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Efficacy Study of Adalimumab to Treat Interstitial Cystitis

Primary Purpose

Interstitial Cystitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Adalimumab
inactive drug
Sponsored by
ICStudy, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial cystitis, Humira, Adalimumab

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Philip C. Bosch, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

adalimumab

Inactive drug

Arm Description

Adalimumab 80mg subcutaneous loading dose followed by 40 mg subcutaneous every 2 weeks for 12 weeks

Placebo in identical syringe subcutaneous every 2 weeks for 12 weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
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%)

Full Information

First Posted
February 14, 2011
Last Updated
July 12, 2015
Sponsor
ICStudy, LLC
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT01295814
Brief Title
Efficacy Study of Adalimumab to Treat Interstitial Cystitis
Official Title
An Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Humira® (Adalimumab) For The Treatment of Interstitial Cystitis(IC)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ICStudy, LLC
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis
Keywords
Interstitial cystitis, Humira, Adalimumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adalimumab
Arm Type
Experimental
Arm Description
Adalimumab 80mg subcutaneous loading dose followed by 40 mg subcutaneous every 2 weeks for 12 weeks
Arm Title
Inactive drug
Arm Type
Placebo Comparator
Arm Description
Placebo in identical syringe subcutaneous every 2 weeks for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Description
80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
Intervention Type
Other
Intervention Name(s)
inactive drug
Other Intervention Name(s)
placebo
Intervention Description
80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
Primary Outcome Measure Information:
Title
O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score
Description
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)
Time Frame
Baseline/12 Weeks
Secondary Outcome Measure Information:
Title
Interstitial Cystitis Symptom Index (ICSI)
Description
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)
Time Frame
Baseline/ 12 weeks
Title
Interstitial Cystitis Problem Index (ICPI)
Description
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)
Time Frame
Baseline/12 Weeks
Title
Pelvic Pain Urgency/Frequency (PUF) Score
Description
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)
Time Frame
Baseline12 Weeks
Title
Global Response Assessment (GRA)
Description
Percent(%) of patients who reported 50% or greater overall improvement in their condition. Score on a scale range (improvement 0%-100%)
Time Frame
Measured at12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip C Bosch, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philip C. Bosch, MD
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23792149
Citation
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.
Results Reference
result
PubMed Identifier
32734597
Citation
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.
Results Reference
derived

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Efficacy Study of Adalimumab to Treat Interstitial Cystitis

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