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Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis

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ClinicalTrials.gov Identifier: NCT02497976
Recruitment Status : Completed
First Posted : July 15, 2015
Results First Posted : March 22, 2018
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
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
Enrollment 42
Recruitment Details Patients were recruited from my practice, web site, and Urology clinic at UCSD from December 10, 2015 through March 1, 2017.
Pre-assignment Details 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.
Arm/Group Title Group 1: Experimental Group 2: Placebo Comparator
Hide Arm/Group Description

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

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

Placebo: Normal saline

Period Title: Overall Study
Started 28 14
Completed 26 13
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             2             0
Moved out of area             0             1
Arm/Group Title Certolizumab Pegol Placebo Total
Hide Arm/Group Description Experimental drug certolizumab pegol 400mg. Normal saline Total of all reporting groups
Overall Number of Baseline Participants 28 14 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 14 participants 42 participants
46.9  (12.7) 49.9  (10.7) 47.9  (10.8)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 14 participants 42 participants
Female
28
 100.0%
14
 100.0%
42
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Only females between the age of 18 to 65.
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 14 participants 42 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  
Measure Type: Number
Unit of measure:  Count of participants
United States Number Analyzed 28 participants 14 participants 42 participants
28 14 42
O'Leary Sant Symptom and Problem Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 28 participants 14 participants 42 participants
26.8  (5.2) 26.7  (4.8) 26.8  (5.1)
[1]
Measure Description: 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.
1.Primary Outcome
Title IC/BPS Symptoms Change With Overall Global Response Assessment (GRA)
Hide Description Patient-reported global response assessment (GRA) such as “Compared to when you began this trial, how would you rate your IC symptoms now?” Study subjects reported their response to treatment of their pain, urgency, and overall status compared to their condition at trial start with a symmetric scale global response assessment (GRA) 28 at weeks 2, 4, 10, and 18. Possible responses were markedly worse (100% worse), moderately worse (50% worse), slightly worse (25% worse), no change (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), and markedly improved (100% improved). Treatment responders were defined by rating the GRA as moderately improved or markedly improved.
Time Frame Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Experimental Group 2: Placebo Comparator
Hide Arm/Group Description:

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

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

Placebo: Normal saline

Overall Number of Participants Analyzed 28 14
Measure Type: Count of Participants
Unit of Measure: Participants
2
   7.1%
1
   7.1%
2.Secondary Outcome
Title IC/BPS Symptoms Change With Overall Global Response Assessment (GRA)
Hide Description Patient-reported global response assessment (GRA) such as “Compared to when you began this trial, how would you rate your IC symptoms now?” Study subjects reported their response to treatment of their pain, urgency, and overall status compared to their condition at trial start with a symmetric scale global response assessment (GRA) 28 at weeks 2, 4, 10, and 18. Possible responses were markedly worse (100% worse), moderately worse (50% worse), slightly worse (25% worse), no change (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), and markedly improved (100% improved). Treatment responders were defined by rating the GRA as moderately improved or markedly improved.
Time Frame Week 4, 10, 18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Experimental Group 2: Placebo Comparator
Hide Arm/Group Description:

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

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

Placebo: Normal saline

Overall Number of Participants Analyzed 28 14
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4
8
  28.6%
3
  21.4%
Week 10
12
  42.9%
3
  21.4%
Week 18
15
  53.6%
1
   7.1%
3.Secondary Outcome
Title IC/BPS Symptoms Assessment With the Interstitial Cystitis Symptom Index
Hide Description The Interstitial Cystitis Symptom Index is one of the two O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes. This scale has a 0 if the patient has no symptoms and a maximum of 19 with severe symptoms. Lubeck et al. validated ICSI as a valid measure of change in treatment outcome studies. A change of -4.03 in the ICSI score was the same as a 2 point improvement in GRA. Propert et al. validated the ICSI as responsive to change in IC/BPS symptoms and was recommended as secondary endpoints in clinical trials. A change of -2.4 in the ICSI score was the same as a 2 point improvement in GRA.
Time Frame Value at Weeks 2, 4, 10 and 18 minus Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Experimental Group 2: Placebo Comparator
Hide Arm/Group Description:

