A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis - NCT00694980-27599(Clinical Trial 225671)
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Chapel Hill |
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State:
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NC |
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27599 |
| Conditions: |
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Ulcerative Colitis |
| Purpose: |
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This is a randomized , double-blind, placebo-controlled study of approximately 70 patients
with ulcerative colitis.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Able and willing to provide written informed consent
- 18-70 years of age
- Males and females with reproductive potential: Willing to use a reliable method of
contraception
- Diagnosis of ulcerative colitis
- Eligible to receive biologic therapy
- Disease duration of ≥12 weeks
Exclusion Criteria:
- Requirement for hospitalization due to severity of ulcerative colitis
- Moderate to severe anemia
- Any manifestation of ulcerative colitis or other conditions likely to require, in the
investigator's judgment, treatment with >20 mg/day of prednisone, or prednisone
equivalent, during the course of the study
- Pregnant or lactating
- Lack of peripheral venous access
- Inability to comply with study protocol
- History or presence of contraindicated diseases
- Congenital immune deficiency
- Active or prior infection with HIV or hepatitis B or C
- History of severe systemic bacterial, fungal, viral, or parasitic infections
- History of any other opportunistic infections within 12 weeks prior to initiation of
study treatment
- Received a live attenuated vaccine within 4 weeks prior to screening
- Hospitalized within 4 weeks prior to screening
- Received any contraindicated therapy within 12 weeks prior to screening |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 11, 2010 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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