Primary: To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy (see Definitions).Subjects will be…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The incidence of medically important events including infections (opportunistic
infections and those requiring hospitalization or parenteral therapies),
malignancies, lymphoproliferative disorders, pericolectomy complications (up to
60 days postcolectomy), and other surgeries, after the initiation of salvage
therapy.
Secondary outcome
Assessment of the following parameters:
Health-related quality of life
*Inflammatory bowel disease questionnaire (IBDQ) total score on Day 45 and the
change from baseline (start of salvage therapy) in IBDQ score.
*European quality of life questionnaire (EQ-5D) total score on Day 45 and the
change from baseline (start of salvage therapy) in EQ-5D score.
Pharmacoeconomic outcomes
*Resource utilization, as measured by the frequency of hospitalizations,
emergency room visits, physician office visits, and surgical and other
procedures from the initiation of first salvage therapy to Day 45.
*Work productivity, as measured by the number of days missed from work and
number of reduced activity days from the initiation of first salvage therapy to
Day 45.
Efficacy (in subjects who have not had a colectomy)
*Symptomatic response at Days 15 and 45 after start of salvage medication
(Modified Truelove & Witts Severity Index [MTWSI] * 9 with * 3-point or 30%
reduction).
*Symptomatic remission at Days 15 and 45 after start of salvage medication
(MTWSI * 3).
*Durable clinical response at 6 and 12 months after start of salvage
medication, as defined by lack of disease progression. Disease progression is
defined as a need for a different salvage therapy.
*Time to disease progression after start of salvage medications.
*Colectomy-free at 6 and 12 months after start of salvage medications.
*Time to colectomy after start of salvage medications.
*Prednisone dose (mg/day) at Day 45.
Background summary
To monitor patients who have participated in previous visilizumab studies and
to check their Health-related quality of life.
Study objective
Primary: To assess the effects of visilizumab on the safety of subsequent
salvage therapies in subjects who experienced disease progression in a previous
visilizumab study and subsequently received salvage therapy (see Definitions).
Subjects will be grouped for exploratory analysis in this study based mainly on
covariates of interest, such as the study drug they received and their outcomes
in the previous studies. In particular, the following groups will be
considered: 1) early visilizumab failures, ie, subjects who did not respond to
treatment with visilizumab within 90 days after receipt of study drug, 2) early
placebo failures, ie, subjects who did not have a response within 90 days after
receipt of placebo, and 3) late treatment failures, ie, subjects who had
disease relapse 90 or more days after receipt of visilizumab or placebo.
Subjects in the late treatment failure group will also be analyzed as two
subgroups (late visilizumab failures and late placebo failures) if appropriate.
The rates of medically important events will be summarized for each subject
group as appropriate.
Secondary: To assess the health-related quality of life and pharmacoeconomic
outcomes of colectomy and other salvage therapies, and the response to salvage
medications in subjects who received salvage therapy.
Study design
Observational follow-up study to monitor safety and efficacy in subjects with
IVSR-UC who were previously enrolled in a visilizumab study and who experienced
disease progression, ie, required salvage therapy (colectomy or
immunosuppressive or other experimental medications; see Definitions).
While enrolled in this study, subjects may be treated with any salvage therapy
including colectomy; immunosuppressive or immunomodulatory medications;
biologic or cytotoxic drugs; leukocyte filtration devices; bone marrow or stem
cell transplantation; etc. They also may be enrolled concurrently in their
previous visilizumab study to complete, per (the previous) protocol, safety
follow-ups up to Day 90, followed by quarterly follow-ups up to Month 12 for
medically important infections, malignancies, lymphoproliferative disorders,
and surgery.
Study burden and risks
Generally, 3 years from the time of enrollment in this protocol. However, if a
subject receives a colectomy, the follow-up period is 1 year from the time of
surgery, regardless of when the colectomy occurs within the 3-year follow up.
Subjects also may be enrolled concurrently in their prior study in order to
complete, per the previous protocol, a 90-day safety follow up and a 1-year
follow up for medically significant infections, malignancies,
lymphoproliferative disorders, and surgery.
34801 Campus Drive
Fremont, CA 94555
USA
34801 Campus Drive
Fremont, CA 94555
USA
Listed location countries
Age
Inclusion criteria
-Previous participation in a visilizumab study of IVSR-UC.
-Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy (see Definitions).
Exclusion criteria
Unable to understand the purpose and risks of the study, or unwilling or unable to provide a signed and dated informed consent.
For U.S. sites, unwilling or unable to provide authorization to use protected health information.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2005-004105-28-NL |
| ClinicalTrials.gov | NCT00355901 |
| CCMO | NL13689.018.06 |