Relapsing Multiple SclerosisPhase 3RebiQoLNCT00472797
Rebif New Formulation (RNF) Quality of Life (QOL) Study
A Phase 3 study testing Rebif New Formulation Non Titrated and Rebif New Formulation Titrated in people with Relapsing Multiple Sclerosis, run by EMD Serono at 1 site in United States.
Trial summary
To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and injection site redness Rebif treated subjects with relapsing forms of MS who transition to a new formulation of Rebif (RNF). 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 Non Titrated and Rebif New Formulation Titrated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Nov 2009
- 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 a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria
- Subject currently taking Rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment
- Subject currently using Rebiject II and 29 gauge needle
- Subject is between 18 and 60 years old inclusive
- Subject is able to read and understand English
- Subject is willing to follow study procedures
- Subject has given written informed consent and signed HIPAA
- Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either: i) Being post-menopausal or surgically sterile, or ii) Using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study. (Confirmation required within 30 days prior to start of the study)
Who cannot join
- Use of any other injectable medications on a regular basis during the week prior to the screening period or during the screening or treatment periods. Receiving a single injection for treatment or prophylaxis of a condition unrelated to the subject's multiple sclerosis or the subject's Rebif® therapy (e.g., receiving a influenza or pneumococcus vaccination) is acceptable
- Subject receiving MS therapy in addition (i.e., combination therapy) to Rebif® within 3 months prior to study enrollment or at any time during study protocol.
- Subjects who have previously been on Rebif New Formulation (RNF).
- Subject with progressive forms of Multiple Sclerosis (MS).
- Subject with history of any chronic pain syndrome.
- Subject has any other disease apart from MS that could better explain the subjects signs and symptoms.
Show all 15Show fewer
- Subject has complete transverse myelitis or bilateral optic neuritis.
- Subjects that use any investigational drug or experimental procedure within 12 weeks of visit 1.
- Subject received oral or systemic corticosteroids or ACTH within 30 days of visit 1 (prior to enrollment).
- Subject has inadequate liver function, defined by a total bilirubin, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of the normal values.
- Subject has inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal.
- Subject suffers from other current autoimmune disease.
- Subject suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
- Subject is pregnant or attempting to conceive
- Visual or physical impairment that precludes completion of diaries and questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF)
To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and injection site redness Rebif treated subjects with relapsing forms of MS who transition to a new formulation of Rebif (RNF).
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Rebif New Formulation Non Titrated, Rebif New Formulation Titrated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebif New Formulation Non TitratedDrug
human interferon beta 1a - Rebif New Formulation
Rebif New Formulation TitratedDrug
Human interferon beta 1a Rebif New Formulation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Rebif New Formulation - Non Titrated Receives: Drug: Rebif New Formulation Non Titrated |
| 2 | Active comparator | Rebif New Formulation - Titrated Receives: Drug: Rebif New Formulation Titrated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)
The MSTCQ Global Side Effect domain assesses the degree of satisfaction on global side effect questions 9, 10 \& 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied). Percent change calculated as 100% * (score at week 12 - score at baseline) / score at baseline.
Measured: % change from Baseline to Week 12
Secondary outcomes (5)
Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
The MSTCQ Global Side Effect domain assesses the subjects degree of satisfaction on global side effect questions 9, 10 \& 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied).
Measured: Baseline and Week 12
Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
The MSTCQ in all domains assesses quality of life. The score for all domains other than the Global Side Effect ranges from 17 (most favorable) to 85 (least favorable). Change calculated as (score at week 12 - score at baseline.
Measured: Baseline to Week 12
Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12
The SF-MPQ assesses Tolerability of Pain with 15 questions to evaluate the type and severity of pain experienced 60 minutes after an injection of study drug. Scores range from 0 (no pain) to 45 (severe pain).
Measured: Baseline to Week 12
Tolerability in Pain Using Visual Analog Scale (VAS)
The SF-MPQ included a visual analog scale, ranging from 0 to 100 mm, on which subjects rate pain from no pain (0 mm) to worst possible pain (100 mm). A rating of <5 mm was considered pain-free.
Measured: Baseline to Week 12
Tolerability - Redness at Injection Site
Change in Baseline to Week 12 Last Observation Carried Forward(LOCF)- A blinded assessment of injection site redness was conducted by a health care professional (1-72 hours) after the most recent injection measuring redness at its widest diameter in mm. Diameter of Redness, lower is better.
Measured: Baseline to Week 12 (LOCF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startApr 2007
- Primary completionFeb 2009
- Study completionNov 2009
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
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Fernando Dangond, MD, Study director, EMD Serono
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472797
- Sponsor's protocol ID
- 27955
- Acronym
- RebiQoL
- Status last verified
- Aug 2013
- First submitted
- 10 May 2007
- Last updated
- 7 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF)
- ClinicalTrials.gov ID
- NCT00472797
- Acronym / sponsor ID
- RebiQoL / 27955
- Conditions
- Relapsing Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 14 May 2007 (estimated)
- Results
- Posted 2 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the impact on Quality of Life (QOL), tolerability, treatment satisfaction, and injection site redness Rebif treated subjects with relapsing forms of MS who transition to a new formulation of Rebif (RNF).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Rebif New Formulation Non TitratedRebif New Formulation - Non Titrated |
| 2 | Active comparator | Drug: Rebif New Formulation TitratedRebif New Formulation - Titrated |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject with a relapsing form of MS; diagnosis of MS is in accordance with the McDonald criteria
- Subject currently taking Rebif 44mcg tiw, and has been on this treatment for at least 6 months (24 weeks) prior to study enrollment
- Subject currently using Rebiject II and 29 gauge needle
- Subject is between 18 and 60 years old inclusive
- Subject is able to read and understand English
Key exclusion criteria (15 listed)
- Use of any other injectable medications on a regular basis during the week prior to the screening period or during the screening or treatment periods. Receiving a single injection for treatment or prophylaxis of a condition unrelated to the subject's multiple sclerosis or the subject's Rebif® therapy (e.g., receiving a influenza or pneumococcus vaccination) is acceptable
- Subject receiving MS therapy in addition (i.e., combination therapy) to Rebif® within 3 months prior to study enrollment or at any time during study protocol.
- Subjects who have previously been on Rebif New Formulation (RNF).
- Subject with progressive forms of Multiple Sclerosis (MS).
- Subject with history of any chronic pain syndrome.
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 Non Titratedhuman interferon beta 1a - Rebif New Formulation | Drug | 1 |
| Rebif New Formulation TitratedHuman interferon beta 1a Rebif New Formulation | Drug | 2 |
Primary outcome
Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ)
Time frame: % change from Baseline to Week 12
The MSTCQ Global Side Effect domain assesses the degree of satisfaction on global side effect questions 9, 10 \& 11 on a scale from 3 (not at all satisfied) to 15 (extremely satisfied). Percent change calculated as 100% * (score at week 12 - score at baseline) / score at baseline.
5 secondary outcomes
Total Score for Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
Time frame: Baseline and Week 12
Change in Score From Baseline to Week 12 for All Domains Other Than Global Side Effects on Multiple Sclerosis Treatment Concerns Questionnaire (MSTCQ)
Time frame: Baseline to Week 12
Total Score on Short-Form McGill Pain Questionnaire (SF-MPQ): Change in Baseline to Wk 12
Time frame: Baseline to Week 12
Tolerability in Pain Using Visual Analog Scale (VAS)
Time frame: Baseline to Week 12
Tolerability - Redness at Injection Site
Time frame: Baseline to Week 12 (LOCF)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Full FDA approved prescribing information can be found hereLink provided by the sponsor.
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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.
Fernando Dangond, MD study director
EMD Serono
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rebif New Formulation Non Titrated and Rebif New Formulation Titrated in people with Relapsing Multiple Sclerosis, run by EMD Serono at 1 site in United States.
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 8 inclusion and 15 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 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 Sep 2009). 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?
Percent Change in Global Side Effects (GSE) on Multiple Sclerosis Treatment Concerns Quesionnaire (MSTCQ) (time frame: % change from Baseline to Week 12). 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 7 Aug 2013.