Efficacy Study of Adalimumab to Treat Interstitial Cystitis

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 tuberculosis 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