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Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02497976
First Posted: July 15, 2015
Last Update Posted: March 3, 2017
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.
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Philip C. Bosch, M.D., ICStudy, LLC
  Purpose
Randomized, double-blind, placebo controlled study evaluating the efficacy of certolizumab pegol in the treatment of interstitial cystitis/ bladder pain syndrome.

Condition Intervention Phase
Cystitis, Interstitial Biological: Certolizumab pegol Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis

Resource links provided by NLM:


Further study details as provided by Philip C. Bosch, M.D., ICStudy, LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • Adverse events [ Time Frame: Screening through the phone follow-up at week 14 ]
    Any untoward medical occurrence associated with the use of the drug, whether or not considered drug related.


Enrollment: 42
Actual Study Start Date: December 15, 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Biological: Certolizumab pegol
400 mg
Other Name: Cimzia
Placebo Comparator: Group 2: Placebo Comparator
Placebo: given subcutaneously at week 0, 2, 4, and week 8
Drug: Placebo
Normal saline
Other Name: Normal saline

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Able to provide informed consent to participate in the study and comply with study requirements
  2. Able to provide written authorization for use and release of health and research study information
  3. Written documentation of being provided California's Experimental Subject's Bill of Rights
  4. Females ≥18 and ≤ 70 years of age previously diagnosed with interstitial cystitis/ bladder pain syndrome (IC/BPS) for a duration of greater than 6 months
  5. Female patients of child-bearing potential must have a negative serum pregnancy test at Screening and use birth control while in the study.
  6. O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes (OSPI) score ≥ 18
  7. No history of urethral or bladder cancer, high grade dysplasia or carcinoma in situ
  8. No bacterial cystitis in previous 1 month
  9. No active herpes in previous 3 months
  10. Never treated with cyclophosphamide
  11. No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy)
  12. 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, 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: Tuberculosis, bladder cancer, urethral cancer, lower urinary tract anatomical anomaly, pelvic radiotherapy, or active genital herpes
  8. Patients who have undergone cystoscopy under anesthesia with bladder biopsy, hydrodistension, or fulguration of Hunner's ulcer within 3 months
  9. Patients taking the following treatments for interstitial cystitis at Screening: Intravesical BCG, corticosteroid therapy, cyclosporine, TNF-alpha inhibitors, or live vaccines.
  10. History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
  11. Patients with a history of alcohol, analgesic or drug abuse within 2 years of Screening.
  12. History of cancer within the last 3 years except for cutaneous basal cell or squamous cell cancer resolved by excision.
  13. Patients with history of active Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) infection, or who are known carriers (Hepatitis B)
  14. 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497976


Locations
United States, California
Philip C. Bosch, MD
Escondido, California, United States, 92025
Sponsors and Collaborators
ICStudy, LLC
UCB Pharma
Investigators
Principal Investigator: Philip C Bosch, MD IC Study, LLC
  More Information

Additional Information:
Responsible Party: Philip C. Bosch, M.D., Philip C Bosch, MD, 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
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Philip C. Bosch, M.D., ICStudy, LLC:
Interstitial
Cystitis
Bladder
Pain

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents