Expired Study
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Escondido, California 92025


Purpose:

Randomized, double-blind, placebo controlled study evaluating the efficacy of certolizumab pegol in the treatment of interstitial cystitis/ bladder pain syndrome.


Study summary:

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.


Criteria:

Inclusion Criteria: 1. Able to provide informed consent to participate in the study and comply with study requirements 2. Able to provide written authorization for use and release of health and research study information 3. Written documentation of being provided California's Experimental Subject's Bill of Rights 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 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, 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: Tuberculosis, bladder cancer, urethral cancer, lower urinary tract anatomical anomaly, pelvic radiotherapy, or active genital herpes 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 vaccines. 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 Screening. 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.


NCT ID:

NCT02497976


Primary Contact:

Principal Investigator
Philip C Bosch, MD
IC Study, LLC


Backup Contact:

N/A


Location Contact:

Escondido, California 92025
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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