A 6 months, multicenter study to evaluate the effect of an individualized patient support program on treatment satisfaction in Fingolimod (FTY720)-treated patients with relapsing-remitting multiple sclerosis

• Conditions: Treatment statisfaction in patients with relapsing remitting Multiple Sclerosis; MedDRA version: 15.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-002637-11-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-09
• Last Update Posted: 11 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed.
2.Male or female subjects aged 18 – 65 years.
3.Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria.
4.Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.
5.Patients under Fingolimod Therapy, according to German label, for at least 6 months at Study Visit 1 (Day 1).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients, who are registered in any patient support program (e.g. Extracare)
2.Patients with any relevant medically unstable condition, as assessed by the primary treating physician at each site.
3.Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator’s discretion
4.History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
5.Patients who have received an investigational drug (excluding Fingolimod) or therapy within 90 days or 5 half-lives prior to screening, whichever is longer.
6.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 pregnancy test (serum)
7.Women of childbearing potential unwilling to use contraceptive precautions throughout the study (see section 7.9.5 for details).
8.Simultaneous participation in another clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified