A PHASE 4 MULTICENTER SINGLE-ARM OPENLABEL STUDY TO EVALUATE THE IMPACT OF APREMILAST (CC-10004) ON MRI OUTCOMES IN SUBJECTS WITH PSORIATIC ARTHRITIS

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Psa
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects have signed the Informed Consent Form (ICF) prior to any trial related procedures.
    2. Subjects are able to adhere to the study visit schedule and other protocol requirements
    3. Subjects have a documented diagnosis of PsA of = 3 months AND = 5 years in duration, meeting the CASPAR criteria for PsA
    4. Subjects have = 3 swollen AND = 3 tender joints, with hand involvement (defined as = 1 swollen joint or dactylitis
    5. Subjects have at least 1 active enthesitis site
    6. Subjects must not have been treated previously with a TNF blocker or other biologic drug for PsA treatment
    7. Subjects must not have been treated with more than 2 csDMARDs
    8. Subjects taking csDMARDs,with the exception of MTX, cyclosporine, or LEF
    9. Subjects should not be pregnant and willing to take effective contraception during the study

You may not be eligible for this study if the following are true:

    1. Subjects who have contraindication to MRI examination
    2. Subjects with Severe renal impairment
    3. Subjects with history of clinically significant (as determined by the investigator) cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease
    4. Subjects with any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
    5. Subjects who have prior history of suicide attempt at any time in the subject’s lifetime prior to signing the informed consent, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent
    6. Subjects are pregnant or breastfeeding
    7. Active substance abuse or a history of substance abuse
    8. Has history of allergy to any component of the IP
    9. History of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency
    10. Active tuberculosis or a history of incompletely treated tuberculosis
    11. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections,
    12. Malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas;
    13. Major surgery (including joint surgery)
    14. Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia
    15. Prior history of or current inflammatory joint disease other than PsA
    16. Prior treatment with apremilast, or participation in a clinical study involving apremilast



If you are registered as a volunteer, please log in to contact the study team/express interest in this study.