Efficacy Study of Adalimumab to Treat Interstitial Cystitis

Part of paid clinical trials in Escondido, California.

Sponsor
ICStudy, LLC
Study ID
NCT01295814
Phase
PHASE3
Status
Completed

Conditions

  • Interstitial Cystitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
  • inactive drug — OTHER
    80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period

Study Details

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.

Key Dates

Start date
Mar 31, 2011
Status verified
Jul 2015
Primary completion
Jun 30, 2013
Completion
Jul 31, 2013

Study Design

Enrollment
43 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: adalimumab
    Adalimumab 80mg subcutaneous loading dose followed by 40 mg subcutaneous every 2 weeks for 12 weeks
  • Placebo Comparator: Inactive drug
    Placebo in identical syringe subcutaneous every 2 weeks for 12 weeks

Primary Outcome Measure

O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score [ Time Frame: Baseline/12 Weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Philip C. Bosch, MDEscondidoCalifornia92025-

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Philip C. Bosch, MD· Escondido, CA

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