Multiple SclerosisPhase 3NCT00915577
Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex Syringe
A Phase 3 study testing Interferon beta-1a and Single-use autoinjector in people with Multiple Sclerosis, run by Biogen.
Trial summary
Determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled Avonex syringe. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon beta-1a and Single-use autoinjector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Apr 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be using liquid AVONEX® to treat MS. In addition, the subject must be on liquid AVONEX® for 12 weeks prior to the Screening Visit.
- Must have a BMI of 19 to 28 kg/m², inclusive, and a minimum body weight of 50 kg at Screening.
- Must be able to physically demonstrate use of the device and be able to self-administer all injections.
- Must be English speaking.
- Must be able to understand and comply with the protocol.
Who cannot join
- Abnormal screening or screening blood tests determined to be clinically significant by the investigator for: white blood count (WBC) or differential, platelet count, hemoglobin, serum creatinine, bilirubin, alanine transaminase (ALT) aspartate transaminase (AST), prothrombin time (PT).
- Known sensitivity to dry natural rubber.
- Treatment with other agents to treat MS symptoms or underlying disease as specified in the protocol.
- History of severe allergic or anaphylactic reactions.
- History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, and aspirin that would preclude the use of at least one of these during the study.
- Serious local infection
- Other inclusion and exclusion criteria apply as per Biogen Idec Protocol
About this study
Official title: An Open-Label, Multicenter Study to Determine Subject Satisfaction in Using the Single-Use Autoinjector With a Pre-Filled Liquid AVONEX® Syringe in Multiple Sclerosis Subjects
Determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled Avonex syringe.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon beta-1a, Single-use autoinjector
- Keywords
- Multiple Sclerosis, interferon beta-1a, Avonex, liquid Avonex
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon beta-1aDrug
Also called Avonex
30mcg, IM once-a-week
Single-use autoinjectorDevice
Single-use autoinjector with Avonex 30mcg pre-filled syringe
| Study group | Role | What they receive |
|---|---|---|
| 1st Injection | Experimental | Manual injection with pre-filled syringe. Receives: Drug: Interferon beta-1a |
| Single-use autoinjector | Experimental | Single-use autoinjector with Avonex pre-filled syringe Receives: Device: Single-use autoinjector |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled AVONEX® syringe
Measured: The study duration is 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startAug 2005
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Biogen-Idec Investigator, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915577
- Sponsor's protocol ID
- C-872
- Status last verified
- Jun 2009
- First submitted
- 5 Jun 2009
- Last updated
- 8 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Study to Determine Subject Satisfaction in Using the Single-Use Autoinjector With a Pre-Filled Liquid AVONEX® Syringe in Multiple Sclerosis Subjects
- ClinicalTrials.gov ID
- NCT00915577
- Acronym / sponsor ID
- C-872
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, interferon beta-1a, Avonex, liquid Avonex
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 8 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled Avonex syringe.
Study design
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1st Injection | Experimental | Drug: Interferon beta-1aManual injection with pre-filled syringe. |
| Single-use autoinjector | Experimental | Device: Single-use autoinjectorSingle-use autoinjector with Avonex pre-filled syringe |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be using liquid AVONEX® to treat MS. In addition, the subject must be on liquid AVONEX® for 12 weeks prior to the Screening Visit.
- Must have a BMI of 19 to 28 kg/m², inclusive, and a minimum body weight of 50 kg at Screening.
- Must be able to physically demonstrate use of the device and be able to self-administer all injections.
- Must be English speaking.
- Must be able to understand and comply with the protocol.
Key exclusion criteria (7 listed)
- Abnormal screening or screening blood tests determined to be clinically significant by the investigator for: white blood count (WBC) or differential, platelet count, hemoglobin, serum creatinine, bilirubin, alanine transaminase (ALT) aspartate transaminase (AST), prothrombin time (PT).
- Known sensitivity to dry natural rubber.
- Treatment with other agents to treat MS symptoms or underlying disease as specified in the protocol.
- History of severe allergic or anaphylactic reactions.
- History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, and aspirin that would preclude the use of at least one of these during the study.
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 |
|---|---|---|
| Interferon beta-1aAlso: Avonex30mcg, IM once-a-week | Drug | 1st Injection |
| Single-use autoinjectorSingle-use autoinjector with Avonex 30mcg pre-filled syringe | Device | Single-use autoinjector |
Primary outcome
The primary objective of the study is to determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled AVONEX® syringe
Time frame: The study duration is 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2009.
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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.
Biogen-Idec Investigator study director
Biogen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interferon beta-1a and Single-use autoinjector in people with Multiple Sclerosis, run by Biogen.
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 5 inclusion and 7 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 8 Jun 2009. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective of the study is to determine patient satisfaction with the single-use autoinjector for the delivery of pre-filled AVONEX® syringe (time frame: The study duration is 8 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 8 Jun 2009.