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(BDA-0688) Psoriasis Inflammation and Systemic Co-Morbidities: Is it Preventable or Reversible?

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Psoriasis Inflammation and Systemic Co-Morbidities: Is it Preventable or Reversible?

Principal Investigator:
Batya Davidovici M.D.


Contact Information:
Clinical Research Support Office
1230 York Avenue
New York, NY 10065
Telephone: 1.800.RU.CARES
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
Psoriasis is an often uncomfortable and itchy chronic skin condition that produces red, swollen (“inflamed”) patches on the skin. The patches, which are not contagious, are usually covered with a white, scaly buildup of dead skin cells. Scientists are not sure what causes psoriasis, but they do know that a person with psoriasis has immune cells (part of the body’s defense mechanism) that are triggered to respond in the wrong way, producing this build-up of skin cells. In fact, many of the treatments now available for psoriasis act to slow down this immune process.

Lately, it has been observed that when the immune system is activated, it can lead to the development not only of psoriasis, but other diseases such as:
- arthritis (pain and swelling of the joints)
- Crohn's disease (inflammation in the intestines)
- the metabolic syndrome (a combination of high blood sugar, high blood pressure, obesity, and high cholesterol)
- cardio-vascular diseases (CVD)

Some research has shown that people with psoriasis are at higher risk for CVD than people without psoriasis. In this research study, we would like to understand if treating the immune problem in psoriasis can also help prevent, slow down, or reverse some of these other diseases.

The purpose of this research study is to see if effective, long-term treatment of psoriasis can prevent or reverse some of these other diseases. We are asking you to take part in this research study because you have the most common type of psoriasis known as plaque psoriasis and may also be prone to developing the metabolic syndrome and CVD. If you decide to join the study and you meet all of the screening criteria, you will be taking Enbrel, the study drug, for 52 weeks. This research study is funded by a drug company known as Amgen.

Detailed Description of Protocol:
The study involves:
- 2 screening visits
- Outpatient clinic visits for one year
- Participants will receive Enbrel** at no cost for the length of the study

**Enbrel is FDA approved for the treatment of psoriasis.

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

- Men and women ages 18+
- Have plaque-type psoriasis on over 10% of the body



Children permitted to participate:

Potential Benefits.....
Participants may find out during the research study, that the study therapy, Enbrel, is helpful to them.

No compensation is provided during the study.