RNF and Betaseron® Tolerability Study

NCT00428584 | Completed Phase 3 Results

• 1 other identifier: 27133
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing Remitting Multiple Sclerosis (RRMS)

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

Secondary Outcomes (4)

• Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and Immediately After Injection Timepoints

  Pre-Injection to Immediately after Injection

• Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and 10 Minutes Post-injection Timepoints

  Pre-injection to 10 minutes post-injection

• Number of Pain Free Patients at 30 Minutes Post-injection

  30 minutes post injection

• Diameter of Injection Site Redness

  1-72 hours post injection over the first 12 weeks including the titration period

Other Outcomes (5)

• Secondary Outcome - Extension Phase: Change in Mean (mm) VAS for Pre-injection and Immediately After Injection Timepoints

  Pre-injection and immediately after injection

• Secondary Outcome - Extension Phase: Change in Mean VAS at Pre-injection and 10 Minutes Post Injection

  Pre-injection and 10 minutes post injection

• Secondary Outcome - Extension Phase: Number of Pain Free Patients at 30 Minutes Post Injection

  Pain free patients at 30 minutes post injection

Study Arms (2)

1

EXPERIMENTAL

interferon beta-1a

Drug: New Formulation of rebif - human interferon beta-1a

2

ACTIVE COMPARATOR

interferon beta-1b

Drug: Interferon beta -1b

Interventions

New Formulation of rebif - human interferon beta-1a DRUG

New Formulation of rebif- 44 mcg, SC (sub-cutaneous) thrice weekly (tiw) injection.

1

Interferon beta -1b DRUG

Betaseron - 250 mcg, SC (sub-cutaneous) every other day injection.

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject with diagnosis of RRMS according to McDonald criteria or Poser
• Subject is between 18 and 60 years old inclusive
• Subject is willing to follow study procedures
• Subject has given written informed consent
• 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.

You may not qualify if:

• Subject has Clinically Isolated Syndrome (CIS), Primary Progressive MS, or Secondary Progressive MS without superimposed relapses.
• Subject has had any prior interferon beta therapy (either beta-1b or beta-1a) prior to study Day 1.
• 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.
• 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.
• Subject had prior use of Cladribine or has previously received total lymphoid irradiation.
• 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).
• 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.
• History of any chronic pain syndrome.
• Subject has any other disease apart from MS that could better explain the subjects signs and symptoms.
• Subject has complete transverse myelitis or bilateral optic neuritis.
• Subjects who used any investigational drug or experimental procedure within 12 weeks prior to visit 1.
• 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.
• Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
• Subject suffers from current autoimmune disease (other than RRMS).
• 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

Sponsors & Collaborators

• EMD Serono: lead
• Pfizer: collaborator

Study Sites (1)

EMD Serono Med Info

Rockland, Massachusetts, 02370, United States

Location

Related Publications (1)

• 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 interferonbeta-1a versus subcutaneous interferonbeta-1b: results of the randomized, multicenter, Phase IIIb REFORMS study. BMC Neurol. 2012 Dec 6;12:154. doi: 10.1186/1471-2377-12-154.

  PMID: 23216674 DERIVED

Related Links

• Full FDA approved prescribing information can be found here

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1b

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Fernando Dangond, MD
• Organization: EMD Serono, Inc.

fernando.dangond@emdserono.com

781-681-2348

Study Officials

• Fernando Dangond, MD

  EMD Serono

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 30, 2007
• Study Start: December 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: September 1, 2009
• Last Updated: August 7, 2013
• Results First Posted: March 4, 2010

Record last verified: 2013-08

Locations

US (1)