Plegridy Observational Program

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2022
• Main ID: NCT02230969
• Date of registration: 29/08/2014
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Plegridy Observational Program POP
• Scientific title: Plegridy™ (Peginterferon ß-1a) Real World Effectiveness and Safety Observational Program
• Date of first enrolment: November 12, 2014
• Target sample size: 1208
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02230969
• Study type: Observational

Countries of recruitment

Australia, Austria, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom, United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- Patient with MS who is newly, or is currently, prescribed Plegridy according to local
label including patients who participated in Study 105MS302 (NCT01332019) or Study
105MS303 (NCT01939002).

- Patient willing and able to complete patient-reported outcomes (PRO) with minimal
assistance.

Key Exclusion Criteria:

- 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Forms of Multiple Sclerosis

Intervention(s)

Drug: peginterferon beta-1a

Primary Outcome(s)

Clinical no evidence of disease activity (NEDA) as measured by the proportion of participants with no relapses [Time Frame: Up to 5 years]

Safety as measured by the incidence proportion of SAEs [Time Frame: Up to 5 years]

Clinical NEDA as measured by the proportion of participants with no disability progression [Time Frame: Up to 5 years]

Safety as measured by the incidence rate of SAEs [Time Frame: Up to 5 years]

Secondary Outcome(s)

Disability progression as measured by the time to sustained disability progression for at least six months [Time Frame: Up to 5 years]

Relapse activity as measured by annualized relapse rate (ARR) [Time Frame: Up to 5 years]

Relapse activity as measured by time to first relapse [Time Frame: Up to 5 years]

Prescription and utilization patterns as measured by the primary reason for discontinuation of Plegridy [Time Frame: Up to 5 years]

Incidence rate of non-serious AEs leading to treatment discontinuation [Time Frame: Up to 5 years]

Relapse activity as measured by the proportion of participants with relapse [Time Frame: Up to 5 years]

Changes in FLS assessment and FLS-VAS over time [Time Frame: Baseline to 5 years]

Prescription and utilization patterns as measured by duration of Plegridy use [Time Frame: Up to 5 years]

Impact of the severity of FLS on the ability to successfully manage symptoms via prophylaxis as measured by the participant-reported FLS-VAS [Time Frame: Up to 5 years]

Incidence proportion of non-serious AEs leading to treatment discontinuation [Time Frame: Up to 5 years]

Relapse activity as measured by the distribution of the number of relapses [Time Frame: Up to 5 years]

Treatment adherence as measured by changes in adherence over time as reported in the treatment adherence questionnaires [Time Frame: Baseline to 5 years]

Prescription and utilization patterns as measured by prescribed dosing frequency [Time Frame: Up to 5 years]

Changes in EuroQoL EQ-5D, 3-level (EQ-5D-3L) score over time [Time Frame: Baseline to 5 years]

Disability progression as measured by the proportion of participants with sustained progression for at least six months [Time Frame: Up to 5 years]

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 [Time Frame: Up to 5 years]

Secondary ID(s)

105MS401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors