Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis
Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis
A Randomized, Double-blind, Placebo Controlled Trial of Certolizumab Pegol in Women with
 Refractory Interstitial Cystitis/Bladder Pain Syndrome
Interstitial cystitis (IC) is a chronic disabling bladder syndrome characterized by urinary
 frequency, nocturia, urinary urgency, and pain or discomfort with bladder filling. 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. Cimzia (certolizumab pegol) is a medication that
 blocks the effect of TNF. Cimzia (certolizumab pegol) is FDA approved for the treatment of
 rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and Crohn's disease. These
 diseases are similar to IC. In this study, the hypothesis being tested is that Cimzia
 (certolizumab pegol) will show efficacy in improving the symptoms of patients with IC.
Inclusion Criteria:

 1. 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.

 2. Only those patients with moderate to severe IC/BPS will be included in the study.

 3. Able to provide informed consent to participate in the study and comply with study
 requirements

 4. Able to provide written authorization for use and release of health and research study
 information

 5. Written documentation of being provided California's Experimental Subject's Bill of
 Rights

 6. 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

 7. Female patients of child-bearing potential must have a negative serum pregnancy test
 at Screening and use birth control while in the study.

 8. O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes (OSPI) score ≥ 18

 9. No history of any cancer.

 10. No bacterial cystitis in previous 1 month

 11. No active herpes in previous 3 months

 12. Never treated with cyclophosphamide

 13. No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's
 disease, multiple sclerosis, spina bifida or diabetic cystopathy)

 14. Absence of bladder, ureteral or urethral calculi for previous 3 months

 Exclusion criteria:

 1. Symptoms are relieved at one month reevaluation visit after receiving IC/BPS behavior
 modification advice at screening visit.

 2. Symptoms are relieved by antimicrobials, antibiotics, or other medications for IC/BPS

 3. 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

 4. Males

 5. Patients with inadequate renal, hepatic, or cardiac function

 6. Patients with history of gross hematuria within 2 years.

 7. Patients with the following medical history: Lower urinary tract anatomical anomaly,
 pelvic radiotherapy, or active genital herpes

 8. 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.

 9. Patients who have undergone cystoscopy under anesthesia with bladder biopsy,
 hydrodistension, or fulguration of Hunner's ulcer within 3 months

 10. Patients taking the following treatments for interstitial cystitis at Screening:
 Intravesical BCG, corticosteroid therapy, cyclosporine, or TNF-alpha inhibitors.

 11. Patients with a history of receiving live vaccine including Flumist® influenza vaccine
 in the past 3 months.

 12. Patients with a history of allergic or anaphylactic reaction to a therapeutic or
 diagnostic monoclonal antibody or IgG-fusion protein.

 13. Patients with a history of alcohol, analgesic or drug abuse within 2 years of
 Screening.

 14. Patients with a history of any cancer.

 15. Patients with a history of active Hepatitis B, Hepatitis C, or Human Immunodeficiency
 Virus (HIV) infection, or who are known carriers (Hepatitis B).

 16. 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.

 17. Patients with a history of diabetes mellitus.

 18. 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.

 19. 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 interpretation of
 study results and, in the judgment of the Investigator, would make the patient
 inappropriate for entry into this study.