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Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod

NCT ID: NCT01499667

Last Updated: 2014-08-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-11-30

Brief Summary

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This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.

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Detailed Description

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Patient were screened, signed an informed consent at visit 1, at the 2nd visit, all patient received a baseline infusion of Natalizumub and subsequently randomized to one of 3 treatment arms. At the randomization visit, the Washout Phase started, and eligible patients were randomized 1:1:1 to one of three treatment groups:

* 8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod,
* 12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod, or
* 16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod.

Conditions

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Relapsing Remitting Multiple Sclerosis (RRMS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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8-week washout + Fingolimod (FTY720)

8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day

Group Type EXPERIMENTAL

Fingolimod

Intervention Type DRUG

Fingolimod 0.5 mg capsules for oral administration once daily

12-week washout + Fingolimod (FTY720)

12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day

Group Type EXPERIMENTAL

Fingolimod

Intervention Type DRUG

Fingolimod 0.5 mg capsules for oral administration once daily

Placebo

Intervention Type DRUG

Matching placebo in capsules for oral administration once daily.

16-week washout + Fingolimod (FTY720)

16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day

Group Type EXPERIMENTAL

Fingolimod

Intervention Type DRUG

Fingolimod 0.5 mg capsules for oral administration once daily

Placebo

Intervention Type DRUG

Matching placebo in capsules for oral administration once daily.

Interventions

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Fingolimod

Fingolimod 0.5 mg capsules for oral administration once daily

Intervention Type DRUG

Placebo

Matching placebo in capsules for oral administration once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients must:

* Have relapsing remitting multiple sclerosis
* Have been on treatment with natalizumab for at least 6 months prior to screening and discontinuation is an option.

Exclusion Criteria

Patients with:

* History of chronic immune disease
* Crohn's disease
* Certain cancers
* Uncontrolled diabetes
* Certain eye disorders
* Negative for varicella-zoster virus IgG antibodies
* Certain hepatic conditions
* Low white blood cell count
* On certain immunosuppressive medications or heart medications
* Resting heart rate less than 45 bpm.
* Certain heart conditions or certain lung conditions
* Inability to undergo MRI scans
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Box Hill, Victoria, Australia

Site Status

Novartis Investigative Site

Heidelberg, Victoria, Australia

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Novartis Investigative Site

Vienna, , Austria

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Novartis Investigative Site

Prague, , Czechia

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Prague, , Czechia

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Teplice, , Czechia

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Novartis Investigative Site

Helsinki, , Finland

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Novartis Investigative Site

Ostfildern, Baden-Wurttemberg, Germany

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Novartis Investigative Site

Celle, Germany, Germany

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Bad Mergentheim, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Bochum, , Germany

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Erbach im Odenwald, , Germany

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Erfurt, , Germany

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Hamburg, , Germany

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Itzehoe, , Germany

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Kandel, , Germany

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Krefeld, , Germany

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Leipzig, , Germany

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Münster, , Germany

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Neuburg am Inn, , Germany

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Neuruppin, , Germany

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Rüdersdorf, , Germany

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Siegen, , Germany

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Ulm, , Germany

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Novartis Investigative Site

Athens, GR, Greece

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Ioannina, GR, Greece

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Thessaloniki, GR, Greece

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Novartis Investigative Site

Athens, , Greece

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Athens, , Greece

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Novartis Investigative Site

Budapest, , Hungary

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Budapest, , Hungary

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Ashkelon, , Israel

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Jerusalem, , Israel

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Milan, MI, Italy

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Novartis Investigative Site

Cefalù, PA, Italy

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Novartis Investigative Site

Málaga, Andalusia, Spain

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Novartis Investigative Site

Seville, Andalusia, Spain

Site Status

Novartis Investigative Site

Barcelona, Barcelona, Spain

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Madrid, Madrid, Spain

Site Status

Novartis Investigative Site

Basel, , Switzerland

Site Status

Countries

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Australia Austria Czechia Finland Germany Greece Hungary Israel Italy Spain Switzerland

References

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Derfuss T, Kovarik JM, Kappos L, Savelieva M, Chhabra R, Thakur A, Zhang Y, Wiendl H, Tomic D. alpha4-integrin receptor desaturation and disease activity return after natalizumab cessation. Neurol Neuroimmunol Neuroinflamm. 2017 Aug 25;4(5):e388. doi: 10.1212/NXI.0000000000000388. eCollection 2017 Sep.

Reference Type DERIVED
PMID: 28856176 (View on PubMed)

Other Identifiers

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2011-001442-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CFTY720D2324

Identifier Type: -

Identifier Source: org_study_id

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