A Study of the Safety and Effectiveness of CNTO 148 (Golimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (CR014179) - NCT00488631- (Clinical Trial 108573)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy108573.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 CNTO 148 (golimumab) maintenance therapy administered subcutaneously (under
the skin) in patients with active ulcerative colitis who have participated in C0524T16
(CR014176) or C0524T17 (CR014179). Approximately 1350 patients will take part in the study
at approximately 300 centers. Following participation in one of the previous 6-week
induction studies, patients will be eligible to participate in this maintenance study that
will last up to 54 weeks. On completing this study, patients will have the opportunity to
continue to receive study medication in a study extension that will last up to approximately
3 years. If a patient discontinues at any time during the maintenance study or the study
extension, they will be asked to return for a follow up visit 16 weeks after their last dose
of study medication. Patients who discontinue prior to Week 54 will be contacted for
follow-up colectomy information within 1 year of entering the study.Patients whose
ulcerative colitis symptoms improved with CNTO 148 (golimumab) treatment in either the
C0524T16 (CR014176) or C0524T17 (CR014179) study will be equally assigned to one of three
maintenance treatment groups and will receive subcutaneous injections of either placebo or
CNTO 148 (golimumab), 50mg or 100mg at Week 0 and every 4 weeks thereafter through Week 52.
Patients whose ulcerative colitis symptoms improved with placebo treatment in either the
C0524T16 (CR014176) or C0524T17 (CR014179) study will continue to receive placebo in the
maintenance study.Patients entering one of the above-mentioned treatments who have an
increase in their ulcerative colitis symptoms will be eligible for a dose adjustment of
study medication (up to 200 mg of CNTO 148 (golimumab)). If the patient's symptoms improve
after 4 treatments at the adjusted dose, they will be eligible to continue receiving study
medication thereafter through Week 52. If their symptoms do not improve, they will be
discontinued from receiving further study medication and will return for a final visit 16
weeks after their last dose of study medication.Patients whose ulcerative colitis symptoms
did NOT improve with either CNTO 148 (golimumab) or placebo treatment in either the C0524T16
(CR014176) or C0524T17 (CR014179) study will be eligible to receive 100mg of CNTO 148
(golimumab) every 4 weeks through Week 12. If the patient's symptoms improve during this
time, they will be eligible to continue to receive 100mg of CNTO 148 (golimumab) every 4
weeks thereafter through Week 52. If the patient's symptoms do not improve, they will be
discontinued from receiving further CNTO 148 (golimumab) treatment, and return for a final
visit 16 weeks after their last dose of study medication.This entire study is "blinded."
This means that neither the patient nor the study doctor will know which treatment the
patient has received. The overall purpose of this trial is to determine if treatment with
CNTO 148 (golimumab) is better than treatment with placebo in controlling a patient's
ulcerative colitis. Patients will receive multiple subcutaneous (under the skin) injections
of placebo or a total dose of CNTO 148 (golimumab), 50mg, 100mg, or 200mg, every 4 weeks
through Week 52. |
| Criteria: |
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Inclusion Criteria:
- Have received all study agent administrations and completed the Week 6 Mayo score
evaluation in one of the induction studies of CNTO 148 (golimumab) for (UC)
Ulcerative Colitis (CR014176, CR014179)
Exclusion Criteria:
- Had changes to concomitant UC medications since Week 0 of an induction study
(CR014176, CR014179) |
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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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March 15, 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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