Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) (CONNECT)
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|ClinicalTrials.gov Identifier: NCT02283853|
Recruitment Status : Active, not recruiting
First Posted : November 5, 2014
Last Update Posted : September 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Relapsing-Remitting Multiple Sclerosis||Drug: dimethyl fumarate Drug: Interferon β-1a||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label, Randomized, Multicenter, Multiple-Dose,Active-Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension|
|Actual Study Start Date :||August 28, 2014|
|Estimated Primary Completion Date :||September 25, 2020|
|Estimated Study Completion Date :||May 30, 2025|
Participants will receive 120 mg capsule(s) taken orally.
Drug: dimethyl fumarate
Active Comparator: IFN β-1a (Avonex)
Participants will receive the recommended dose of 30 μg (weekly)
Drug: Interferon β-1a
administered by intramuscular injection
Other Name: Avonex
- Proportion of participants free of new/newly enlarging T2 hyperintense lesions on brain MRI scans [ Time Frame: At week 96 ]Part 1
- Number of participants that experience Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Up to 5 years ]Part 2 will be an optional open-label extension phase in subjects who complete Part 1 and who meet the Part 2 entry criteria.
- Number of participants who discontinue study treatment due to an AE [ Time Frame: Up to 5 years ]Part 2
- The number of new/newly enlarging T2 hyperintense lesions on brain MRI scans [ Time Frame: At Week 24 and Week 96 ]
- Proportion of participants free of new/newly enlarging T2 hyperintense lesions on brain MRI scans [ Time Frame: At Week 24 and Week 48 ]
- Proportion of participants free of new MRI activity as measured by brain MRI scans [ Time Frame: At Weeks 24, 48 and 96 ]New MRI Activitiy includes: Gd-enhancing MRI lesions on brain MRI scans; New T2 MRI lesions on brain MRI scans and newly enlarging MRI lesions on brain MRI scans
- Time to first relapse [ Time Frame: Up to Week 96 ]
- Proportion of participants who do not experience relapse [ Time Frame: Up to Week 96 ]
- Annualized relapse rate [ Time Frame: At Weeks 48 and 96 ]
- Number of participants that experience Adverse Events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to Week 96 ]Including prospective and follow-up of flushing, nausea, abdominal pain and diarrhea
- Fatigue as measured by the Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale scores [ Time Frame: Up to Week 96 ]Multidimensional Fatigue Scale scores - designed as a generic symptom-speciﬁc instrument to measure fatigue in patients with acute and chronic health conditions as well as healthy school and community populations.
- Quality of Life as measured by the PedsQL [ Time Frame: Up to Week 96 ]
- Change from baseline to Week 96 in the Expanded Disability Status Scale (EDSS) score [ Time Frame: Up to Week 96 ]The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The first levels 1.0 to 4.5 refer to people with a high degree of ambulatory ability and the subsequent levels 5.0 to 9.5 refer to the loss of ambulatory ability. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS.
- Vital signs, electrocardiograms (ECGs) and changes in clinical laboratory data, including monitoring of liver function, renal function, hematologic, and coagulation parameters [ Time Frame: Up to Week 96 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283853
|Study Director:||Medical Director||Biogen|