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Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)

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 Who Have Not Been Previously Treated With Disease-modifying Antirheumatic Drugs

NCT01307423•Amgen

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis who have not been previously treated with DMARDs. Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects must satisfy the following criteria to be enrolled in the study:
•1. Male or female, aged ≥ 18 years at time of consent.
•2. Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.
•3. Able to adhere to the study visit schedule and other protocol requirements.
•4. Have a documented diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 3 months duration.
•5. Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria for PsA at time of screening.
•6. Have ≥ 3 swollen AND ≥ 3 tender joints.
•7. Have not been previously treated with disease-modifying antirheumatic drugs (DMARDS) (small molecules or biologics)
•8. Be receiving treatment on an outpatient basis.
•9. If taking oral corticosteroids, must be on a stable dose of prednisone ≤ 10 mg/day or equivalent for at least 1 month prior to screening.
+22 more criteria

Exclusion Criteria

•1. History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.
•2. Any condition, including the presence of laboratory abnormalities that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
•3. Clinically significant abnormality on 12-lead electrocardiography (ECG) at Screening.
•4. Pregnant or breast feeding.
•5. History of allergy to any component of the IP.
•6. Hepatitis B surface antigen positive at screening.
•7. Hepatitis C antibody positive at screening.
•8. AST/SGOT and/or ALT/SGPT \> 1.5 x ULN and total bilirubin \> ULN or albumin \< lower limit of normal (LLN).
•9. History of positive Human Immunodeficiency Virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease).
•10. Active tuberculosis or a history of incompletely treated tuberculosis.
+6 more criteria

Locations (118)

Arizona Research Center

Phoenix, Arizona, United States

Desert Medical Advances

Palm Desert, California, United States

In Vivo Clinical Research

Doral, Florida, United States

Centre For Rheumatology, Immun. And Arthritis

Fort Lauderdale, Florida, United States

North Florida Dermatology

Jacksonville, Florida, United States

Florida Center for Dermatology, PA

Saint Augustine, Florida, United States

Tampa Medical Group Pa

Tampa, Florida, United States

Atlanta Dermatology, Vein and Research Center, PC

Alpharetta, Georgia, United States

Arthritis and Rheumatology of Georgia

Atlanta, Georgia, United States

Sonora Clinical Research, LLC

Boise, Idaho, United States

Key Dates

Start Date

December 9, 2010

Primary Completion Date

February 21, 2013

Completion Date

August 16, 2017

Last Updated

June 14, 2022

Enrollment

529

ACTUAL participants

Conditions

Psoriatic Arthritis

Interventions

Apremilast 20mg

DRUG

Apremilast 30mg

DRUG

Placebo

DRUG

A Study of Picankibart in Patients With Active Psoriatic Arthritis

NCT07295509

Psoriatic Arthritis

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RECRUITINGPHASE3

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

NCT06100744

Juvenile Psoriatic Arthritis

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RECRUITING

Rheumatology Patient Registry and Biorepository

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)

Inclusion Criteria

Exclusion Criteria

A Study of Picankibart in Patients With Active Psoriatic Arthritis

A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab

Rheumatology Patient Registry and Biorepository

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A Phase II Study to Evaluate the Efficacy and Safety of D-2570 in Subjects With Active Psoriatic Arthritis

Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis