RNF and Betaseron® Tolerability Study (REFORMS)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00428584
First received: January 29, 2007
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis (RRMS)
Drug: New Formulation of rebif - human interferon beta-1a
Drug: Interferon beta -1b
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Visual Analog Scale (VAS) of Patient Reported Pain: Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 30 Minutes Post-injection Timepoints [ Time Frame: From pre-injection to 30 minutes post injection of the VAS pain scores across the first 21 injections of full dose therapy of a new formulation of rebif and Betaseron ] [ Designated as safety issue: No ]
    Subject reported perception of pain on the VAS where the slash drawn by the patient represents pain of increasing intensity from 0 (no pain) to 100 (worse possible pain), measured in millimeters. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 30 minutes post-injection


Secondary Outcome Measures:
  • Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and Immediately After Injection Timepoints [ Time Frame: Pre-Injection to Immediately after Injection ] [ Designated as safety issue: No ]
    A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection.

  • Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 10 Minutes Post-injection Timepoints [ Time Frame: Pre-injection to 10 minutes post-injection ] [ Designated as safety issue: No ]
    A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient 10 minutes post injection.

  • Number of Pain Free Patients at 30 Minutes Post-injection [ Time Frame: 30 minutes post injection ] [ Designated as safety issue: No ]

    A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used.

    Pain-free was defined as a VAS score of 0 for all 21 full-dose injections for the Intent-to-Treat (ITT) population.


  • Diameter of Injection Site Redness [ Time Frame: 1-72 hours post injection over the first 12 weeks including the titration period ] [ Designated as safety issue: No ]
    Blinded assessment of mean change in diameter of redness (in mm) at an injection site following an injection


Other Outcome Measures:
  • Secondary Outcome - Extension Phase: Change in Mean (mm) VAS for Pre-injection and Immediately After Injection Timepoints [ Time Frame: Pre-injection and immediately after injection ] [ Designated as safety issue: No ]
    A visual analog scale (VAS) ranging from 0 to 100 mm on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm) was used. Mean VAS of 21 injections for each patient at pre-injection compared to mean VAS of 21 injections for each patient immediately after injection.

  • Secondary Outcome - Extension Phase: Change in Mean VAS at Pre-injection and 10 Minutes Post Injection [ Time Frame: Pre-injection and 10 minutes post injection ] [ Designated as safety issue: No ]
  • Secondary Outcome - Extension Phase: Number of Pain Free Patients at 30 Minutes Post Injection [ Time Frame: Pain free patients at 30 minutes post injection ] [ Designated as safety issue: No ]
  • Secondary Outcome - Extension Phase: Diameter in Injection Site Redness [ Time Frame: 1 to 72 hours post injection ] [ Designated as safety issue: No ]
  • Primary Outcome - Extension Phase: Visual Analog Scale (VAS) of Patients Reported Pain; Change in Mean VAS at Pre-injection and 30 Minutes Post Injection [ Time Frame: Pre-injection and 30 minutes post injection ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: December 2006
Study Completion Date: September 2009
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
interferon beta-1a
Drug: New Formulation of rebif - human interferon beta-1a
New Formulation of rebif- 44 mcg, SC (sub-cutaneous) thrice weekly (tiw) injection.
Active Comparator: 2
interferon beta-1b
Drug: Interferon beta -1b
Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428584

Locations
United States, Massachusetts
EMD Serono Med Info
Rockland, Massachusetts, United States, 02370
Sponsors and Collaborators
EMD Serono
Pfizer
Investigators
Study Director: Fernando Dangond, MD EMD Serono
  More Information

Additional Information:
No publications provided by EMD Serono

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fernando Dangond, EMD Serono
ClinicalTrials.gov Identifier: NCT00428584     History of Changes
Other Study ID Numbers: 27133
Study First Received: January 29, 2007
Results First Received: November 26, 2008
Last Updated: August 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Interferon beta-1b
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 23, 2014