Relapsing Multiple SclerosisPhase 3TRANSFERNCT00619307
Transition to Rebif New Formulation
A Phase 3 study testing Rebif New Formulation + prophylactic Ibuprofen and Rebif New Formulation + ibuprofen PRN in people with Relapsing Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Rebif New Formulation + prophylactic Ibuprofen and Rebif New Formulation + ibuprofen PRN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2007to Apr 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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
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.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Rebif New Formulation + prophylactic Ibuprofen, Rebif New Formulation + ibuprofen PRN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebif New Formulation + prophylactic IbuprofenDrug
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
Rebif New Formulation + ibuprofen PRNDrug
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 group | Role | What they receive |
|---|---|---|
| Transition with prophylactic ibuprofen | Active comparator | Not described Receives: Drug: Rebif New Formulation + prophylactic Ibuprofen |
| Transition with PRN ibuprofen | Active comparator | Not described Receives: Drug: Rebif New Formulation + ibuprofen PRN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score
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.
Measured: 4 weeks
Secondary outcomes (4)
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score
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.
Measured: 4 weeks
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score
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.
Measured: 4 weeks
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score
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.
Measured: 4 weeks
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Relapsing Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sabine Latour, MD, Study director, Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619307
- Sponsor's protocol ID
- 27571
- Acronym
- TRANSFER
- Status last verified
- Jan 2014
- First submitted
- 8 Feb 2008
- Last updated
- 27 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00619307
- Acronym / sponsor ID
- TRANSFER / 27571
- Conditions
- Relapsing Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Posted 26 Jul 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transition with prophylactic ibuprofen | Active comparator | Drug: Rebif New Formulation + prophylactic Ibuprofen |
| Transition with PRN ibuprofen | Active comparator | Drug: Rebif New Formulation + ibuprofen PRN |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rebif New Formulation + prophylactic IbuprofenSubjects, 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 | Drug | Transition with prophylactic ibuprofen |
| Rebif New Formulation + ibuprofen PRNSubjects, 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. | Drug | Transition with PRN ibuprofen |
Primary outcome
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score
Time frame: 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.
4 secondary outcomes
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score
Time frame: 4 weeks
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score
Time frame: 4 weeks
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score
Time frame: 4 weeks
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Latour, MD study director
Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rebif New Formulation + prophylactic Ibuprofen and Rebif New Formulation + ibuprofen PRN in people with Relapsing Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2014.