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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

Brief Summary:
A Randomized, Double-blind, Placebo Controlled Trial of Certolizumab Pegol in Women with Refractory Interstitial Cystitis/Bladder Pain Syndrome

Condition or disease Intervention/treatment Phase
Cystitis, Interstitial Biological: Certolizumab pegol Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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
Actual Study Start Date : December 15, 2015
Actual Primary Completion Date : April 16, 2017
Actual Study Completion Date : July 12, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. IC/BPS Symptoms Change With Overall 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?" 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.


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

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

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

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

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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 Flumist® 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.

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
  Study Documents (Full-Text)

Documents provided by Philip C. Bosch, M.D., ICStudy, LLC:
Statistical Analysis Plan  [PDF] January 24, 2018
Study Protocol  [PDF] November 5, 2015
Informed Consent Form  [PDF] July 21, 2015


Publications of Results:
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 Posted: July 15, 2015    Key Record Dates
Results First Posted: March 22, 2018
Last Update Posted: May 17, 2018
Last Verified: April 2018
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