Relapsing-remitting Multiple SclerosisPhase 4NCT01701856

Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis

A Phase 4 study testing Interferon beta-1b in people with Relapsing-remitting Multiple Sclerosis, run by Claudio Gobbi at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Relapsing-remitting Multiple Sclerosis
What is being tested?: Interferon beta-1b
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteSwitzerland
Study dates: Sep 2012to Oct 2013
Phase: Phase 4
Are there results?: None posted in the registry

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Female or male patients with relapsing-remitting forms of multiple sclerosis (according to McDonald's criteria);
Age between 18 and 70 years;
Natalizumab-treatment for at least 12 months following the current Swiss guidelines for treatment initiation;
Treated with a disease-modifying therapy other than interferon beta-1b for at least 12 months before natalizumab was initiated;
Never treated with interferon beta-1b;
Eligible patients are clinically stable (free from relapses and 6-month confirmed disability progression for at least 6 months) while on natalizumab-treatment and do not show any Gd-enhancement on their last MRI performed while on Tysabri;

Show all 17Show fewer

In eligible patients MRI were performed in the past as following
6-18 months prior to natalizumab-treatment
at natalizumab start
12 months after natalizumab initiation;
Good records with regard to clinical disease activity (relapse rate, EDSS progression) in the year prior to natalizumab and during natalizumab;
Patients who decide to stop natalizumab treatment after a careful benefit/risk assessment. Risk for PML increases with duration of natalizumab exposure, pre-treatment with an immunosuppressant agent or serological status of anti-JC-virus positivity;
Patients, who in context with cessation of natalizumab have decided, after a careful benefit/risk assessment, to continue treatment of their MS with Interferon beta-1b;
Women of potential childbearing with active contraceptive methods;
Patients who are willing to undergo study procedures;
Patients who are willing to undergo MRI;
Patients who are willing and able to sign informed consent.

Who cannot join

Patients who have previously entered this study;
Natalizumab-treatment for less than 12 months following the current Swiss guidelines for treatment initiation;
Prior treatment with interferon beta-1b (ever interferon beta-1b);
Sign of clinical disease activity within the 6 months;
One or more relapses and/or 6-month confirmed disability progression during the 6 months prior to the study;
Secondary progressive MS;

Show all 22Show fewer

Primary progressive MS;
Pregnancy - Serum pregnancy test at screening visit positive- or breast feeding;
Uncontrolled, clinically significant heart diseases, such as arrhythmias, angina, or uncompensated congestive heart failure;
History of severe depression or attempted suicide or current suicidal ideation;
Medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study;
Uncontrolled seizure disorder;
Myopathy or clinically significant liver disease;
Inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study;
Known hypersensitivity to interferon-beta or other human proteins including albumin;
Any contraindication for MRI or contrast administration;
A history of drug abuse in the 6 months prior to screening;
Treatment with any of the following in the 30 days before day 1: systemic corticosteroids, ACTH, or other investigational drugs;
Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study;
Current participation on other clinical trials;
Treatment with drugs which might interfere with the evaluation of study drugs during the study protocol such as immunomodulants, immunosuppressives other than interferon beta-1b;
Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol such as immunomodulants, immunosuppressives other than interferon beta-1b.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Ospedale Regionale di Lugano - Civico
Lugano, Canton Ticino, 6903

Other trials in Switzerland

About this study

Official title: Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis: A Swiss Multicenter Study Prospective, Controlled, Single-arm, Open-label, Multi-centre, Phase IV Study

Multiple Sclerosis (MS) is the most common neurological disorder causing disability in young adults affecting approximately 1 in 1.000 people in western countries. The clinical manifestations usually begin at the age of 20 to 40 years with a median age of 28 years at onset with acute episodes of neurological dysfunction, followed by periods of partial or complete remission and clinical stability in between relapses. This relapsing-remitting phase (RR-MS) of the disease is usually followed by progressive clinical disability (secondary progressive phase, SP-MS).

At present, there is no cure for MS. Based on the pathological concept that neuroinflammation is the common element leading or contributing to neurodegenerative changes, immune interventions have been introduced into clinical practice such as Natalizumab (Tysabri), a humanized monoclonal antibody. Natalizumab (Tysabri) is indicated as a disease-modifying monotherapy of highly active relapsing MS. The associated risks, especially progressive multifocal leukoencephalopathy, necessitate active monitoring of patients and a continuous discussion of optimum use of this drug. In clinical practice, the question how to manage patients on natalizumab at a higher risk for progressive multifocal leukoencephalopathy remains unresolved.

