Ulcerative Colitis and Crohn’s Disease MedDRA version: 14.1 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
Millennium Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Previous treatment in prior MLN0002 study that, in the opinion of the Investigator, was well tolerated. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1812 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 388
Exclusion criteria
Exclusion criteria: 1. Female patients who are lactating or pregnant. 2. Had any surgical procedure requiring general anesthesia within 30 days prior to enrollment or is planning to undergo major surgery during the study period 3. Any live vaccinations within 30 days prior to MLN0002 administration except for the influenza vaccine. 4. Any new, unstable or uncontrolled major medical conditions that would confound study results or compromise patient safety 5. Withdrawal from a previous MLN0002 study due to a study-drug related AE. 6. Active psychiatric or substance abuse problems that, in the investigator’s opinion, may interfere with compliance with the study procedures. 7. Unable to attend all the study visits or comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective • To determine the safety profile of long-term MLN0002 treatment ;Secondary Objective: Resource Utilization and Patient Reported Outcome Objectives • To determine the effect of long-term MLN0002 treatment on time to major IBD-related events (hospitalizations, surgeries, and IBD-related procedures) • To determine the effect of long-term MLN0002 treatment on health-related quality of life (QOL) measurements Exploratory Objective • To obtain data regarding the effect of long-term MLN0002 treatment on maintaining clinical response and remission ;Primary end point(s): Primary Endpoints • SAEs, AEs, vital signs, standard laboratory tests (clinical chemistry, hematology, coagulation, urinalysis, and HAHA), and electrocardiograms (ECGs) ;Timepoint(s) of evaluation of this end point: Evaluated up to a maximum of 352 weeks or until vedolizumab (MLN0002) becomes available in the applicable country, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): n/a;Timepoint(s) of evaluation of this end point: n/a | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Estonia, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Korea, Republic of, Latvia, Malaysia, Malta, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactDrug Information Call Center
Millennium Pharmaceuticals, Inc.
Outcome results
None listed