NCT01709812WithdrawnPhase 4
A 6 Months, Randomized, Multicenter, Parallel-group, Open-label Study to Evaluate the Effect of an Individualized Patient Support Program on Treatment Satisfaction in Fingolimod-treated Patients With Relapsing-remitting Multiple Sclerosis
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Novartis Pharmaceuticals
- Primary Endpoint
- change in treatment satisfaction (TSQM-9) from baseline to month 6
Study Overview
Brief Summary
A 6 months prospective, randomized, multicenter, controlled, parallel-group, open-label study in RRMS patients to assess the impact of an individualized patient support program (PSP) on treatment satisfaction and to evaluate whether this individualized support improves satisfaction and with it adherence to medication compared to standard care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients eligible for inclusion in this trial have to fulfill all of the following criteria:
- •Written informed consent from patients capable of giving or withholding full informed consent must be obtained before any assessment is performed.
- •Male or female subjects aged 18 - 65 years.
- •Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria.
- •Patients with Expanded Disability Status Scale (EDSS) score of 0-6.
- •Patients under Fingolimod Therapy, according to German label, for at least 6 months at Study Visit 1 (Day 1).
Exclusion Criteria
- •Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- •Patients, who are registered in any patient support program (e.g. Extracare)
- •Patients with any relevant medically unstable condition, as assessed by the primary treating physician at each site.
- •Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator's discretion
- •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
- •Patients who have received an investigational drug (excluding Fingolimod) or therapy within 90 days or 5 half-lives prior to screening, whichever is longer.
- •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)
- •Women of childbearing potential unwilling to use contraceptive precautions throughout the study (see section 7.13.6 for details).
- •Simultaneous participation in another clinical trial.
- •Patients, who have already been randomized into this trial earlier must not be included a second time.
- •Study personnel or first degree relatives of investigator(s) must not be included in the study.
Arms & Interventions
1 standard care
Other
standard care
Intervention: Standard care (Other)
2 individualized PSP
Experimental
individualized patient support program
Intervention: individualized patient support program (Other)
Outcomes
Primary Outcomes
change in treatment satisfaction (TSQM-9) from baseline to month 6
Time Frame: 6 months
To evaluate the effect of an individualized patient support program vs. a standard patient support program on treatment satisfaction, measured by a treatment satisfaction questionnaire (TSQM-9) in Fingolimod-treated patients with relapsing-remitting multiple sclerosis over 6 months.
Secondary Outcomes
- change in Modified Morisky Scale score from baseline to month 6(6 months)
- change in mFIS score from baseline to month 6(6 months)
- change in BDI from baseline to month 6(6 months)
- quantification of therapy adherence (pill-count) over 6 months(6 months)
Investigators
Similar Trials
Terminated
Phase 3
Evaluating PN 400 (VIMOVO) in Reducing Gastric Ulcers in High Risk Subjects Compared to ArthrotecGastric UlcerNCT00594854POZEN20
Completed
Phase 4
Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)Relapsing Remitting Multiple SclerosisNCT01534182Novartis Pharmaceuticals298
Completed
Phase 3
SLV308 for Treatment of Patients With Early Parkinson's DiseaseEarly Stage Parkinson's DiseaseNCT00269516Solvay Pharmaceuticals468
Completed
Not Applicable
Effects of Henagliflozin on the Brain Function in T2DM Patients With Mild Cognitive Impairment: a Randomized, Parallel Controlled Clinical TrialMild Cognitive ImpairmentType 2 Diabetes MellitusNCT06085703The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School24
Completed
Phase 3
A 6 Month Safety and Efficacy Study of Once Daily Ciclesonide Hydrofluoroalkane (HFA) in the Treatment of Perennial Allergic Rhinitis (PAR) in Subjects 12 Years and OlderAllergic RhinitisPerennial Allergic RhinitisNCT00953147Sumitomo Pharma America, Inc.1,110