A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohns Disease Who Have Been Previously Treated With Anti-TNF Therapy - NCT00771667-10021A (Clinical Trial 247092)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy247092.aspx
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10021 |
| Conditions: |
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Crohn's Disease |
| Purpose: |
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A medical research study in adult patients who have moderate to severe Crohns disease
designed to determine whether or not treatment with an experimental drug called ustekinumab
(or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of
Crohns disease.
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| Study summary: |
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In Crohns disease there is inflammation (changes in body tissue which normally happen during
injury or infection) and or ulceration (open sores) in the intestines.This occurs because
the immune system (the part of the body that fights off infection) has an abnormal and
overactive response against the intestine and bowel tissues of the body. Crohns disease is
usually treated with medications that either directly decrease inflammation or decrease the
general activity of the immune system to improve the diarrhea, abdominal pain, and other
symptoms of Crohns Disease. Ustekinumab antibodies (natural substances made by your immune
system to stick to and help remove foreign materials in your body that cause diseases) have
been created to stick to and block the activity of two of the immune substances thought to
cause abnormal inflammation of Crohns disease. Patients who are eligible and who have
received Remicade, Humira, or Cimzia and failed or been intolerant to one of these drugs
will be randomized to either active drug (ustekinumab) or placebo. All patients will be
randomized (like flipping a coin) at week 0 to be in one of 4 groups. At week 0 the study
drug will be given by IV administration and at weeks 8 and 16 by subcutaneous injection.
There will be 11 study visits in total and the study will continue until week 36. Blood and
stool samples will be collected and studied, questionnaires to check on how you are doing in
terms of your disease will be completed, an Electrocardiogram (EKG) obtained, safety
evaluations conducted and diary cards distributed to be completed during the entire study.
One of 4 groups: Grp 1-placebo, Grp 2-active drug 1mg/kg IV, Grp 3-active drug 3mg/kg IV,
Grp 4-active drug 6mg/kg IV. Based on the clinical response status at Week 6, patients from
Grps 2, 3 and 4 will be re-randomized at week 8 to receive either placebo or 90 mg SC at
both weeks 8 and 16 and patients from Grp 1 will receive placebo at Week 8 and Week 16 or a
270 mg SC injection at Week 8 and 90 mg SC at Week 16. |
| Criteria: |
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Inclusion Criteria:
- Must have Crohn's disease or fistulizing Crohn's disease of at least 3 months
duration
- Must have received Remicade, adalimumab or Cimzia at a dose approved for the
treatment of Crohn's disease
- Must have failed or been intolerant to Remicade, Humira or Cimzia for treatment of
Crohn's disease
- Must be 18 years of age or older
- Must have active Crohn's disease according to the Crohn's Disease Activity Index
(CDAI > =220 and < =450)
Exclusion Criteria:
- Patients who have had any kind of bowel resection, diversions or placement of a stoma
within 6 months
- Are pregnant, nursing or planning pregnancy (both men and women) while enrolled in
the study or within 1 year after receiving study agent
- Patients who have received Remicade, Humira or Cimzia < =8 weeks before the first
administration of study drug
- Patients with certain complications of Crohn's disease that would make it hard to
assess response to study drug
- Patients with a history of or ongoing chronic or recurrent infectious disease |
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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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February 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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