Efficacy Study of Adalimumab to Treat Interstitial Cystitis

Interstitial Cystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295814
• Other study ID #: IMM 10-0061
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2011
• Last updated: July 12, 2015
• Start date: March 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2015
• Source: ICStudy, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis

Intervention

Drug:
• Adalimumab
80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period

Other:
• inactive drug
80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period

Locations

Country	Name	City	State
United States	Philip C. Bosch, MD	Escondido	California

Sponsors (2)

Lead Sponsor	Collaborator
ICStudy, LLC	Abbott

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No