This prospective, controlled (comparison to the period prior to natalizumab treatment), single-arm, open-label, multi-centre, phase IV study aims to evaluating the concept of natalizumab de-escalation to interferon-beta-1b e.o.d in relapsing-remitting multiple sclerosis patients, who consider stopping natalizumab due to a benefit-risk assessment. In particular, to evaluating if interferon beta-1b treatment may be able to overcome the recurrence of significant clinical and radiological disease activity after natalizumab cessation and may keep disease activity better under control as compared to the time prior to natalizumab.

The study population includes patients with relapsing-remitting multiple sclerosis (RR-MS) being treated at least for 12 months with natalizumab and having decided to stop natalizumab treatment and to de-escalate their therapy to a first line treatment with interferon beta-1b. They will be treated during 12 months with interferon-beta 1b 250 mcg given subcutaneously every other day. A 12-month follow-up period with the same treatment is planned.

Conditions: Relapsing-remitting Multiple Sclerosis
Being tested: Interferon beta-1b
Keywords: relapsing-remitting multiple sclerosis, natalizumab, de-escalation, interferon beta-1b
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.

Interferon beta-1bDrug
Also called Betaferon®
250 mcg, s.c., each other day for 12 months

Study groups in NCT01701856
Study group	Role	What they receive
Interferon beta-1b	Experimental	Interferon beta-1b 250 mcg s.c. every other day Receives: Drug: Interferon beta-1b

What is being measured

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

Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Measured: 12 months
Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Measured: 3 months
Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Measured: 6 months
Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Measured: 9 months
Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Measured: 15 months
Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Measured: 18 months
Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Measured: 21 months
Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Measured: 24 months

Secondary outcomes (54)

