Relapsing Remitting Multiple SclerosisPhase 3NCT01337427
Using Optical Coherence Tomography (OCT) to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Patients With Relapsing Multiple Sclerosis
A Phase 3 study testing BIIB017 in people with Relapsing Remitting Multiple Sclerosis, run by Johns Hopkins University.
Trial summary
This research sub-study is being completed as a part of the Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis (Protocol #: NA_00028117). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- BIIB017
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Aug 2013
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- A participant in the ADVANCE study aged 18 to 55 years old, inclusive, at the time of informed consent
Who cannot join
- As per the ADVANCE main study
- History of intraocular surgery, retinal disease, glaucoma, or diabetes
- Refractive errors of more than ±6.0 diopters
- Inability to tolerate OCT procedure
About this study
Official title: Optical Coherence Tomography (OCT) in a Multicenter, Randomized,Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
This research sub-study is being completed as a part of the Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis (Protocol #: NA_00028117). This substudy is being done to understand the efficacy of BIIB017 by measuring the nerve fiber thickness in the eye.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- BIIB017
- Keywords
- multiple sclerosis, relapsing, MS, injectable, subcutaneous, SC, PEGylated, interferon, PEG, OCT, Optical Coherence Tomography
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB017Drug
Also called PEGylated Interferon beta-1a, PEG IFN β-1a
BIIB017 is supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 mcg dose) of 20 kDa mPEG-O-2-methylpropionaldehyde-modified human IFN β-1a in 20 mM acetic acid/sodium acetate buffer pH 4.8, 150 mM arginine hydrochloride, and 0.005% Polysorbate 20.
| Study group | Role | What they receive |
|---|---|---|
| Placebo for 48 weeks, BIIB017 for 48 weeks | Placebo comparator | Placebo every 2 weeks for 48 weeks followed by 125 mcg BIIB017 SC every 2 or 4 weeks for 48 weeks. Receives: Drug: BIIB017 |
| BIIB017 every 2 weeks for 96 weeks | Experimental | 125 mcg BIIB017 SC every 2 weeks for 96 weeks. Receives: Drug: BIIB017 |
| BIIB017 every 4 weeks for 96 weeks | Experimental | 125 mcg BIIB017 SC every 4 weeks for 96 weeks. Receives: Drug: BIIB017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 12 in the BIIB-17 vs. placebo arms.
Measured: 1 year
To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 24 in the BIIB-17 vs. placebo arms.
Measured: 2 years
Secondary outcomes (11)
Analysis of proportion of patients with a decrease of >10 percent of baseline value in any RNFL quadrant from baseline to month 12 in the BIIB-17 vs. placebo arms.
Measured: baseline and 1 year
Analysis of decrease between baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population.
Measured: baseline and 3 months
Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (12 months) in this study population.
Measured: 3 months and 1 year
Analysis of macular volume decreases from baseline or 3 months to follow up scans at 12 months in this study population.
Measured: baseline and 1 year
Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 12 months in this study population.
Measured: baseline and 1 year
Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.
Measured: 1 year
Analysis of proportion of patients with a decrease of >10 percent of baseline value in any RNFL quadrant from baseline to month 24 in the BIIB-17 vs. placebo arms.
Measured: baseline and 2 years
Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (24 months) in this study population.
Measured: 3 months and 2 years
Analysis of macular volume decreases from baseline or 3 months to follow up scans at 24 months in this study population.
Measured: baseline and 2 years
Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 24 months in this study population.
Measured: baseline and 2 years
Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Why it stopped: The study was not feasible to conduct in the US and abroad.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Investigators
- Peter Calabresi, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337427
- Sponsor's protocol ID
- NA_00028117
- Status last verified
- Sep 2014
- First submitted
- 7 Apr 2011
- Last updated
- 15 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography (OCT) in a Multicenter, Randomized,Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01337427
- Acronym / sponsor ID
- NA_00028117
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- multiple sclerosis, relapsing, MS, injectable, subcutaneous, SC, PEGylated, interferon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not feasible to conduct in the US and abroad.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 18 Apr 2011 (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.
This research sub-study is being completed as a part of the Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis (Protocol #: NA_00028117). This substudy is being done to understand the efficacy of BIIB017 by measuring the nerve fiber thickness in the eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo for 48 weeks, BIIB017 for 48 weeks | Placebo comparator | Drug: BIIB017Placebo every 2 weeks for 48 weeks followed by 125 mcg BIIB017 SC every 2 or 4 weeks for 48 weeks. |
| BIIB017 every 2 weeks for 96 weeks | Experimental | Drug: BIIB017125 mcg BIIB017 SC every 2 weeks for 96 weeks. |
| BIIB017 every 4 weeks for 96 weeks | Experimental | Drug: BIIB017125 mcg BIIB017 SC every 4 weeks for 96 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- A participant in the ADVANCE study aged 18 to 55 years old, inclusive, at the time of informed consent
Key exclusion criteria (4 listed)
- As per the ADVANCE main study
- History of intraocular surgery, retinal disease, glaucoma, or diabetes
- Refractive errors of more than ±6.0 diopters
- Inability to tolerate OCT procedure
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 |
|---|---|---|
| BIIB017Also: PEGylated Interferon beta-1a, PEG IFN β-1aBIIB017 is supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 mcg dose) of 20 kDa mPEG-O-2-methylpropionaldehyde-modified human IFN β-1a in 20 mM acetic acid/sodium acetate buffer pH 4.8, 150 mM arginine hydrochloride, and 0.005% Polysorbate 20. | Drug | BIIB017 every 2 weeks for 96 weeks, BIIB017 every 4 weeks for 96 weeks, Placebo for 48 weeks, BIIB017 for 48 weeks |
Primary outcome
To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 12 in the BIIB-17 vs. placebo arms.
Time frame: 1 year
To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 24 in the BIIB-17 vs. placebo arms.
Time frame: 2 years
11 secondary outcomes
Analysis of proportion of patients with a decrease of >10 percent of baseline value in any RNFL quadrant from baseline to month 12 in the BIIB-17 vs. placebo arms.
Time frame: baseline and 1 year
Analysis of decrease between baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population.
Time frame: baseline and 3 months
Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (12 months) in this study population.
Time frame: 3 months and 1 year
Analysis of macular volume decreases from baseline or 3 months to follow up scans at 12 months in this study population.
Time frame: baseline and 1 year
Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 12 months in this study population.
Time frame: baseline and 1 year
Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.
Time frame: 1 year
Analysis of proportion of patients with a decrease of >10 percent of baseline value in any RNFL quadrant from baseline to month 24 in the BIIB-17 vs. placebo arms.
Time frame: baseline and 2 years
Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (24 months) in this study population.
Time frame: 3 months and 2 years
Analysis of macular volume decreases from baseline or 3 months to follow up scans at 24 months in this study population.
Time frame: baseline and 2 years
Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 24 months in this study population.
Time frame: baseline and 2 years
Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis.
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
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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.
Peter Calabresi, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BIIB017 in people with Relapsing Remitting Multiple Sclerosis, run by Johns Hopkins University.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 15 Sep 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 12 in the BIIB-17 vs. placebo arms. (time frame: 1 year). The study lists 2 primary outcomes in all. 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 15 Sep 2014.