Efficacy Study of Adalimumab to Treat Interstitial Cystitis
Клучни зборови
Апстракт
Опис
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.
Датуми
| Последен пат проверено: | 06/30/2015 |
| Прво доставено: | 02/13/2011 |
| Поднесено е проценето запишување: | 02/13/2011 |
| Прво објавено: | 02/14/2011 |
| Последното ажурирање е доставено: | 07/11/2015 |
| Последно ажурирање објавено: | 07/15/2015 |
| Датум на први доставени резултати: | 07/19/2013 |
| Датум на први доставени резултати за КК: | 07/11/2015 |
| Датум на објавување на првите резултати: | 07/15/2015 |
| Крај на датумот на започнување на студијата: | 02/28/2011 |
| Проценет датум на примарно завршување: | 05/31/2013 |
| Проценет датум на завршување на студијата: | 06/30/2013 |
Состојба или болест
Интервенција / третман
Drug: adalimumab
Other: Inactive drug
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| Experimental: adalimumab Adalimumab 80mg subcutaneous loading dose followed by 40 mg subcutaneous every 2 weeks for 12 weeks | Drug: adalimumab 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period |
| Placebo Comparator: Inactive drug Placebo in identical syringe subcutaneous every 2 weeks for 12 weeks | Other: Inactive drug 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period |
Критериуми за подобност
| Возраст подобни за студии | 18 Years До 18 Years |
| Полови квалификувани за студии | All |
| Прифаќа здрави волонтери | Да |
| Критериуми | 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 |
Исход
Мерки на примарниот исход
1. O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score [Baseline/12 Weeks]
Секундарни мерки на исходот
1. Interstitial Cystitis Symptom Index (ICSI) [Baseline/ 12 weeks]
2. Interstitial Cystitis Problem Index (ICPI) [Baseline/12 Weeks]
3. Pelvic Pain Urgency/Frequency (PUF) Score [Baseline12 Weeks]
4. Global Response Assessment (GRA) [Measured at12 Weeks]
