CompletedPhase 3Relapsing MSNCT00428584

What it found

Missed its main goal

The main measure did not show a significant benefit.

MeasureEstimate95% CIp
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 0.524

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Compared with

Results by group

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

GroupValueIntervalNumber analysed
New Formulation of Rebif0.43 mm0–16.2964
Betaseron0.40 mm0–12.4264
New Formulation of Rebif1.10 mm0–32.964
Betaseron1.54 mm0–38.3264
New Formulation of Rebif0.67 mm-0.43–16.6264
Betaseron1.14 mm-0.33–38.0564

p = 0.524

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
New Formulation of Rebif654 (6.2%)
Betaseron645 (7.8%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main 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

    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

    PainQuality of life (reported by participants)

Other measures (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

    Pain
  • 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

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

    30 minutes post injection

    Pain
  • Diameter of Injection Site Redness

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

    Safety

Who could take part

Relapsing MS · 18 to 60

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      Dec 2006

    2. Main results due

      Nov 2007

    3. Finished

      Sept 2009

    4. Results posted

      Mar 2010

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