Study Seeking to Evaluate of the Effectiveness of Cimzia in Females with Interstitial Cystitis/Bladder Pain Syndrome
Do you or someone you know who has IC and lives in, or is willing to travel to Southern California? If so, UCB Pharmaceuticals is sponsoring a study evaluating the drug certolizumab pegol (Cimzia) for improving the symptoms of patients with IC. Certolizumab pegol is an injectable anti-inflammatory medication. It has been available for use in the United States since the US Food and Drug Administration (FDA) approval for the treatment of Crohn’s disease on April 22, 2008. Certolizumab pegol (Cimzia) has subsequently been FDA approved for the treatment of rheumatoid arthritis, psoriasis, and ankylosing spondylitis. These diseases have similar characteristics to IC. This study is experimental as it will evaluate a new investigational use of certolizumab pegol (Cimzia) for the treatment of IC. Basic research has demonstrated that certolizumab pegol (Cimzia) should improve the symptoms of Interstitial Cystitis/Bladder Pain Syndrome.
Name of Study: Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy of Certolizumab Pegol in the Treatment of Interstitial Cystitis/ Bladder Pain Syndrome
Sponsoring Organization: UCB Pharmaceuticals
Who is eligible for the Study?
Females who have been diagnosed with interstitial cystitis for more than six months and are between the ages of 18 and 65 are eligible to participate in this research study.
Recruitment Start Date: April 2016
Recruitment End Date: September 2016
Time Commitment: If you qualify for the study, your will participation will last 8 weeks.
Cost to Patient: There are no costs associated with being in this study. However, there is no travel assistance or compensation available.
What Will Happen During the Study?
The first visit done in person, over the phone or via Skype will be determine eligibility and provide a thorough description of the study. In addition, advice will be given to the patient about various behavior modification techniques that can be used to improve IC symptoms. If the patient decides to move forward in the study, they will be required to sign and date an informed consent form before any procedures take place. The actual study drug is administered via subcutaneous injections over an eight week time frame. It is a blinded study with 1/3 of patients receiving placebo, while 2/3 of patients receiving Cimzia. Patients will be closely monitored for improvement in their IC symptoms.
Who to Contact to Participate?
Principal Investigator: Philip C. Bosch, MD
651 E. Pennsylvania Ave. Ste. 201
Escondido, CA 92025
Web site: http://www.icstudy.net/
Phone number: 760 743-3135
For additional study information please go to: https://www.clinicaltrials.gov/ct2/show/NCT02497976?term=NCT02497976&rank=1
Revised Thursday, April 14th, 2016