Randomized, double-blind, placebo controlled study evaluating the efficacy of certolizumab
pegol in the treatment of 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.
1. Able to provide informed consent to participate in the study and comply with study
2. Able to provide written authorization for use and release of health and research
3. Written documentation of being provided California's Experimental Subject's Bill of
4. Females ≥18 and ≤ 70 years of age previously diagnosed with interstitial cystitis/
bladder pain syndrome (IC/BPS) for a duration of greater than 6 months
5. Female patients of child-bearing potential must have a negative serum pregnancy test
at Screening and use birth control while in the study.
6. O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes (OSPI) score ≥ 18
7. No history of urethral or bladder cancer, high grade dysplasia or carcinoma in situ
8. No bacterial cystitis in previous 1 month
9. No active herpes in previous 3 months
10. Never treated with cyclophosphamide
11. No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's
disease, multiple sclerosis, spina bifida or diabetic cystopathy)
12. Absence of bladder, ureteral or urethral calculi for previous 3 months
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, women suspected of being pregnant and woman who
plan to be pregnant during the course of the clinical trial
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: Tuberculosis, bladder cancer, urethral
cancer, lower urinary tract anatomical anomaly, pelvic radiotherapy, or active
8. Patients who have undergone cystoscopy under anesthesia with bladder biopsy,
hydrodistension, or fulguration of Hunner's ulcer within 3 months
9. Patients taking the following treatments for interstitial cystitis at Screening:
Intravesical BCG, corticosteroid therapy, cyclosporine, TNF-alpha inhibitors, or live
10. History of allergic or anaphylactic reaction to a therapeutic or diagnostic
monoclonal antibody or IgG-fusion protein.
11. Patients with a history of alcohol, analgesic or drug abuse within 2 years of
12. History of cancer within the last 3 years except for cutaneous basal cell or squamous
cell cancer resolved by excision.
13. Patients with history of active Hepatitis B, Hepatitis C, or Human Immunodeficiency
Virus (HIV) infection, or who are known carriers (Hepatitis B)
14. 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.