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Rituximab in Active Ulcerative Colitis

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
University of Liverpool
Information provided by (Responsible Party):
Jonathan Michael Rhodes, Royal Liverpool University Hospital
ClinicalTrials.gov Identifier:
NCT00261118
First received: November 29, 2005
Last updated: November 5, 2014
Last verified: November 2014
  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 record. 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 (Subject, Investigator)
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 [ Time Frame: week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response defined as a decrease in Mayo score by ≥ 3 points at weeks 4, 8 (partial Mayo score) and 12. [ Time Frame: Week 4, 8 & 12 ] [ Designated as safety issue: No ]
  • Remission at weeks 8 and 12. [ Time Frame: week 8 &12 ] [ Designated as safety issue: No ]
  • Endoscopic mucosal healing at week 4 and 12 [ Time Frame: Week 4 & 12 ] [ Designated as safety issue: No ]
  • Improvement in Inflammatory Bowel Disease specific Quality of Life Index at weeks 4 and 12 [ Time Frame: weeks 4 &12 ] [ Designated as safety issue: No ]
  • Histological improvement of disease activity at 4 and 12 weeks compared with baseline. [ Time Frame: week 4 & 12 weeks ] [ Designated as safety issue: No ]
  • Treatment tolerability as defined by adverse events. [ Time Frame: all visits ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: April 2004
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 (i)
Rituximab 1g in 500 mls of 0.9% normal saline infused into a peripheral vein
Drug: Rituximab
Rituximab 1g in 500 mls Normal Saline Placebo 500 mls Normal Saline
Other Name: MabThera (Roche)
Placebo Comparator: 2 (ii)
500 mls of 0.9% NORMAL SALINE INFUSED INTO A PERIPHERAL VEIN
Drug: Rituximab
Rituximab 1g in 500 mls Normal Saline Placebo 500 mls Normal Saline
Other Name: MabThera (Roche)

  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

Locations
United Kingdom
Royal Liverpool University Hospital
Liverpool, Merseyside, United Kingdom, L7 8XP
Sponsors and Collaborators
Royal Liverpool University Hospital
Hoffmann-La Roche
University of Liverpool
Investigators
Principal Investigator: Jonathan M Rhodes, MD University of Liverpool
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jonathan Michael Rhodes, Invesitgator, Royal Liverpool University Hospital
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: November 5, 2014
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
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014