Efficacy Study of Adalimumab to Treat Interstitial Cystitis

Phase 3

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
adalimumab	Adalimumab	Adalimumab 80mg subcutaneous loading dose followed by 40 mg subcutaneous every 2 weeks for 12 weeks
Inactive drug	inactive drug	Placebo in identical syringe subcutaneous every 2 weeks for 12 weeks

Primary Outcome Measures

Name	Time	Method
O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score	Baseline/12 Weeks	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)

Secondary Outcome Measures

Name	Time	Method
Interstitial Cystitis Problem Index (ICPI)	Baseline/12 Weeks	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)
Interstitial Cystitis Symptom Index (ICSI)	Baseline/ 12 weeks	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)
Pelvic Pain Urgency/Frequency (PUF) Score	Baseline12 Weeks	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)
Global Response Assessment (GRA)	Measured at12 Weeks	Percent(%) of patients who reported 50% or greater overall improvement in their condition. Score on a scale range (improvement 0%-100%)