Relapsing Remitting Multiple SclerosisPhase 4NCT00367484
Study To Evaluate The Immunogenicity And Safety Of r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In Multiple Sclerosis
A Phase 4 study testing Rebif® (clone 484-39) in people with Relapsing Remitting Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany.
Trial summary
The objectives of the study are: comparison of the incidence and time course of the development of neutralizing antibodies (NAbs) to Rebif after 48 weeks of therapy, to historical data from Serono clinical trial databases to assess the safety and tolerability of Rebif® Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Rebif® (clone 484-39)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- No sites listed yet
- Study dates
- May 2004to Jan 2006
- Phase
- Phase 4
- 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
- Have multiple sclerosis (MS) with two or more relapses in the past two years and is eligible for interferon therapy.
- Be between 18 and 60 years of age, inclusive.
- Have given written informed consent, prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
- Be willing and able to follow all study procedures for the duration of the study.
- Have an Expanded Disability Scale Score (EDSS) less than 6.0
- If female, she must either
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- be post menopausal or surgically sterilised; or
- use a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and
- be neither pregnant nor breast feeding. Confirmation that the subject is not pregnant must be established by a negative SERUM human Chorionic Gonadotrophin (hCG) pregnancy test between 28 to 7 days before Study Day 0.Urine pregnancy test must be done if serum hCG pregnancy test was performed more than 7 days before Study Day 0. A pregnancy test is not required if the subject is post menopausal or surgically sterilised.
Who cannot join
- Prior Interferon beta therapy (either beta-1b or beta-1a).
- 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.
- Significant immunosuppressive therapy within the 6 months prior to enrolment.
- Known history of hypersensitivity to natural or recombinant interferon beta, human serum albumin, or any other component of the formulation.
- Epilepsy with a history of seizures not adequately controlled by treatment.
- Have greater than Grade 1 toxicity for liver function tests (Aspartate Transaminase (AST), Alanine Transaminase (ALT), Gamma-Glutamyl Transferase (GGT) or total bilirubin) at the Screening visit
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- Have significant leukopenia (greater than Grade 1 toxicity for total white blood cell count or lymphopenia) at the Screening visit
- Have had treatment with oral or systemic corticosteroids or Adrenocorticotrophic hormone (ACTH) within 1 month of the Screening visit or between the screening visit and study day 0.
- Cytokine or anti-cytokine therapy within the 3 months prior to the Screening visit or between the screening visit and study day 0.
- Use of immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide) within the 6 months prior to the Screening visit or between the screening visit and study day 0.
- Have taken intravenous immunoglobulin or glatiramer acetate or mitoxantrone or any investigational drug or experimental procedure within the 3 months prior to the Screening visit or between the screening visit and study day 0.
- Prior use of cladribine or have received total lymphoid irradiation.
- Presence of systemic disease that might interfere with patient safety, compliance or evaluation of the condition under study (e.g. poorly controlled insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, human immunodeficiency virus (HIV), human T-lymphotrophic virus 1 (HTLV-1)).
- Other concurrent systemic disorders incompatible with the study (at the Investigator's discretion).
About this study
Official title: Multicentre, Single Arm, Open, Phase IV Study To Evaluate Immunogenicity And Safety Of Subcutaneous r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In The Treatment Of Relapsing Remitting Multiple Sclerosis
The objectives of the study are:
- comparison of the incidence and time course of the development of neutralizing antibodies (NAbs) to Rebif after 48 weeks of therapy, to historical data from Serono clinical trial databases to assess the safety and tolerability of Rebif®
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Rebif® (clone 484-39)
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebif® (clone 484-39)Biological
Also called Recombinant-human interferon beta-1a, r-hIFN Beta-1a
s.c. administered Rebif®
| Study group | Role | What they receive |
|---|---|---|
| Rebif® (clone 484-39) | Experimental | Rebif® 44 mcg, three times per week (tiw), subcutaneously (s.c.) During the first 4 weeks of the study, subjects underwent a dose titration regimen of 40% of Rebif® 22 mcg or 20% of Rebif® 44 mcg tiw (8.8 mcg per injection) in the first and second week followed by 100% of Rebif® 22 mcg or 50% of Rebif® 44 mcg (22 mcg per injection) in the third and fourth week. After 4 weeks, subjects received 44 mcg injected s.c. tiw. Receives: Biological: Rebif® (clone 484-39) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Testing Positive for Neutralising Antibody (NAb)
Participants who were NAb+ at 48 weeks (or at the last available NAb assessment up to Week 48). The NAb+ value was defined as NAb ≥ 20 NU/ml.
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startMay 2004
- Primary completionJan 2006
- Study completionJan 2006
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 Remitting 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bettina Stubinski, M.D., Study director, Merck Serono SA - Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367484
- Sponsor's protocol ID
- 24810
- Status last verified
- Jan 2014
- First submitted
- 21 Aug 2006
- 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
- Multicentre, Single Arm, Open, Phase IV Study To Evaluate Immunogenicity And Safety Of Subcutaneous r-hIFN Beta-1a (Rebif®) Using Clone 484-39 In The Treatment Of Relapsing Remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00367484
- Acronym / sponsor ID
- 24810
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 23 Aug 2006 (estimated)
- Results
- Posted 27 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of the study are:
- comparison of the incidence and time course of the development of neutralizing antibodies (NAbs) to Rebif after 48 weeks of therapy, to historical data from Serono clinical trial databases to assess the safety and tolerability of Rebif®
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rebif® (clone 484-39) | Experimental | Biological: Rebif® (clone 484-39)Rebif® 44 mcg, three times per week (tiw), subcutaneously (s.c.) During the first 4 weeks of the study, subjects underwent a dose titration regimen of 40% of Rebif® 22 mcg or 20% of Rebif® 44 mcg tiw (8.8 mcg per injection) in the first and second week followed by 100% of Rebif® 22 mcg or 50% of Rebif® 44 mcg (22 mcg per injection) in the third and fourth week. After 4 weeks, subjects received 44 mcg injected s.c. tiw. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Have multiple sclerosis (MS) with two or more relapses in the past two years and is eligible for interferon therapy.
- Be between 18 and 60 years of age, inclusive.
- Have given written informed consent, prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
- Be willing and able to follow all study procedures for the duration of the study.
- Have an Expanded Disability Scale Score (EDSS) less than 6.0
Key exclusion criteria (14 listed)
- Prior Interferon beta therapy (either beta-1b or beta-1a).
- 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.
- Significant immunosuppressive therapy within the 6 months prior to enrolment.
- Known history of hypersensitivity to natural or recombinant interferon beta, human serum albumin, or any other component of the formulation.
- Epilepsy with a history of seizures not adequately controlled by treatment.
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® (clone 484-39)Also: Recombinant-human interferon beta-1a, r-hIFN Beta-1as.c. administered Rebif® | Biological | Rebif® (clone 484-39) |
Primary outcome
Number of Participants Testing Positive for Neutralising Antibody (NAb)
Time frame: 48 Weeks
Participants who were NAb+ at 48 weeks (or at the last available NAb assessment up to Week 48). The NAb+ value was defined as NAb ≥ 20 NU/ml.
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.
- 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.
Bettina Stubinski, M.D. study director
Merck Serono SA - Geneva
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rebif® (clone 484-39) in people with Relapsing Remitting Multiple Sclerosis, run by Merck KGaA, Darmstadt, Germany.
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 14 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.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 27 Aug 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?
Number of Participants Testing Positive for Neutralising Antibody (NAb) (time frame: 48 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.