Multiple Sclerosis Clinical Trial

The Multicenter, Open-label, Single-use Autoinjector Convenience Study

Summary

The purpose of this trial is to test the Single-Use Autoinjector for a) ease of use; b) multiple domains related to subject's acceptability and satisfaction, and c) reliability of the correct function for self-injection of Rebif® 44 mcg sc tiw in subjects with relapsing multiple sclerosis (RMS).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature
RMS diagnosed according to the McDonald criteria
Currently receiving Rebif® 44mcg sc tiw using manual injections and/or Rebiject II autoinjector for greater than twelve weeks
Capable of self-injecting using the single-use autoinjector
Be willing and able to comply with the study procedures for the duration of the trial
Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study-related activities are carried out
Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential

Exclusion Criteria:

Have used any other injectable medications (i.e. for pain) on a regular basis during the week prior to Screening or throughout the duration of the trial (the administration of a single injection for treatment or prophylaxis of a condition unrelated to MS or Rebif® therapy (e.g., influenza or pneumococcus vaccination) will be acceptable)
Have received MS therapy other than Rebif® within twelve weeks prior to Screening or at any time during the trial (e.g., other disease modifying drugs, Rebif® New Formulation, combination therapy, immunomodulatory and/or immunosuppressive agents, including but not limited to any interferon, glatiramer acetate (Copolymer I), cyclophosphamide, cyclosporine, methotrexate, linomide, azathioprine, mitoxantrone, teriflunomide, laquinimod, cladribine, total lymphoid irradiation, anti-lymphocyte monoclonal antibody treatment (e.g. natalizumab, alemtuzumab/Campath, anti- CD4), Intravenous immunoglobulin (IVIg), cytokines or anti-cytokine therapy) and telbivudine
Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 2.5x upper limit of normal (ULN), or alkaline phosphatase > 2.5x ULN, or total bilirubin > 2.5x ULN
Have inadequate bone marrow reserve, defined as a total white blood cell count < 3.0x 109/L, platelet count < 75x109/L, haemoglobin < 100g/L
Have complete transverse myelitis or bilateral optic neuritis
Have a history of alcohol or drug abuse
Have thyroid dysfunction
Have moderate to severe renal impairment
Have a major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
Have a history of seizures not adequately controlled by treatment
Have serious or acute cardiac disease, such as uncontrolled dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
Have, in the opinion of the investigator, any visual, physical or cognitive impairment that would preclude the subject from self-injecting with the single-use autoinjector
Have a known hypersensitivity or allergy to interferon-beta or any of the excipients
Have participated in another clinical trial within the past thirty days
Are pregnant or attempting to conceive

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

109

Study ID:

NCT00958009

Recruitment Status:

Completed

Sponsor:

EMD Serono

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There is 1 Location for this study

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EMD Serono, Inc.
Rockland Massachusetts, 02370, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

109

Study ID:

NCT00958009

Recruitment Status:

Completed

Sponsor:


EMD Serono

How clear is this clinincal trial information?

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