Severity of relapses
Measured: 3 months
Severity of relapses
Measured: 6 months
Severity of relapses
Measured: 9 months
Severity of relapses
Measured: 12 months
Severity of relapses
Measured: 15 months
Severity of relapses
Measured: 18 months
Severity of relapses
Measured: 21 months
Severity of relapses
Measured: 24 months
Proportion of relapse free patients
Measured: 3 months
Proportion of relapse free patients
Measured: 6 months
Proportion of relapse free patients
Measured: 9 months
Proportion of relapse free patients
Measured: 12 months
Proportion of relapse free patients
Measured: 15 months
Proportion of relapse free patients
Measured: 18 months
Proportion of relapse free patients
Measured: 21 months
Proportion of relapse free patients
Measured: 24 months
3-month confirmed EDSS progression
of at least 1.0 points if score < 5.5, at least 0.5 points if score ≥ 5.5
Measured: 3 months
3-month confirmed EDSS progression
of at least 1.0 points if score < 5.5, at least 0.5 points if score ≥ 5.5
Measured: 6 months
3-month confirmed EDSS progression
of at least 1.0 points if score < 5.5, at least 0.5 points if score ≥ 5.5
Measured: 9 months
3-month confirmed EDSS progression
of at least 1.0 points if score < 5.5, at least 0.5 points if score ≥ 5.5
Measured: 12 months
3-month confirmed EDSS progression
of at least 1.0 points if score < 5.5, at least 0.5 points if score ≥ 5.5
Measured: 15 months
3-month confirmed EDSS progression
of at least 1.0 points if score < 5.5, at least 0.5 points if score ≥ 5.5
Measured: 18 months
3-month confirmed EDSS progression
of at least 1.0 points if score < 5.5, at least 0.5 points if score ≥ 5.5
Measured: 21 months
3-month confirmed EDSS progression
of at least 1.0 points if score < 5.5, at least 0.5 points if score ≥ 5.5
Measured: 24 months
MSFC
Three part instrument composed of Timed-25-foot (7.62 m)-walk, 9 hole-peg-test (9 HPT), 3'' paced auditory serial addition test (PASAT).
Measured: 3 months
MSFC
Three part instrument composed of Timed-25-foot (7.62 m)-walk, 9 hole-peg-test (9 HPT), 3'' paced auditory serial addition test (PASAT).
Measured: 6 months
MSFC
Three part instrument composed of Timed-25-foot (7.62 m)-walk, 9 hole-peg-test (9 HPT), 3'' paced auditory serial addition test (PASAT).
Measured: 9 months
MSFC
Three part instrument composed of Timed-25-foot (7.62 m)-walk, 9 hole-peg-test (9 HPT), 3'' paced auditory serial addition test (PASAT).
Measured: 12 months
MSFC
Three part instrument composed of Timed-25-foot (7.62 m)-walk, 9 hole-peg-test (9 HPT), 3'' paced auditory serial addition test (PASAT).
Measured: 18 months
MSFC
Three part instrument composed of Timed-25-foot (7.62 m)-walk, 9 hole-peg-test (9 HPT), 3'' paced auditory serial addition test (PASAT).
Measured: 21 months
MSFC
Three part instrument composed of Timed-25-foot (7.62 m)-walk, 9 hole-peg-test (9 HPT), 3'' paced auditory serial addition test (PASAT).
Measured: 24
Change of EDSS score compared to change in the year prior to natalizumab treatment (month -24 to-12
Measured: 3 months
Change of EDSS score compared to change in the year prior to natalizumab treatment (month -24 to-12
Measured: 6 months
Change of EDSS score compared to change in the year prior to natalizumab treatment (month -24 to-12
Measured: 9 months
Change of EDSS score compared to change in the year prior to natalizumab treatment (month -24 to-12
Measured: 12 months
Change of MSFC score compared to change in the year prior to natalizumab treatment (month -24 to-12
Measured: 3 months
Change of MSFC score compared to change in the year prior to natalizumab treatment (month -24 to-12
Measured: 6 months
Change of MSFC score compared to change in the year prior to natalizumab treatment (month -24 to-12
Measured: 9 months
Change of MSFC score compared to change in the year prior to natalizumab treatment (month -24 to-12
Measured: 12 months
Number of new/enlarging T2-hyperintense lesions
MRI
Measured: 6 months
Number of new/enlarging T2-hyperintense lesions
MRI
Measured: 12 months
Number of new/enlarging T2-hyperintense lesions
MRI
Measured: 24 months
Number of Gd-enhancing lesions
MRI
Measured: 6 months
Number of Gd-enhancing lesions
MRI
Measured: 12 months
Number of Gd-enhancing lesions
MRI
Measured: 24 months
EQ-5D
Quality of life questionnaire
Measured: 6 months
EQ-5D
Quality of life questionnaire
Measured: 12 months
EQ-5D
Quality of life questionnaire
Measured: 24 months
FAMS
Quality of life questionnaire
Measured: 6 months
FAMS
Quality of life questionnaire
Measured: 24 months
MSFC
Three part instrument composed of Timed-25-foot (7.62 m)-walk, 9 hole-peg-test (9 HPT), 3'' paced auditory serial addition test (PASAT).
Measured: 15 months
EQ-5D
Quality of life questionnaire
Measured: 18 months
FAMS
Quality of life questionnaire
Measured: 12 months
FAMS
Quality of life questionnaire
Measured: 18 months

Timeline

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

Sep 2012Oct 2013

First posted5 Oct 2012 (estimated)
Study startSep 2012
Primary completionOct 2013
Study completionOct 2013

Why it stopped: Problems to recruit the needed number of patients in the planned time

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Relapsing-remitting Multiple SclerosisStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01701856
Sponsor's protocol ID: EOC.NSI.11.01
Status last verified: Jan 2014
First submitted: 18 Sep 2012
Last updated: 22 Jan 2014
Results posted: No
Data monitoring committee: Yes

