Clinical Trial: Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis

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

Detailed 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.
Sponsor: ICStudy, LLC

Current Primary Outcome:

  • IC/BPS symptoms change with the Global response assessment (GRA) [ Time Frame: Week 2 ]
    Patient-reported global response assessment (GRA) such as "Compared to when you began this trial, how would you rate your IC symptoms now?"
  • IC/BPS symptoms assessment with the Interstitial Cystitis Symptom Index (ICSI) [ Time Frame: Week 2 ]
    The Interstitial Cystitis Symptom Index (ICSI) is one of the two O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • IC/BPS symptoms change with the Global response assessment (GRA) [ Time Frame: Week 4, and 10 ]
    Patient-reported global response assessment (GRA) such as "Compared to when you began this trial, how would you rate your IC symptoms now?"
  • IC/BPS symptoms assessment with the Interstitial Cystitis Symptom Index (ICSI) [ Time Frame: Week 4, and 10 ]
    The Interstitial Cystitis Symptom Index (ICSI) is one of the two O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes.


Original Secondary Outcome: Same as current

Information By: ICStudy, LLC

Dates:
Date Received: July 10, 2015
Date Started: December 15, 2015
Date Completion: July 2017
Last Updated: March 1, 2017
Last Verified: March 2017