An Investigator Initiated, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Humira® (Adalimumab) For The Treatment of Interstitial Cystitis(IC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
adalimumab
Adalimumab 80mg subcutaneous loading dose followed by 40 mg subcutaneous every 2 weeks for 12 weeks
干预措施: Adalimumab (Drug)
Inactive drug
Placebo in identical syringe subcutaneous every 2 weeks for 12 weeks
干预措施: inactive drug (Other)
结局指标
主要结局
O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score
时间窗: Baseline/12 Weeks
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)
次要结局
- Interstitial Cystitis Problem Index (ICPI)(Baseline/12 Weeks)
- Interstitial Cystitis Symptom Index (ICSI)(Baseline/ 12 weeks)
- Pelvic Pain Urgency/Frequency (PUF) Score(Baseline12 Weeks)
- Global Response Assessment (GRA)(Measured at12 Weeks)
研究者
Philip C. Bosch, M.D.
Urologist
ICStudy, LLC