Assessment of Strategies for the Management of Flu-like Symptoms in MS Patients Commencing Treatment With Betaferon (INFLUENCE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

COMPLETED

Total Enrollment

629 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-03-31

Brief Summary

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

This will be prospective, multicentre, observational study. Patients who will initiate treatment with IFNβ-1b (Betaferon) will be followed up to 6 months. Baseline visit (visit 0) i.e. treatment initiation plus four follow-up visits (visits 1-4). For each patient demographics, medical history data, safety parameters, presence of flu-like symptoms and measures to prevent or treat these symptoms will be collected.

Related Clinical Trials

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

Depression and Fatigue in MS Patients Treated With Betaferon.

NCT01354665

Multiple Sclerosis

COMPLETED

Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017)

NCT01939002

Relapsing Multiple Sclerosis

COMPLETED PHASE3

Noninterventional Study Assessing Cognitive Function and Physical Activity in People With Multiple Sclerosis

NCT01491100

Multiple Sclerosis

COMPLETED

A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple Sclerosis

NCT03347370

Multiple Sclerosis, Relapsing-Remitting

COMPLETED

Betaseron 16-Year Long-Term Follow-Up (LTF) in Patients With Relapsing-Remitting Multiple Sclerosis

NCT00206635

Multiple Sclerosis

COMPLETED

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.

Multiple Sclerosis

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Group 1

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

Intervention Type BIOLOGICAL

Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic.

Interventions

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

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

Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic.

Intervention Type BIOLOGICAL

Eligibility Criteria

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

Inclusion Criteria

* Diagnosis of relapsing-remitting multiple sclerosis (RRMS) according to McDonald (2005) criteria
* Age \>/= 18 years old
* Treatment MS patients in whom the attending physician has decided to initiate therapy with interferon beta-1b; Betaferon
* Minimum 6 months wash-out period from previous IFNβ
* Written Informed Consent signed

Exclusion Criteria

* Patients previously treated with any of the disease modifying drugs (DMDs), with the exception of IFNβ therapy which ended at least 6 months earlier
* Patients receiving treatment with IFN beta other than Betaferon (Bayer)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No