Trial Outcomes & Findings for Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif (NCT NCT00317941)
NCT ID: NCT00317941
Last Updated: 2013-10-21
Results Overview
An injection site is seen as developing a reaction if the patient's score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
220 participants
Primary outcome timeframe
Up to 3 months assessed every 24 hours after each injection
Results posted on
2013-10-21
Participant Flow
Participant milestones
| Measure |
Group A: IFNB-1b 250 Mcg (Betaseron) Via Betaject
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
|
Group B: IFNB-1b 250 Mcg (Betaseron) Via Betaject Light
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
|
Group C: IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Overall Study
STARTED
|
73
|
79
|
68
|
|
Overall Study
Participants Received Treatment
|
73
|
79
|
68
|
|
Overall Study
Fulfilled Requirement Safety Population
|
73
|
77
|
65
|
|
Overall Study
Fulfilled Requirements PP Population
|
66
|
76
|
63
|
|
Overall Study
COMPLETED
|
66
|
74
|
60
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Receiving Betaferon or Rebif
Baseline characteristics by cohort
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=142 Participants
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=63 Participants
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
Total
n=205 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
39.2 Years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
38.4 Years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
38.7 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Number of relapses
|
2.2 Relapses
STANDARD_DEVIATION 1.2 • n=5 Participants
|
2.1 Relapses
STANDARD_DEVIATION 1.0 • n=7 Participants
|
2.1 Relapses
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Expanded disability status scale at screening (EDSS)
|
1.7 Scores on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
1.9 Scores on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants
|
1.8 Scores on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Time since diagnosis
|
3.3 Years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
3.3 Years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
3.3 Years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 months assessed every 24 hours after each injectionAn injection site is seen as developing a reaction if the patient's score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed
Outcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=16 injection sites per month per patient
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=16 injection sites per month per patient
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Percentage of the Sites Developing a Injection Site Reaction (ISR) Reported by Participants 24 Hours After Each Injection
|
31 Percentage of sites
|
37 Percentage of sites
|
—
|
PRIMARY outcome
Timeframe: Up to 3 months assessed every 48 hours after each injectionAn injection site is seen as developing a reaction if the patient's score for this site is of a reaction intensity ≥ 1. Number of injection sites per month per participant analyzed
Outcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=16 Injection sites per month per patient
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=16 Injection sites per month per patient
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Percentage of Sites Developing a Injection Site Reaction (ISR) Reported by Participants 48 Hours After Each Injection
|
27 Percentage of sites
|
41 Percentage of sites
|
—
|
PRIMARY outcome
Timeframe: Up to 3 months assessed every 24 and 48 hours after injectionScore range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis
Outcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=16 Injection sites per month per patient
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=16 Injection sites per month per patient
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Mean Scores of Reaction After Injection Reported by Participants
|
0.368 Scores on a scale
Standard Deviation 3.11
|
0.500 Scores on a scale
Standard Deviation 3.45
|
—
|
SECONDARY outcome
Timeframe: Up to 3 monthsOutcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=16 Injection sites per month per patient
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=16 Injection sites per month per patient
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Percentage of Injection Sites With Pain Reported by Physicians
|
6.2 Percentage of sites
|
5.2 Percentage of sites
|
—
|
SECONDARY outcome
Timeframe: Up to 3 monthsOutcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=16 Injection sites per month per patient
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=16 Injection sites per month per patient
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Percentage of Injection Sites Per Participant With Reaction Reported by Physicians
|
14.1 Percentage of ISR
|
18.6 Percentage of ISR
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months assessed every 24 hours after each injectionOutcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=142 Participants
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=63 Participants
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Percentage of Participants Without ISR Reported by Participants
|
21.3 Percentage of participants
|
9.5 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months assessed every 24 hours after each injectionAn ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis
Outcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=16 Injection sites per month per patient
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=16 Injection sites per month per patient
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Percentage of Sites Developing a Severe Reaction 24 Hours After Injection
|
6.1 Percentage of sites
|
8.45 Percentage of sites
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months assessed every 48 hours after each injectionAn ISR is considered as severe if the score reported by the patient is above 2 (at least one red skin) 0- no abnormal reaction, 1- erythema, 2-edema, 3- infiltration 4- ulceration or necrosis
Outcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=16 Injection sites per month per patient
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=16 Injection sites per month per patient
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Percentage of Sites Developing a Severe Reaction 48 Hours After Injection
|
4.97 Percentage of sites
|
8.76 Percentage of sites
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months assessed 24 hours after each injectionOutcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=142 Participants
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=63 Participants
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Percentage of Participants Without Pain Reported by Participants
|
5.6 Percentage of participants
|
17.7 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 3 monthsOutcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=16 Injection sites per month per patient
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=16 Injection sites per month per patient
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Percentage of Injection Sites Without Pain Reported by Physicians
|
85.9 Percentage of injection sites
|
81.4 Percentage of injection sites
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months assessed 24 hours after each injectionOutcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=16 Injection sites per month per patient
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=16 Injection sites per month per patient
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Percentage of Injection Sites Without Pain Reported by Participants
|
30.3 Percentage of injection sites
|
42.0 Percentage of injection sites
|
—
|
SECONDARY outcome
Timeframe: Immediately after injectionVisual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).
Outcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=142 Participants
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=63 Participants
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants Immediately After Injection
|
1.1992 Scores on a scale
Interval 0.0 to 8.6714
|
1.4502 Scores on a scale
Interval 0.0 to 6.1636
|
—
|
SECONDARY outcome
Timeframe: 30 min after injectionVisual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).
Outcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=142 Participants
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=63 Participants
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 30 Minutes After Injection
|
0.7046 Scores on a scale
Interval 0.0 to 8.7429
|
0.8461 Scores on a scale
Interval 0.0 to 6.8286
|
—
|
SECONDARY outcome
Timeframe: 1h after injectionVisual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).
Outcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=142 Participants
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=63 Participants
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 1 Hour After Injection
|
0.5737 Scores on a scale
Interval 0.0 to 8.5857
|
0.6666 Scores on a scale
Interval 0.0 to 9.6
|
—
|
SECONDARY outcome
Timeframe: 24h after injectionVisual analogue scale was used to report the pain from 0 (no pain ) to 10 (maximal pain).
Outcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=142 Participants
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=63 Participants
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Mean Pain Assessment Using Visual Analogue Scale (VAS) Reported by Participants 24 Hours After Injection
|
0.6411 Scores on a scale
Interval 0.0 to 8.8071
|
0.5811 Scores on a scale
Interval 0.0 to 9.2333
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months assessed every 24 hours after each injectionOutcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=16 Injection sites per month per patient
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=16 Injection sites per month per patient
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Percentage of Sites Without Reaction 24 Hours After Injection Reported by Participants
|
62.2 Percentage of sites
|
63.0 Percentage of sites
|
—
|
SECONDARY outcome
Timeframe: Up to 3 months assessed every 48 hours after each injectionif the patient score is missing, at the injection site, then the patient is not considered without or with developping reaction. An injection site is seen as developing no reaction if the patient's score for this site is of a reaction intensity = 0.
Outcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=16 Injection sites per month per patient
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=16 Injection sites per month per patient
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Percentage of Sites Without Reaction 48 Hours After Injection Reported by Participants
|
71.8 Percentage of sites
|
54.6 Percentage of sites
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 monthsScore range is: 0 - no abnormal reaction, 1 -erythema, 2-edema, 3-infiltration, 4-ulceration or necrosis
Outcome measures
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=16 Injection sites per month per patient
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=16 Injection sites per month per patient
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=16 Injection sites per month per patient
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
|
|---|---|---|---|
|
Mean Scores of Reaction After Injection Reported by Patients Between Different Auto Injectors
|
0.372 Scores on a scale
Standard Deviation 2.82
|
0.363 Scores on a scale
Standard Deviation 3.34
|
0.5 Scores on a scale
Standard Deviation 3.45
|
Adverse Events
IFNB-1b 250 Mcg (Betaseron)
Serious events: 2 serious events
Other events: 83 other events
Deaths: 0 deaths
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=150 participants at risk
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light. Participants at risk from Group A and Group B in Participant flow.
