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View Clinical Trial (Medical Research Study)
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A Study of the Safety and Effectiveness of CNTO 148 (Golimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (CR014176) - NCT00487539- (Clinical Trial 172598)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy172598.aspx
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Milwaukee |
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State:
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WI |
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| Conditions: |
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Ulcerative Colitis |
| Purpose: |
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The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab)
therapy in patients with ulcerative colitis.
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| Study summary: |
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CNTO 148 (golimumab) is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally
occurring substance in the body and this substance may cause long-term inflammation. CNTO
148 (golimumab) may help treat this disease by blocking the activity of TNF in the body and
reducing the symptoms of ulcerative colitis(UC).This study will assess the safety and
effectiveness of subcutaneously (under the skin) administered CNTO 148 (golimumab) and
determine if there is a reduction of signs and symptoms (such as diarrhea and rectal
bleeding) in patients with active ulcerative colitis. The effect of subcutaneously (SC)
administered CNTO 148 (golimumab) on the quality of life in patients with ulcerative colitis
will also be assessed. About 676 patients will take part in the study at approximately 150
centers.Participation in the study will last for six weeks. At week 6, patients will be
asked to participate in an additional 54-week maintenance study and a long-term extension
study (CR014188) that will last approximately 3 years. If the patient chooses not to
participate in the maintenance study, their participation in this study will extend 16 weeks
after the last dose of study medication.There are two parts to this study. Part 1 is called
"dose-ranging" and will enroll 176 patients. Patients enrolled in Part 1 will be equally
assigned to subcutaneous (under the skin) injections at Week 0 of either placebo, or a total
dose of CNTO 148 (golimumab), 100mg, 200mg, or 400mg followed by injections at Week 2 of
either placebo, or total dose of CNTO 148 (golimumab) 50mg, 100mg, or 200mg,
respectively.Part 2 of this study is called "dose confirming" and will enroll 500 patients.
Patients will be equally assigned to the same doses as studied in Part 1 until the doses for
Part 2 are selected. At the time that the final doses are selected, all newly enrolled
patients will be equally assigned to one of the selected doses or placebo. This entire study
is "blinded." This means that neither the patient nor the study doctor will know which
treatment the patient received. The overall purpose of this trial is to determine if
treatment with CNTO 148 (golimumab) is better than treatment with placebo in reducing a
patient's ulcerative colitis signs and symptoms. Patients will receive multiple injections
(under the skin) for a total dose of 0, 100, 200 or 400 mgCNTO 148 at Week 0 followed a
total dose of 0, 50, 100 or 200 mg CNTO 148 (golimumab), respectively, at Week 2. |
| Criteria: |
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Inclusion Criteria:
- Have a biopsy consistent with the diagnosis of moderately to severely active
ulcerative colitis (UC) prior to the beginning of the trial
- Must either be currently receiving treatment with, or have a history of having failed
to respond to, or tolerate, at least 1 of the following therapies: oral 5-ASAs, oral
corticosteroids, 6-mercaptopurine(6MP) and azathioprine (AZA )
- Have or have had a history of corticosteroid dependency (i.e. an inability to
successfully taper corticosteroids without a return of the symptoms of UC)
Exclusion Criteria:
- Have severe extensive ulcerative colitis that is likely to require a colectomy within
12 weeks of study entry
- Have UC limited to the rectum only or to < 20 cm of the colon
- Presence of a stoma
- Presence or history of a fistula
- Previous exposure to anti-TNF therapies |
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| Study is available at: |
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Milwaukee, WI
United States
Primary Contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:
Email: info1@veritasmedicine.com |
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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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