Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03177083
• Date of registration: 26/01/2017
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy PLENO
• Scientific title: Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients With Relapsing Remitting Multiple Sclerosis (MS) Transitioning From Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)
• Date of first enrolment: January 30, 2017
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03177083
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Portugal

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- A confirmed diagnosis of RRMS, as defined by McDonald criteria (2017).

- An EDSS score between 0 and 5.0.

- All female participants of childbearing potential must practice effective
contraception during the study and be willing and able to continue contraception for 3
months after their last dose of study treatment.

- On continual treatment for =6 months with a single current SC IFN-ß therapy, including
IFN-ß-1b 0.25 mg SC every other day or IFN-ß-1a 22 µg or 44 µg SC 3 times weekly

Key Exclusion Criteria:

- Known history of human immunodeficiency virus.

- Known history of or positive test result for antibodies to hepatitis C, or current
hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg]
and/or positive for hepatitis B core antibody [HBcAb]) at Screening. Participants with
immunity to hepatitis B from either active vaccination (defined as negative HBsAg,
positive hepatitis B surface antibody [HBsAb], and negative HBcAb) or from previous
natural infection (defined as negative HBsAg, positive HBsAb immunoglobulin G, and
positive HBcAb) are eligible to participate in the study (definitions are based on the
Centers for Disease Control and Prevention's interpretation of the hepatitis B
serology panel [CDC 2007]).

- An MS relapse that has occurred within the 50 days prior to randomization and/or lack
of stabilization from a previous relapse prior to randomization (Day 1).

- Any previous treatment with PLEGRIDY.

NOTE: Other protocol defined Inclusion/Exclusion may apply



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Remitting Multiple Sclerosis

Intervention(s)

Drug: interferon beta-1a

Drug: peginterferon beta-1a

Drug: interferon beta-1b

Primary Outcome(s)

Combined Counts of AEs of ISR Pain (ISRP) [Time Frame: Up to Week 24]

Combined Counts of Adverse Events (AEs) of Flu-Like Symptoms (FLS) [Time Frame: Up to Week 24]

Combined Counts of AEs of Injection Site Reactions (ISRs) [Time Frame: Up to Week 24]

Secondary Outcome(s)

Change in PRO Measures in FSS Score in Participants Who Switched from Current SC IFN-? Therapy to PLEGRIDY at the End of the Comparator Period [Time Frame: Baseline, Week 24, Week 48 and Week 72]

Change in PRO Measures in SF-12 Score in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-? Therapy to PLEGRIDY at the End of the Comparator Period [Time Frame: Week 24, Week 48 and Week 72]

Change in PRO Measures in EQ-5D-3L Index in Participants Who Switched from Current SC IFN-? Therapy to PLEGRIDY at the End of the Comparator Period [Time Frame: Baseline, Week 24, Week 48 and Week 72]

Change in PRO Measures in FSS Score in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-? Therapy to PLEGRIDY at the End of the Comparator Period [Time Frame: Week 24, Week 48 and Week 72]

Change in PRO Measures in HADS Score in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-? Therapy to PLEGRIDY at the End of the Comparator Period [Time Frame: Week 24, Week 48 and Week 72]

Participants Adherence to Study Treatment as Measured by Treatment Adherence Questionnaire in Participants Who Switched from Current SC IFN-? Therapy to PLEGRIDY at the End of the Comparator Period [Time Frame: Baseline, Week 24, Week 48 and Week 72]

Change in PRO Measures in WPAI: MS Score in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-? Therapy to PLEGRIDY at the End of the Comparator Period [Time Frame: Week 24, Week 48 and Week 72]

Change in PRO Measures in WPAI: MS Score in Participants Who Switched from Current SC IFN-? Therapy to PLEGRIDY at the End of the Comparator Period [Time Frame: Baseline, Week 24, Week 48 and Week 72]

Participants Adherence to Study Treatment as Measured by Treatment Adherence Questionnaire [Time Frame: Week 24 and Week 72]

Percentage of Participants with an AE, Serious AE, and Discontinuation of Study Treatment due to an AE Continuously Treated with PLEGRIDY [Time Frame: Week 24, Week 48 and Week 72]

Annualized Relapse Rate (ARR) in Participants in the Overall Population [Time Frame: Week 72]

