Rituximab in Ulcerative Colitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2004 by Royal Liverpool University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Royal Liverpool University Hospital
ClinicalTrials.gov Identifier:
NCT00261118
First received: November 29, 2005
Last updated: February 1, 2006
Last verified: October 2004
  Purpose

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 recortd. This is a small placebo-controlled trial to assess its efficacy and safety in patients with steroid-resistant active ulcerative colitis.


Condition Intervention Phase
Ulcerative Colitis
Drug: Rituximab
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 3: Randomised Controlled Trial of Rituximab in Active Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Royal Liverpool University Hospital:

Primary Outcome Measures:
  • Remission defined as a decrease in Mayo score to ≤ 2 points at week 4

Secondary Outcome Measures:
  • Clinical response defined as a decrease in Mayo score by ≥ 3 points at weeks 4, 8 (partial Mayo score) and 12.
  • Remission at weeks 8 and 12.
  • Endoscopic mucosal healing at week 4 and 12
  • Improvement in Inflammatory Bowel Disease specific Quality of Life Index [22] [Appendix 2] at weeks 4 and 12
  • Histological improvement of disease activity at 4 and 12 weeks compared with baseline. Scored as follows:
  • 0 = no polymorphs
  • 1 = small numbers of polymorphs in the lamina propria with minimal infiltration of crypts
  • 2 = prominent polymorphs in the lamina propria with infiltration of ³ 50% of crypts
  • 3 = florid polymorph infiltrate with crypt abscesses
  • 4 = florid acute inflammation with ulceration
  • Treatment tolerability as defined by adverse events.

Estimated Enrollment: 24
Study Start Date: April 2004
Estimated Study Completion Date: December 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients over age of 18 years who are capable of providing written informed consent.
  2. Confirmed diagnosis of ulcerative colitis by conventional clinical, endoscopic and histological criteria.
  3. Failure of response to at least two weeks of oral prednisolone 40mg/day.
  4. Active colitis as assessed by a Mayo score [21] of 6-12 inclusive (see Appendix 1)

Exclusion Criteria:

  1. Patients under 18 or unable to give informed consent.
  2. Patients in their first attack of ulcerative colitis.
  3. Patients with severe ulcerative colitis as defined by presence of any of: temperature >37.5oC, pulse rate >100, focal severe or rebound abdominal tenderness, haemoglobin < 10.0g/dl, serum albumin <3.5 g/dl, transverse colon diameter greater than 5.0cms on plain abdominal X ray.
  4. Patients who are pregnant, post partum (<3months) or breast feeding
  5. Patients who are at risk of pregnancy and not using a reliable form of contraception (oral contraceptive and barrier or barrier plus spermicide).
  6. Patients with a stoma
  7. Positive stool culture for pathogens or test for C difficile at screening within 7 days prior to trial entry
  8. Patients for whom a baseline Mayo score can not be reliably calculated: frequent use of laxatives (for proximal constipation) or antimotility agents (for control of diarrhoea)
  9. Any change to maintenance medication for ulcerative colitis: azathioprine or 6-mercaptopurine within previous 3 months or 5-aminosalicylates within previous one month
  10. Any change to rectal therapy for colitis within the previous two weeks.
  11. Participation in other trials in the last 3 months.
  12. Serious intercurrent infection or other clinically important active disease (including renal and hepatic disease)

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00261118

Contacts
Contact: Kate Martin, RGN 441517064194 kate.martin@rlbuht.nhs.uk
Contact: Jonathan M Rhodes, MD 441517064073 rhodesjm@liverpool.ac.uk

Locations
United Kingdom
Royal Liverpool University Hospital Recruiting
Liverpool, Merseyside, United Kingdom, L7 8XP
Contact: Kate Martin, RGN    441517064194    kate.martin@rlbuht.nhs.uk   
Contact: Jonathan M Rhodes, MD    441517064073    rhodesjm@liverpool.ac.uk   
Sub-Investigator: Keith Leiper, MB         
Sponsors and Collaborators
Royal Liverpool University Hospital
Hoffmann-La Roche
Investigators
Principal Investigator: Jonathan M Rhodes, MD University of Liverpool
  More Information

No publications provided by Royal Liverpool University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00261118     History of Changes
Other Study ID Numbers: RLBUHT R&D 2709, DDX exemption from MRHA ref:-, MF 8000/12794
Study First Received: November 29, 2005
Last Updated: February 1, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Royal Liverpool University Hospital:
colitis
rituximab

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 20, 2014