RNF and Betaseron® Tolerability Study

Phase 3

Completed

Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)

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

Registration Number: NCT00428584

Lead Sponsor: EMD Serono

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 available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 129

Inclusion Criteria

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.

Exclusion Criteria

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
Subject is pregnant or attempting to conceive
Visual or physical impairment that precludes completion of diaries and questionnaires.
Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	New Formulation of rebif - human interferon beta-1a	interferon beta-1a
2	Interferon beta -1b	interferon beta-1b

Primary Outcome Measures

Name	Time	Method
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	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	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

Name	Time	Method
Diameter of Injection Site Redness	1-72 hours post injection over the first 12 weeks including the titration period	Blinded assessment of mean change in diameter of redness (in mm) at an injection site following an injection
Change in Mean VAS for the 21 Full-dose Injections at Pre-injection and Immediately After Injection Timepoints	Pre-Injection to Immediately after Injection	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	Pre-injection to 10 minutes post-injection	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	30 minutes post injection	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.