| Registry | NCT02652091 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 146 (Actual) |
| Sponsor | Bayer (Industry) |
| Conditions | Multiple Sclerosis, Relapsing-Remitting |
| Interventions | Interferon beta-1b (Betaseron, BAY86-5046), BETACONNECT device (Drug, device) |
| Dates | start 2016-02-05, primary completion 2017-08-11, completion 2017-09-13, first posted 2016-01-11, last updated 2018-09-06 |
| Locations | 23 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Multiple Sclerosis, Relapsing-Remitting All trials of Interferon beta-1b (Betaseron, BAY86-5046) All trials of BETACONNECT device
The primary objective of this study is to assess adherence and persistence to BETASERON therapy in patients who are using the BETACONNECT auto-injector device (BETACONNECT device).
The secondary objective of this study is to assess patient-reported satisfaction with the BETACONNECT device.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Interferon beta-1b | Drug: Interferon beta-1b (Betaseron, BAY86-5046); Device: BETACONNECT device | Patients diagnosed with relapse-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are injecting Betaseron via the Betaconnect device. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Male and females greater than or equal to 18 years of age * Diagnosis of RRMS according to revised McDonald Criteria (2010) or (CIS) * Prescribed BETASERON (note: decision to treat with BETASERON must be made independent of participation in this study) * Confirmation of insurance coverage for BETASERON treatment * Access to a personal computer to complete online patient satisfaction survey at Week 6 Exclusion Criteria: * Currently enrolled in a clinical trial or other observational study for Multiple Sclerosis treatment * Documented substance abuse within the previous 6 months prior to study enrollment * Any major laboratory value abnormality that the investigator believes would preclude the patient from participating in the study * Any medical disorder, condition or history that in the opinion of the investigator would impair the patient's ability to participate in or complete the study * Pregnant or nursing
| Facility | City | Country | Status |
|---|---|---|---|
| Cullman, Alabama | United States | ||
| Boca Raton, Florida | United States | ||
| New Port Richey, Florida | United States | ||
| Tampa, Florida | United States | ||
| Atlanta, Georgia | United States | ||
| Fulton, Maryland | United States | ||
| Foxborough, Massachusetts | United States | ||
| Deckerville, Michigan | United States | ||
| St Louis, Missouri | United States | ||
| Stratford, New Jersey | United States | ||
| Teaneck, New Jersey | United States | ||
| Staten Island, New York | United States | ||
| Medford, Oregon | United States | ||
| Medford, Oregon | United States | ||
| Bala-Cynwyd, Pennsylvania | United States | ||
| Lititz, Pennsylvania | United States | ||
| Franklin, Tennessee | United States | ||
| Memphis, Tennessee | United States | ||
| Nashville, Tennessee | United States | ||
| Lubbock, Texas | United States | ||
| Round Rock, Texas | United States | ||
| Fairfax, Virginia | United States | ||
| Virginia Beach, Virginia | United States |