Overview

This trial is active, not recruiting.

Condition psoriatic arthritis
Treatments apremilast 20mg, apremilast 30mg, placebo + 20 mg apremilast, placebo + 30 mg apremilast
Phase phase 3
Sponsor Celgene Corporation
Start date September 2010
End date July 2012
Trial size 505 participants
Trial identifier NCT01212770, CC-10004-PSA-004

Summary

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis and a qualifying psoriasis lesion.

Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily for up to 4.5 years in the active treatment / long-term safety phase
apremilast 20mg CC-10004
Apremilast 20 mg twice daily, orally
(Experimental)
30 mg Apremilast tablets administered twice a day for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice a day for up to 4.5 years in the active treatment / long-term safety phase orally twice daily
apremilast 30mg CC-10004
Apremilast 30 mg twice daily, orally
(Placebo Comparator)
Placebo + 20 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 20 mg Apremilast tablets administered twice daily 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 twice daily at Week 16
placebo + 20 mg apremilast Placebo
Placebo + 20 mg Apremilast
(Placebo Comparator)
Placebo + 30 mg Apremilast tablets administered twice daily for 24 weeks during the placebo-controlled phase followed by 30 mg Apremilast tablets administered twice daily 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 twice daily at Week 16.
placebo + 30 mg apremilast Placebo
Placebo + 30 mg Apremilast

Primary Outcomes

Measure
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16
time frame: Baseline and Week 16

Secondary Outcomes

Measure
Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 16
time frame: Baseline and Week 16
Percentage of Participants With an ACR 20 Response at Week 24
time frame: Baseline and Week 24
Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24
time frame: Baseline and Week 24
Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 16
time frame: Baseline and Week 16
Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 16
time frame: Baseline and Week 16
Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 16
time frame: Baseline and Week 16
Change From Baseline in Patient's Assessment of Pain at Week 16
time frame: Baseline and Week 16
Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 16
time frame: Baseline and Week 16
Change From Baseline in Dactylitis Severity Score at Week 16
time frame: Baseline and Week 16
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 16
time frame: Baseline and Week 16
Change From Baseline in the Disease Activity Score (DAS28) at Week 16
time frame: Baseline and Week 16
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 16
time frame: Baseline and Week 16
Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Functioning Domain at Week 24
time frame: Baseline and Week 24
Percentage of Participants With a Modified Psoriatic Arthritis Response Criteria (PsARC) Response at Week 24
time frame: Baseline and Week 24
Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 24
time frame: Baseline and Week 24
Change From Baseline in Patient's Assessment of Pain at Week 24
time frame: Baseline and week 24
Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 24
time frame: Baseline and week 24
Change From Baseline in Dactylitis Severity Score at Week 24
time frame: Baseline and Week 24
Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 24
time frame: Baseline and Week 24
Change From Baseline in the Disease Activity Score (DAS28) at Week 24
time frame: Baseline and Week 24
Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24
time frame: Baseline and Week 24
Percentage of Participants With MASES Improvement ≥ 20% at Week 16
time frame: Baseline and Week 16
Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 16
time frame: Baseline and Week 16
Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Week 16
time frame: Baseline and Week 16
Percentage of Participants With MASES Improvement ≥ 20% at Week 24
time frame: Baseline and Week 24
Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 24
time frame: Baseline and Week 24
Percentage of Participants With Good or Moderate EULAR Response at Week 24
time frame: Baseline and Week 24
Percentage of Participants With a ACR 50 Response at Week 16
time frame: Baseline and Week 16
Percentage of Participants With an ACR 70 Response at Week 16
time frame: Baseline and Week 16
Percentage of Participants With an ACR 50 Response at Week 24
time frame: Baseline and Week 24
Percentage of Participants With a ACR 70 Response at Week 24
time frame: Baseline and Week 24
Percentage of Participants Achieving a MASES Score of Zero at Week 16
time frame: Week 16
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 16
time frame: Week 16
Percentage of Participants Achieving a MASES Score of Zero at Week 24
time frame: Week 24
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 24
time frame: Week 24
Percentage of Participants With an ACR 20 Response at Week 52
time frame: Baseline and Week 52
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 52
time frame: Baseline and Week 52
Change From Baseline in the SF-36 Physical Functioning Scale Score at Week 52
time frame: Baseline and Week 52
Percentage of Participants With a Modified PsARC Response at Week 52
time frame: Baseline and Week 52
Percentage of Participants Achieving a ≥ 75% Improvement in Psoriasis Area and Severity Index Score (PASI75) at Week 52
time frame: Baseline and Week 52
Change From Baseline in the Patient Assessment of Pain at Week 52
time frame: Baseline and Week 52
Change From Baseline in Maastricht Ankylosing Spondylitis Entheses Score (MASES) at Week 52
time frame: Baseline and Week 52
Change From Baseline in the Dactylitis Severity Score at Week 52
time frame: Baseline and Week 52
Change From Baseline in the CDAI Score at Week 52
time frame: Baseline and Week 52
Change From Baseline in the DAS28 at Week 52
time frame: Baseline and Week 52
Change From Baseline in the FACIT-Fatigue Scale Score at Week 52
time frame: Baseline and Week 52
Percentage of Participants With MASES Improvement ≥ 20% at Week 52
time frame: Baseline and Week 52
Percentage of Participants With Dactylitis Improvement ≥ 1 Point at Week 52
time frame: Baseline and Week 52
Percentage of Participants Achieving Good or Moderate EULAR Response at Week 52
time frame: Baseline and Week 52
Percentage of Participants With an ACR 50 Response at Week 52
time frame: Baseline and Week 52
Percentage of Participants With an ACR 70 Response at Week 52
time frame: Baseline and Week 52
Percentage of Participants Achieving a MASES Score of Zero at Week 52
time frame: Week 52
Percentage of Participants Achieving a Dactylitis Score of Zero at Week 52
time frame: Week 52
Number of Participants With Adverse Events
time frame: Up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Males or females, aged ≥ 18 years at time of consent. - Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 6 months duration. - Meet the Classification Criteria for Psoriatic Arthritis (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. - Have at least one ≥2 cm psoriasis lesion Exclusion Criteria: - Pregnant or breast feeding. - History of allergy to any component of the investigational product Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening. - Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF) blocker

Additional Information

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 and a Qualifying Psoriasis Lesion
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Celgene Corporation.