Relapsing-Remitting Multiple SclerosisPhase 2REFINENCT01405820

Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)

A Phase 2 study testing natalizumab IV and natalizumab SC in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 64 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS). Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Relapsing-Remitting Multiple Sclerosis
What is being tested?: natalizumab IV and natalizumab SC
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 290 participants
Where: 64 sitesin 5 countries
Study dates: Aug 2011to Oct 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Ability to provide written informed consent
Subjects of childbearing potential must practice effective contraception during the study
A documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS)
Free of MS relapse for 12 months prior to randomization
Treatment with natalizumab for a minimum of 12 months immediately prior to randomization.
In the 12 months prior to commencing natalizumab, subject must have experienced a minimal level of disease activity as defined by 2 or more documented clinical relapses OR 1 relapse and documented MRI activity, defined by the presence of at least 1 Gd enhancing lesion on MRI, unrelated to the relapse.

Who cannot join

Known history of Human Immunodeficiency Virus (HIV), hepatitis C and/or hepatitis B virus
Positive for anti-natalizumab antibodies at screening
MRI positive for Gd-enhancing lesions at study entry
Subjects for whom MRI is contraindicated
History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease
History of malignant disease, including solid tumors and hematologic malignancies (with the exception of cured basal cell and squamous cell carcinomas of the skin)

Show all 11Show fewer

History of transplantation or any anti-rejection therapy
History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug
A clinically significant infectious illness within 30 days prior to screening or progressive multifocal leukoencephalopathy (PML) or other opportunistic infections at any time
Signs or symptoms suggestive of any serious infection, based on medical history, physical examination or laboratory testing
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

64 sites in 5 countries.

Country

City, postcode or hospital

64 sites in 5 countries

Germany21 sites

Research Site
Andernach
Research Site
Bamberg
Research Site
Berlin
Research Site
Bochum
Research Site
Bonn
Research Site
Dresden
Research Site
Emmendingen
Research Site
Erbach im Odenwald
Research Site
Erlangen
Research Site
Frankfurt
Research Site
Freiburg im Breisgau
Research Site
Heidelberg
Research Site
Jena
Research Site
Mainz
Research Site
Marburg
Research Site
München
Research Site
Neuburg am Inn
Research Site
Regensburg
Research Site
Tübingen
Research Site
Ulm
Research Site
Wermsdorf

Other trials in Germany

Italy18 sites

Research Site
Bari
Research Site
Catania
Research Site
Cefalù
Research Site
Chieti
Research Site
Florence
Research Site
Gallarate
Research Site
L’Aquila
Research Site
Milan
Research Site
Montichiari
Research Site
Naples
Research Site
Orbassano
Research Site
Padova
Research Site
Palermo
Research Site
Pavia
Research Site
Pozzilli
Research Site
Roma
Research Site
Sassari
Research Site
Torino

Other trials in Italy

France11 sites

Research Site
Amiens
Research Site
Besançon
Research Site
Bron
Research Site
Lille
Research Site
Montpellier
Research Site
Nantes
Research Site
Nice
Research Site
Paris
Research Site
Rennes
Research Site
Strasbourg
Research Site
Toulouse

Other trials in France

Spain10 sites

Research Site
Barcelona
Research Site
Donostia / San Sebastian
Research Site
Girona
Research Site
Lleida
Research Site
Málaga
Research Site
Murcia
Research Site
Oviedo
Research Site
Pamplona
Research Site
Santa Cruz de Tenerife
Research Site
Seville

Other trials in Spain

Belgium4 sites

Research Site
Brasschaat
Research Site
Liège
Research Site
Overpelt
Research Site
Wilrijk

Other trials in Belgium

About this study

Official title: A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis

The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS).

Read the detailed description

This is a a dose and frequency (but not route of administration) blinded, prospective, randomized, dose-ranging study in patients with RRMS who have received natalizumab for at least 12 months according to the local prescribing guidelines. The study will explore dosing of natalizumab by subcutaneous and intravenous routes. Participants will be randomly assigned to 1 of 6 dosing regimens, blinded to natalizumab dose, but not route, for 60 weeks of treatment.

