Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- IC/BPS Symptoms Change With Overall Global Response Assessment (GRA)
研究概览
简要总结
A Randomized, Double-blind, Placebo Controlled Trial of Certolizumab Pegol in Women with Refractory Interstitial Cystitis/Bladder Pain Syndrome
详细描述
Interstitial cystitis (IC) is a chronic disabling bladder syndrome characterized by urinary frequency, nocturia, urinary urgency, and pain or discomfort with bladder filling. 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. Cimzia (certolizumab pegol) is a medication that blocks the effect of TNF. Cimzia (certolizumab pegol) is FDA approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and Crohn's disease. These diseases are similar to IC. In this study, the hypothesis being tested is that Cimzia (certolizumab pegol) will show efficacy in improving the symptoms of patients with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A diagnosis of IC/BPS defined based on AUA guidelines as the following: an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than 6 months duration, in the absence of infection or identifiable causes, documented history or patient reported.
- •Only those patients with moderate to severe IC/BPS will be included in the study.
- •Able to provide informed consent to participate in the study and comply with study requirements
- •Able to provide written authorization for use and release of health and research study information
- •Written documentation of being provided California's Experimental Subject's Bill of Rights
- •Females ≥18 and ≤ 65 years of age previously diagnosed with interstitial cystitis/ bladder pain syndrome (IC/BPS) for a duration of greater than 6 months
- •Female patients of child-bearing potential must have a negative serum pregnancy test at Screening and use birth control while in the study.
- •O'Leary-Sant Interstitial Cystitis Symptom and Problem Indexes (OSPI) score ≥ 18
- •No history of any cancer.
- •No bacterial cystitis in previous 1 month
- •No active herpes in previous 3 months
- •Never treated with cyclophosphamide
- •No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy)
- •Absence of bladder, ureteral or urethral calculi for previous 3 months
- •Exclusion criteria:
- •Symptoms are relieved at one month reevaluation visit after receiving IC/BPS behavior modification advice at screening visit.
- •Symptoms are relieved by antimicrobials, antibiotics, or other medications for IC/BPS
- •Pregnant women, lactating mothers, nursing mothers, women suspected of being pregnant and woman who plan to be pregnant during the course of the clinical trial
- •Patients with inadequate renal, hepatic, or cardiac function
- •Patients with history of gross hematuria within 2 years.
- •Patients with the following medical history: Lower urinary tract anatomical anomaly, pelvic radiotherapy, or active genital herpes
- •Patients with a history of tuberculosis (TB), recent exposure to TB, or recent travel to TB endemic regions. Patients should have a recent negative PPD (or negative CXR) prior to receiving treatment.
- •Patients who have undergone cystoscopy under anesthesia with bladder biopsy, hydrodistension, or fulguration of Hunner's ulcer within 3 months
- •Patients taking the following treatments for interstitial cystitis at Screening: Intravesical BCG, corticosteroid therapy, cyclosporine, or TNF-alpha inhibitors.
- •Patients with a history of receiving live vaccine including Flumist® influenza vaccine in the past 3 months.
- •Patients with a history of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
- •Patients with a history of alcohol, analgesic or drug abuse within 2 years of Screening.
- •Patients with a history of any cancer.
- •Patients with a history of active Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) infection, or who are known carriers (Hepatitis B).
- •Patients with a history of invasive fungal infections, recent travel to regions endemic for the following invasive fungal infections: San Joaquin Fever, aspergillosis, histoplasmosis, candidiasis, coccidiodomycosis, blastomycosis, and pneumocystosis.
- •Patients with a history of diabetes mellitus.
- •Patients with a history of a neurologic disease included but not limited to central demyelinating diseases, including multiple sclerosis; and a history of peripheral demyelinating disease, including Guillain-Barre syndrome.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.
排除标准
- 未提供
研究组 & 干预措施
Group 2: Placebo Comparator
Placebo: given subcutaneously at week 0, 2, 4, and week 8
干预措施: Placebo (Drug)
Group 1: Experimental
Biological: Certolizumab pegol (Cimzia) 400 mg loading dose given subcutaneously at week 0, 2, and 4 followed by a maintenance dose at week 8
干预措施: Certolizumab pegol (Biological)
结局指标
主要结局
IC/BPS Symptoms Change With Overall Global Response Assessment (GRA)
时间窗: Week 2
Patient-reported global response assessment (GRA) such as "Compared to when you began this trial, how would you rate your IC symptoms now?" Study subjects reported their response to treatment of their pain, urgency, and overall status compared to their condition at trial start with a symmetric scale global response assessment (GRA) 28 at weeks 2, 4, 10, and 18. Possible responses were markedly worse (100% worse), moderately worse (50% worse), slightly worse (25% worse), no change (0% improvement), slightly improved (25% improvement), moderately improved (50% improvement), and markedly improved (100% improved). Treatment responders were defined by rating the GRA as moderately improved or markedly improved.
次要结局
- Pain Scale(Value at Weeks 2, 4, 10, and 18 minus baseline)
- IC/BPS Symptoms Assessment With the Interstitial Cystitis Problem Index (ICPI)(Value of Weeks 2, 4, 10, and 18 minus baseline)
- IC/BPS Symptoms Change With Overall Global Response Assessment (GRA)(Week 4, 10, 18)
- IC/BPS Symptoms Assessment With the Interstitial Cystitis Symptom Index(Value at Weeks 2, 4, 10 and 18 minus Baseline)
- Urgency Scale(Value of Weeks 2, 4, 10, and 18 minus baseline)
研究者
Philip C. Bosch, M.D.
Philip C Bosch, MD
ICStudy, LLC