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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02497976
Date of registration: 10/07/2015
Prospective Registration: Yes
Primary sponsor: ICStudy, LLC
Public title: Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis
Scientific title: Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis
Date of first enrolment: December 15, 2015
Target sample size: 42
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02497976
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Philip C Bosch, MD
Address: 
Telephone:
Email:
Affiliation:  IC Study, LLC
Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

2. Only those patients with moderate to severe IC/BPS will be included in the study.

3. Able to provide informed consent to participate in the study and comply with study
requirements

4. Able to provide written authorization for use and release of health and research study
information

5. Written documentation of being provided California's Experimental Subject's Bill of
Rights

6. 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

7. Female patients of child-bearing potential must have a negative serum pregnancy test
at Screening and use birth control while in the study.

8. O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes (OSPI) score = 18

9. No history of any cancer.

10. No bacterial cystitis in previous 1 month

11. No active herpes in previous 3 months

12. Never treated with cyclophosphamide

13. No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's
disease, multiple sclerosis, spina bifida or diabetic cystopathy)

14. 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, nursing 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: Lower urinary tract anatomical anomaly,
pelvic radiotherapy, or active genital herpes

8. 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.

9. Patients who have undergone cystoscopy under anesthesia with bladder biopsy,
hydrodistension, or fulguration of Hunner's ulcer within 3 months

10. Patients taking the following treatments for interstitial cystitis at Screening:
Intravesical BCG, corticosteroid therapy, cyclosporine, or TNF-alpha inhibitors.

11. Patients with a history of receiving live vaccine including FlumistĀ® influenza vaccine
in the past 3 months.

12. Patients with a history of allergic or anaphylactic reaction to a therapeutic or
diagnostic monoclonal antibody or IgG-fusion protein.

13. Patients with a history of alcohol, analgesic or drug abuse within 2 years of
Screening.

14. Patients with a history of any cancer.

15. Patients with a history of active Hepatitis B, Hepatitis C, or Human Immunodeficiency
Virus (HIV) infection, or who are known carriers (Hepatitis B).

16. Patients with a history of invasive fungal infections, recent travel to regions
endemic for the following invasive fungal infections: San Joaquin Fever,
aspergillosis, histoplasmosis, candidiasis, coccidiodomycosis, blastomycosis, and
pneumocystosis.

17. Patients with a history of diabetes mellitus.

18. Patients with a history of a neurologic disease included but not limited to central
demyelinating diseases, including multiple sclerosis; and a history of peripheral
demyelinating disease, including Guillain-Barre syndrome.

19. 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Cystitis, Interstitial
Intervention(s)
Biological: Certolizumab pegol
Drug: Placebo
Primary Outcome(s)
IC/BPS Symptoms Change With Overall Global Response Assessment (GRA) [Time Frame: Week 2]
Secondary Outcome(s)
IC/BPS Symptoms Assessment With the Interstitial Cystitis Problem Index (ICPI) [Time Frame: Value of Weeks 2, 4, 10, and 18 minus baseline]
IC/BPS Symptoms Assessment With the Interstitial Cystitis Symptom Index [Time Frame: Value at Weeks 2, 4, 10 and 18 minus Baseline]
IC/BPS Symptoms Change With Overall Global Response Assessment (GRA) [Time Frame: Week 4, 10, 18]
Pain Scale [Time Frame: Value at Weeks 2, 4, 10, and 18 minus baseline]
Urgency Scale [Time Frame: Value of Weeks 2, 4, 10, and 18 minus baseline]
Secondary ID(s)
IC-201
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
UCB Pharma
Ethics review
Results
Results available: Yes
Date Posted: 22/03/2018
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02497976
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