Long-term Follow-up of Fingolimod Phase II Study Patients

NCT ID: NCT02307838

Last Updated: 2017-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-12-31

Brief Summary

This study collected follow-up data on approximately 90% of participants who were randomized and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or required. Participants were required to be assessed at one or two visits, preferably at the original study site, but the option to be interviewed via phone or seen at home was provided. Information was gathered also on deceased participants. Assessments were performed only once within an 8 week period and included medical history, Multiple Sclerosis (MS) and Multiple Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale (EDSS), Magnetic Resonance Imaging (MRI), and Multiple Sclerosis Functional Composite (MSFC).

Detailed Description

This was a multicenter follow-up study of patients originally enrolled in the Phase 2 D2201 study. Patients did not receive any protocol specified treatment. The original D2201 study sites who agreed to participate in this study were required to locate their patients who were randomized in Study D2201 and asked them to return for a 10-year assessment, regardless of their current treatment status. Locating the patient may have required the use of search and advertising strategies to find those patients currently lost to follow-up, in accordance with local privacy legislation. Patients currently being followed within Study FTY720D2399 (NCT01201356) were asked to participate in Study FTY720D2201E2 and if patients gave consent, were enrolled concurrently in both studies.

Conditions

Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Phase 2 CFTY720D2201 (NCT02307838) participants

CFTY720D2201E2 participants did not receive any protocol specified treatment. The original D2201 study sites, who agreed to participate in this study, were required to locate their participants who were randomized in D2201 and asked them to return for a 10 year assessment, regardless of current treatment status.

Group Type: OTHER

Assessments arm

Intervention Type: OTHER

Protocol required assessments not provided in standard of care

Interventions

Assessments arm

Protocol required assessments not provided in standard of care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Written informed consent must be obtained before any assessment is performed.
• Randomized in study FTY720D2201 and received at least one dose of study drug.

Exclusion Criteria

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Ottawa, Ontario, Canada

Novartis Investigative Site

Toronto, Ontario, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Copenhagen, , Denmark

Novartis Investigative Site

Glostrup Municipality, , Denmark

Novartis Investigative Site

Marseille, France, France

Novartis Investigative Site

Lille, , France

Novartis Investigative Site

Würzburg, , Germany

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Gallarate, VA, Italy

Novartis Investigative Site

Warsaw, , Poland

Novartis Investigative Site

Warsaw, , Poland

Novartis Investigative Site

Coimbra, Portugal, Portugal

Novartis Investigative Site

Lisbon, Portugal, Portugal

Novartis Investigative Site

Málaga, Andalusia, Spain

Novartis Investigative Site

Seville, Andalusia, Spain

Novartis Investigative Site

Barcelona, Catalonia, Spain

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, Spain

Novartis Investigative Site

Madrid, Madrid, Spain

Novartis Investigative Site

Valencia, Valencia, Spain

Novartis Investigative Site

Basel, , Switzerland

Novartis Investigative Site

Zurich, , Switzerland

Novartis Investigative Site

Newcastle upon Tyne, , United Kingdom

Countries

Canada; Denmark; France; Germany; Italy; Poland; Portugal; Spain; Switzerland; United Kingdom

Other Identifiers

CFTY720D2201E2

Identifier Type: -

Identifier Source: org_study_id