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=65 participants at risk
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II. Participants at risk from Group C in Participant flow.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Lumbago
|
0.67%
1/150
|
0.00%
0/65
|
|
Hepatobiliary disorders
Cytolitic hepatitis
|
0.67%
1/150
|
0.00%
0/65
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/150
|
1.5%
1/65
|
Other adverse events
| Measure |
IFNB-1b 250 Mcg (Betaseron)
n=150 participants at risk
Interferon beta 1b (\[IFNB-1b\] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light. Participants at risk from Group A and Group B in Participant flow.
|
IFNB-1a 44 Mcg (Rebif) Via Rebiject II
n=65 participants at risk
Interferon beta-1a (\[IFNB-1a\] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II. Participants at risk from Group C in Participant flow.
|
|---|---|---|
|
General disorders
Injection site pruritus
|
0.67%
1/150
|
0.00%
0/65
|
|
General disorders
Irritability
|
1.3%
2/150
|
0.00%
0/65
|
|
General disorders
Malaise
|
1.3%
2/150
|
1.5%
1/65
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/150
|
1.5%
1/65
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.3%
2/150
|
0.00%
0/65
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/150
|
1.5%
1/65
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/150
|
3.1%
2/65
|
|
Cardiac disorders
Palpitations
|
2.7%
4/150
|
0.00%
0/65
|
|
Eye disorders
Eye pain
|
1.3%
2/150
|
1.5%
1/65
|
|
Eye disorders
Ophtalmoplegia
|
0.00%
0/150
|
1.5%
1/65
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/150
|
1.5%
1/65
|
|
Gastrointestinal disorders
Diarrhoea
|
0.67%
1/150
|
1.5%
1/65
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/150
|
1.5%
1/65
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.3%
2/150
|
0.00%
0/65
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.67%
1/150
|
0.00%
0/65
|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/150
|
1.5%
1/65
|
|
Gastrointestinal disorders
Vomiting
|
0.67%
1/150
|
0.00%
0/65
|
|
General disorders
Asthenia
|
4.0%
6/150
|
7.7%
5/65
|
|
General disorders
Fatigue
|
4.0%
6/150
|
3.1%
2/65
|
|
General disorders
Feeling hot
|
0.67%
1/150
|
0.00%
0/65
|
|
General disorders
Hot flush
|
0.67%
1/150
|
1.5%
1/65
|
|
General disorders
Injection site inflammation
|
0.67%
1/150
|
0.00%
0/65
|
|
General disorders
Influenza like illness
|
21.3%
32/150
|
23.1%
15/65
|
|
General disorders
Injection site erythema
|
2.0%
3/150
|
1.5%
1/65
|
|
General disorders
Injection site oedema
|
0.67%
1/150
|
0.00%
0/65
|
|
General disorders
Injection site pain
|
4.7%
7/150
|
9.2%
6/65
|
|
General disorders
Pyrexia
|
2.7%
4/150
|
4.6%
3/65
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/150
|
1.5%
1/65
|
|
Hepatobiliary disorders
Hepatocellular injury
|
1.3%
2/150
|
1.5%
1/65
|
|
Hepatobiliary disorders
Jaundice
|
0.67%
1/150
|
0.00%
0/65
|
|
Hepatobiliary disorders
Liver disorder
|
0.67%
1/150
|
0.00%
0/65
|
|
Infections and infestations
Furuncle
|
0.67%
1/150
|
0.00%
0/65
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/150
|
1.5%
1/65
|
|
Infections and infestations
Pharyngitis
|
0.67%
1/150
|
0.00%
0/65
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.67%
1/150
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/150
|
1.5%
1/65
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.67%
1/150
|
0.00%
0/65
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.3%
2/150
|
0.00%
0/65
|
|
Investigations
Alanine aminotransferase increase
|
1.3%
