RNF and Betaseron® Tolerability Study

NCT00428584

Last updated date
Study Location
EMD Serono Med Info
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.
Relapsing Remitting Multiple Sclerosis (RRMS)
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

1. Subject with diagnosis of RRMS according to McDonald criteria or Poser

2. Subject is between 18 and 60 years old inclusive

3. Subject is willing to follow study procedures

4. Subject has given written informed consent

5. Female subjects 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.

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


1. Subject has Clinically Isolated Syndrome (CIS), Primary Progressive MS, or Secondary
Progressive MS without superimposed relapses.


2. Subject has had any prior interferon beta therapy (either beta-1b or beta-1a) prior to
study Day 1.


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


4. Subject received immunomodulatory or immunosuppressive therapy (including but not
limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide,
mitoxantrone, teriflunomide, natalizumab, laquinimod, Campath and cladribine) within
the 12 months prior to Study Day 1.


5. Subject had prior use of Cladribine or has previously received total lymphoid
irradiation.


6. Subject has known allergy to natural or recombinant interferon or any other component
of formulation excipient(s) of Rebif® or Betaseron®: Mannitol, Poloxamer 188,
Methionine, Benzyl alcohol or Albumin (human).


7. Use of any other injectable medications on a regular basis during the week prior to
the screening period or during the screening or treatment periods. Receiving a single
injection for treatment or prophylaxis of a condition unrelated to the subject's
multiple sclerosis or the subject's Rebif® or Betaseron® therapy (e.g. receiving a
influenza or pneumococcus vaccination) is acceptable.


8. History of any chronic pain syndrome.


9. Subject has any other disease apart from MS that could better explain the subjects
signs and symptoms.


10. Subject has complete transverse myelitis or bilateral optic neuritis.


11. Subjects who used any investigational drug or experimental procedure within 12 weeks
prior to visit 1.


12. Subject 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.


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


14. Subject suffers from current autoimmune disease (other than RRMS).


15. Subject 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


16. Subject is pregnant or attempting to conceive


17. Visual or physical impairment that precludes completion of diaries and questionnaires.


18. Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1.

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Relapsing Remitting Multiple Sclerosis (RRMS)RNF and Betaseron® Tolerability Study
NCT00428584
  1. Rockland, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE RNF and Betaseron® Tolerability Study
Official Title  ICMJE A Randomized, Multicenter, Two Arm, Open Label, Twelve Week Phase IIIb Study to Evaluate the Tolerability of Rebif (New Formulation) (IFN Beta-1a) and Betaseron (IFN Beta-1b) in IFN-naive Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) Followed by a Single Arm, Eighty-two Week Minimum, Rebif (New Formulation) Only Safety Extension
Brief Summary To evaluate the tolerability of a new formulation of rebif and Betaseron in subjects with relapsing-remitting multiple sclerosis (RRMS) by comparing the mean change in injection site pain scores from pre-injection to 30 minutes post therapy administration.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsing Remitting Multiple Sclerosis (RRMS)
Intervention  ICMJE
  • Drug: New Formulation of rebif - human interferon beta-1a
    New Formulation of rebif- 44 mcg, SC (sub-cutaneous) thrice weekly (tiw) injection.
  • Drug: Interferon beta -1b
    Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection.
Study Arms  ICMJE
  • Experimental: 1
    interferon beta-1a
    Intervention: Drug: New Formulation of rebif - human interferon beta-1a
  • Active Comparator: 2
    interferon beta-1b
    Intervention: Drug: Interferon beta -1b
Publications * Singer B, Bandari D, Cascione M, LaGanke C, Huddlestone J, Bennett R, Dangond F; REFORMS Study Group. Comparative injection-site pain and tolerability of subcutaneous serum-free formulation of interferon?-1a versus subcutaneous interferon?-1b: results of the randomized, multicenter, Phase IIIb REFORMS study. BMC Neurol. 2012 Dec 6;12:154. doi: 10.1186/1471-2377-12-154.

*   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: February 18, 2010)
129
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject with diagnosis of RRMS according to McDonald criteria or Poser
  2. Subject is between 18 and 60 years old inclusive
  3. Subject is willing to follow study procedures
  4. Subject has given written informed consent
  5. Female subjects 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.

Exclusion Criteria:

  1. Subject has Clinically Isolated Syndrome (CIS), Primary Progressive MS, or Secondary Progressive MS without superimposed relapses.
  2. Subject has had any prior interferon beta therapy (either beta-1b or beta-1a) prior to study Day 1.
  3. Subject received any other approved disease modifying therapy for MS (glatiramer acetate) or any cytokine or anti-cytokine therapy within the 3 months prior to Study Day 1.
  4. Subject received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone, teriflunomide, natalizumab, laquinimod, Campath and cladribine) within the 12 months prior to Study Day 1.
  5. Subject had prior use of Cladribine or has previously received total lymphoid irradiation.
  6. Subject has known allergy to natural or recombinant interferon or any other component of formulation excipient(s) of Rebif® or Betaseron®: Mannitol, Poloxamer 188, Methionine, Benzyl alcohol or Albumin (human).
  7. Use of any other injectable medications on a regular basis during the week prior to the screening period or during the screening or treatment periods. Receiving a single injection for treatment or prophylaxis of a condition unrelated to the subject's multiple sclerosis or the subject's Rebif® or Betaseron® therapy (e.g. receiving a influenza or pneumococcus vaccination) is acceptable.
  8. History of any chronic pain syndrome.
  9. Subject has any other disease apart from MS that could better explain the subjects signs and symptoms.
  10. Subject has complete transverse myelitis or bilateral optic neuritis.
  11. Subjects who used any investigational drug or experimental procedure within 12 weeks prior to visit 1.
  12. Subject 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.
  13. Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
  14. Subject suffers from current autoimmune disease (other than RRMS).
  15. Subject 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
  16. Subject is pregnant or attempting to conceive
  17. Visual or physical impairment that precludes completion of diaries and questionnaires.
  18. Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1.
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 NCT00428584
Other Study ID Numbers  ICMJE 27133
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fernando Dangond, EMD Serono
Study Sponsor  ICMJE EMD Serono
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Fernando Dangond, MDEMD Serono
PRS Account EMD Serono
Verification Date August 2013

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