Trial Condition(s):

Multiple Sclerosis, Relapsing-Remitting

Impact of the BETACONNECT auto-injector on BETASERON therapy adherence and patient satisfaction

Bayer Identifier:

17942

ClinicalTrials.gov Identifier:

NCT02652091

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal

146

Trial Dates

February2016

September2017

Phase

Could I receive a placebo?

Products

Betaseron (Interferon beta-1b, BAY86-5046)

Accepts Healthy Volunteers

Where to Participate

Locations

Status

Locations	Status
Locations Investigative Site Lubbock, United States, 79430	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Stratford, United States, 08084	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Deckerville, United States, 48427	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Memphis, United States, 38104	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Tampa, United States, 33609	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Boca Raton, United States, 33428	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Teaneck, United States, 07666	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Round Rock, United States, 78681	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Fulton, United States, 20759	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Franklin, United States, 37064	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Cullman, United States, 35058	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Lititz, United States, 17543	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Nashville, United States, 37212	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Foxboro, United States, 02035	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Staten Island, United States, 10306	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site New Port Richey, United States, 34653	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Fairfax, United States, 22031	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site St. Louis, United States, 63131	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Bala Cynwyd, United States, 19004	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Atlanta, United States, 30309-1465	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Medford, United States, 97504	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Virginia Beach, United States	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available
Locations Investigative Site Medford, United States	Status Completed	Contact Us: E-mail: [email protected] Phone: Not Available

Trial Design

Impact of the BETACONNECT auto-injector on BETASERON therapy adherence and patient satisfaction

Trial Type:

Observational

Intervention Type:

Drug

Trial Purpose:

N/A

Allocation:

N/A

Blinding:

N/A

Assignment:

N/A

Trial Arms:

Primary Outcome

Number of BETASERON injections as captured by the BETACONNECT device
Timeframe: At 6 months

Time (days) between BETASERON injections as captured by BETACONNECT device
Timeframe: At 6 months

Secondary Outcome

Patient reported satisfaction by a questionnaire
Timeframe: At 6 weeks

Multiple Sclerosis, Relapsing-Remitting

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

Trial Purpose

Key Participation Requirements

sex

age

18 Years

No Limit

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Secondary Outcome

Additional Information