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

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

Placebo: Normal saline

Overall Number of Participants Analyzed 28 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 -1.9  (2.7) -0.6  (2.4)
Week 4 -3.3  (3.4) -1.5  (3.0)
Week 10 -4.1  (4.8) -2.8  (3.2)
Week 18 -5.1  (4.9) -1.5  (4.6)
4.Secondary Outcome
Title IC/BPS Symptoms Assessment With the Interstitial Cystitis Problem Index (ICPI)
Hide Description The Interstitial Cystitis Symptom Index (ICPI) is one of the two O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes. This scale has a 0 if the patient has no symptoms and a maximum of 16 with severe symptoms.
Time Frame Value of Weeks 2, 4, 10, and 18 minus baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Experimental Group 2: Placebo Comparator
Hide Arm/Group Description:

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

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

Placebo: Normal saline

Overall Number of Participants Analyzed 28 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 -1.4  (2.4) -1.4  (2.0)
Week 4 -2.3  (3.4) -2.3  (4.0)
Week 10 -4.1  (4.4) -2.3  (3.2)
Week 18 -4.8  (4.8) -1.8  (3.9)
5.Secondary Outcome
Title Pain Scale
Hide Description an 11-point pain intensity numerical rating scale. Subjects rated their average pain, pressure, or discomfort associated with their bladder using an 11-point pain intensity numerical rating scale of 0-no pain to 10-worse ever pain at baseline, and at weeks 2, 4, 10, and 18. Meaningful, clinically important pain relief is a reduction in pain of approximately 30% from baseline.
Time Frame Value at Weeks 2, 4, 10, and 18 minus baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Experimental Group 2: Placebo Comparator
Hide Arm/Group Description:

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

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

Placebo: Normal saline

Overall Number of Participants Analyzed 28 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 -0.9  (1.7) -0.8  (1.8)
Week 4 -1.1  (1.9) -0.1  (1.4)
Week 10 -2.0  (2.8) -0.6  (2.1)
Week 18 -2.4  (2.9) -0.4  (2.2)
6.Secondary Outcome
Title Urgency Scale
Hide Description Subjects rated their average urinary urgency or need to urinate using an 11-point numerical rating scale of 0-no urgency to 10-worse ever urgency
Time Frame Value of Weeks 2, 4, 10, and 18 minus baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1: Experimental Group 2: Placebo Comparator
Hide Arm/Group Description:

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

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

Placebo: Normal saline

Overall Number of Participants Analyzed 28 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 2 -0.8  (1.7) -0.6  (1.4)
Week 4 -1.0  (2.1) -0.6  (2.1)
Week 10 -1.6  (3.0) -1.1  (2.4)
Week 18 -2.6  (2.9) -0.8  (1.6)
Time Frame From screening to last visit at 18 weeks for a total of at least 22 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: Experimental Group 2: Placebo Comparator
Hide Arm/Group Description

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

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

Placebo: Normal saline

All-Cause Mortality
Group 1: Experimental Group 2: Placebo Comparator
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)      0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Experimental Group 2: Placebo Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: Experimental Group 2: Placebo Comparator
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/28 (25.00%)      4/14 (28.57%)    
Infections and infestations     
urinary infection  1  7/28 (25.00%)  7 4/14 (28.57%)  4
1
Term from vocabulary, SNOMED CT
Indicates events were collected by systematic assessment
Limitations include a larger, longer, multi-center randomized controlled trial is warranted with the primary endpoint at 18 weeks.
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
Responsible Party: Philip C. Bosch, M.D., ICStudy, LLC
ClinicalTrials.gov 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