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Monoclonal Antibodies

Single Group Study for Ulcerative Colitis (PROTOS Trial)

N/A
Waitlist Available
Research Sponsored by Alimentiv Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22 weeks
Awards & highlights

Summary

This trial studies infliximab in people with a severe type of inflammatory bowel disease called ulcerative colitis.

Eligible Conditions
  • Ulcerative Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 22 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Inter-compartmental Difference in Infliximab Concentration
Secondary outcome measures
Change in Mayo Clinic Endoscopic Score
Change in Proteome
Change in Robarts Histopathologic Index
+1 more

Side effects data

From 2020 Phase 4 trial • 42 Patients • NCT03006393
52%
Laceration
38%
Headache
24%
Bruises
19%
Sore throat
14%
Muscle tension
10%
Nausea
10%
Change in urination
10%
Heartburn
10%
Fatigue
10%
Dizziness
10%
Itchiness
5%
Pain in joints
5%
Chest pain
5%
Stomach ache
5%
Syncope
5%
Menstruation
5%
Migraine
5%
Swelling
5%
Bloody stool
5%
Pain in leg
5%
Allergies
5%
Change in blood pressure
5%
Vertigo
5%
Change in appetite
5%
Numbness
5%
Motor vehicle accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Infliximab
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Group StudyExperimental Treatment1 Intervention
Patients with Acute Severe Ulcerative Colitis who are either a) biologic-naïve or b) biologic-experienced without a known history of anti-infliximab antibodies requiring infliximab infusion therapy as a part of standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infliximab
FDA approved

Find a Location

Who is running the clinical trial?

Alimentiv Inc.Lead Sponsor
13 Previous Clinical Trials
3,186 Total Patients Enrolled
4 Trials studying Ulcerative Colitis
116 Patients Enrolled for Ulcerative Colitis
Niels Vande CasteeleStudy DirectorUCSD
~3 spots leftby Sep 2025
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