Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis

NCT ID: NCT02497976

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-15
• Study Completion Date: 2017-07-12

Brief Summary

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

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.

Conditions

Cystitis, Interstitial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Certolizumab pegol

Intervention Type: BIOLOGICAL

400 mg

Group 2: Placebo Comparator

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal saline

Interventions

Certolizumab pegol

400 mg

Intervention Type: BIOLOGICAL

Placebo

Normal saline

Intervention Type: DRUG

Other Intervention Names

Cimzia; Normal saline

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: collaborator

ICStudy, LLC

OTHER

Sponsor Role: lead

Responsible Party

Philip C. Bosch, M.D.

Philip C Bosch, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip C Bosch, MD

Role: PRINCIPAL_INVESTIGATOR

IC Study, LLC

Locations

Philip C. Bosch, MD

Escondido, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23792149 (View on PubMed)

Bosch 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.

Reference Type: RESULT

PMID: 24958479 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IC-201

Identifier Type: -

Identifier Source: org_study_id