Efficacy Study of Adalimumab to Treat Interstitial Cystitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by ICStudy, LLC.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Philip C. Bosch, M.D., ICStudy, LLC
ClinicalTrials.gov Identifier:
First received: February 14, 2011
Last updated: January 10, 2013
Last verified: January 2013

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.

Condition Intervention Phase
Interstitial Cystitis
Drug: Adalimumab
Other: inactive drug
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Humira® (Adalimumab) For The Treatment of Interstitial Cystitis(IC)

Resource links provided by NLM:

Further study details as provided by ICStudy, LLC:

Primary Outcome Measures:
  • Improvement of the Baseline O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) score [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of the Baseline Pelvic Pain and Urgency/Frequency patient symptom scale (PUF) score [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Patient global assessment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Physical exam including SQ injection site [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: 21 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: March 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: adalimumab Drug: Adalimumab
80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
Other Name: Humira
Placebo Comparator: Inactive drug Other: inactive drug
80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
Other Name: placebo

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 TB 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01295814

United States, California
Philip C. Bosch, MD
Escondido, California, United States, 92025
Sponsors and Collaborators
ICStudy, LLC
Principal Investigator: Philip C Bosch, MD
  More Information

No publications provided by ICStudy, LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philip C. Bosch, M.D., Urologist, ICStudy, LLC
ClinicalTrials.gov Identifier: NCT01295814     History of Changes
Other Study ID Numbers: IMM 10-0061
Study First Received: February 14, 2011
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ICStudy, LLC:
Interstitial cystitis

Additional relevant MeSH terms:
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on June 29, 2015