An Open-Label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease (GEMINI III)
Summary: This multicenter, 2-year open-label study will collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
| HR#: |
18654 |
| PRINCIPAL INVESTIGATOR: |
Brenda J. Hoffman, , MD, FACP, FACG |
| SPONSOR: |
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| TARGET ENROLLMENT: |
3 |
| DISEASE TYPE: |
Crohns Disease |
| BODY LOCATION(S): |
Large Intestine, |
| PRIMARY OBJECTIVE: |
Primary Outcome Measures:
To determine adverse events, serious adverse events, results of standard laboratory tests and ECGs, time to major IBD-related events (hospitalizations, surgeries or procedures), and improvements in quality of life. [ Time Frame: A maximum of 100 weeks or until vedolizumab (MLN0002) becomes commercially available, whichever occurs first. ] |
| SECONDARY OBJECTIVE(S): |
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| INCLUSION CRITERIA: |
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1
| Voluntarily able to give informed consent. |
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2
| Previous treatment in Study C13007 that, in the opinion of the investigator, was tolerated well. Patients who withdrew early from C13007 must have withdrawn due to one of the following: A. Sustained nonresponse for patients with CD in C13007: Failure to achieve a clinical response (70 point improvement in CDAI score) by Week 14 and a minimum CDAI score of 220 points; B. Disease worsening for patients with CD in C13007: A =100 point increase in CDAI score on 2 consecutive visits from the Week 6 value at any study visit and a minimum CDAI score of 220 points; C. Rescue medications for patients in C13007: any new medication or any increase in dose of baseline medication required to treat new or unresolved UC or CD symptoms (other than antidiarrheals for control of chronic diarrhea). |
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3
| The first dose of MLN0002 in this study (ie, Week 0) must occur not more than 5 weeks after the last dose of study drug in the previous MLN0002 study. |
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4
| Female patients who: A. Are post-menopausal for at least 1 year before enrollment, OR B. Are surgically sterile, OR C. If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from four weeks before the first dose of MLN0002 through 6 months after the last dose of MLN0002, OR D. Agree to completely abstain from heterosexual intercourse. Male patients, even if surgically sterilized (ie, status post-vasectomy), who: A. Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of MLN0002, OR B. Agree to completely abstain from heterosexual intercourse. |
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5
| Patients with extensive colitis or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of enrollment. |
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6
| Patients with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance. |
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7
| May be receiving a therapeutic dose of the following drugs: a. oral 5-ASA compounds, b. oral corticosteroid therapy (prednisone at a stable dose =30mg/day, budesonide at a stable dose =9mg/day, or equivalent steroid); c. topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories; d. probiotics (eg, Culturelle, Saccharomyces boulardii); e. antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of chronic diarrhea; f. antibiotics used for the treatment of CD (ie, ciprofloxacin, metronidazole). |
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| EXCLUSION CRITERIA: |
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1
| Female patients who are lactating or pregnant. |
|
2
| Required surgical intervention for IBD during or after participation in a prior MLN002 study, currently requires surgical intervention for IBD, or is anticipated to require surgical intervention for IBD during this study. |
|
3
| Any live vaccinations within 30 days prior to MLN0002 administration except for the influenza vaccine. |
|
4
| Development of any new, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other medical disorder during or after participation in a prior MLN0002 study that, in the opinion of the investigator, would confound the study results or compromise patient safety. |
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5
| Withdrawal from a previous MLN0002 study due to a study-drug related AE. |
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6
| Active psychiatric or substance abuse problems that, in the investigator's opinion, may interfere with compliance with the study procedures. |
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7
| Unable to attend all the study visits or comply with study procedures. |
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| TREATMENT GROUPS: |
Vedolizumab |
| LENGTH OF STUDY: |
100 |
| CONTACTS: |
- Rebekah Whichard, , BA, CCRC (Primary Study Coordinator)
(843) 876-7233 or richreb@musc.edu
- Kyle Orrell, MSHP (DDC Research Program Manager)
843-876-4303 or orrell@musc.edu
- Brenda J. Hoffman, , MD, FACP, FACG (Principal Investigator)
(843) 876-4265 or hoffmanb@musc.edu
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