ABOUT THIS STUDY
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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.
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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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |