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Immunomodulator

Dimethyl Fumarate for Multiple Sclerosis (CONNECT Trial)

Phase 3
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have a body weight of ≥30 kg
Must have a diagnosis of RRMS (consensus definition for pediatric RRMS [Krupp 2007])
Must not have
History of human immunodeficiency virus
History of clinically significant cardiovascular, pulmonary, GI, dermatologic, growth, developmental, psychiatric (including depression), neurologic (other than MS), and/or other major disease that would preclude participation in a clinical study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of BG00012 in children with RRMS, compared to another disease-modifying treatment. The long-term safety of BG00012 will also be assessed in children who completed Week 96 in Part 1 of the study.

Who is the study for?
This trial is for kids over 30 kg with Relapsing-remitting Multiple Sclerosis (RRMS) who can walk and have had recent MS activity but no relapse or steroids in the last 50 days. They must not have other similar diseases, severe allergies to the drugs being tested, or any major health issues that could interfere with the study.
What is being tested?
The trial tests BG00012 against a standard treatment for pediatric RRMS. It aims to see if BG00012 is safe, tolerable, and effective in managing symptoms and slowing disability progression over time compared to existing treatments.
What are the potential side effects?
Possible side effects of dimethyl fumarate (BG00012) include flushing, stomach pain, diarrhea, nausea, vomiting. Interferon β-1a may cause flu-like symptoms, injection site reactions, liver problems and blood cell count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My body weight is at least 30 kg.
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I have been diagnosed with relapsing-remitting MS.
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I can walk without help, with a disability score up to 5.5.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of HIV.
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I do not have any major health issues that would stop me from joining a study.
Select...
I cannot swallow the BG00012 capsule whole.
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I have previously taken Fumaderm or BG00012.
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I haven't taken mitoxantrone, cyclophosphamide, or rituximab in the last year.
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I haven't taken specific immune system affecting drugs or had certain blood treatments in the last 6 months.
Select...
My MS is in a progressive stage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants That Experience Adverse Events (AEs) or Serious Adverse Events (SAEs)
Number of Participants Who Discontinue Study Treatment due to an AE
Secondary study objectives
Annualized Relapse Rate
Change from Baseline in Bone Age
Change from Baseline in Brief Visuospatial Memory Test - Revised (BVMT-R) Score
+19 more

Side effects data

From 2015 Phase 4 trial • 241 Patients • NCT02090413
56%
Flushing
29%
Nausea
24%
Diarrhoea
23%
Headache
20%
Nasopharyngitis
18%
Vomiting
13%
Abdominal pain
13%
Urinary tract infection
9%
Abdominal pain upper
9%
Lower respiratory tract infection
9%
Pain in extremity
9%
Fatigue
8%
Fall
8%
Oropharyngeal pain
6%
Cough
6%
Constipation
6%
Abdominal distension
6%
Sinusitis
6%
Paraesthesia
6%
Lymphocyte count decreased
6%
Multiple sclerosis relapse
5%
Gastrooesophageal reflux disease
5%
Dizziness
5%
Dyspepsia
5%
Upper respiratory tract infection
5%
Hypoaesthesia
5%
Pruritus
5%
Rash
5%
Influenza like illness
4%
Optic neuritis
4%
Arthralgia
4%
Musculoskeletal pain
4%
Balance disorder
4%
Rhinorrhea
4%
Alanine aminotransferase increased
4%
Back pain
4%
Gait disturbance
4%
Viral infection
4%
Muscle spasms
3%
Abdominal pain lower
3%
Toothache
3%
Asthenia
3%
Chills
3%
Depressed mood
3%
Tonsillitis
3%
Abdominal discomfort
3%
Candida infection
3%
Gastroenteritis
3%
Influenza
3%
Gastric infection
3%
Muscular weakness
3%
Alopecia
3%
Rash generalised
3%
Dyspnoea
3%
Chest discomfort
3%
Vaginal haemorrhage
3%
Vision blurred
3%
Anxiety
1%
Gingival bleeding
1%
Haematemesis
1%
Herpes zoster
1%
Amnesia
1%
Memory impairment
1%
Feeling abnormal
1%
Irritability
1%
Menorrhagia
1%
Breast mass
1%
Conjunctival haemorrhage
1%
Hypertension
1%
Tinnitus
1%
Gout
1%
Oral candidiasis
1%
Gastroenteritis norovirus
1%
Herpes simplex
1%
Labyrinthitis
1%
Dysarthria
1%
Musculoskeletal discomfort
1%
Pain in jaw
1%
Pruritis generalised
1%
Head injury
1%
Limb injury
1%
Patella fracture
1%
Chest pain
1%
Device failure
1%
Hypophosphataemia
1%
Costochondritis
1%
Pneumonia
1%
Drug intolerance
1%
Eructation
1%
Flatulence
1%
Gastroenteritis viral
1%
Infected dermal cyst
1%
Migraine
1%
Syncope
1%
Tremor
1%
Limb discomfort
1%
Myalgia
1%
Urticaria
1%
Pain
1%
Epicondylitis
1%
Liver function test abnormal
1%
Smear cervix abnormal
1%
Hypersensitivity
1%
Lyme disease
1%
Pyuria
1%
Lethargy
1%
Nerve compression
1%
Weight decreased
1%
Haemoglobin decreased
1%
Muscle strain
1%
Wrist fracture
1%
Eye pain
1%
Vertigo
1%
Metrorrhagia
1%
Testicular cyst
1%
Lymphopenia
1%
Biliary colic
1%
Bowen's disease
1%
Contusion
1%
Skin infection
1%
Blood alkaline phosphatase increased
1%
Ear pain
1%
Gastrointestinal disorder
1%
Accidental overdose
1%
Mastication disorder
1%
Psoriasis
1%
Type 2 diabetes mellitus
1%
Bronchitis
1%
Viral upper respiratory tract infection
1%
Food allergy
1%
Seasonal allergy
1%
Micturition urgency
100%
80%
60%
40%
20%
0%
Study treatment Arm
DMF + ASA-Placebo BID
DMF + ASA 150 mg BID
DMF + ASA 75 mg QAM

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BG00012Experimental Treatment1 Intervention
Participants will receive the recommended dose of 240 mg orally, twice a day
Group II: IFN β-1a (Avonex)Active Control1 Intervention
Participants will receive the recommended dose of 30 μg (weekly)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dimethyl fumarate
2016
Completed Phase 4
~11110

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
646 Previous Clinical Trials
466,536 Total Patients Enrolled
227 Trials studying Multiple Sclerosis
142,002 Patients Enrolled for Multiple Sclerosis
Medical DirectorStudy DirectorBiogen
2,900 Previous Clinical Trials
8,090,278 Total Patients Enrolled
136 Trials studying Multiple Sclerosis
126,043 Patients Enrolled for Multiple Sclerosis

Media Library

BG00012 (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT02283853 — Phase 3
Multiple Sclerosis Research Study Groups: IFN β-1a (Avonex), BG00012
Multiple Sclerosis Clinical Trial 2023: BG00012 Highlights & Side Effects. Trial Name: NCT02283853 — Phase 3
BG00012 (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02283853 — Phase 3
~9 spots leftby Sep 2025
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