Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis

NCT00110396

Last updated date
Study Location
Local US Medical Information
Rockland, Massachusetts, 02370, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Multiple Sclerosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Participant has a relapsing form of Multiple Sclerosis (MS); diagnosis of MS is in accordance with the McDonald criteria

- Participant is eligible for interferon therapy

- Participant is between 18 and 60 years old

- Participant has an Expanded Disability Status Scale (EDSS) < 6.0.

- Participant is willing to follow study procedures

- Participant has given written informed consent

- Female participants must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:

- Being post-menopausal or surgically sterile, or

- Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study.

- Confirmation that the participant is not pregnant must be established by a negative serum or urinary hCG test within 7 days prior to start of study treatment. A pregnancy test is not required if the participant is post-menopausal or surgically sterile.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Participant has a Clinically Isolated Syndrome (CIS), Primary Progressive MS, or
Secondary Progressive MS without superimposed relapses.


- Participant had any prior interferon beta therapy (either beta-1b or beta-1a)


- Participant has an ongoing MS relapse.


- Participant received any other approved disease modifying therapy for MS (e.g.
glatiramer acetate) or any cytokine or anti-cytokine therapy within the 3 months prior
to Study Day 1(SD1).


- Participant had prior use of cladribine or has previously received total lymphoid
irradiation.


- Participant received oral or systemic corticosteroids or adrenocorticotropic hormone
(ACTH) within 30 days of SD1.


- Participant received intravenous immunoglobulins or underwent plasmapheresis within
the 6 months prior to SD1.


- Participant received immunomodulatory or immunosuppressive therapy (including but not
limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide,
mitoxantrone, teriflunomide, natalizumab, laquinimod, Campath) within the 12 months
prior to SD1.


- Participant requires chronic or monthly pulse corticosteroids during the study.


- Participant received any investigational drug or experimental procedure within 12
weeks of SD1.


- Participant has inadequate liver function, defined by a total bilirubin, aspartate
aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5
times the upper limit of the normal values.


- Participant has inadequate bone marrow reserve, defined as a white blood cell count
less than 0.5 x lower limit of normal.


- Participant suffers from current autoimmune disease.


- Participant suffers from 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.


- Participant has a known allergy to IFN or the excipients.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis
Official Title  ICMJE A Multicentre, Single Arm, Open-Label, Phase IIIB Study to Evaluate the Safety and Antigenicity of Rebif® (Interferon-beta-1a) in Subjects With Relapsing Forms of Multiple Sclerosis
Brief Summary The primary objective of the study is to compare the immunogenicity of the new fetal bovine serum (FBS)-free/human serum albumin (HSA)-free Rebif® formulation (RNF) to historical data.
Detailed Description As has been seen with other recombinant protein molecules, the use of injectable recombinant proteins may result in the development of neutralising antibodies (NAbs). Antibodies are considered neutralising by their ability to inhibit the biological effect of interferon in a bioassay system. EMD Serono has actively pursued improvements in the formulation of interferon (IFN) beta-1a to reduce aggregate levels and to develop a formulation that is HSA-free. Reducing aggregates should reduce antigenicity of the product while removal of HSA may have an unpredictable effect on antigenicity. EMD Serono will conduct a study to assess the immunogenicity and safety of the new HSA-free formulation, manufactured using IFN-ß-1a drug substance produced by a new clone from the FBS-free process.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Biological: Interferon-beta-1a FBS-free/HSA-free
Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks.
Study Arms  ICMJE Experimental: Rebif New Formulation Cohort
Intervention: Biological: Interferon-beta-1a FBS-free/HSA-free
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2010)
260
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
230
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participant has a relapsing form of Multiple Sclerosis (MS); diagnosis of MS is in accordance with the McDonald criteria
  • Participant is eligible for interferon therapy
  • Participant is between 18 and 60 years old
  • Participant has an Expanded Disability Status Scale (EDSS) < 6.0.
  • Participant is willing to follow study procedures
  • Participant has given written informed consent
  • Female participants must be neither pregnant nor breast-feeding, and must lack childbearing potential, as defined by either:
  • Being post-menopausal or surgically sterile, or
  • Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study.
  • Confirmation that the participant is not pregnant must be established by a negative serum or urinary hCG test within 7 days prior to start of study treatment. A pregnancy test is not required if the participant is post-menopausal or surgically sterile.

Exclusion Criteria:

  • Participant has a Clinically Isolated Syndrome (CIS), Primary Progressive MS, or Secondary Progressive MS without superimposed relapses.
  • Participant had any prior interferon beta therapy (either beta-1b or beta-1a)
  • Participant has an ongoing MS relapse.
  • Participant received any other approved disease modifying therapy for MS (e.g. glatiramer acetate) or any cytokine or anti-cytokine therapy within the 3 months prior to Study Day 1(SD1).
  • Participant had prior use of cladribine or has previously received total lymphoid irradiation.
  • Participant received oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 30 days of SD1.
  • Participant received intravenous immunoglobulins or underwent plasmapheresis within the 6 months prior to SD1.
  • Participant received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone, teriflunomide, natalizumab, laquinimod, Campath) within the 12 months prior to SD1.
  • Participant requires chronic or monthly pulse corticosteroids during the study.
  • Participant received any investigational drug or experimental procedure within 12 weeks of SD1.
  • Participant has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of the normal values.
  • Participant has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
  • Participant suffers from current autoimmune disease.
  • Participant suffers from 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.
  • Participant has a known allergy to IFN or the excipients.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00110396
Other Study ID Numbers  ICMJE 25632
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan Fischer, EMD Serono Inc
Study Sponsor  ICMJE EMD Serono
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Bettina Stubinski, MDMerck Serono SA - Geneva
PRS Account EMD Serono
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP