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ALPCO Calprotectin ELISA - Measurement of Calprotectin Levels in Human Stool
The ALPCO Calprotectin ELISA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. This study will estimate the predictive values of a negative (NPV) and positive (PPV) test by utilizing the...
22 Years and OverLearn More -
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed prior 12-week induction study AMAN (NCT03518086).
18 Years - 80 YearsLearn More -
Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis
The purpose of this study is to determine whether aminosalicylic acid (ASA) can be safely withdrawn in patients with long-standing clinical inactive UC.
18 Years and OverLearn More -
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
16 Years - 80 YearsLearn More -
A Multicentre Study on Rifaximin in Post-operative Endoscopic Crohn's Disease Recurrence Prevention
Crohn's Disease (CD) is a chronic pathology characterized by exacerbations and remissions. Recurrent inflammation can cause bowel strictures, fistulae (often perianal) or abscesses. CD often requires intestinal resection. Surgery in CD is not curative, Therefore, endoscopic follow-up 6-12 months after surgery is recommended. Given the association between enteric bacteria and postoperative CD recurrence, antibacterial agents were shown to be effective in reducing the severity of endoscopic recurrence, but prolonged administration causes significant toxicity. The efficacy of "systemic antibiotics" and the experimental evidence of the central...
18 Years - 75 YearsLearn More -
An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis [EXPEDITION]
The present study (3151-201-008) seeks to evaluate the efficacy and safety of brazikumab versus placebo in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy.
18 Years - 80 YearsLearn More -
An Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's Disease
The purpose of this program is to provide early access to ustekinumab where it is commercially unavailable for the treatment of participants with moderately to severely active Crohn's disease who have failed treatment with conventional Crohn's disease therapy (example, immunomodulators or corticosteroids) and Tumor Necrosis Factor alpha (TNF alpha) antagonist therapy (e.g., infliximab, adalimumab, certolizumab pegol, or their biosimilars), or who are intolerant to, or have a contraindication to these treatments. During the course of this early access program (EAP), through the reporting of serious adverse events (SAEs) and non-serious...
18 Years and OverLearn More -
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
This is a Phase 3, open-label, multicenter extension study to evaluate safety and efficacy of ozanimod in subjects with moderately to severely active Crohn's Disease.
18 Years - 75 YearsLearn More -
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.
18 Years - 80 YearsLearn More -
An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
The purpose of this study is to compare the incidence of lymphoma in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi versus those treated with thiopurines.
18 Years and OverLearn More
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