Publications

Multiple Sclerosis Therapy Consensus Group (MSTCG); Wiendl H, Toyka KV, Rieckmann P, Gold R, Hartung HP, Hohlfeld R. Basic and escalating immunomodulatory treatments in multiple sclerosis: current therapeutic recommendations. J Neurol. 2008 Oct;255(10):1449-63. doi: 10.1007/s00415-008-0061-1. Epub 2008 Oct 29.
PubMed 19005625
Kappos L, Bates D, Edan G, Eraksoy M, Garcia-Merino A, Grigoriadis N, Hartung HP, Havrdova E, Hillert J, Hohlfeld R, Kremenchutzky M, Lyon-Caen O, Miller A, Pozzilli C, Ravnborg M, Saida T, Sindic C, Vass K, Clifford DB, Hauser S, Major EO, O'Connor PW, Weiner HL, Clanet M, Gold R, Hirsch HH, Radu EW, Sorensen PS, King J. Natalizumab treatment for multiple sclerosis: updated recommendations for patient selection and monitoring. Lancet Neurol. 2011 Aug;10(8):745-58. doi: 10.1016/S1474-4422(11)70149-1.
PubMed 21777829
Kappos L, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Radu EW, Metzig C, Bauer L, Lanius V, Sandbrink R, Pohl C; BENEFIT Study Group. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. Lancet Neurol. 2009 Nov;8(11):987-97. doi: 10.1016/S1474-4422(09)70237-6. Epub 2009 Sep 10.
PubMed 19748319
Putzki N, Yaldizli O, Buhler R, Schwegler G, Curtius D, Tettenborn B. Natalizumab reduces clinical and MRI activity in multiple sclerosis patients with high disease activity: results from a multicenter study in Switzerland. Eur Neurol. 2010;63(2):101-6. doi: 10.1159/000276400. Epub 2010 Jan 16.
PubMed 20090344

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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All Relapsing-remitting Multiple Sclerosis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis: A Swiss Multicenter Study Prospective, Controlled, Single-arm, Open-label, Multi-centre, Phase IV Study
ClinicalTrials.gov ID: NCT01701856
Acronym / sponsor ID: EOC.NSI.11.01
Conditions: Relapsing-remitting Multiple Sclerosis
Keywords: relapsing-remitting multiple sclerosis, natalizumab, de-escalation, interferon beta-1b
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Problems to recruit the needed number of patients in the planned time
Enrolment: 5 participants (actual)
Lead sponsor: Claudio GobbiOther government
Collaborators: Bayer
Study start: Sep 2012
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 5 Oct 2012 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Interferon beta-1b	Experimental	Drug: Interferon beta-1bInterferon beta-1b 250 mcg s.c. every other day

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Female or male patients with relapsing-remitting forms of multiple sclerosis (according to McDonald's criteria);
Age between 18 and 70 years;
Natalizumab-treatment for at least 12 months following the current Swiss guidelines for treatment initiation;
Treated with a disease-modifying therapy other than interferon beta-1b for at least 12 months before natalizumab was initiated;
Never treated with interferon beta-1b;

Key exclusion criteria (22 listed)

Patients who have previously entered this study;
Natalizumab-treatment for less than 12 months following the current Swiss guidelines for treatment initiation;
Prior treatment with interferon beta-1b (ever interferon beta-1b);
Sign of clinical disease activity within the 6 months;
One or more relapses and/or 6-month confirmed disability progression during the 6 months prior to the study;

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
Interferon beta-1bAlso: Betaferon®250 mcg, s.c., each other day for 12 months	Drug	Interferon beta-1b

Primary outcome

Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Time frame: 12 months
Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Time frame: 3 months
Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Time frame: 6 months
Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Time frame: 9 months
Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Time frame: 15 months
Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Time frame: 18 months
Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Time frame: 21 months
Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12)
Time frame: 24 months

54 secondary outcomes

Severity of relapses
Time frame: 3 months
Severity of relapses
Time frame: 6 months
Severity of relapses
Time frame: 9 months
Severity of relapses
Time frame: 12 months
Severity of relapses
Time frame: 15 months
Severity of relapses
Time frame: 18 months
Severity of relapses
Time frame: 21 months
Severity of relapses
Time frame: 24 months
Proportion of relapse free patients
Time frame: 3 months
Proportion of relapse free patients
Time frame: 6 months
Proportion of relapse free patients
Time frame: 9 months
Proportion of relapse free patients
Time frame: 12 months
Proportion of relapse free patients
Time frame: 15 months
Proportion of relapse free patients
Time frame: 18 months
Proportion of relapse free patients
Time frame: 21 months
Proportion of relapse free patients
Time frame: 24 months
3-month confirmed EDSS progression
Time frame: 3 months
3-month confirmed EDSS progression
Time frame: 6 months
3-month confirmed EDSS progression
Time frame: 9 months
3-month confirmed EDSS progression
Time frame: 12 months
3-month confirmed EDSS progression
Time frame: 15 months
3-month confirmed EDSS progression
Time frame: 18 months
3-month confirmed EDSS progression
Time frame: 21 months
3-month confirmed EDSS progression
Time frame: 24 months
MSFC
Time frame: 3 months
MSFC
Time frame: 6 months
MSFC
Time frame: 9 months
MSFC
Time frame: 12 months
MSFC
Time frame: 18 months
MSFC
Time frame: 21 months
MSFC
Time frame: 24
Change of EDSS score compared to change in the year prior to natalizumab treatment (month -24 to-12
Time frame: 3 months
Change of EDSS score compared to change in the year prior to natalizumab treatment (month -24 to-12
Time frame: 6 months
Change of EDSS score compared to change in the year prior to natalizumab treatment (month -24 to-12
Time frame: 9 months
Change of EDSS score compared to change in the year prior to natalizumab treatment (month -24 to-12
Time frame: 12 months
Change of MSFC score compared to change in the year prior to natalizumab treatment (month -24 to-12
Time frame: 3 months
Change of MSFC score compared to change in the year prior to natalizumab treatment (month -24 to-12
Time frame: 6 months
Change of MSFC score compared to change in the year prior to natalizumab treatment (month -24 to-12
Time frame: 9 months
Change of MSFC score compared to change in the year prior to natalizumab treatment (month -24 to-12
Time frame: 12 months
Number of new/enlarging T2-hyperintense lesions
Time frame: 6 months

