Efficacy Study of Adalimumab to Treat Interstitial Cystitis

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

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Cystitis
• Intervention / Treatment: Drug: Adalimumab; Other: inactive drug

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Escondido, California, United States, 92025
      • Philip C. Bosch, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ICStudy, LLC
• Collaborators: Abbott
• Investigators: Principal Investigator: Philip C Bosch, MD

Publications and helpful links

General Publications

• Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
• Bosch PC. A randomized, double-blind, placebo controlled trial of adalimumab for interstitial cystitis/bladder pain syndrome. J Urol. 2014 Jan;191(1):77-82. doi: 10.1016/j.juro.2013.06.038. Epub 2013 Jun 20.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 14, 2011
• First Submitted That Met QC Criteria: February 14, 2011
• First Posted (Estimate): February 15, 2011

Study Record Updates

• Last Update Posted (Estimate): July 16, 2015
• Last Update Submitted That Met QC Criteria: July 12, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Interstitial cystitis; Adalimumab; Humira
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: IMM 10-0061