Efficacy Study of Adalimumab to Treat Interstitial Cystitis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate an investigational treatment for interstitial cystitis. Interstitial cystitis is a chronic bladder disease that includes the following symptoms: Urinary frequency during the day,urinary frequency at night, urinary urgency and bladder discomfort relieved by voiding. Presently, there is no cure for interstitial cystitis. The response to current treatments is poor. Patients with interstitial cystitis have a poorer quality of life. The cause of interstitial cystitis is unknown. This study is evaluating the drug Humira® (adalimumab) for improving the symptoms of patients with interstitial cystitis. Humira® is an injectable anti-inflammatory medication that has been available for use since December 31, 2002. Humira® has been FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, and Crohn's disease. These diseases have similar characteristics to interstitial cystitis. This study will evaluate an investigational use of Humira® for the treatment of interstitial cystitis.

Detailed Description
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Interstitial cystitis (IC) is a chronic disabling bladder syndrome characterized by urinary frequency, nocturia, urinary urgency, and pain with bladder filling-relieved by emptying. 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. Humira® (adalimumab) is a medication that blocks the effect of TNF. Humira® (adalimumab) is FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, and Crohn's disease. These diseases are similar to IC. In this study, the hypothesis being tested is that Humira® (adalimumab) will show efficacy at reducing the symptoms of IC.

Official Title
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An Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Humira® (Adalimumab) For The Treatment of Interstitial Cystitis(IC)

Conditions
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Interstitial Cystitis

Intervention / Treatment
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* Drug: Adalimumab
* Other: inactive drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females ≥18 and ≤ 65 years of age previously diagnosed with Interstitial Cystitis Currently have symptoms of urinary urgency, frequency or pain for more than 6 months Urinating at least 7 times a day or having some urgency or pain (measured on linear analog scales) Must be post-menopausal or surgically sterile or willing to use an adequate form of birth control Not pregnant or lactating Capable of voiding independently Willing to provide informed consent to participate Exclusion Criteria: Have symptoms that are presently relieved on other medications for interstitial cystitis Have absence of nocturia Have symptoms that are relieved by antimicrobials or antibiotics. Have a body mass index (BMI) of >39 kg/m2 Have uncontrolled hypertension Have Type I or type 2 diabetes Have active Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) infection, or who are known carriers (Hepatitis B) at Screening Have a positive tuberculosis test at screening Have had a urinary tract infection for 6 weeks Have had bacterial cystitis in previous 3 months Have had previous exposure to Humira® (adalimumab) Have taken investigational medication within 30 days of screening Have any other condition/disease which, in the opinion of the investigator, could compromise subject safety or confound the interpretation of study results Are unable or unwilling to comply with protocol requirements

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adalimumab<br>Adalimumab 80mg subcutaneous loading dose followed by 40 mg subcutaneous every 2 weeks for 12 weeks | Drug: Adalimumab<br>* 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period<br>* Other names: Humira;|
| Placebo Comparator: Inactive drug<br>Placebo in identical syringe subcutaneous every 2 weeks for 12 weeks | Other: inactive drug<br>* 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score | Improvement in the O'Leary Sant Symptom and Problem Index from baseline to week 12 Total scores on a scale range: 0-36 (0, meaning no symptoms to 36, meaning the most severe symptoms) | Baseline/12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial Cystitis Symptom Index (ICSI) | Improvement in O'Leary Sant Interstitial Cystitis Symptom Index (ICSI) Total scores on a range scale: 0-20 (0, meaning no symptoms, to 20, meaning the most severe symptoms) | Baseline/ 12 weeks | 
| Interstitial Cystitis Problem Index (ICPI) | Improvement in O'Leary Sant Interstitial Cystitis Problem Index (ICPI) Total scores on a scale: 0-16 (0, meaning no symptoms, to 16, meaning the most severe symptoms) | Baseline/12 Weeks | 
| Pelvic Pain Urgency/Frequency (PUF) Score | Pelvic Pain, Urgency/Frequency Symptom Scale Total scores on a scale range: 0-35 (0, meaning no symptoms, to 35, meaning the most severe symptoms) | Baseline12 Weeks | 
| Global Response Assessment (GRA) | Percent(%) of patients who reported 50% or greater overall improvement in their condition. Score on a scale range (improvement 0%-100%) | Measured at12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interstitial cystitis, Humira, Adalimumab