Updated on 23 November 2020




A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) Monotherapy in Subjects with Active Psoriatic Arthritis

IRB Number: 013-194

Location: Baylor Research Institute

Facility Name: Arthritis Care and Research Institute

Facility Street Address: 9900 N. Central Expy Suite 550
City: Dallas, TX Zip Code: 75231

Lead Principal Investigator: Dr. John Cush

Clinical Study IdentifierTX138972
Last Modified on23 November 2020


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Inclusion Criteria

Is your age between 18 yrs and 0 yrs?
Gender: Male or Female
Age 18 or older
Diagnosis of Psoriatic Arthritis greater than or equal to 3 months
Disease activity defined by = 3 tender joint out of 68 & = 3 swollen joints out of 66
Must not have taken a TNF blocker medication (such as Enbrel, Humira, Cimzia, Simponi, etc.)
Taking 1 DMARD only
If taking oral corticosteroids, must be on a stable dose of less than or equal to 10mg per day for at least 30 days

Exclusion Criteria

Prior treatment of more than one DMARD (such as Methotrexate, Sulfazalazine, Leflunomide, Cyclosporine, etc.)
Malignancy or a history of malignancy
Previous treatment with biologic agents for rheumatic diseases (such as Enbrel, Humira, Cimzia, Simponi, etc.)
Prior history of a rheumatic autoimmune disease such as SLE (lupus), Rheumatoid Arthritis, Ankylosing Spondylitis, Lyme disease, Fibromyalgia, etc
Other exclusion criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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