Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PALACE-1)

This study is currently recruiting participants.
Verified by Celgene Corporation, November 2010
First Received: July 6, 2010 Last Updated: November 11, 2010

Sponsor:
Celgene Corporation
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01172938

Purpose
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis, specifically in improving signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

Condition Intervention Phase
Psoriatic Arthritis Drug: apremilast
Other: Placebo
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Two Doses Of Apremilast (CC-10004) In Subjects With Active Psoriatic Arthritis

Further study details as provided by Celgene Corporation:
Primary Outcome Measures:

  • Proportion of subjects in each treatment group who achieve the American College of Rheumatology criteria for a 20% improvement (ACR 20), compared with baseline [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: Yes]

Secondary Outcome Measures:

  • Type, frequency, severity, and relationship of adverse events to apremilast [ Time Frame: Weeks 0 - 264 ] [ Designated as safety issue: Yes ]
  • Number of subjects who prematurely discontinue study medication due to any adverse event [ Time Frame: Weeks 0 - 264 ] [ Designated as safety issue: Yes ]
  • Frequency of clinically significant changes in physical examination, vital signs, electrocardiogram, and/or laboratory findings [ Time Frame: Weeks 0 - 264 ] [ Designated as safety issue: Yes ]
  • Change from baseline in physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI]) in each treatment group [ Time Frame: Weeks 0 - 264 ] [ Designated as safety issue: No ]
  • Change from baseline in the physical function domain score of the Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36) in each treatment group [ Time Frame: Weeks 0 - 264 ] [ Designated as safety issue: No ]
  • Change from baseline in the Clinical Disease Activity Index (CDAI) in each treatment group [ Time Frame: Weeks 0 - 264 ] [ Designated as safety issue: No ]
  • Change from baseline in the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) score in each treatment group [ Time Frame: Weeks 0 - 264 ] [ Designated as safety issue: No ]
  • Proportion of subjects in each treatment group who achieve the American College of Rheumatology criteria for a 50% improvement (ACR 50), compared with baseline [ Time Frame: Weeks 0 - 264 ] [ Designated as safety issue: No ]
  • Proportion of subjects in each treatment group who achieve the American College of Rheumatology criteria for a 70% improvement (ACR 70), compared with baseline [ Time Frame: Weeks 0 - 264 ] [ Designated as safety issue: No ]
  • Change from baseline in the Disease Activity Score (DAS-28) in each treatment group [ Time Frame: Weeks 0 - 264 ] [ Designated as safety issue: No ]
  • Change from baseline in health-related quality of life measures in each treatment group [ Time Frame: Weeks 0 - 264 ] [ Designated as safety issue: No ]
  • Plasma trough levels of apremilast in each active treatment group [ Time Frame: Weeks 0 - 24 ] [ Designated as safety issue: No ]
  • Change from baseline in plasma levels of biomarkers in each treatment group [ Time Frame: Weeks 0 - 24 ] [ Designated as safety issue: No ]
Estimated Enrollment: 495
Study Start Date: June 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
 

Arms
Assigned Interventions

A: Experimental
30 mg apremilast tablets administered BID for 24 weeks during the placebo-controlled phase followed by 30 mg apremilast tablets administered BID for up to 4.5 years in the active treatment / long-term safety phase
Intervention: Drug: apremilast

Drug: apremilast
Apremilast 20 mg BID, PO Apremilast 30 mg BID, P
Other Names:

  • Apremilast
  • CC-10004
B: Experimental
20 mg apremilast tablets administered BID for 24 weeks during the placebo-controlled phase followed by 20 mg apremilast tablets administered BID for up to 4.5 years in the active treatment / long-term safety phase
Intervention: Drug: apremilast

Drug: apremilast
Apremilast 20 mg BID, PO Apremilast 30 mg BID, PO
Other Names:

  • Apremilast
  • CC-10004
C: Placebo Comparator
placebo tablets administered BID for 24 weeks during the placebo-controlled phase followed by 20 mg apremilast tablets administered BID for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 20 mg apremilast BID at Week 16
Intervention: Other: Placebo
Other: Placebo
Placebo 20mg or 30mg, BID PO
D: Placebo Comparator
placebo tablets administered BID for 24 weeks during the placebo-controlled phase followed by 30 mg apremilast tablets administered BID for up to 4.5 years in the active treatment / long-term safety phase. Subjects who do not have at least 20% improvement in their swollen and tender joint counts at Week 16 will escape to 30 mg apremilast BID at Week 16.
Intervention: Other: Placebo
Other: Placebo
Placebo 20mg or 30mg, BID PO

Detailed Description:
Psoriatic arthritis (PsA) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and endothelial cells, and inflammatory cells attracted to the synovium by cytokines and chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore, apremilast has the potential to be effective in the treatment of PsA.

Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
Inclusion Criteria:

  • Males or females, aged ? 18 years at time of consent.
  • Have a diagnosis of PsA (by any criteria) of ? 6 months' duration.
  • Meet the CASPAR criteria for PsA at time of screening.
  • Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)
  • May not have axial involvement alone
  • Concurrent Tx allowed with methotrexate, leflunomide, or sulfasalazine,
  • Have ? 3 swollen AND ? 3 tender joints.
  • Males & Females must use contraception
  • Stable dose of NSAIDs, narcotics and low dose oral corticosteroids allowed.

Exclusion Criteria:

  • Pregnant or breast feeding.
  • History of allergy to any component of the investigational product (IP).
  • Hepatitis B surface antigen and/or hepatitis C antibody positive at screening.
  • Therapeutic failure on > 3 agents for PsA or > 1 biologic TNF blocker
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