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 years - 100 years
-
Gender: Male or Female
-
Other Inclusion Criteria:
- Subjects have signed the Informed Consent Form (ICF) prior to any trial related procedures.
- Subjects are able to adhere to the study visit schedule and other protocol requirements
- Subjects have a documented diagnosis of PsA of = 3 months AND = 5 years in duration, meeting the CASPAR criteria for PsA
- Subjects have = 3 swollen AND = 3 tender joints, with hand involvement (defined as = 1 swollen joint or dactylitis
- Subjects have at least 1 active enthesitis site
- Subjects must not have been treated previously with a TNF blocker or other biologic drug for PsA treatment
- Subjects must not have been treated with more than 2 csDMARDs
- Subjects taking csDMARDs,with the exception of MTX, cyclosporine, or LEF
- 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:
-
- Subjects who have contraindication to MRI examination
- Subjects with Severe renal impairment
- 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
- 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
- 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
- Subjects are pregnant or breastfeeding
- Active substance abuse or a history of substance abuse
- Has history of allergy to any component of the IP
- History of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency
- Active tuberculosis or a history of incompletely treated tuberculosis
- Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections,
- 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;
- Major surgery (including joint surgery)
- Rheumatic autoimmune disease other than PsA, including, but not limited to: systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or fibromyalgia
- Prior history of or current inflammatory joint disease other than PsA
- 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.