Rituximab in Active Ulcerative Colitis

Sponsor
Royal Liverpool University Hospital
Study ID
NCT00261118
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab 1g in 500 mls Normal Saline Placebo 500 mls Normal Saline

Study Details

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.

Key Dates

Start date
Apr 30, 2004
Status verified
Nov 2014
Primary completion
Aug 31, 2009
Completion
Oct 31, 2009

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1 (i)
    Rituximab 1g in 500 mls of 0.9% normal saline infused into a peripheral vein
  • Placebo Comparator: 2 (ii)
    500 mls of 0.9% NORMAL SALINE INFUSED INTO A PERIPHERAL VEIN

Primary Outcome Measure

Remission defined as a decrease in Mayo score to ≤ 2 points at week 4 [ Time Frame: week 4 ]

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