Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease (GEMINI III)
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| ClinicalTrials.gov Identifier: NCT01224171 |
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Recruitment Status :
Completed
First Posted : October 19, 2010
Results First Posted : July 21, 2014
Last Update Posted : July 21, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Crohn's Disease | Drug: vedolizumab Other: Placebo | Phase 3 |
After completing the study, patients were eligible to enroll in a long term safety study with continued access to vedolizumab (study C13008; NCT00790933) if study drug was well tolerated, and no major surgical intervention for Crohn's disease occurred or was required.
Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 416 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease |
| Study Start Date : | November 2010 |
| Actual Primary Completion Date : | February 2012 |
| Actual Study Completion Date : | April 2012 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
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Other: Placebo
Placebo intravenous infusion |
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Experimental: Vedolizumab
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
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Drug: vedolizumab
Vedolizumab for intravenous infusion
Other Names:
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- Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation [ Time Frame: Week 6 ]
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
- Number of liquid or soft stools each day for 7 days;
- Abdominal pain (graded from 0-3 on severity) each day for 7 days;
- General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
- Presence of complications;
- Taking Lomotil or opiates for diarrhea;
- Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
- Hematocrit of < 0.47 in men and < 0.42 in women;
- Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
- Percentage of Participants in Clinical Remission at Week 6 in the Overall Population [ Time Frame: Week 6 ]
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
- Number of liquid or soft stools each day for 7 days;
- Abdominal pain (graded from 0-3 on severity) each day for 7 days;
- General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
- Presence of complications;
- Taking Lomotil or opiates for diarrhea;
- Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
- Hematocrit of < 0.47 in men and < 0.42 in women;
- Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
- Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation [ Time Frame: Week 10 ]
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
- Number of liquid or soft stools each day for 7 days;
- Abdominal pain (graded from 0-3 on severity) each day for 7 days;
- General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
- Presence of complications;
- Taking Lomotil or opiates for diarrhea;
- Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
- Hematocrit of < 0.47 in men and < 0.42 in women;
- Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
- Percentage of Participants in Clinical Remission at Week 10 in the Overall Population [ Time Frame: Week 10 ]
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
- Number of liquid or soft stools each day for 7 days;
- Abdominal pain (graded from 0-3 on severity) each day for 7 days;
- General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
- Presence of complications;
- Taking Lomotil or opiates for diarrhea;
- Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
- Hematocrit of < 0.47 in men and < 0.42 in women;
- Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
- Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population [ Time Frame: Week 6 and Week 10 ]
Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
- Number of liquid or soft stools each day for 7 days;
- Abdominal pain (graded from 0-3 on severity) each day for 7 days;
- General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
- Presence of complications;
- Taking Lomotil or opiates for diarrhea;
- Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
- Hematocrit of < 0.47 in men and < 0.42 in women;
- Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission.
- Percentage of Participants With Sustained Clinical Remission in the Overall Population [ Time Frame: Week 6 and Week 10 ]
Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
- Number of liquid or soft stools each day for 7 days;
- Abdominal pain (graded from 0-3 on severity) each day for 7 days;
- General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
- Presence of complications;
- Taking Lomotil or opiates for diarrhea;
- Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
- Hematocrit of < 0.47 in men and < 0.42 in women;
- Percentage deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission.
- Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation [ Time Frame: Baseline and Week 6 ]
Enhanced clinical response is defined as a ≥ 100-point decrease in CDAI score from Baseline.
The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:
- Number of liquid or soft stools each day for 7 days;
- Abdominal pain (graded from 0-3 on severity) each day for 7 days;
- General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
- Presence of complications;
- Taking Lomotil or opiates for diarrhea;
- Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
- Hematocrit of < 0.47 in men and < 0.42 in women;
- Percent deviation from standard weight.
The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.
All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response.
- Number of Participants With Adverse Events (AEs) [ Time Frame: From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments. ]
An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was any AE, occurring at any dose and regardless of causality that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event based upon appropriate medical judgment that may have jeopardized the patient and may have required medical or surgical intervention to prevent 1 of the outcomes listed above, or any diagnosis of progressive multifocal leukoencephalopathy (PML).
Relationship to study drug administration was determined by the investigator responding yes or no to the question: Is there a reasonable possibility that the AE is associated with the study drug?
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 to 80
- Diagnosis of moderately to severely active Crohn's disease
- Crohn's Disease involvement of the ileum and/or colon
- Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
- May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol
Exclusion Criteria
- Evidence of abdominal abscess at the initial screening visit
- Extensive colonic resection, subtotal or total colectomy
- History of >3 small bowel resections or diagnosis of short bowel syndrome
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
- Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection
- Active or latent tuberculosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224171
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| Study Director: | Medical Monitor | Millennium Pharmaceuticals, Inc. |
| Responsible Party: | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01224171 |
| Other Study ID Numbers: |
C13011 U1111-1158-2581 ( Registry Identifier: WHO ) 2009-016488-12 ( EudraCT Number ) NL34356.078.10 ( Registry Identifier: CCMO ) |
| First Posted: | October 19, 2010 Key Record Dates |
| Results First Posted: | July 21, 2014 |
| Last Update Posted: | July 21, 2014 |
| Last Verified: | June 2014 |
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Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Intestinal Diseases Vedolizumab Gastrointestinal Agents |