Clinical trial NCT03177083: Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy
Official 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™)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2017-06-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate safety and tolerability as defined by the frequency of the adverse events (AEs) of flu-like symptoms (FLS) \[chills, pyrexia, myalgia, and asthenia\], injection site reactions (ISRs), and injection site reaction pain (ISR-P), over 24 weeks of treatment (the active comparator period) with PLEGRIDY 125 microgram (μg) subcutaneous (SC) every 2 weeks versus current SC IFN-β therapy in participants with Relapsing Remitting Multiple Sclerosis (RRMS).


Eligibility 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-β therapy, including IFN-β-1b 0.25 mg SC every other day or IFN-β-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

Primary outcomes:
measure: Combined Counts of Adverse Events (AEs) of Flu-Like Symptoms (FLS)
timeFrame: Up to Week 24
measure: Combined Counts of AEs of Injection Site Reactions (ISRs)
timeFrame: Up to Week 24
measure: Combined Counts of AEs of Injection Site Reactions (ISRs)
timeFrame: Up to Week 24
measure: Combined Counts of AEs of ISR Pain (ISRP)
timeFrame: Up to Week 24
Secondary outcomes:
measure: Change in Participant-Reported Treatment Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM-9) in Participants Treated with PLEGRIDY Versus Current SC IFN-β
timeFrame: Baseline to Week 24
measure: Change in Participant-Reported Treatment Satisfaction Using TSQM-9 in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period
timeFrame: Week 24 and Week 48
measure: 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-Β
timeFrame: Baseline and Week 24
measure: Change in PRO Measures in EQ-5D-3L Index in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period
timeFrame: Week 24, Week 48 and Week 72
measure: Change in PRO Measures in EQ-5D-3L Index in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period
timeFrame: Baseline, Week 24, Week 48 and Week 72
measure: 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-Β
timeFrame: Baseline and Week 24
measure: Change in PRO Measures in WPAI: MS Score in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period
timeFrame: Week 24, Week 48 and Week 72
measure: Change in PRO Measures in WPAI: MS Score in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period
timeFrame: Baseline, Week 24, Week 48 and Week 72
measure: Percentage of Participants with Changes in Clinical Status Assessed Using the Expanded Disability Status Scale (EDSS)
timeFrame: Week 48
measure: Change in PRO Measures in 12-Item Short Form Survey (SF-12) Score in Participants Treated with PLEGRIDY Versus Current SC IFN-Β
timeFrame: Baseline and Week 24
measure: Change in PRO Measures in SF-12 Score in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period
timeFrame: Week 24, Week 48 and Week 72
measure: Change in PRO Measures in SF-12 Score in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period
timeFrame: Baseline, Week 24, Week 48 and Week 72
measure: Change in PRO Measures in Fatigue Severity Scale (FSS) Score in Participants Treated with PLEGRIDY Versus Current SC IFN-Β
timeFrame: Baseline and Week 24
measure: Change in PRO Measures in FSS Score in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period
timeFrame: Week 24, Week 48 and Week 72
measure: Change in PRO Measures in FSS Score in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period
timeFrame: Baseline, Week 24, Week 48 and Week 72
measure: Change in PRO Measures in Hospital Anxiety And Depression Scale (HADS) Score in Participants Treated with PLEGRIDY Versus Current SC IFN-Β
timeFrame: Baseline and Week 24
measure: Change in PRO Measures in HADS Score in Participants Continuously Treated with PLEGRIDY Versus Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period
timeFrame: Week 24, Week 48 and Week 72
measure: Change in PRO Measures in HADS Score in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period
timeFrame: Baseline, Week 24, Week 48 and Week 72
measure: Participants Adherence to Study Treatment as Measured by Treatment Adherence Questionnaire
timeFrame: Week 24 and Week 72
measure: Participants Adherence to Study Treatment as Measured by Returned Injection Pens
timeFrame: Week 24 and Week 72
measure: Participants Adherence to Study Treatment as Measured by Treatment Adherence Questionnaire in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period
timeFrame: Baseline, Week 24, Week 48 and Week 72
measure: Participants Adherence to Study Treatment as Measured by Returned Injection Pens in Participants Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period
timeFrame: Baseline, Week 24, Week 48 and Week 72
measure: 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-Β
timeFrame: Week 24
measure: 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-Β
timeFrame: Week 24
measure: 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-Β
timeFrame: Week 24
measure: Average Change in Participant-Reported VAS Pain Score from Pre-Injection to Immediate Post-Injection in Participants Treated with PLEGRIDY Versus Current SC IFN-Β
timeFrame: Week 24
measure: Percentage of Participants with Changes in Relapse Activity
timeFrame: Week 72
measure: Annualized Relapse Rate (ARR) in Participants in the Overall Population
timeFrame: Week 72
measure: Proportion of Relapsed Participants in Overall Population
timeFrame: Week 72
measure: 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-β
timeFrame: Week 24
measure: Percentage of Participants with an AE, Serious AE, and Discontinuation of Study Treatment due to an AE Continuously Treated with PLEGRIDY
timeFrame: Week 24, Week 48 and Week 72
measure: Percentage of Participants with an AE, Serious AE, and Discontinuation of Study Treatment due to an AE Who Switched from Current SC IFN-Β Therapy to PLEGRIDY at the End of the Comparator Period
timeFrame: Week 24, Week 48 and Week 72
Other outcomes:
Locations:
city: Amadora
country: Portugal
facility: Hospital Fernando Fonseca
city: Braga
country: Portugal
facility: Hospital de Braga
city: Covilhã
country: Portugal
facility: Centro Hospitalar Cova da Beira
city: Evora
country: Portugal
facility: Hospital Evora
city: Funchal
country: Portugal
facility: Hospital Dr. Nelio Mendonça
city: Guimaraes
country: Portugal
facility: Hospital da Senhora da Oliveira
city: Leiria
country: Portugal
facility: Centro Hospitalar de Leiria
city: Lisboa
country: Portugal
facility: Hospital Egas Moniz
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte - Hosp Santa Maria
city: Loures
country: Portugal
facility: Hospital Beatriz Ângelo, EPE
city: Matosinhos
country: Portugal
facility: ULS Matosinhos
city: Porto
country: Portugal
facility: Hospital Santo Antonio
city: Santa Maria da Feira
country: Portugal
facility: Hospital de Sao Sebastiao
city: Viana do Castelo
country: Portugal
facility: Hospital Viana do Castelo
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: