Basiliximab in Moderate to Severe Ulcerative Colitis
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| ClinicalTrials.gov Identifier: NCT00430898 |
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Recruitment Status :
Completed
First Posted : February 2, 2007
Last Update Posted : December 18, 2008
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Sponsor:
Cerimon Pharmaceuticals
Information provided by:
Cerimon Pharmaceuticals
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Brief Summary:
The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ulcerative Colitis | Drug: Basiliximab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 181 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis |
| Study Start Date : | January 2007 |
| Actual Primary Completion Date : | September 2008 |
| Actual Study Completion Date : | September 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
Drug Information available for:
Basiliximab
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: 1. Placebo
Placebo to mimic 40 mg of Simulect
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Drug: Basiliximab
3 doses of 40mg, IV at baseline, week 2, and week 4
Other Name: Simulect |
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Experimental: 2. 40 mg Simulect
40 mg of Simulect
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Drug: Basiliximab
3 doses of 40mg, IV at baseline, week 2, and week 4
Other Name: Simulect |
Primary Outcome Measures :
- Change in Mayo Score, Safety [ Time Frame: At week 8 ]
Secondary Outcome Measures :
- Clinical remission at week 4; clinical response at weeks 4 and 8; use of rescue medication; hospitalization or colectomy; and concomitant steroid use [ Time Frame: at week 4 and 8 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
In addition to others,
- Men or women age 18-75
- Diagnosis of ulcerative colitis confirmed through screening endoscopy.
- Extent of disease must involve at least the left colon
- Moderate to severe disease (Mayo Score 6-12). Systemic features of tachycardia, fever, and/or significant anemia should not be present.
- Inadequate response despite treatment with prednisone 40 - 50 mg/day (or other oral steroid at equivalent dose) orally for a minimum of 14 days immediately preceding study entry
Exclusion Criteria:
In addition to other protocol-defined conditions,
- Pregnancy
- Stool study that shows presence of ova and parasites, significant bacterial pathogens, or C. difficile toxin
- Colitis that is indeterminate, suggestive of Crohn's disease, or isolated to the rectum, based on endoscopic and/or biopsy findings
- Severely ill patients as evidenced by protocol-defined systemic criteria
- Chest radiograph abnormalities consistent with an infectious process
- History of colonic dysplasia
- HIV infection
- Known viral Hepatitis B or C infection
- History of or exposure to tuberculosis within 6 months before study entry
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430898
Locations
Show 68 study locations
Sponsors and Collaborators
Cerimon Pharmaceuticals
Investigators
| Study Director: | Daniel Levitt, MD, PhD | Cerimon Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cerimon Pharmaceuticals, Inc, Cerimon Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00430898 |
| Other Study ID Numbers: |
BSX-001 |
| First Posted: | February 2, 2007 Key Record Dates |
| Last Update Posted: | December 18, 2008 |
| Last Verified: | December 2008 |
Keywords provided by Cerimon Pharmaceuticals:
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ulcerative colitis basiliximab |
Additional relevant MeSH terms:
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Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases |
Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases Basiliximab Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |