BIRMINGHAM, Ala. -- *To see if you qualify for this Ulcerative Colitis Clinical Trial in Alabama (http://www.achieveclinical.com/trial/ulcerative-colitis/), visit Achieve Clinical Research on the web (http://www.achieveclinical.com (http://www.achieveclinical.com)) or contact us directly at (205) 380-6434. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
DURATION OF STUDY PARTICIPATION
The study will consist of up to a 30-day screening period, a 24-week randomized, double-blind, placebo-controlled period, an approximately 108 week open-label period, and an approximately 2 year safety follow-up period. The placebo-controlled period of the study will consist of a 24 week treatment period for assessment of induction and sustained remission. The maximal duration of trial participation for an individual subject is approximately 216 weeks (approximately 4.5 years).
BACKGROUND & RATIONALE
Inflammatory bowel disease (IBD) affects approximately 1.4 million people in the US and 2.2 million people in Europe. The peak onset for this disease is seen in persons 15 to 30 years of age. IBD comprises 2 types of chronic intestinal disorders: Crohn’s Disease (CD) (http://www.achieveclinical.com/clinical-trials/crohns-dis...) and UC. Mounting evidence suggests that IBD is the result of an inappropriate inflammatory response to intestinal microbes in a genetically susceptible host.
Treatment of ulcerative colitis includes lifestyle alterations, medical management, and surgical interventions. The overarching goals of treatment for this condition are induction and maintenance of remission of Ulcerative Colitis symptoms (http://www.achieveclinical.com/clinical-trials/ulcerative...) to provide an improved quality of life, reduction in need for long-term corticosteroids, and minimization of cancer risk. Medical management of IBD patients typically uses a step-up approach.
PRIMARY OBJECTIVE
To evaluate the effect of a new UC drug on the induction of remission in subjects with moderate to severe ulcerative colitis (UC) at week 8 after treatment as assessed by a total Mayo Score of 2 points or lower, with no individual subscore exceeding 1 point.
SECONDARY OBJECTIVES
To evaluate the effects of this new drug on induction of response at week 8 as assessed by the total Mayo Score
To evaluate the effects of this new drug on mucosal healing at week 8 as assessed by rectosigmoidoscopy
INCLUSION CRITERIA
Age 18 to 65 at screening (inclusive)
Diagnosis of UC established ≥ 3 months before baseline by clinical and endoscopic evidence and corroborated by a histopathology report
Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with a centrally read rectosigmoidoscopy score ≥ 2 prior to baseline
Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments as defined below:
-- Immunomodulators defined as:
--- Signs and symptoms of persistently active disease despite a history of at least one 8-week regimen of oral azathioprine or 6-mercaptopurine, or methotrexate OR
--- History of intolerance to at least one immunomodulator (including, but not limited to nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities, lymphopenia, thiopurine S-methyltransferase genetic mutation, infection)
-- Anti-TNF agents defined as:
--- Signs and symptoms of persistently active disease despite a history of at least one induction regimen consisting of at least 2 doses at least 2 weeks apart OR
--- Recurrence of symptoms during maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not qualify) OR
--- History of intolerance to at least one anti-TNF agent (including, but not limited to infusion/injection related reaction, demyelination, congestive heart failure, infection)
-Subjects can be receiving the following treatments:
-- Azathioprine or 6-mercaptopurine if treatment initiated at least 12 weeks prior to baseline and if stable dosage for ≥ 8 weeks prior to baseline
-- Methotrexate up to 25 mg/week if stable dosage for ≥ 8 weeks prior to baseline
-- 5-aminosalicylates and/or oral prednisone or equivalent up to 20 mg/day, if stable dosage for ≥ 2 weeks prior to baseline
Neurological exam, free of clinically significant, unexplained signs or symptoms in the opinion of the investigator during screening and no clinically significant change prior to randomization
Subject has no known history of active tuberculosis
Subject has a negative test for tuberculosis during screening defined as either:
-- negative purified protein derivative (PPD) (< 5 mm of induration at 48 to 72 hours after test is placed) OR
-- negative Quantiferon test
-- Subjects with a positive PPD and a history of Bacillus Calmette-Guérin vaccination are allowed with a negative Quantiferon test.
-- Subjects with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or subjects with a positive or indeterminate Quantiferon test are allowed if they have all of the following:
--- no symptoms per tuberculosis worksheet
--- documented history of a completed course of adequate prophylaxis (per local standard of care)
--- no known exposure to a case of active tuberculosis after most recent prophylaxis
--- no evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product
Subject has provided informed consent
*Achieve Clinical Research conducts Phase II-IV Clinical Trials in Alabama (http://www.achieveclinical.com/trials/). For more information about participating in a Ulcerative Colitis Clinical Study, please visit our website or contact us directly at (205) 380-6434.
