As many as 1.4 million Americans suffer from Crohn’s Disease or ulcerative colitis, collectively known as inflammatory bowel disease. Since many are diagnosed before age 30, patients can spend decades alternating between periods of painful flare-ups and symptom-free remission. Reliance on long-term treatment also means patients can develop resistance to medications that worked initially. Now, the Crohn’s & Colitis Foundation of America (CCFA) is launching a new IBD Clinical Trial Community to educate patients and providers about clinical trials and help accelerate the drug development process.
Crohn’s vs. Colitis
To understand the need for better treatments, it helps to understand IBD. According to the CCFA, Crohn’s and colitis are similar but uniquely distinct. Both IBDs cause chronic inflammation in the gastrointestinal tract, which is responsible for food digestion, nutrients absorption and waste elimination. In patients with IBD, inflammation impairs the ability of affected GI organs to function properly, leading to symptoms including persistent diarrhea, abdominal pain, cramping, rectal bleeding and fatigue.
A key difference is that Crohn’s can affect any part of the GI tract, from the mouth to the anus, and may appear in “patches.” Ulcerative colitis is limited to the large intestine and the rectum. Inflammation occurs only in the innermost layer of the lining of the intestine, while Crohn’s-related inflammation can permeate the entire intestinal wall. The exact cause of IBDs isn’t understood, but it’s known to involve an interaction between genes, the immune system and environmental factors.
Pharmaceutical Options
James Testaverde, senior director of patient services for CCFA, said treatment of IBD encompasses three main goals: achieving remission, maintaining remission and improving quality of life. Five classes of medications are used to achieve these goals: aminosalicylates, corticosteroids, immunomodulators, biologic therapies, and antibiotics. Currently there are 39 brand name medications approved for the treatment of IBD, with the most recent being infliximab-dyyb, a biosimilar of infliximab (Remicade®) that was approved in April.
IBD Clinical Trials
Still, newer treatments are always on the horizon. The National Institutes of Health lists nearly 900 recent clinical trials for Crohn’s Disease and 700 for ulcerative colitis. More than 150 trials include both diagnoses. That’s nearly 2,000 opportunities for patients to access potentially life-changing treatments not yet available to the public, and Testaverde wants more patients – and gastroenterologists – to know about these opportunities.
According to the CCFA, only six percent of IBD trials are completed on time due to unfulfilled enrollment, among other issues. Testaverde said these delays create significant barriers to the drug approval process and result in fewer available treatments for patients. To that end, the IBD Clinical Trials Community is being formed to provide education and support to IBD patients interested in participating in trials and to encourage collaboration and efficiency among providers, researchers and patients.
The IBD Clinical Trial Community will include a website to help patients and providers find trials suited to their needs and location, plus a peer-to-peer support program to connect someone interested in a clinical trial with an experienced clinical trial peer mentor.
Spreading the Word
“We’re right in the beginning of creating the resources necessary to conduct this initiative, but one challenge is reaching out to and working with gastroenterologists to help them better educate patients about trials,” Testaverde said. “There’s a general lack of awareness of trials on the patient side, and also a significant number of physicians who don’t let patients know about clinical trials as potential options for treatment.”
A recent CCFA study showed less than 20 percent of providers present trials as an option to patients. While the CCFA has long listed educational opportunities and specific trials on their website, they still wanted to create a larger initiative to make a greater impact.
“It’s just something we’ve been talking about for a while and decided that now’s as good a time as any to move forward,” Testaverde said. “We want to make sure we’re doing what we can as a foundation to ensure success with as many clinical trials as possible and decrease the time it takes to get medications on the market.”
CCFA Resources
In 2015, CCFA’s database included a half million individuals who receive support across multiple modalities, from print and online materials to in-person education and support. CCFA received initial funding for its IBD Clinical Trials Community earlier this year through educational grants from Celgene Corporation, Genentech, and Takeda Pharmaceuticals U.S.A., Inc. Additional support is provided by CCFA’s annual giving donors.
CCFA currently maintains a website that lists IBD clinical trials that are recruiting patients, and it is searchable by geographic region and disease type. CCFA’s clinical trial registry can be found at ccfa.org/clinicaltrials.
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