Phase 4 N=220 Randomized Treatment

Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif

Relapsing-remitting Multiple Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT00317941 ↗

Enrolled (actual)

220

Serious AEs

1.4%

Results posted

Oct 2013

Primary outcome: Primary: Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection — 31; 37 Percentage of sites

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Betaferon/Betaseron (Drug); Rebif (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Bayer
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection	31; 37	—
PRIMARY Percentage of Sites Developing a Injection Site Reaction (ISR) Reported by Participants 48 Hours After Each Injection	27; 41	—
PRIMARY Mean Scores of Reaction After Injection Reported by Participants	0.368; 0.500	—
SECONDARY Percentage of Injection Sites With Pain Reported by Physicians	6.2; 5.2	—
SECONDARY Percentage of Injection Sites Per Participant With Reaction Reported by Physicians	14.1; 18.6	—
SECONDARY Percentage of Participants Without ISR Reported by Participants	21.3; 9.5	—
SECONDARY Percentage of Sites Developing a Severe Reaction 24 Hours After Injection	6.1; 8.45	—
SECONDARY Percentage of Sites Developing a Severe Reaction 48 Hours After Injection	4.97; 8.76	—
SECONDARY Percentage of Participants Without Pain Reported by Participants	5.6; 17.7	—
SECONDARY Percentage of Injection Sites Without Pain Reported by Physicians	85.9; 81.4	—
SECONDARY Percentage of Injection Sites Without Pain Reported by Participants	30.3; 42.0	—
SECONDARY Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection	1.1992; 1.4502	—
SECONDARY Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection	0.7046; 0.8461	—
SECONDARY Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection	0.5737; 0.6666	—
SECONDARY Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection	0.6411; 0.5811	—
SECONDARY Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants	62.2; 63.0	—
SECONDARY Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants	71.8; 54.6	—

Summary

The purpose of this study is to compare the injection site reaction and injection site pain after subcutaneous administration of either Betaferon 250µg or Rebif 44µg using different autoinjectors.

Eligibility Criteria

Inclusion Criteria

Males or females
Age >= 18 years old
Patients after a first demyelinating event suggestive of MS (only for Betaferon) as well as patients with a definite diagnosis of RRMS (Betaferon et Rebif)
First justified prescription of one interferon beta by subcutaneous route (as described in Summary of Product Characteristics [SmPC] of Betaferon or Rebif)
Females of child-bearing potential must agree to practice adequate contraceptive methods over the duration of the study (not applicable for men)
Patient can follow and comply with all study procedures of the trial protocol
Laboratory evaluations (i.e., evaluation of hepatic enzyme gamma-GT, full blood count and differential white blood cell count [WBC]) must be available and the results must be normal.
Written informed consent

Exclusion Criteria

Any contraindication to the prescription of Betaferon or Rebif, as described in the SmPC of products:
Pregnancy or lactation
Known hypersensitivity to natural or recombinant interferon beta, to mannitol, to human albumin or any other excipients used
History of severe depression or suicide attempt or current suicidal ideation.
Patient with decompensated liver disease
Epilepsy not adequately controlled by treatment
Patient previously included in this study.
Patient previously treated by sub-cutaneous route with either Betaferon or Rebif.
Participation in any clinical trial within the past 30 days involving the investigational drug intake.
Medical, psychiatric or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00317941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.