Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA

Inclusion Criteria

• •Understand and voluntarily sign an informed consent form
• •18 years of age at the time of signing the informed consent form.
• •Able to adhere to the study visit schedule and other protocol requirements
• •Must have a diagnosis of RA of at least 6 months duration based on the ACR criteria
• •Must have evidence of active disease with DAS-28 \> 3.8
• •May be on one of the following DMARDs for at least 12 weeks and at a stable dose for at least 6 weeks:
• •* Methotrexate 7.5-25mg/week
• •* Hydroxychloroquine (200-400mg/day)
• •Must be on one of the following SQ TNF inhibitors at a stable, label approved dose for at least 12 weeks:
• •* adalimumab (Humira®, Abbott Laboratories, North Chicago, IL)
• •* certolizumab pegol (Cimzia®, UCB, Inc, Smyrna, GA)
• •* golimumab (Simponi®, Johnson \& Johnson, New Brunswick, NJ)
• •* etanercept (Enbrel®, Amgen, Thousand Oaks, CA and Wyeth Pharmaceuticals, Philadelphia, PA)
• •Concommitant use of non-steroidal anti-inflammatory drugs and/or oral corticosteroids (prednisone\<10mg/day or equivalent) are permitted if doses have been stable for at least 14 days.
• •If taking methotrexate, patient must also be taking folic or folinic acid at at dose of no less then 5mg/week.
• •Must meet the following laboratory criteria:
• •* Hemoglobin \> 9 g/dL
• •* White blood cell (WBC) count; 3000 /;L (3.0 X 109/L) and 14,000/L (\< 14 X 109/L)
• •* Platelets; 100,000 /L (100 X 109/L)
• •* Serum creatinine; 1.5 mg/dL (or 133mol/L)
• •* Total bilirubin; 2.0 mg/dL
• •* Aspartate transaminase (AST \[serum glutamic oxaloacetic transaminase, SGOT\]) and alanine transaminase (ALT \[serum glutamate pyruvic transaminase, SGPT\]); 1.5x upper limit of normal (ULN)
• •Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active FCBP must agree to use TWO of the following adequate forms of contraception while on study medication: oral, injectable, or implantable hormonal contraceptives; tubal ligation; intrauterine device; barrier contraceptive with spermicide; or vasectomized partner while on study. A FCBP must agree to have pregnancy tests every 4 weeks while on study medication and for one month after taking the last dose of study medication.
• •Males (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with FCBP while on study medication and for 28 days after taking the last dose of study medication