Transition to Rebif New Formulation

A Randomized, Multicenter, Two-arm, Open-label, Phase IIIb Study to Evaluate the Satisfaction in Relapsing Multiple Sclerosis Subjects Transitioning to Rebif® New Formulation From Rebif® (Interferon Beta-1a) With Ibuprofen When Necessary (PRN) or as Prophylaxis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00619307

Acronym

TRANSFER

Enrollment

117

Registered

2008-02-20

Start date

2007-07-31

Completion date

2008-04-30

Last updated

2014-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Multiple Sclerosis

Brief summary

To assess patient satisfaction with respect to the incidence of flu-like symptoms (FLS) in patients with multiple sclerosis transitioned from current Rebif (subcutaneously injected interferon beta-1a, 44 mcg three-times-weekly) to the new formulation of Rebif (RNF) while receiving ibuprofen either prophylactically or only when necessary (PRN) after the occurence of flu-like symptoms.

Interventions

DRUGRebif New Formulation + prophylactic Ibuprofen

Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, receives systematically 400 mg ibuprofen as prophylactic treatment against flu-like symptoms on days when Rebif New Formulation 44 mcg three times a week is injected

DRUGRebif New Formulation + ibuprofen PRN

Subjects, currently on Rebif® 44 mcg three times a week, using Rebiject II as an injection device and having received Rebif® full dose 44 mcg three times a week for at least 6 months, should not administer Ibuprofen before the first Rebif New Formulation injection. If flu-like symptoms occur after the 44 mcg Rebif New Formulation injection then the subject can administer 400 mg ibuprofen. This should only be administered after the Rebif New Formulation injection and not before the Rebif New Formulation injection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Subject with relapsing forms of Multiple Sclerosis (MS) * Expanded disability status scale (EDSS) score \< 5.5 at study entry * Subjects who have been administering Rebif 44 mcg three times a week for at least 6 months prior to study enrolment * Subject currently using Rebiject II and who will use their own Rebiject II for the Rebif New Formulation injections * Subject is between 18 and 60 years old inclusive * Female subjects must be neither pregnant nor breast-feeding and must lack childbearing potential, as defined by either: post-menopausal or surgically sterile, or use a highly effective method of contraception. * Subject is willing to follow study procedures * Subject is willing and must not present any contra-indication to taking ibuprofen during 4 weeks of the study * Subject has given written informed consent

Exclusion criteria

* Secondary Progressive Multiple Sclerosis without superimposed attacks * Use of any other injectible medications during the week prior to the screening period, during the screening or treatment periods * Subject receiving MS therapy in addition (i.e. combination therapy) to Rebif within 3 months prior to study enrolment or at any time during study protocol * History of any chronic pain syndrome * Subjects that use any investigational drug or experimental procedure within 12 weeks of visit * Subject received corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days of visit 1 * Subject with flu-like symptoms (FLS) associated with any cause (i.e. no current flu and no FLS related to Interferon in the week prior to baseline) * Subject has abnormal liver function, defined by a total bilirubin \> 1.5 times the upper limit of normal, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 times the upper limit of the normal values. * Subject has inadequate bone marrow reserve, defined as a total white blood cell count \< 3.0 x 109/L, platelet count \< 75 x 109/L, haemoglobin \< 100 g/L. * Subject suffers from an active autoimmune disease other than MS * Subject suffers from major medical or psychiatric illness * Subject has seizures history or is currently experiencing seizures not adequately controlled by anti-epileptics * Subject is pregnant or attempting to conceive * Visual or physical impairment that precludes completion of diaries and questionnaires by himself/herself * Contraindication to ibuprofen:known hypersensitivity to the active ingredient ibuprofen * Known hypersensitivity to non-steroidal anti-inflammatory drugs which can lead to asthmatic attacks, gastric and/or intestinal ulcers, gastro-intestinal bleeding, cerebro-vascular bleeding or other active bleeding, severe hepatic dysfunction, severe kidney dysfunction, severe cardiac insufficiency, or systemic lupus erythematosus

Design outcomes

Primary

Measure	Time frame	Description
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score	4 weeks	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.

Secondary

Measure	Time frame	Description
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score	4 weeks	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.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score	4 weeks	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.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score	4 weeks	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.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score	4 weeks	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.

Countries

France, Germany

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	60
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.	57
Total	117

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	0	1
Overall Study	Lost to Follow-up	0	1
Overall Study	MS attack plus steroids	0	1
Overall Study	Protocol Violation	3	0
Overall Study	Severe migraine	0	1
Overall Study	Withdrew consent	1	0

Baseline characteristics

Characteristic	Transition With Prophylactic Ibuprofen	Transition With PRN Ibuprofen	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	60 Participants	57 Participants	117 Participants
Age, Continuous	41.7 years STANDARD_DEVIATION 8.4	41.5 years STANDARD_DEVIATION 8.9	41.6 years STANDARD_DEVIATION 8.6
Region of Enrollment France	14 participants	14 participants	28 participants
Region of Enrollment Germany	46 participants	43 participants	89 participants
Sex: Female, Male Female	48 Participants	40 Participants	88 Participants
Sex: Female, Male Male	12 Participants	17 Participants	29 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	50 / 59	47 / 57
serious Total, serious adverse events	1 / 59	0 / 57

Arm	Measure	Value (MEAN)
Transition With Prophylactic Ibuprofen	Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score	36.8 MSTCQ score (units on a scale)
Transition With PRN Ibuprofen	Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score	38.3 MSTCQ score (units on a scale)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026