CLINICAL TRIAL

HLADQA1*05A>G screening for Inflammatory Bowel Diseases

Waitlist Available · 18+ · All Sexes · London, Canada

This study is evaluating whether a genetic test can help predict if a person will form ADAs to infliximab.

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About the trial for Inflammatory Bowel Diseases

Eligible Conditions
Ulcerative Colitis · Crohn Disease · Intestinal Diseases · Inflammatory Bowel Diseases · Colitis, Ulcerative

Treatment Groups

This trial involves 2 different treatments. HLADQA1*05A>G Screening is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
HLADQA1*05A>G screening
GENETIC
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Standard of Care
OTHER

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Individuals with prior biologic exposure to a non-TNF-based therapy are eligible
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 1 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether HLADQA1*05A>G screening will improve 1 primary outcome and 8 secondary outcomes in patients with Inflammatory Bowel Diseases. Measurement will happen over the course of 1 year.

incidence of combination therapy (infliximab and one of methotrexate or azathioprine) -related adverse drug events
1 YEAR
defined in outcome 4 and 5
time to infliximab anti-drug antibody formation
1 YEAR
measured from the time of treatment initiation to the time of antibody formation
incidence of immunomodulator-related adverse drug events
1 YEAR
defined as any injury presumed secondary to azathioprine or methotrexate exposure as decided by the treating gastroenterologist. This is including, but not limited to: infection, nausea and dyspepsia, myelotoxicity, hepatoxicity, pancreatitis
incidence of infliximab discontinuation
1 YEAR
when stopped by treating physician
incidence of infliximab loss of response
1 YEAR
defined as a relapse in clinical symptoms after week 14 of infliximab dosing, with an increase in the Harvey Bradshaw index (HBI) ≥ 3 points or the partial Mayo score ≥ 3 points, following a response to infliximab induction therapy where a 3-point reduction was seen in the HBI or partial Mayo score
time to infliximab discontinuation
1 YEAR
measured from the time of treatment initiation to the time of cessation as decided by the treating physician.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes inflammatory bowel diseases?

Crohn diseases are genetically linked to environmental factors such as smoking and diet and the immune system plays a role in the development of inflammatory bowel diseases.\n

Anonymous Patient Answer

How many people get inflammatory bowel diseases a year in the United States?

About 1.1 million adults have an ulcerative colitis, 1.8 million have a Crohn's disease, and 1.4 million have or have had a pouchitis in the United States a year.

Anonymous Patient Answer

What are common treatments for inflammatory bowel diseases?

The common treatments for IBD and other immunologic conditions, such as rheumatoid arthritis and psoriasis, are anti-inflammation agents and immunosuppressive therapy. Common treatments for IBD are anti-inflammatory agents such as prednisone, azathioprine, and cyclosporine. In addition, a combination of these drugs are often used by physicians. Common treatment for psoriasis is antiobiotics, such as metronidazole, trimethoprim/sulfamethoxazole, or tetracyclines. For psoriasis, combination therapy including corticosteroids and anti-inflammatory drugs are common.

Anonymous Patient Answer

Can inflammatory bowel diseases be cured?

Although Crohn's disease is treatable, the effect of the medications used is not a cure, and in many cases patients have to take medication indefinitely in order to stay free from symptoms. At present, there are no effective medications for Crohn's disease. Drugs that act on the inflammatory aspect of the disease may not cure the condition, but at the same time may prevent the disease from progressing from mild to life-threatening. On the other hand, patients with ulcerative colitis may have a chance of being free from their condition by using medications that alter the course of the disease. The effectiveness of the drugs used to treat UC are still under research by clinical trials.

Anonymous Patient Answer

What is inflammatory bowel diseases?

The IBD is a group of illnesses characterized by gastrointestinal inflammation, or gastrointestinal symptoms caused by inflammation of the gastrointestinal tract. The diseases affect the GI tract, but may cause other systemic manifestations, such as fatigue. The IBD group includes Crohn's disease and ulcerative colitis. Crohn's disease is an inflammatory disease that typically affects the intestines in the form of an ulcer.

Anonymous Patient Answer

What are the signs of inflammatory bowel diseases?

Crohn's disease and [ulcerative colitis](https://www.withpower.com/clinical-trials/ulcerative-colitis) both cause similar symptoms at any presentation, but this may give clinicians reason for concern if patients present with gastrointestinal complaints. Ulcerative colitis tends to present with a more severe course than Crohn's disease, and in Crohn's patients, there may be increased suspicion of autoimmune disease. Other rarer forms of IBD include microscopic colitis, which typically affects older patients and can present with diarrhea, weight loss, anemia, and vitamin deficiency. Patients with microscopic colitis are often prescribed long-term immunosuppressants, as well as vitamin B supplementation supplements.

Anonymous Patient Answer

What are the latest developments in hladqa1*05a>g screening for therapeutic use?

Results from a recent clinical trial emphasize the need for a highly sensitive molecular diagnostic assay to confirm diagnosis for PBC in HLA 05a>g05a*05b(4) homozygous IBD cases. Moreover, the authors' data emphasize the need for more accurate genetic characterization of CD risk in the future and raise the important issue of the optimal timing of diagnostic testing from 5 to 10 yr of disease or at earlier age with a more aggressive treatment approach.

Anonymous Patient Answer

Is hladqa1*05a>g screening typically used in combination with any other treatments?

In this registry, HLA-DQ1*05 was used by most rituximab combinations, with or without cyclosporin and methotrexate. By contrast, only a minority of patients received treatment with tacrolimus, tacrolimus alone or azathioprine alone.

Anonymous Patient Answer

Does inflammatory bowel diseases run in families?

There are significant associations between IBDs and multiple family members at both the disease and disease subtype level. Such associations may explain why IBDs are commonly diagnosed in families.

Anonymous Patient Answer

Is hladqa1*05a>g screening safe for people?

The hladqa1*05a>g CAG (GGGT) mutation is found in a minority of our patients. Routine screening for people with IBD or AIB seems to be safe.

Anonymous Patient Answer

What is the latest research for inflammatory bowel diseases?

This review highlights the advances in studying the etiology and pathogenesis of inflammatory bowel disease. The discovery of nucleotide base-sequence polymorphisms and genotype-phenotype correlations, which are potential factors of genetic susceptibility, and new classifications of the disease will help develop better and individualized treatment modalities.

Anonymous Patient Answer

Has hladqa1*05a>g screening proven to be more effective than a placebo?

Results from a recent paper show that HLA-DR5 genotype is associated with increased risk of developing T1D but not with T2D, and that the HLA-DR5 genotype is also more effective in preventing T1D compared with a placebo (0.47 % versus 0.20 % [OR = 2.3; p = 0.03] for the 2× relative risk reduction of T1D). Moreover, this study provides compelling evidence indicating HLA-DR5 as the major T1D-predisposing gene.

Anonymous Patient Answer
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