NCT01295814

Efficacy Study of Adalimumab to Treat Interstitial Cystitis

An Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Humira® (Adalimumab) For The Treatment of Interstitial Cystitis(IC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: ICStudy, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Interstitial Cystitis

Interventions

Type	Name	Description
DRUG	Adalimumab	80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
OTHER	inactive drug	80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-06-01
• Completion: 2013-07-01
• First posted: 2011-02-15
• Last updated: 2015-07-16
• Results posted: 2015-07-16

Locations

1 site across 1 country: United States