard Deviation)	7.76 (8.254)	7.83 (8.621)	6.82 (7.592)	7.47 (8.163)

Outcome Measures

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1. Primary:

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

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2. Secondary:

Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16 [ Time Frame: Baseline and Week 16 ]

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3. Secondary:

Percentage of Participants With an ACR 20 Response at Week 24 [ Time Frame: Baseline and Week 24 ]

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4. Secondary:

Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24 [ Time Frame: Baseline and Week 24 ]

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5. Secondary:

Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16 [ Time Frame: Baseline and Week 16 ]

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6. Secondary:

Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16 [ Time Frame: Baseline and Week 16 ]

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7. Secondary:

Change From Baseline in Patient’s Assessment of Pain at Week 16 [ Time Frame: Baseline and Week 16 ]

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8. Secondary:

Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16 [ Time Frame: Baseline and Week 16 ]

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9. Secondary:

Change From Baseline in Dactylitis Severity Score at Week 16 [ Time Frame: Baseline and Week 16 ]

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10. Secondary:

Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16 [ Time Frame: Baseline and Week 16 ]

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11. Secondary:

Change From Baseline in the Disease Activity Score (DAS28) at Week 16 [ Time Frame: Baseline and Week 16 ]

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12. Secondary:

Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16 [ Time Frame: Baseline and Week 16 ]

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13. Secondary:

Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24 [ Time Frame: Baseline and Week 24 ]

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14. Secondary:

Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24 [ Time Frame: Baseline and Week 24 ]

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15. Secondary:

Change From Baseline in Patient’s Assessment of Pain at Week 24 [ Time Frame: Baseline and Week 24 ]

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16. Secondary:

Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24 [ Time Frame: Baseline and Week 24 ]

Show Outcome Measure 16

17. Secondary:

Change From Baseline in Dactylitis Severity Score at Week 24 [ Time Frame: Baseline and Week 24 ]

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18. Secondary:

Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24 [ Time Frame: Baseline and Week 24 ]

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19. Secondary:

Change From Baseline in the Disease Activity Score (DAS28) at Week 24 [ Time Frame: Baseline and Week 24 ]

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20. Secondary:

Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24 [ Time Frame: Baseline and Week 24 ]

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21. Secondary:

Percentage of Participants With MASES Improvement ≥ 20% at Week 16 [ Time Frame: Baseline and Week 16 ]

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22. Secondary:

Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16 [ Time Frame: Baseline and Week 16 ]

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23. Secondary:

Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16 [ Time Frame: Baseline and Week 16 ]

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24. Secondary:

Percentage of Participants With MASES Improvement ≥ 20% at Week 24 [ Time Frame: Baseline and Week 24 ]

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25. Secondary:

Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24 [ Time Frame: Baseline and Week 24 ]

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26. Secondary:

Percentage of Participants With Good or Moderate EULAR Response at Week 24 [ Time Frame: Baseline and Week 24 ]

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27. Secondary:

Percentage of Participants With a ACR 50 Response at Week 16 [ Time Frame: Baseline and Week 16 ]

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28. Secondary:

Percentage of Participants With an ACR 70 Response at Week 16 [ Time Frame: Baseline and Week 16 ]

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29. Secondary:

Percentage of Participants With an ACR 50 Response at Week 24 [ Time Frame: Baseline and Week 24 ]

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30. Secondary:

Percentage of Participants With a ACR 70 Response at Week 24 [ Time Frame: Baseline and Week 24 ]

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31. Secondary:

Percentage of Participants Achieving a MASES Score of Zero at Week 16 [ Time Frame: Week 16 ]

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32. Secondary:

Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16 [ Time Frame: Week 16 ]

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33. Secondary:

Percentage of Participants Achieving a MASES Score of Zero at Week 24 [ Time Frame: Week 24 ]

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34. Secondary:

Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24 [ Time Frame: Week 24 ]

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35. Secondary:

Percentage of Participants With a ACR 20 Response at Week 52 [ Time Frame: Baseline and Week 52 ]

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36. Secondary:

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52 [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 36

37. Secondary:

Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52 [ Time Frame: Baseline and Week 52 ]

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38. Secondary:

Percentage of Participants With a Modified PsARC Response at Week 52 [ Time Frame: Baseline and Week 52 ]

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39. Secondary:

Change From Baseline in the Patient Assessment of Pain at Week 52 [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 39

40. Secondary:

Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52 [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 40

41. Secondary:

Change From Baseline in the Dactylitis Severity Score at Week 52 [ Time Frame: Baseline and Week 52 ]

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42. Secondary:

Change From Baseline in the CDAI Score at Week 52 [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 42

43. Secondary:

Change From Baseline in the DAS28 at Week 52 [ Time Frame: Baseline and Week 52 ]

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44. Secondary:

Change From Baseline in the FACIT-Fatigue Scale Score at Week 52 [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 44

45. Secondary:

Percentage of Participants With MASES Improvement ≥ 20% at Week 52 [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 45

46. Secondary:

Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52 [ Time Frame: Baseline and Week 52 ]

Show Outcome Measure 46

47. Secondary:

Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52 [ Time Frame: Baseline and Week 52 ]

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48. Secondary:

Percentage of Participants With an ACR 50 Response at Week 52 [ Time Frame: Baseline and Week 52 ]

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49. Secondary:

Percentage of Participants With an ACR 70 Response at Week 52 [ Time Frame: Baseline and Week 52 ]

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50. Secondary:

Percentage of Participants Achieving a MASES Score of Zero at Week 52 [ Time Frame: Week 52 ]

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51. Secondary:

Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52 [ Time Frame: Week 52 ]

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52. Secondary:

Number of Participants With Adverse Events [ Time Frame: Up to 5 years ]

Results not yet reported. Anticipated Reporting Date: 12/2017

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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 60 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 information before submission or defer publication to permit patent applications.

Results Point of Contact:

Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com

Publications:

Cutolo M, Myerson GE, Fleischmann RM, Lioté F, Díaz-González F, Van den Bosch F, Marzo-Ortega H, Feist E, Shah K, Hu C, Stevens RM, Poder A. A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial. J Rheumatol. 2016 Sep;43(9):1724-34. doi: 10.3899/jrheum.151376. Epub 2016 Jul 15.

Responsible Party:	Celgene
ClinicalTrials.gov Identifier:	NCT01212757 History of Changes
Other Study ID Numbers:	CC-10004-PSA-003 2010-018386-32 ( EudraCT Number )
Study First Received:	September 29, 2010
Results First Received:	April 21, 2014
Last Updated:	May 18, 2017

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