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Rituximab in Active Ulcerative Colitis

NCT00261118 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-11-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Rituximab

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

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • University of Liverpool

    collaborator OTHER

  • Royal Liverpool University Hospital

    lead OTHER_GOV

Principal Investigators

  • Jonathan M Rhodes, MD · University of Liverpool

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2009-08-31
Completion
2009-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00261118 on ClinicalTrials.gov