Results and safety

The study was stopped early (reason given: Problems to recruit the needed number of patients in the planned time). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
Background: PubMed 19005625Multiple Sclerosis Therapy Consensus Group (MSTCG); Wiendl H, Toyka KV, Rieckmann P, Gold R, Hartung HP, Hohlfeld R. Basic and escalating immunomodulatory treatments in multiple sclerosis: current therapeutic recommendations. J Neurol. 2008 Oct;255(10):1449-63. doi: 10.1007/s00415-008-0061-1. Epub 2008 Oct 29.
Background: PubMed 21777829Kappos L, Bates D, Edan G, Eraksoy M, Garcia-Merino A, Grigoriadis N, Hartung HP, Havrdova E, Hillert J, Hohlfeld R, Kremenchutzky M, Lyon-Caen O, Miller A, Pozzilli C, Ravnborg M, Saida T, Sindic C, Vass K, Clifford DB, Hauser S, Major EO, O'Connor PW, Weiner HL, Clanet M, Gold R, Hirsch HH, Radu EW, Sorensen PS, King J. Natalizumab treatment for multiple sclerosis: updated recommendations for patient selection and monitoring. Lancet Neurol. 2011 Aug;10(8):745-58. doi: 10.1016/S1474-4422(11)70149-1.
Background: PubMed 19748319Kappos L, Freedman MS, Polman CH, Edan G, Hartung HP, Miller DH, Montalban X, Barkhof F, Radu EW, Metzig C, Bauer L, Lanius V, Sandbrink R, Pohl C; BENEFIT Study Group. Long-term effect of early treatment with interferon beta-1b after a first clinical event suggestive of multiple sclerosis: 5-year active treatment extension of the phase 3 BENEFIT trial. Lancet Neurol. 2009 Nov;8(11):987-97. doi: 10.1016/S1474-4422(09)70237-6. Epub 2009 Sep 10.
Background: PubMed 20090344Putzki N, Yaldizli O, Buhler R, Schwegler G, Curtius D, Tettenborn B. Natalizumab reduces clinical and MRI activity in multiple sclerosis patients with high disease activity: results from a multicenter study in Switzerland. Eur Neurol. 2010;63(2):101-6. doi: 10.1159/000276400. Epub 2010 Jan 16.
home page of the main facilityLink provided by the sponsor.
home page of supporting society for MS patients in SwitzerlandLink provided by the sponsor.

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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.

Claudio Gobbi, MD principal investigator

Ospedale Regionale di Lugano - Civico

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Interferon beta-1b in people with Relapsing-remitting Multiple Sclerosis, run by Claudio Gobbi at 1 site in Switzerland.

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 17 inclusion and 22 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: stopped early, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study was stopped early (reason given: Problems to recruit the needed number of patients in the planned time). Results are not available in the source record.

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?

Annualized relapse rate on study compared to annualized relapse rate in the year prior to natalizumab initiation on first line disease modifying treatment (month -24 to -12) (time frame: 12 months). The study lists 8 primary outcomes in all. 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 NCT01701856, which also lists 4 linked publications.

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 22 Jan 2014.