CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 24 enrolled
Drug / intervention
Rituximabdrug
Likely dose
Rituximab 1gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00261118
NCT00261118Phase 3Completed
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Phase 3: Randomised Controlled Trial of Rituximab in Active Ulcerative Colitis

Royal Liverpool University Hospital·interventional·Posted Dec 2, 2005·Updated Nov 6, 2014

In Brief

A Phase 3 clinical trial evaluating Rituximab for Ulcerative Colitis. Completed, enrolled 24 participants across 1 site.

Detailed Summary

There is broad support for the hypothesis that Ulcerative colitis is an auto-immune disease. Rituximab is an antibody protein that removes a subgroup of white blood cells (B lymphocytes) from the circulation. These cells have the capacity to generate the auto-antibodies that typify auto-immune disease. Although Rituximab has been mainly used for treating B lymphocyte malignancies (lymphoma) it has also been used with promising results in Rheumatoid arthritis and has an excellent safety record. This is a small placebo-controlled trial to assess its efficacy and safety in patients with steroid-resistant active ulcerative colitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesUnited Kingdom
CollaboratorsHoffmann-La Roche, University of Liverpool

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2, 2005
Enrollment StartApr 1, 2004
Primary CompletionAug 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.6 years ago

Interventions

Rituximabdrug

Rituximab 1g in 500 mls Normal Saline Placebo 500 mls Normal Saline