Efficacy Study of Adalimumab to Treat Interstitial Cystitis

NCT01295814 | Completed Phase 3 Results DMC

• 1 other identifier: IMM 10-0061
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Cystitis

Keywords

Interstitial cystitis; Humira; Adalimumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Interstitial Cystitis Symptom Index (ICSI)

  Baseline/ 12 weeks

• Interstitial Cystitis Problem Index (ICPI)

  Baseline/12 Weeks

• Pelvic Pain Urgency/Frequency (PUF) Score

  Baseline12 Weeks

• Global Response Assessment (GRA)

  Measured at12 Weeks

Study Arms (2)

adalimumab

EXPERIMENTAL

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

Drug: Adalimumab

Inactive drug

PLACEBO COMPARATOR

Placebo in identical syringe subcutaneous every 2 weeks for 12 weeks

Other: inactive drug

Interventions

Adalimumab DRUG

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

Also known as: Humira

adalimumab

inactive drug OTHER

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

Also known as: placebo

Inactive drug

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ICStudy, LLC: lead
• Abbott: collaborator

Study Sites (1)

Philip C. Bosch, MD

Escondido, California, 92025, United States

Location

Related Publications (2)

• 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.

  PMID: 23792149 RESULT

• 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.

  PMID: 32734597 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Philip C. Bosch, MD
• Organization: IC Study, LLC

pboschmd@gmail.com

760-743-3135

Study Officials

• Philip C Bosch, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 15, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 16, 2015
• Results First Posted: July 16, 2015

Record last verified: 2015-07

Locations

US (1)