2/150
|
1.5%
1/65
|
|
Investigations
Aspartate aminotransferase increase
|
0.67%
1/150
|
0.00%
0/65
|
|
Investigations
Transaminase increase
|
3.3%
5/150
|
1.5%
1/65
|
|
Metabolism and nutrition disorders
Decrease appetite
|
0.67%
1/150
|
0.00%
0/65
|
|
Metabolism and nutrition disorders
Hypokalaemie
|
0.67%
1/150
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.67%
1/150
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
Lumbago
|
0.00%
0/150
|
3.1%
2/65
|
|
Musculoskeletal and connective tissue disorders
Chills
|
0.00%
0/150
|
1.5%
1/65
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.67%
1/150
|
3.1%
2/65
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.67%
1/150
|
0.00%
0/65
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
5/150
|
1.5%
1/65
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
2/150
|
0.00%
0/65
|
|
Nervous system disorders
Headache
|
4.0%
6/150
|
4.6%
3/65
|
|
Nervous system disorders
Hypoaesthesia
|
2.0%
3/150
|
0.00%
0/65
|
|
Nervous system disorders
Insomnia
|
0.67%
1/150
|
4.6%
3/65
|
|
Nervous system disorders
Multiple sclerosis relapse
|
8.0%
12/150
|
12.3%
8/65
|
|
Nervous system disorders
Paresthesia
|
1.3%
2/150
|
1.5%
1/65
|
|
Nervous system disorders
Somnolence
|
0.67%
1/150
|
0.00%
0/65
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.67%
1/150
|
0.00%
0/65
|
|
Psychiatric disorders
Agitation
|
0.67%
1/150
|
0.00%
0/65
|
|
Psychiatric disorders
Anxiety
|
0.67%
1/150
|
1.5%
1/65
|
|
Psychiatric disorders
Depressed mood
|
0.67%
1/150
|
0.00%
0/65
|
|
Psychiatric disorders
Depression
|
0.67%
1/150
|
0.00%
0/65
|
|
Psychiatric disorders
Parasomnia
|
0.00%
0/150
|
1.5%
1/65
|
|
Renal and urinary disorders
Cystitis
|
0.67%
1/150
|
0.00%
0/65
|
|
Renal and urinary disorders
Urinary track infection
|
1.3%
2/150
|
1.5%
1/65
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/150
|
1.5%
1/65
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.67%
1/150
|
0.00%
0/65
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.67%
1/150
|
0.00%
0/65
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
3/150
|
3.1%
2/65
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/150
|
1.5%
1/65
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.3%
2/150
|
0.00%
0/65
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
3/150
|
1.5%
1/65
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
1.3%
2/150
|
0.00%
0/65
|
|
Surgical and medical procedures
Hospitalization
|
0.00%
0/150
|
1.5%
1/65
|
|
Vascular disorders
Dizziness
|
0.67%
1/150
|
0.00%
0/65
|
|
Vascular disorders
Hematoma
|
0.67%
1/150
|
0.00%
0/65
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/150
|
1.5%
1/65
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.67%
1/150
|
3.1%
2/65
|
|
Eye disorders
Optic neuritis
|
0.67%
1/150
|
0.00%
0/65
|
|
Nervous system disorders
Initial insomnia
|
0.67%
1/150
|
0.00%
0/65
|
|
Nervous system disorders
Muscular weakness
|
0.67%
1/150
|
0.00%
0/65
|
|
Nervous system disorders
Motor dysfunction
|
0.67%
1/150
|
0.00%
0/65
|
|
General disorders
Pain
|
0.67%
1/150
|
1.5%
1/65
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee According the contract he signed, If results should have been edited, the Principal Investigators (PI) should have been obtained the agreement from the sponsor 90 days before the publication. The PI was not allowed to communicate within a public way the information on the study without having obtained the sponsor's agreement.
- Publication restrictions are in place
Restriction type: OTHER