Efficacy Study of Adalimumab to Treat Interstitial Cystitis

• Improvement of the Baseline Pelvic Pain and Urgency/Frequency patient symptom scale (PUF) score [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Patient global assessment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
• Physical exam including SQ injection site [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
• Vital signs [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
• Adverse events [ Time Frame: 21 Weeks ] [ Designated as safety issue: Yes ]

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.

• Drug: Adalimumab
  80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
  Other Name: Humira
• Other: inactive drug
  80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
  Other Name: placebo

• Experimental: adalimumab
  Intervention: Drug: Adalimumab
• Placebo Comparator: Inactive drug
  Intervention: Other: inactive drug

Inclusion Criteria:

• Males or females ≥18 and ≤ 65 years of age previously diagnosed with Interstitial Cystitis
• Currently have symptoms of urinary urgency, frequency or pain for more than 6 months
• Urinating at least 7 times a day or having some urgency or pain (measured on linear analog scales)
• Must be post-menopausal or surgically sterile or willing to use an adequate form of birth control
• Not pregnant or lactating
• Capable of voiding independently
• Willing to provide informed consent to participate

Exclusion Criteria:

• Have symptoms that are presently relieved on other medications for interstitial cystitis
• Have absence of nocturia
• Have symptoms that are relieved by antimicrobials or antibiotics.
• Have a body mass index (BMI) of >39 kg/m2
• Have uncontrolled hypertension
• Have Type I or type 2 diabetes
• Have active Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) infection, or who are known carriers (Hepatitis B) at Screening
• Have a positive TB test at screening
• Have had a urinary tract infection for 6 weeks
• Have had bacterial cystitis in previous 3 months
• Have had previous exposure to Humira® (adalimumab)
• Have taken investigational medication within 30 days of screening
• Have any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the interpretation of study results
• Are unable or unwilling to comply with protocol requirements