Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis
Condition: Cystitis, Interstitial
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: Certolizumab pegol; Placebo
Intervention description: 400 mg; Normal saline
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Interstitial; Cystitis; Bladder; Pain

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

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.