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

Novartis

Status and phase: Terminated; Phase 3

Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)

Treatments: Drug: Placebo; Drug: Fingolimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT01499667

2011-001442-15 (EudraCT Number)

CFTY720D2324

Details and patient eligibility

About

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

Full description

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.

Enrollment: 142 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

142 participants in 3 patient groups

8-week washout + Fingolimod (FTY720)

Experimental group

Description:

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

Treatment:

Drug: Fingolimod

12-week washout + Fingolimod (FTY720)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Fingolimod

16-week washout + Fingolimod (FTY720)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: Fingolimod