MedDataX Logo

Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)

NCT ID: NCT02720107

Last Updated: 2019-02-08

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-12

Study Completion Date

2016-11-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this single visit extension study is to explore immune status in RRMS patients treated for at least 48 months with fingolimod. Long-term changes in T cell counts will be compared to short-term changes in immune status (baseline to month 6) after treatment start with fingolimod as assessed in the original Biobank study (CFTY720DDE01).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

NCT01310166

Relapsing-remitting Multiple Sclerosis
COMPLETED PHASE4

Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program

NCT01281657

Multiple Sclerosis
COMPLETED

Long-term Effect of Fingolimod on Circulating Immunocompetent Mononuclear Cells in Patients With Multiple Sclerosis

NCT01755871

Relapsing Remitting Multiple Sclerosis
TERMINATED PHASE4

A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis

NCT01216072

Relapsing Forms of Multiple Sclerosis
COMPLETED PHASE4

Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.

NCT01623596

Relapsing Remitting Multiple Sclerosis
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Relapsing-remitting Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

fingolimod

Patients did not receive any protocol specified treatment during this follow-up study. Patients remained on their current treatment regime (fingolimod), as determined by their regular treating physician (i.e. 0.5 mg fingolimod daily, single-arm).

Group Type EXPERIMENTAL

fingolimod

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fingolimod

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Written informed consent before any assessment was performed.
2. Randomized in study CFTY720DDE01 and received at least one dose of study drug (fingolimod) and completed the study.
3. Continuous intake of fingolimod after end of study CFTY720DDE01 with a maximum treatment interruption of 3 months in total before entering this study.
4. Parallel participation at study CFTY720DDE02 (Pangaea NIS) was allowed.

Exclusion Criteria

1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test.
2. Patients with onset of an acute relapse had to postpone their evaluation until deemed stable from relapse by treating physician, but at least for 1 month since end of relapse.
3. Patients that received immunomodulating or immunosuppressive MS treatments other than fingolimod since completion of study CFTY720DDE01 as for example: Natalizumab,Alemtuzumab, Dimethyl fumarate, Teriflunomide, intravenous Immunoglobulins,Mitoxantrone, Methotrexate, Azathioprine or experimental immunomodulating-immunosuppressive therapies.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Ostfildern, Baden-Wurttemberg, Germany

Site Status

Novartis Investigative Site

Altenholz-Stift, Germany, Germany

Site Status

Novartis Investigative Site

Aschaffenburg, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Böblingen, , Germany

Site Status

Novartis Investigative Site

Celle, , Germany

Site Status

Novartis Investigative Site

Dortmund, , Germany

Site Status

Novartis Investigative Site

Dresden, , Germany

Site Status

Novartis Investigative Site

Erbach im Odenwald, , Germany

Site Status

Novartis Investigative Site

Frankfurt, , Germany

Site Status

Novartis Investigative Site

Göttingen, , Germany

Site Status

Novartis Investigative Site

Jena, , Germany

Site Status

Novartis Investigative Site

Kiel, , Germany

Site Status

Novartis Investigative Site

Klingenmünster, , Germany

Site Status

Novartis Investigative Site

Lappersdorf, , Germany

Site Status

Novartis Investigative Site

Leverkusen, , Germany

Site Status

Novartis Investigative Site

Mönchengladbach, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

Neuburg an der Donau, , Germany

Site Status

Novartis Investigative Site

Siegen, , Germany

Site Status

Novartis Investigative Site

Singen, , Germany

Site Status

Novartis Investigative Site

Troisdorf, , Germany

Site Status

Novartis Investigative Site

Ulm, , Germany

Site Status

Novartis Investigative Site

Unterhaching, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CFTY720DDE01E1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720
NCT01578330 COMPLETED PHASE4
A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod
NCT03257358 COMPLETED PHASE4
Long-term Follow-up of Fingolimod Phase II Study Patients
NCT02307838 COMPLETED PHASE4
Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis
NCT01201356 COMPLETED PHASE3
MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone
NCT01633112 TERMINATED PHASE3
This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.
NCT00731692 TERMINATED PHASE3
Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod
NCT01499667 TERMINATED PHASE3
Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change
NCT01317004 COMPLETED PHASE4
Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
NCT01497262 COMPLETED PHASE3
Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy
NCT01498887 COMPLETED PHASE4
Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
NCT00662649 COMPLETED PHASE3
Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis
NCT03345940 TERMINATED PHASE4
Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS)
NCT02776072 COMPLETED
Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
NCT00355134 COMPLETED PHASE3
Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)
NCT01534182 COMPLETED PHASE4
Disease Control in RRMS Transferring Treatment From Natalizumab to Fingolimod
NCT02277964 COMPLETED
Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya
NCT02325440 UNKNOWN PHASE4
Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients
NCT01127750 COMPLETED PHASE3
Administration of Fingolimod in Greek Patients With Multiple Sclerosis.
NCT06949956 NOT_YET_RECRUITING
Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants
NCT02342704 TERMINATED PHASE4
Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)
NCT01199861 COMPLETED PHASE3
Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis
NCT05080270 COMPLETED EARLY_PHASE1
Safety and Efficacy of Fingolimod in MS Patients in China
NCT01941004 WITHDRAWN PHASE3
Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks
NCT02232061 COMPLETED PHASE4
Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
NCT02525874 COMPLETED PHASE3