CRA Archived Studies

MERIT-UC: MEthotrexate Response In Treatment of Ulcerative Colitis

Randomized, double blind, prospective trial investigating the efficacy of Methotrexate in induction and maintenance of steroid free remission in ulcerative colitis

The study has been completed

PI: Hans Herfarth

Co-PI:  Kim Isaacs, James Lewis, Mark Osterman, Bruce Sands

We are facing a persistent unmet need for additional effective and affordable therapies for patients with ulcerative colitis (UC). Methotrexate (MTX) 25 mg once weekly administered subcutaneously (sq) or intramuscularly (im) is an efficient therapy to induce and maintain steroid free remission in patients with Crohn’s disease (CD). Several retrospective and prospective case series demonstrate similar clinical efficacy of MTX in patients with UC, when the drug was administered in a comparable dose and similar route (im or sq) as in CD 1, 2.

MERIT-UC is a prospective placebo controlled study to investigate the safety and efficacy of 25 mg MTX applied subcutaneously once weekly in patients with active UC, who are either steroid dependent or are intolerant or not responding to mesalamine or azathioprine/6-mercaptopurine therapy or have no response/ lost response to infliximab prior to the study inclusion. After an open label Induction Period in which each study participant applies MTX 25 mg sq once weekly over a 16 week time period with a concomitant steroid taper over 12 weeks, all participants of the study are randomized in the Maintenance Period to continue therapy with methotrexate or placebo weekly in a blinded fashion for 32 weeks.

MERIT-UC is conducted at sites of the Crohn’s and Colitis Foundation's Clinical Research Alliance and is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

RODIN – CD: A Randomized Controlled Trial of High Dose Vitamin D Therapy in Crohn’s Disease (RODIN-CD)

PI: Shail Govani, Peter Higgins

Background

There is emerging evidence to support the importance of the role of vitamin D in autoimmune diseases. There is a well-known north-south gradient with respect to the incidence of Crohn’s disease, with more cases farther from the equator. This ecological finding is believed to be mediated through UV-induced production of vitamin D. Among patients with Crohn’s, retrospective studies have shown a link between vitamin D levels and severity of disease, with patients with lower levels more likely to undergo surgery. The single prospective study examining Crohn’s related outcomes found a trend towards improved disease activity (based on CDAI) in patients supplemented with 1200 IU of vitamin D3.

In this study, we aim to prospectively study the impact of high dose supplementation (10,000 IU vitamin D3) in Crohn’s patients with vitamin D deficiency. We have selected a composite endpoint of hospitalizations, surgeries, emergency room visits and steroid prescriptions the primary outcome.

In the pilot phase, we plan to follow 50 patients at 4 sites around the country for 1 year with the goal of fine-tuning the protocol for a large study in subsequent years.