Efficacy Study of Adalimumab to Treat Interstitial Cystitis
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: Adalimumab; inactive drug
Intervention description: 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period; 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Interstitial cystitis; Humira; Adalimumab

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.
    

Eligibility criteria:

        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