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Monoclonal Antibodies

Natalizumab for Multiple Sclerosis

Q: Are we looking for participants who are at least 18 years old?

The age bracket for patients that this study is recruiting falls between 18 to 60 years old.

Q: What other medical studies have included Natalizumab in their research?

Natalizumab is being researched in 7 different clinical trials, 2 of which are in Phase 3. Although the majority of Natalizumab studies are based out of Fort Collins, <a href="https://www.withpower.com/clinical-trials/colorado">Colorado</a>, there are 173 total research sites for this treatment across the United States.

Q: Is this trial being conducted in a large number of hospitals across the United States?

Currently, this clinical trial is being conducted in 48 different locations. If you are interested in participating, it would be best to select a site near Fairfield, Saint Louis or Miami to limit travel.

Q: Does Natalizumab have a good safety profile?

There is previous clinical evidence supporting the safety of Natalizumab, which is why it received a score of 3.

Q: To what purpose is Natalizumab most often put?

Natalizumab can be used to manage patients that cannot tolerate standard treatments, those being treated as monotherapy, and those with <a href="https://www.withpower.com/clinical-trials/crohn&#x27;s-disease">Crohn's disease</a>.

Q: As of right now, approximately how many people have signed up for this research project?

Unfortunately, this particular study has stopped looking for participants. The trial was first made available on December 26th 2018 and experienced its last update September 17th 2020. However, there are presently 563 studies actively searching for patients with <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a> and 7 trials for Natalizumab that need volunteers.

Q: Are there any patients required for this research project?

This study is no longer enrolling patients. According to the clinicaltrials.gov listing, it was posted on December 26th, 2018 and last updated September 17th, 2020. 563 other trials for <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a> are ongoing, as well as 7 for Natalizumab specifically.

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24, 48, 72 and 84

Awards & highlights

Study Summary

This trial is evaluating the efficacy of natalizumab extended interval dosing (EID) in participants who have previously been treated with natalizumab standard interval dosing (SID) for at least 12 months, in relation to continued SID treatment. The trial will also evaluate relapse-based clinical efficacy measures, disability worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of EID in participants who have previously been treated with natalizumab SID for at least 12 months, in relation to continued SID treatment.

Eligible Conditions

Multiple Sclerosis, Relapsing-Remitting

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24, 48, 72 and 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24, 48, 72 and 84

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24, 48, 72 and 84 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1: Number of New or Newly Enlarging T2 Hyperintense Lesions at Week 72

Part 2: Percentage of Participants Indicating a Preference for Natalizumab SC Administration at the End of Part 2

Secondary outcome measures

Part 1: Annualized Relapse Rate at Week 72

Part 1: Number of New Gadolinium (Gd) Enhancing and New T1 Hypointense Lesions at Weeks 24, 48 and 72

Part 1: Number of New or Newly Enlarging T2 Hyperintense Lesions at Weeks 24 and 48

+17 more

Side effects data

From 2011 Phase 4 trial • 19 Patients • NCT01144052

70%

Infection

10%

gastroenteritis

100%

80%

60%

40%

20%

Study treatment Arm

Natalizumab

Interferon-beta-1b

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 2: EID SC, then EID IVExperimental Treatment1 Intervention

Participants will receive natalizumab 300 mg SC injection every 6 weeks from Week 108 through Week 126 followed by natalizumab 300 mg IV infusion every 6 weeks from Week 132 through Week 150.

Group II: Part 2: EID IV, then EID SCExperimental Treatment1 Intervention

Participants will receive natalizumab 300 mg IV infusion every 6 weeks from Week 108 through Week 126 followed by natalizumab 300 mg SC injection every 6 weeks from Week 132 through Week 150.

Group III: Part 1: Standard Interval Dosing (SID) IVExperimental Treatment1 Intervention

Participants will receive natalizumab 300 milligram (mg) intravenous (IV) infusion every 4 weeks (-2/+5 days) up to Week 72.

Group IV: Part 1: Extended Interval Dosing (EID) IVExperimental Treatment1 Intervention

Participants will receive natalizumab 300 mg IV infusion every 6 weeks (-2/+5 days) up to Week 72.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Natalizumab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor

639 Previous Clinical Trials

466,937 Total Patients Enrolled

226 Trials studying Multiple Sclerosis

141,833 Patients Enrolled for Multiple Sclerosis

Medical DirectorStudy DirectorBiogen

2,777 Previous Clinical Trials

8,062,987 Total Patients Enrolled

136 Trials studying Multiple Sclerosis

125,900 Patients Enrolled for Multiple Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I participate in this clinical trial?

"This clinical trial is seeking 500 individuals aged 18-60 who have been diagnosed with acute relapsing multiple sclerosis. In order to be eligible, patients must also meet the following requirements: • Treatment with natalizumab as disease-modifying monotherapy for RRMS that is consistent with the approved dosing for a minimum of 12 months prior to randomization. The participant must have received at least 11 doses of natalizumab in the 12 months prior to randomization with no missed doses in the 3 months prior to randomization., • Expanded Disability Status Scale (EDSS) score <=5"

Answered by AI

Are we looking for participants who are at least 18 years old?

"The age bracket for patients that this study is recruiting falls between 18 to 60 years old."

Answered by AI

What other medical studies have included Natalizumab in their research?

"Natalizumab is being researched in 7 different clinical trials, 2 of which are in Phase 3. Although the majority of Natalizumab studies are based out of Fort Collins, Colorado, there are 173 total research sites for this treatment across the United States."

Answered by AI

Is this trial being conducted in a large number of hospitals across the United States?

"Currently, this clinical trial is being conducted in 48 different locations. If you are interested in participating, it would be best to select a site near Fairfield, Saint Louis or Miami to limit travel."

Answered by AI

Does Natalizumab have a good safety profile?

"There is previous clinical evidence supporting the safety of Natalizumab, which is why it received a score of 3."

Answered by AI

To what purpose is Natalizumab most often put?

"Natalizumab can be used to manage patients that cannot tolerate standard treatments, those being treated as monotherapy, and those with Crohn's disease."

Answered by AI

As of right now, approximately how many people have signed up for this research project?

"Unfortunately, this particular study has stopped looking for participants. The trial was first made available on December 26th 2018 and experienced its last update September 17th 2020. However, there are presently 563 studies actively searching for patients with multiple sclerosis and 7 trials for Natalizumab that need volunteers."

Answered by AI

Are there any patients required for this research project?

"This study is no longer enrolling patients. According to the clinicaltrials.gov listing, it was posted on December 26th, 2018 and last updated September 17th, 2020. 563 other trials for multiple sclerosis are ongoing, as well as 7 for Natalizumab specifically."

Answered by AI

Recent research and studies

The Lancet NeurologyJournal

Comparison of Switching to 6-week Dosing of Natalizumab Versus Continuing with 4-week Dosing in Patients with Relapsing-remitting Multiple Sclerosis (NOVA): A Randomised, Controlled, Open-label, Phase 3b Trial

Foley, John F, Gilles Defer, Lana Zhovtis Ryerson, Jeffrey A Cohen, Douglas L Arnold, Helmut Butzkueven, Gary Cutter, et al.. 2022. “Comparison of Switching to 6-week Dosing of Natalizumab Versus Continuing with 4-week Dosing in Patients with Relapsing-remitting Multiple Sclerosis (NOVA): A Randomised, Controlled, Open-label, Phase 3b Trial”. The Lancet Neurology. Elsevier BV. doi:10.1016/s1474-4422(22)00143-0.

The Lancet NeurologyJournal

clinicaltrials.govStudy

A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration

2018. "A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03689972.