Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02497976
Recruitment Status : Completed
First Posted : July 15, 2015
Results First Posted : March 22, 2018
Last Update Posted : May 17, 2018
UCB Pharma
Information provided by (Responsible Party):
Philip C. Bosch, M.D., ICStudy, LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cystitis, Interstitial
Interventions: Biological: Certolizumab pegol
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from my practice, web site, and Urology clinic at UCSD from December 10, 2015 through March 1, 2017.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 3 patients who did not meet screening criteria. Twenty-four patients had sufficient improvement in their IC/BPS symptoms and did not continue with the drug versus placebo phase of the study.

Reporting Groups
Group 1: Experimental

Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8

Certolizumab pegol: 400 mg

Group 2: Placebo Comparator

Placebo: given subcutaneously at week 0, 2, 4, and week 8

Placebo: Normal saline

Participant Flow:   Overall Study
    Group 1: Experimental   Group 2: Placebo Comparator
STARTED   28   14 
COMPLETED   26   13 
Withdrawal by Subject                2                0 
Moved out of area                0                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Certolizumab Pegol Experimental drug certolizumab pegol 400mg.
Placebo Normal saline
Total Total of all reporting groups

Baseline Measures
   Certolizumab Pegol   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   14   42 
[Units: Years]
Median (Standard Deviation)
 46.9  (12.7)   49.9  (10.7)   47.9  (10.8) 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
Female      28 100.0%      14 100.0%      42 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
[1] Only females between the age of 18 to 65.
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      1   3.6%      1   7.1%      2   4.8% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   3.6%      0   0.0%      1   2.4% 
White      24  85.7%      13  92.9%      37  88.1% 
More than one race      2   7.1%      0   0.0%      2   4.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Count of participants]
United States   28   14   42 
O'Leary Sant Symptom and Problem Index [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 26.8  (5.2)   26.7  (4.8)   26.8  (5.1) 
[1] Subjects rated the presence and extent of IC/BPS symptoms by completing the O'Leary-Sant Interstitial Cystitis Symptom Index and the O’Leary-Sant Interstitial Cystitis Problem Index (ICPI) at baseline and at weeks 2, 4, 10, and 18. Lubeck et al validated ICSI as a valid measure of change in treatment outcome studies. Propert et al validated the ICSI as responsive to change in IC/BPS symptoms and was recommended as secondary endpoints in clinical trials. No urinary symptoms would have a score of 0. The most severe symptoms would be a maximum of 35. Normal patients have a value of 7 or less.

  Outcome Measures

1.  Primary:   IC/BPS Symptoms Change With Overall Global Response Assessment (GRA)   [ Time Frame: Week 2 ]

2.  Secondary:   IC/BPS Symptoms Change With Overall Global Response Assessment (GRA)   [ Time Frame: Week 4, 10, 18 ]

3.  Secondary:   IC/BPS Symptoms Assessment With the Interstitial Cystitis Symptom Index   [ Time Frame: Value at Weeks 2, 4, 10 and 18 minus Baseline ]

4.  Secondary:   IC/BPS Symptoms Assessment With the Interstitial Cystitis Problem Index (ICPI)   [ Time Frame: Value of Weeks 2, 4, 10, and 18 minus baseline ]

5.  Secondary:   Pain Scale   [ Time Frame: Value at Weeks 2, 4, 10, and 18 minus baseline ]

6.  Secondary:   Urgency Scale   [ Time Frame: Value of Weeks 2, 4, 10, and 18 minus baseline ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations include a larger, longer, multi-center randomized controlled trial is warranted with the primary endpoint at 18 weeks.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Philip C. Bosch, MD
Organization: IC Study LLC
phone: 760 743-3135

Publications of Results:

Responsible Party: Philip C. Bosch, M.D., ICStudy, LLC Identifier: NCT02497976     History of Changes
Other Study ID Numbers: IC-201
First Submitted: July 10, 2015
First Posted: July 15, 2015
Results First Submitted: January 25, 2018
Results First Posted: March 22, 2018
Last Update Posted: May 17, 2018