|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT00783718 |
|
Date of registration:
|
31/10/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis
GEMINI I |
|
Scientific title:
|
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis |
|
Date of first enrolment:
|
January 2009 |
|
Target sample size:
|
895 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00783718 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Canada
|
Puerto Rico
|
United States
| | | | | |
|
Contacts
|
|
Name:
|
Medical Monitor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Millennium Pharmaceuticals, Inc. |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
1. Diagnosis of moderately to severely active ulcerative colitis
2. Demonstrated, over the previous 5 year period, an inadequate response to, loss of
response to, or intolerance at least 1 of the following agents:
1. Immunomodulators
2. Tumor necrosis factor-alpha (TNFa) antagonists
3. Corticosteroids
3. May be receiving a therapeutic dose of conventional therapies for inflammatory bowel
disease (IBD) as defined by the protocol
Exclusion Criteria:
1. Evidence of abdominal abscess at the initial screening visit
2. Extensive colonic resection, subtotal or total colectomy
3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
4. Have received non permitted IBD therapies within either 30 or 60 days, depending on
the medication, as stated in the protocol
5. Chronic hepatitis B or C infection
6. Active or latent tuberculosis
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Ulcerative Colitis
|
|
Intervention(s)
|
|
Other: Placebo
|
|
Drug: vedolizumab
|
|
Primary Outcome(s)
|
|
Induction Phase: Percentage of Participants With a Clinical Response at Week 6
[Time Frame: Baseline and Week 6]
|
|
Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52
[Time Frame: Week 52]
|
|
Secondary Outcome(s)
|
|
Induction Phase: Percentage of Participants in Clinical Remission at Week 6
[Time Frame: Week 6]
|
|
Maintenance Phase: Percentage of Participants With Durable Clinical Response
[Time Frame: Baseline, Week 6 and Week 52]
|
|
Maintenance Phase: Percentage of Participants With Corticosteroid-free Remission at Week 52
[Time Frame: Week 52]
|
|
Induction Phase: Percentage of Participants With Mucosal Healing at Week 6
[Time Frame: Week 6]
|
|
Maintenance Phase: Percentage of Participants With Durable Clinical Remission
[Time Frame: Week 6 and Week 52]
|
|
Maintenance Phase: Percentage of Participants With Mucosal Healing at Week 52
[Time Frame: Week 52]
|
|
Secondary ID(s)
|
|
NL25207.096.08
|
|
09/H1102/66
|
|
C13006
|
|
C13006CTIL
|
|
CTRI/2009/091/000128
|
|
2008-002782-32
|
|
NMRR-08-1046-2201
|
|
U1111-1156-8422
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|