Interstitial Cystitis Clinical Trial
Official title:
An Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Humira® (Adalimumab) For The Treatment of Interstitial Cystitis(IC)
The purpose of this study is to evaluate an investigational treatment for interstitial
cystitis. Interstitial cystitis is a chronic bladder disease that includes the following
symptoms: Urinary frequency during the day,urinary frequency at night, urinary urgency and
bladder discomfort relieved by voiding.
Presently, there is no cure for interstitial cystitis. The response to current treatments is
poor. Patients with interstitial cystitis have a poorer quality of life. The cause of
interstitial cystitis is unknown. This study is evaluating the drug Humira® (adalimumab) for
improving the symptoms of patients with interstitial cystitis. Humira® is an injectable
anti-inflammatory medication that has been available for use since December 31, 2002.
Humira® has been FDA approved for the treatment of rheumatoid arthritis, psoriasis,
ankylosing spondylitis, and Crohn's disease. These diseases have similar characteristics to
interstitial cystitis. This study will evaluate an investigational use of Humira® for the
treatment of interstitial cystitis.
Interstitial cystitis (IC) is a chronic disabling bladder syndrome characterized by urinary frequency, nocturia, urinary urgency, and pain with bladder filling—relieved by emptying. There is no cure for IC and the treatment options are suboptimal. Patients with IC report significant negative effects on their physical and mental quality of life. The etiology of IC is unknown. Certain aspects of IC suggest that autoimmunity may play a role in initiating or sustaining the chronic inflammatory response. Bladder biopsies of patients with IC demonstrate an increase number of mast cells. Mast cell activation with the release of tumor necrosis factor (TNF) may mediate this bladder inflammation. Humira® (adalimumab) is a medication that blocks the effect of TNF. Humira® (adalimumab) is FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, and Crohn's disease. These diseases are similar to IC. In this study, the hypothesis being tested is that Humira® (adalimumab) will show efficacy at reducing the symptoms of IC. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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