Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis

Inclusion Criteria

• A diagnosis of IC/BPS defined based on AUA guidelines as the following: an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than 6 months duration, in the absence of infection or identifiable causes, documented history or patient reported.
• Only those patients with moderate to severe IC/BPS will be included in the study.
• Able to provide informed consent to participate in the study and comply with study requirements
• Able to provide written authorization for use and release of health and research study information
• Written documentation of being provided California's Experimental Subject's Bill of Rights
• Females ≥18 and ≤ 65 years of age previously diagnosed with interstitial cystitis/ bladder pain syndrome (IC/BPS) for a duration of greater than 6 months
• Female patients of child-bearing potential must have a negative serum pregnancy test at Screening and use birth control while in the study.
• O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes (OSPI) score ≥ 18
• No history of any cancer.
• No bacterial cystitis in previous 1 month
• No active herpes in previous 3 months
• Never treated with cyclophosphamide
• No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy)
• Absence of bladder, ureteral or urethral calculi for previous 3 months

Exclusion criteria

• Symptoms are relieved at one month reevaluation visit after receiving IC/BPS behavior modification advice at screening visit.
• Symptoms are relieved by antimicrobials, antibiotics, or other medications for IC/BPS
• Pregnant women, lactating mothers, nursing mothers, women suspected of being pregnant and woman who plan to be pregnant during the course of the clinical trial
• Males
• Patients with inadequate renal, hepatic, or cardiac function
• Patients with history of gross hematuria within 2 years.
• Patients with the following medical history: Lower urinary tract anatomical anomaly, pelvic radiotherapy, or active genital herpes
• Patients with a history of tuberculosis (TB), recent exposure to TB, or recent travel to TB endemic regions. Patients should have a recent negative PPD (or negative CXR) prior to receiving treatment.
• Patients who have undergone cystoscopy under anesthesia with bladder biopsy, hydrodistension, or fulguration of Hunner's ulcer within 3 months
• Patients taking the following treatments for interstitial cystitis at Screening: Intravesical BCG, corticosteroid therapy, cyclosporine, or TNF-alpha inhibitors.
• Patients with a history of receiving live vaccine including Flumist® influenza vaccine in the past 3 months.
• Patients with a history of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
• Patients with a history of alcohol, analgesic or drug abuse within 2 years of Screening.
• Patients with a history of any cancer.
• Patients with a history of active Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) infection, or who are known carriers (Hepatitis B).
• Patients with a history of invasive fungal infections, recent travel to regions endemic for the following invasive fungal infections: San Joaquin Fever, aspergillosis, histoplasmosis, candidiasis, coccidiodomycosis, blastomycosis, and pneumocystosis.
• Patients with a history of diabetes mellitus.
• Patients with a history of a neurologic disease included but not limited to central demyelinating diseases, including multiple sclerosis; and a history of peripheral demyelinating disease, including Guillain-Barre syndrome.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the