Conditions: Relapsing-Remitting Multiple Sclerosis
Being tested: natalizumab IV, natalizumab SC, IV Placebo, SC Placebo
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

natalizumab IVDrug
Also called Tysabri, BG00002
natalizumab for IV Infusion
natalizumab SCDrug
Also called Tysabri, BG00002
natalizumab for Subcutaneous Injection
IV PlaceboDrug
Intravenous placebo to natalizumab
SC PlaceboDrug
Subcutaneous placebo to natalizumab

Study groups in NCT01405820
Study group	Role	What they receive
Natalizumab 300 mg Intravenous (IV) Every 4 Weeks	Active comparator	Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Receives: Drug: natalizumab IV
Natalizumab 300 mg Subcutaneous (SC) Every 4 Weeks	Experimental	Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Receives: Drug: natalizumab IV; Drug: natalizumab SC
Natalizumab 300 mg IV Every 12 Weeks	Experimental	Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Receives: Drug: natalizumab IV; Drug: IV Placebo
Natalizumab 300 mg SC Every 12 Weeks	Experimental	Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Receives: Drug: natalizumab IV; Drug: natalizumab SC; Drug: SC Placebo
Natalizumab 150 mg IV Every 12 Weeks	Experimental	Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Receives: Drug: natalizumab IV; Drug: IV Placebo
Natalizumab 150 mg SC Every 12 Weeks	Experimental	Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68. Receives: Drug: natalizumab IV; Drug: natalizumab SC; Drug: SC Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative Number of Combined Unique Active Lesions
Cumulative number of combined unique active lesions (sum of the number of new gadolinium (Gd)-enhancing lesions and new or newly enlarging T2 hyperintense lesions not associated with Gd-enhancement on T1 weighted scans) based on brain magnetic resonance imaging (MRI) scans Up to Week 60.
Measured: Up to Week 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Oct 2014

First posted29 Jul 2011 (estimated)
Study startAug 2011
Primary completionApr 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
More trials run by BiogenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01405820
Sponsor's protocol ID: 101MS206
Other IDs: 2010-024000-10
Acronym: REFINE
Status last verified: Aug 2015
First submitted: 14 Jul 2011
Last updated: 21 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis
ClinicalTrials.gov ID: NCT01405820
Acronym / sponsor ID: REFINE / 101MS206
Conditions: Relapsing-Remitting Multiple Sclerosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: BiogenIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Apr 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 29 Jul 2011 (estimated)
Results: Posted 29 Jul 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Natalizumab 300 mg Intravenous (IV) Every 4 Weeks	Active comparator	Drug: natalizumab IVNatalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
Natalizumab 300 mg Subcutaneous (SC) Every 4 Weeks	Experimental	Drug: natalizumab IV, Drug: natalizumab SCNatalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
Natalizumab 300 mg IV Every 12 Weeks	Experimental	Drug: natalizumab IV, Drug: IV PlaceboNatalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
Natalizumab 300 mg SC Every 12 Weeks	Experimental	Drug: natalizumab IV, Drug: natalizumab SC, Drug: SC PlaceboNatalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
Natalizumab 150 mg IV Every 12 Weeks	Experimental	Drug: natalizumab IV, Drug: IV PlaceboNatalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
Natalizumab 150 mg SC Every 12 Weeks	Experimental	Drug: natalizumab IV, Drug: natalizumab SC, Drug: SC PlaceboNatalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Ability to provide written informed consent
Subjects of childbearing potential must practice effective contraception during the study
A documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS)
Free of MS relapse for 12 months prior to randomization
Treatment with natalizumab for a minimum of 12 months immediately prior to randomization.

Key exclusion criteria (11 listed)

Known history of Human Immunodeficiency Virus (HIV), hepatitis C and/or hepatitis B virus
Positive for anti-natalizumab antibodies at screening
MRI positive for Gd-enhancing lesions at study entry
Subjects for whom MRI is contraindicated
History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
natalizumab IVAlso: Tysabri, BG00002natalizumab for IV Infusion	Drug	Natalizumab 150 mg IV Every 12 Weeks, Natalizumab 150 mg SC Every 12 Weeks, Natalizumab 300 mg IV Every 12 Weeks, Natalizumab 300 mg Intravenous (IV) Every 4 Weeks, Natalizumab 300 mg SC Every 12 Weeks, Natalizumab 300 mg Subcutaneous (SC) Every 4 Weeks
natalizumab SCAlso: Tysabri, BG00002natalizumab for Subcutaneous Injection	Drug	Natalizumab 150 mg SC Every 12 Weeks, Natalizumab 300 mg SC Every 12 Weeks, Natalizumab 300 mg Subcutaneous (SC) Every 4 Weeks
IV PlaceboIntravenous placebo to natalizumab	Drug	Natalizumab 150 mg IV Every 12 Weeks, Natalizumab 300 mg IV Every 12 Weeks
SC PlaceboSubcutaneous placebo to natalizumab	Drug	Natalizumab 150 mg SC Every 12 Weeks, Natalizumab 300 mg SC Every 12 Weeks

Primary outcome

Cumulative Number of Combined Unique Active Lesions
Time frame: Up to Week 60
Cumulative number of combined unique active lesions (sum of the number of new gadolinium (Gd)-enhancing lesions and new or newly enlarging T2 hyperintense lesions not associated with Gd-enhancement on T1 weighted scans) based on brain magnetic resonance imaging (MRI) scans Up to Week 60.

