Celgene - FOREMOST Clinical Research Study
A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Early, Oligoarticular Psoriatic Arthritis Despite Initial Stable Treatment With Either NSAIDs and/or = 1 Conventional Synthetic DMARD
Patients who screen and then enroll in the study will receive:
- Study drug (active, comparator or placebo), lab work, visits are included at no cost.
- Patients will be reimbursed ¢.55 per mile traveled both to the office and back to your home; a maximum of $50.00 per visit.
Study Duration for Patients
The total study duration is approximately 56-weeks which consists of approximately 10 visits during the course of the study.
The study consists of four periods:
- Screening Period (2 to 4 weeks before the treatment starts) to see if you are eligible to participate in the study.
- Study Treatment Period (24 weeks). This Study Treatment period is a randomized, double-blinded study drug treatment.
- Active-treatment Extension Phase (24 weeks). All patients will receive apremilast for the remainder of the study. This part of the study is optional for subjects. If subjects decide to leave the study after phase 2, they will proceed directly to phase 4.
- Safety Follow-Up Visit (Up to 4 weeks) A single follow-up visit for observational purposes.
The study may also have some unplanned visits, most commonly for repeat lab work.
Apremilast is a Conventional Synthetic Disease-Modifying Antirheumatic drug (csDMARd).
The following must be met in order to qualify for the study.
- ≥ 18 yrs, male or female subject
- Disease duration since diagnosis ≥ 3 months and ≤ 24 months as based on the Classification Criteria for Psoriatic Arthritis (CASPAR),
- SJC AND TJC must be >1 and ≤ 4
- For all regions, the local Regulatory Label for treatment with apremilast must be followed.
- Stable doses of protocol-allowed PsA medications
- General good health (except for psoriatic arthritis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories. (Note: The definition of good health means a subject does not have uncontrolled significant comorbid conditions).
- Comply with protocol-required contraception measures
Patients with any of the following are ineligible to enroll in the study.
- Prior use of >1 as DMARD.
- Prior exposure to a JAK-inhibitor and/or a biologic DMARD.
- Use of intra-articular (IA) or intra-muscular (IM) glucocorticoid injection within 8 weeks before the Baseline Visit.
- Use of leflunomide within 12 weeks of randomization. Subjects who stopped leflunomide and completed 11 days of treatment with cholestyramine (8 g, 3 x daily) prior to the Baseline Visit may enter the study.
- Prior use of cyclosporine.
- Prior treatment with apremilast, or participation in a clinical study, involving apremilast.
- Use of any investigational drug within 4 weeks of the Baseline Visit, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
** Other eligibility criteria exist to enroll in the study. Study eligibility requirements are subject to change. STAT Research and Dr. Alappatt reserve the right to exclude patients who do qualify for other reasons. Enrollment is limited and may be closed at any time without prior notice.
60 Remick Blvd.
Springboro, OH 45066
See if you Qualify!
Complete the form below and a research coordinator will contact you regarding phone or in-person pre-screening.
Dr. Chacko Alappatt, M.D.
Dr. Alappatt is a graduate of Northeastern Ohio Universities College of Medicine and spent his residency at Indiana University. He operates and serves as Medical Director for the Arthritis & Osteoporosis Center of Southwest Ohio, an adult rheumatology group. Dr. Alappatt began his clinical research experience in 2007. He is passionate about his work as a research investigator and in providing exceptional care for his patients.