Trial Outcomes & Findings for Transition to Rebif New Formulation (NCT NCT00619307)
NCT ID: NCT00619307
Last Updated: 2014-02-27
Results Overview
This is defined as the sum of the scores for the "side effects" section questions 1-4, with a minimum possible total score of 1 and a maximum possible total score of 20 in the MSTCQ. The lower the score, the better the outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
117 participants
Primary outcome timeframe
4 weeks
Results posted on
2014-02-27
Participant Flow
Subjects were enrolled from 16 July 2007 and attended the last visit on 11 April 2008. One hundred and twenty three subjects gave informed consent and 117 were enrolled. Of these, all were treated except one subject scheduled to receive prophylactic ibuprofen, who withdrew consent before treatment.
There were 17 active centres, 6 centres in France and 11 centres in Germany. Screening visit took place within 2 weeks of randomisation. Six subjects were screening failures.
Participant milestones
| Measure |
Transition With Prophylactic Ibuprofen
subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.
|
Transition With PRN Ibuprofen
subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
57
|
|
Overall Study
COMPLETED
|
56
|
53
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Transition With Prophylactic Ibuprofen
subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.
|
Transition With PRN Ibuprofen
subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Withdrew consent
|
1
|
0
|
|
Overall Study
Severe migraine
|
0
|
1
|
|
Overall Study
MS attack plus steroids
|
0
|
1
|
Baseline Characteristics
Transition to Rebif New Formulation
Baseline characteristics by cohort
| Measure |
Transition With Prophylactic Ibuprofen
n=60 Participants
subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.
|
Transition With PRN Ibuprofen
n=57 Participants
subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
60 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41.7 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
41.5 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
41.6 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
46 participants
n=5 Participants
|
43 participants
n=7 Participants
|
89 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: ITT
This is defined as the sum of the scores for the "side effects" section questions 1-4, with a minimum possible total score of 1 and a maximum possible total score of 20 in the MSTCQ. The lower the score, the better the outcome.
Outcome measures
| Measure |
Transition With Prophylactic Ibuprofen
n=56 Participants
subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.
|
Transition With PRN Ibuprofen
n=54 Participants
subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
|
|---|---|---|
|
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score
|
8.5 MSTCQ score (units on a scale)
Interval 7.4 to 9.6
|
9.1 MSTCQ score (units on a scale)
Interval 8.1 to 10.2
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: ITT
This is defined as the sum of the scores for the "injection systems" section questions 1-9 and the "side effects" section questions 1-11, with a minimum possible total score of 20 and a maximum possible total score of 100. The lower the score, the better the outcome.
Outcome measures
| Measure |
Transition With Prophylactic Ibuprofen
n=57 Participants
subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.
|
Transition With PRN Ibuprofen
n=54 Participants
subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
|
|---|---|---|
|
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score
|
36.8 MSTCQ score (units on a scale)
Interval 34.5 to 39.1
|
38.3 MSTCQ score (units on a scale)
Interval 35.4 to 41.1
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: ITT
This is defined as the sum of the scores for the "injection systems" section questions 1-9, with a minimum possible total score of 9 and a maximum possible total score of 45. The lower the score, the better the outcome.
Outcome measures
| Measure |
Transition With Prophylactic Ibuprofen
n=57 Participants
subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.
|
Transition With PRN Ibuprofen
n=55 Participants
subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
|
|---|---|---|
|
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score
|
14.3 MSTCQ score (units on a scale)
Interval 13.3 to 15.2
|
15.0 MSTCQ score (units on a scale)
Interval 13.8 to 16.1
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: ITT
This is defined as the sum of the scores for the "side effects" section questions 5 to 8, with a minimum possible total score of 1 and a maximum possible total score of 20. The lower the score, the better the outcome.
Outcome measures
| Measure |
Transition With Prophylactic Ibuprofen
n=57 Participants
subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.
|
Transition With PRN Ibuprofen
n=54 Participants
subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
|
|---|---|---|
|
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score
|
9.4 MSTCQ score (units on a scale)
Interval 8.5 to 10.3
|
9.2 MSTCQ score (units on a scale)
Interval 8.0 to 10.4
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: ITT
This is defined as the sum of the scores for "side effects" section questions 9 to 11, corresponding to minimum possible total score of 3 and a maximum possible total score of 15. The lower the score, the better the outcome.
Outcome measures
| Measure |
Transition With Prophylactic Ibuprofen
n=57 Participants
subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.
|
Transition With PRN Ibuprofen
n=55 Participants
subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
|
|---|---|---|
|
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score
|
4.7 MSTCQ score (units on a scale)
Interval 4.2 to 5.1
|
5.0 MSTCQ score (units on a scale)
Interval 4.4 to 5.6
|
Adverse Events
Transition With Prophylactic Ibuprofen
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
Transition With PRN Ibuprofen
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Transition With Prophylactic Ibuprofen
n=59 participants at risk
subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.
|
Transition With PRN Ibuprofen
n=57 participants at risk
subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
1/59 • Number of events 1 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
0.00%
0/57 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
Other adverse events
| Measure |
Transition With Prophylactic Ibuprofen
n=59 participants at risk
subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.
Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours.
|
Transition With PRN Ibuprofen
n=57 participants at risk
subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/59 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
5.3%
3/57 • Number of events 3 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
|
General disorders
Chills
|
6.8%
4/59 • Number of events 5 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
7.0%
4/57 • Number of events 5 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
|
General disorders
Fatigue
|
25.4%
15/59 • Number of events 36 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
12.3%
7/57 • Number of events 10 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
|
General disorders
Influenza-like illness
|
66.1%
39/59 • Number of events 182 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
66.7%
38/57 • Number of events 170 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
2/59 • Number of events 2 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
5.3%
3/57 • Number of events 3 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
2/59 • Number of events 2 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
7.0%
4/57 • Number of events 10 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
3/59 • Number of events 3 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
3.5%
2/57 • Number of events 2 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.1%
3/59 • Number of events 3 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
8.8%
5/57 • Number of events 17 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
|
Nervous system disorders
Headache
|
37.3%
22/59 • Number of events 41 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
28.1%
16/57 • Number of events 33 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
|
Nervous system disorders
Migraine
|
0.00%
0/59 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
7.0%
4/57 • Number of events 5 • 4 Weeks
Each subject was given a diary card for recording any adverse events. The table of Other Adverse Events shows all adverse events occurring at or above the reporting threshold.
|
Additional Information
Merck KGaA Communication Center
Merck Serono, a division of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER