Efficacy Study of Adalimumab to Treat Interstitial Cystitis - Full Text View

Sponsor:	ICStudy, LLC
Collaborator:	Abbott
Information provided by (Responsible Party):	Philip C. Bosch, M.D., ICStudy, LLC
ClinicalTrials.gov Identifier:	NCT01295814

Purpose

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:

MedlinePlus related topics: Interstitial Cystitis

Drug Information available for: Adalimumab

U.S. FDA Resources

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:	January 2013
Estimated Primary Completion Date:	October 2012 (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.

Eligibility

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

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 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01295814

Contacts

Contact: Carol Odle

760-752-5016

icstudy@icstudy.net

Locations

United States, California
Philip C. Bosch, MD	Recruiting
Escondido, California, United States, 92025
Principal Investigator: Philip C Bosch, MD

Sponsors and Collaborators

ICStudy, LLC

Abbott

Investigators

Principal Investigator:

Philip C Bosch, MD

More Information

Additional Information:

click here for more information about the interstitial cystitis study This link exits the ClinicalTrials.gov site

No publications provided

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:	May 7, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by ICStudy, LLC:

Interstitial cystitis
Humira
Adalimumab

Additional relevant MeSH terms:

Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Adalimumab

Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2012