This study will be conducted as a prospective, observational study of patients with relapsing forms of MS initiating treatment with Plegridy in routine clinical practice and patients who participated in Study 105MS302 or Study 105MS303. Enrolled…
ID
Source
Brief title
Condition
- Central nervous system infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary:
- Incidence proportion and incidence rates of SAEs
- Clinical no evidence of disease activity (NEDA) evaluated by the proportion
of patients with no evidence of clinical disease activity (no relapses and no
disability progression)
Please refer to the protocol, starting at page 26, chapter 6.2
Secondary outcome
Secondary endpoints:
- Prescription and utilization patterns evaluated by assessment of prescribed
dosing frequency, duration of Plegridy use, and primary reason for
discontinuation of Plegridy
- Relapse activity evaluated by:
o Annualized relapse rate
o Time to first relapse
o Proportion of patients with relapse
o Distribution of the number of relapses
- Disability progression measured by EDSS:
o Proportion of patients with sustained progression for at least six months
o Time to sustained disability progression for at least six months
- Incidence proportion and incidence rates of AEs, including but not limited to
FLS, ISRs, and AEs (including laboratory abnormalities) leading to treatment
discontinuation
- The impact of the severity of FLS on the ability to successfully manage
symptoms via prophylaxis will be evaluated using the patient-reported FLS-VAS
-Changes in FLS assessment and FLS-VAS over time
- Changes in EuroQoL EQ-5D, 3-level (EQ-5D-3L) score over time
Treatment adherence as measured by changes in adherence over time as reported
in the treatment adherence questionnaires
o In countries where pen/syringe collection is locally allowed, treatment
adherence will also be assessed by the proportion of used auto-injector
pens/pre-filled syringes of total prescribed
- Frequency of MS-related and non-MS-related physician visits, specialists*
visits, use of physiotherapy, hospitalizations and lengths of stay, and
emergency room/department visits
Please refer to the protocol, starting at page 26, chapter 6.2
Background summary
Despite recent approval of several new therapeutic agents for treatment of
multiple sclerosis (MS), there continues to be a high unmet medical need in
this patient population for effective therapies with an established safety
profile that are convenient to use over a long time period. Observational
studies are increasingly being used - across many therapeutic areas and chronic
diseases, including MS - to study the long-term effects of medications and
interventions on broad patient populations under real-world conditions.
Interferon beta-1a (IFN β-1a) therapy has been successfully used as a
disease-modifying therapy to demonstrated to be effective in delaying the
progression of disability and in reducing the rate of treat patients with
relapsing forms of MS for over 15 years. Plegridy* (peginterferon β-1a) has a
longer half-life than IFN β-1a. As such, it has been shown to reduce the
frequency of administration versus IFN β-1a, thereby increasing treatment
convenience. Consequently, we expect that it will improve compliance while
maintaining a safety and efficacy profile at least similar to IFN β-1a.
Findings from the pivotal Phase III study (Study 105MS301, 1-year) demonstrated
that Plegridy administered at a dose of 125 µg via subcutaneous injection every
two weeks is an effective treatment for relapsing forms of MS.
In the clinical trial, treatment with Plegridy has clinical relapses, but it
has also been associated with flu-like symptoms (FLS, including muscle aches,
fever, fatigue, and chills) and injection site reactions (ISRs), which are
typical of IFN products. In clinical practice, pre- and post-injection
treatment with acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs)
for the FLS is common. However, the effects of Plegridy did not have a negative
effect on patients* health-related quality of life (HRQoL) compared with
placebo. There is a need to continue to collect long-term data to help optimize
patient management and support continued access to Plegridy in the real-world
setting.
Study objective
This study will be conducted as a prospective, observational study of patients
with relapsing forms of MS initiating treatment with Plegridy in routine
clinical practice and patients who participated in Study 105MS302 or Study
105MS303. Enrolled patients will be followed for a maximum of five years
(regardless of treatment discontinuation) or until patient death, withdrawal,
or the patient is considered lost to follow-up. Data will be collected from
information routinely recorded in the medical record or prospectively collected
by the Prescribing Physician. Patient-reported outcomes (PROs) will be
completed by patients online (±four weeks of routine clinical visit) to allow
for completion of the questionnaires outside the physician*s office.
Study design
This study will be conducted as a prospective, observational study of patients
with relapsing forms of MS initiating
treatment with Plegridy in routine clinical practice and patients who
participated in Study 105MS302 or Study 105MS303. Enrolled patients will be
followed for a maximum of five years (regardless of treatment discontinuation)
or until patient death, withdrawal, or the
patient is considered lost to follow-up. Data will be collected from
information routinely recorded in the medical record or prospectively collected
by the Prescribing Physician. Patient-reported outcomes (PROs) will be
completed by patients online (±four weeks of routine clinical visit) to allow
for completion of the questionnaires outside the physician's office.
Study burden and risks
Not applicable, no expected risks for this study.
Norden Road 70
Maidenhead, Berkshire SL6 4AY
NL
Norden Road 70
Maidenhead, Berkshire SL6 4AY
NL
Listed location countries
Age
Inclusion criteria
1. Patient and or legal representative is willing and able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local patient privacy regulations.
2. Patient with MS who has been newly prescribed Plegridy according to local label or patient who participated in Study 105MS302 or Study 105MS303.
3. Patient age 18 years or older.
4. Patient willing and able to complete PROs with minimal assistance.
Please refer to protocol page 30 chapter 8.1
Exclusion criteria
Patients will be excluded from study entry if the following exclusion criterion exists at the time enrollment.
1. Concurrent enrollment in any clinical trial of an investigational product. Participation in non-interventional study can be allowed as long as this participation does not interfere with this protocol or is likely to affect the subject*s ability to comply with the protocol.
Please refer to page 30 chapter 8.2
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT02230969 |
| CCMO | NL54283.100.15 |