Percentage of Participants with an AE, Serious AE, and Discontinuation of Study Treatment due to an AE Who Switched from Current SC IFN-? Therapy to PLEGRIDY at the End of the Comparator Period [Time Frame: Week 24, Week 48 and Week 72]

Average Change in Participant-Reported VAS Pain Score from Pre-Injection to 30 Minutes Post-Injection in Participants Treated with PLEGRIDY Versus Current SC IFN-? [Time Frame: Week 24]

Change in PRO Measures in EQ-5D-3L Index in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-? Therapy to PLEGRIDY at the End of the Comparator Period [Time Frame: Week 24, Week 48 and Week 72]

Percentage of Participants with Changes in Relapse Activity [Time Frame: Week 72]

Average Change in Participant-Reported VAS Pain Score from Pre-Injection to Immediate Post-Injection in Participants Treated with PLEGRIDY Versus Current SC IFN-? [Time Frame: Week 24]

Change in Participant-Reported Treatment Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM-9) in Participants Treated with PLEGRIDY Versus Current SC IFN-ß [Time Frame: Baseline to Week 24]

Change in PRO Measures in Hospital Anxiety And Depression Scale (HADS) Score in Participants Treated with PLEGRIDY Versus Current SC IFN-? [Time Frame: Baseline and Week 24]

Change in PRO Measures in SF-12 Score in Participants Who Switched from Current SC IFN-? Therapy to PLEGRIDY at the End of the Comparator Period [Time Frame: Baseline, Week 24, Week 48 and Week 72]

Change in PRO Measures in Fatigue Severity Scale (FSS) Score in Participants Treated with PLEGRIDY Versus Current SC IFN-? [Time Frame: Baseline and Week 24]

Change in Participant-Reported Treatment Satisfaction Using TSQM-9 in Participants Who Switched from Current SC IFN-? Therapy to PLEGRIDY at the End of the Comparator Period [Time Frame: Week 24 and Week 48]

Percentage of Participants with an Adverse Event (AE), Serious AE, and Discontinuations of Study Treatment due to an AE in Participants Treated with PLEGRIDY Versus Current SC IFN-ß [Time Frame: Week 24]

Change in PRO Measures in 12-Item Short Form Survey (SF-12) Score in Participants Treated with PLEGRIDY Versus Current SC IFN-? [Time Frame: Baseline and Week 24]

Change in PRO Measures in HADS Score in Participants Who Switched from Current SC IFN-? Therapy to PLEGRIDY at the End of the Comparator Period [Time Frame: Baseline, Week 24, Week 48 and Week 72]

Proportion of Pain-Free Participants 30 Minutes after Injection (Defined as 0 mm for All Full-Dose Injections on VAS of Participant-Reported Pain) at End of the Comparator Period in Participants Treated with PLEGRIDY Versus Current SC IFN-? [Time Frame: Week 24]

Participants Adherence to Study Treatment as Measured by Returned Injection Pens in Participants Who Switched from Current SC IFN-? Therapy to PLEGRIDY at the End of the Comparator Period [Time Frame: Baseline, Week 24, Week 48 and Week 72]

Participants Adherence to Study Treatment as Measured by Returned Injection Pens [Time Frame: Week 24 and Week 72]

Percentage of Participants with Changes in Clinical Status Assessed Using the Expanded Disability Status Scale (EDSS) [Time Frame: Week 48]

Proportion of Relapsed Participants in Overall Population [Time Frame: Week 72]

Change in Participant-Reported Outcome (PRO) Measures in EuroQol Group 5-Dimension 3-Level Version (EQ-5D-3L) Index in Participants Treated with PLEGRIDY Versus Current SC IFN-? [Time Frame: Baseline and Week 24]

Change in PRO Measures in Work Productivity and Activity Impairment Questionnaire: Multiple Sclerosis V2.1 (WPAI: MS) Score in Participants Treated with PLEGRIDY Versus Current SC IFN-? [Time Frame: Baseline and Week 24]

Proportion of Pain-Free Participants Immediately After Injection (Defined as 0 mm for All Full-Dose Injections on VAS of Participant-Reported Pain) at End Of the Comparator Period in Participants Treated with PLEGRIDY Versus Current SC IFN-? [Time Frame: Week 24]

Secondary ID(s)

2016-000434-21

PRT-PEG-15-10880

Source(s) of Monetary Support

Please refer to primary and secondary sponsors