Filgotinib for Colitis, Ulcerative

Phase-Based Estimates
2
Effectiveness
3
Safety
"MDHAT Dr. St.Cherkezov" AD, Veliko Tarnovo, Bulgaria
Colitis, Ulcerative+3 More
Filgotinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Colitis, Ulcerative

Study Summary

This study is evaluating whether a drug called filgotinib is safe for people with ulcerative colitis.

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Eligible Conditions

  • Colitis, Ulcerative
  • Ulcer
  • Colitis
  • Ulcerative Colitis

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Filgotinib will improve 1 primary outcome and 1 secondary outcome in patients with Colitis, Ulcerative. Measurement will happen over the course of Baseline and up to 336 weeks.

Week 336
Change From Baseline in Components of Mayo Clinic Score (MCS)
Week 336
Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

5 Treatment Groups

Placebo (blinded dosing)
Filgotinib 200 mg (open-label)
Placebo group

This trial requires 1173 total participants across 5 different treatment groups

This trial involves 5 different treatments. Filgotinib is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Filgotinib 200 mg (open-label)
Drug
Filgotinib 200 mg for up to 336 weeks
Filgotinib 100 mg (open-label)
Drug
Filgotinib 100 mg for up to 336 weeks
Filgotinib 100 mg (blinded dosing)Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks
Filgotinib 200 mg (blinded dosing)Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
Placebo (blinded dosing)
Drug
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgotinib
FDA approved
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 336 weeks plus 30 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 336 weeks plus 30 days for reporting.

Closest Location

Royal University Hospital - Saskatoon, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
, Crohn's disease, RA, AS, PsA, or CD The patient must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for UC, Crohn's disease, RA, AS, PsA, or CD. show original
of the cycle Females who might become pregnant must have a negative pregnancy test on Day 1 of their cycle. show original
in the protocol, or they will be excluded from the study In order to participate in this study, heterosexual individuals of childbearing potential must agree to use a method of contraception as specified in the protocol, for the duration of the study. show original
The participant is willing to not receive the live or attenuated vaccines during the study and for 12 weeks after the last dose of the study drug. show original
Can understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures associated with this trial. show original
Enrolled in a Gilead-sponsored study on using University of California parents as part of a protocol. show original
Key

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 colitis, ulcerative?

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In contrast to the general view, some of the known triggers of colitis have detrimental effects: smoking tobacco and consuming alcohol increase this risk. Tobacco smoke is considered to be the most frequent cause of colitis. The consumption of foods rich in fat has a negative effect particularly in cases of ulcerative colitis. Although the exact etiology of ulcerative colitis remains unclear, consumption of beer and hard liquor may be a cause of colitis.

Unverified Answer

What is colitis, ulcerative?

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The ulcerative form of colitis presents with three stages, each characterized by systemic symptoms, signs, and radiologic findings. The prognosis depends on which stage of the inflammatory bowel disease that the patient is in.

Unverified Answer

What are common treatments for colitis, ulcerative?

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Common treatments for active colitis or ulcerative colitis include 5-aminosalicylates, corticosteroids, opiate antagonists, and immunosuppressant medications such as azathioprine, biologics such as infliximab and adalimumab and immunomodulators such as thalidomide. Other treatments include antibiotics (e.g., metronidazole), antimicrobial drugs (e.g., ciprofloxacin), antimycotics (e.g., fluconazole), and 5-lipoxygenase inhibitors, such as eicosapentaenoic acid (EPA) and its esters.

Unverified Answer

Can colitis, ulcerative be cured?

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There is a lack of convincing scientific evidences on the ability of any treatment to cure ulcerative colitis. There is an ongoing need to examine the use of new drugs and surgical techniques, and to develop a sound management strategy in order to assure the optimal therapeutic management of patients with UC.

Unverified Answer

What are the signs of colitis, ulcerative?

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The following signs are common to both left-sided colitis (LDC) and right-sided ulcerative colitis (RDC): diarrhea, hematochezia, fever and weight loss. For LDC, a palpable abdominal mass should be tested. Lymphadenopathy is a frequent finding in patients with colitis.

Unverified Answer

How many people get colitis, ulcerative a year in the United States?

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There are at least 493 million people affected by colitis and/or an ulcer in the United States. Over 2 million of these individuals have ulcerative colitis causing up to 40,000 deaths a year.

Unverified Answer

What are the common side effects of filgotinib?

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There was limited data on common side effects with filgotinib as no placebo trials had been performed and the frequency of side effects were as expected as reported with other TIs. There was a case of gastrointestinal-related side effects.\n

Unverified Answer

How does filgotinib work?

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FGTNIB is a promising medication for moderate to severe ulcerative colitis, because it has been shown to not only have anti-TNFα effects, but also the anti-IL23BP effects. Future studies may evaluate the role of FGTNIB in treatment of other IBDs that are attributed to the TNF/IL23/IL17 axis, such as psoriatic arthritis and Crohn's disease"

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Unverified Answer

What is the latest research for colitis, ulcerative?

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The condition for ulcerative colitis is not much different from the previous report. The condition in inflammatory bowel disease has advanced very fast. There are many challenges in research and some of the challenges are research in new and better method of research.

Unverified Answer

Is filgotinib typically used in combination with any other treatments?

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These observations suggest that the use of filgotinib alone or with current therapies does not impair the activity of other drugs in clinical practice. Future research should be directed towards examining the best combination regimen with minimal side effect and treatment resistance.

Unverified Answer

Have there been other clinical trials involving filgotinib?

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Filgotinib was approved by the FDA in March 2012 for the treatment of ulcerative colitis. We were able to search one Filgotinib trial in PubMed using the term 'flagging' (when looking for Filgotinib clinical trials). The first article looked at what happens if Filgotinib is taken continuously by persons with Crohn's disease who are in remission upon treatment discontinuation. However, even though the studies are still very preliminary, they still have some important things to tell us. For example, this is another case where there is no longer enough evidence to determine whether it is safe to use in a patient population that is also at risk for relapse.

Unverified Answer

Is filgotinib safe for people?

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We conclude that filgotinib is safe for people with inflammatory bowel disease. People who need other immunosuppressive medications should reconsider using filgotinib, but there are no absolute contraindications to using it.

Unverified Answer
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