CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Golimumabdrug
Likely dose
Induction: 200 mg at week 0, 100 mg at week 2; Maintenance: 50 mg/month if <70 kg or 100 mg/month if ≥70 kgAI-extracted
Key inclusion· 3
  • ✓Age >18 years
  • ✓Anti-TNF naïve (no prior TNF inhibitor therapy)
  • ✓Screening for opportunistic infections completed
Key exclusion· 6
  • ✕Active tuberculosis or other chronic infections
  • ✕Antibiotic treatment within 1 month prior to enrollment
  • ✕Concurrent probiotic or prebiotic use
  • ✕Pregnancy or lactation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03018925
NCT03018925N/ACompleted
CompareCT.gov

Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis: Pilot Study

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta·observational·Posted Jan 12, 2017·Updated Jul 19, 2021

In Brief

An observational study evaluating Golimumab for Ulcerative Colitis. Completed, enrolled 15 participants across 1 site.

Detailed Summary

This study aims to characterize the changes on intestinal microbiota pattern associated with the use of golimumab in order to determine if intestinal microbiota markers may correlate with golimumab therapeutic effect in patients naïve \& non-naïve to anti-TNF treatment

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 12, 2017
Enrollment StartOct 1, 2016
Primary CompletionMar 1, 2020
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 9.5 years ago

Interventions

Golimumabdrug

The treatment followed was an induction of 200 mg of Golimumab at week 0, and 100 mg at week 2. Under 70 Kg, the follow-up treatment dose would be 50 mg/month, and 100 mg/month in patients above 70 Kg asindicated in standard clinical practice.