Results and safety

Results posted to the registry on 29 Jul 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Natalizumab 300 mg Intravenous (IV) Every 4 Weeks	54	43
Natalizumab 300 mg Subcutaneous (SC) Every 4 Weeks	45	35
Natalizumab 300 mg IV Every 12 Weeks	52	9
Natalizumab 300 mg SC Every 12 Weeks	54	3
Natalizumab 150 mg IV Every 12 Weeks	47	2
Natalizumab 150 mg SC Every 12 Weeks	38	1

Primary outcome: Cumulative Number of Combined Unique Active Lesions

Time frame: Up to Week 60. Mean (Standard Deviation). Unit: lesions

Measure	Randomized Period: Natalizumab 300 mg IV Every 4 Weeks n = 52	Randomized Period: Natalizumab 300 mg SC Every 4 Weeks n = 44	Randomized Period: Natalizumab 300 mg IV Every 12 Weeks n = 45	Randomized Period: Natalizumab 300 mg SC Every 12 Weeks n = 50	Randomized Period: Natalizumab 150 mg IV Every 12 Weeks n = 35	Randomized Period: Natalizumab 150 mg SC Every 12 Weeks n = 32
Value	0.23 (1.262)	0.02 (0.151)	3.84 (8.054)	3.08 (8.216)	6.09 (15.424)	6.44 (11.285)

Population analysed: Modified intent-to-treat (mITT) population: all randomized participants who received at least 1 dose of study drug, had at least 1 efficacy assessment, and had no statistical protocol deviations.

Adverse events

Time frame: AEs were analyzed during the randomized and open-label (OL) periods separately. Randomized period: AEs, after 1st randomized dose on Day 0 and prior to OL infusion of natalizumab at Week 60 (±5 days); SAEs also between Screening and dosing on Day 0.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Randomized Period: Natalizumab 300 mg IV Every 4 Weeks	7 of 54 (13%)	40 of 54 (74.1%)	Not reported
Randomized Period: Natalizumab 300 mg SC Every 4 Weeks	4 of 45 (8.9%)	31 of 45 (68.9%)	Not reported
Randomized Period: Natalizumab 300 mg IV Every 12 Weeks	4 of 52 (7.7%)	31 of 52 (59.6%)	Not reported
Randomized Period: Natalizumab 300 mg SC Every 12 Weeks	3 of 53 (5.7%)	34 of 53 (64.2%)	Not reported
Randomized Period: Natalizumab 150 mg IV Every 12 Weeks	4 of 47 (8.5%)	31 of 47 (66%)	Not reported
Randomized Period: Natalizumab 150 mg SC Every 12 Weeks	1 of 38 (2.6%)	17 of 38 (44.7%)	Not reported
Open-label Period: Natalizumab 300 mg IV Every 4 Weeks	0 of 44 (0%)	2 of 44 (4.5%)	Not reported
Open-label Period: Natalizumab 300 mg SC Every 4 Weeks	1 of 35 (2.9%)	4 of 35 (11.4%)	Not reported
Open-label Period: Natalizumab 300 mg IV Every 12 Weeks	0 of 42 (0%)	2 of 42 (4.8%)	Not reported
Open-label Period: Natalizumab 300 mg SC Every 12 Weeks	1 of 42 (2.4%)	0 of 42 (0%)	Not reported
Open-label Period: Natalizumab 150 mg IV Every 12 Weeks	1 of 42 (2.4%)	4 of 42 (9.5%)	Not reported
Open-label Period: Natalizumab 150 mg SC Every 12 Weeks	2 of 32 (6.3%)	6 of 32 (18.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Biogen

64 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing natalizumab IV and natalizumab SC in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 64 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Germany, Italy, France, Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Number of Combined Unique Active Lesions (time frame: Up to Week 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01405820.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2015.