Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis
1 other identifier
interventional
42
1 country
1
Brief Summary
A Randomized, Double-blind, Placebo Controlled Trial of Certolizumab Pegol in Women with Refractory Interstitial Cystitis/Bladder Pain Syndrome
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2015
CompletedFirst Posted
Study publicly available on registry
July 15, 2015
CompletedStudy Start
First participant enrolled
December 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 12, 2017
CompletedResults Posted
Study results publicly available
March 22, 2018
CompletedMay 17, 2018
April 1, 2018
1.3 years
July 10, 2015
January 25, 2018
April 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IC/BPS Symptoms Change With Overall Global Response Assessment (GRA)
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.
Week 2
Secondary Outcomes (5)
IC/BPS Symptoms Change With Overall Global Response Assessment (GRA)
Week 4, 10, 18
IC/BPS Symptoms Assessment With the Interstitial Cystitis Symptom Index
Value at Weeks 2, 4, 10 and 18 minus Baseline
IC/BPS Symptoms Assessment With the Interstitial Cystitis Problem Index (ICPI)
Value of Weeks 2, 4, 10, and 18 minus baseline
Pain Scale
Value at Weeks 2, 4, 10, and 18 minus baseline
Urgency Scale
Value of Weeks 2, 4, 10, and 18 minus baseline
Study Arms (2)
Group 1: Experimental
ACTIVE COMPARATORBiological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8
Group 2: Placebo Comparator
PLACEBO COMPARATORPlacebo: given subcutaneously at week 0, 2, 4, and week 8
Interventions
Eligibility Criteria
You may qualify if:
- A diagnosis of IC/BPS defined based on AUA guidelines as the following: an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than 6 months duration, in the absence of infection or identifiable causes, documented history or patient reported.
- Only those patients with moderate to severe IC/BPS will be included in the study.
- Able to provide informed consent to participate in the study and comply with study requirements
- Able to provide written authorization for use and release of health and research study information
- Written documentation of being provided California's Experimental Subject's Bill of Rights
- Females ≥18 and ≤ 65 years of age previously diagnosed with interstitial cystitis/ bladder pain syndrome (IC/BPS) for a duration of greater than 6 months
- Female patients of child-bearing potential must have a negative serum pregnancy test at Screening and use birth control while in the study.
- O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes (OSPI) score ≥ 18
- No history of any cancer.
- No bacterial cystitis in previous 1 month
- No active herpes in previous 3 months
- Never treated with cyclophosphamide
- No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy)
- Absence of bladder, ureteral or urethral calculi for previous 3 months
You may not qualify if:
- Symptoms are relieved at one month reevaluation visit after receiving IC/BPS behavior modification advice at screening visit.
- Symptoms are relieved by antimicrobials, antibiotics, or other medications for IC/BPS
- Pregnant women, lactating mothers, nursing mothers, women suspected of being pregnant and woman who plan to be pregnant during the course of the clinical trial
- Males
- Patients with inadequate renal, hepatic, or cardiac function
- Patients with history of gross hematuria within 2 years.
- Patients with the following medical history: Lower urinary tract anatomical anomaly, pelvic radiotherapy, or active genital herpes
- Patients with a history of tuberculosis (TB), recent exposure to TB, or recent travel to TB endemic regions. Patients should have a recent negative PPD (or negative CXR) prior to receiving treatment.
- Patients who have undergone cystoscopy under anesthesia with bladder biopsy, hydrodistension, or fulguration of Hunner's ulcer within 3 months
- Patients taking the following treatments for interstitial cystitis at Screening: Intravesical BCG, corticosteroid therapy, cyclosporine, or TNF-alpha inhibitors.
- Patients with a history of receiving live vaccine including Flumist® influenza vaccine in the past 3 months.
- Patients with a history of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
- Patients with a history of alcohol, analgesic or drug abuse within 2 years of Screening.
- Patients with a history of any cancer.
- Patients with a history of active Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) infection, or who are known carriers (Hepatitis B).
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ICStudy, LLClead
- UCB Pharmacollaborator
Study Sites (1)
Philip C. Bosch, MD
Escondido, California, 92025, United States
Related Publications (2)
Bosch PC. A randomized, double-blind, placebo controlled trial of adalimumab for interstitial cystitis/bladder pain syndrome. J Urol. 2014 Jan;191(1):77-82. doi: 10.1016/j.juro.2013.06.038. Epub 2013 Jun 20.
PMID: 23792149RESULTBosch PC. Examination of the significant placebo effect in the treatment of interstitial cystitis/bladder pain syndrome. Urology. 2014 Aug;84(2):321-6. doi: 10.1016/j.urology.2014.04.011. Epub 2014 Jun 21.
PMID: 24958479RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Limitations include a larger, longer, multi-center randomized controlled trial is warranted with the primary endpoint at 18 weeks.
Results Point of Contact
- Title
- Philip C. Bosch, MD
- Organization
- IC Study LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Philip C Bosch, MD
IC Study, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Philip C Bosch, MD
Study Record Dates
First Submitted
July 10, 2015
First Posted
July 15, 2015
Study Start
December 15, 2015
Primary Completion
April 16, 2017
Study Completion
July 12, 2017
Last Updated
May 17, 2018
Results First Posted
March 22, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share