Relapsing-remitting Multiple SclerosisPhase 4PRTOECTNCT00771043
A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a
A Phase 4 study testing TYSABRI and AVONEX in people with Relapsing-remitting Multiple Sclerosis, run by Biogen.
Trial summary
Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRI®) or Interferon beta-1a (AVONEX®) treatments initiated at the time of acute optic neuritis (AON) as measured by RNFL thickness from Optical Coherence Tomography in… 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?
- TYSABRI and AVONEX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2008to 1 Jun 2010
- Phase
- Phase 4
- 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
- Diagnosis of RRMS.
- Patients with unilateral AON consistent with Multiple Sclerosis (MS).
- Treatment with intravenous methylprednisolone (IVMP) at 1gm daily for three days after the onset of AON, without a taper, and completed within 14 days of the AON symptom onset.
- Age 18-55 years.
- Expanded Disability Status Scale (EDSS) 0 to 5.0.
- Understand and sign informed consent.
Who cannot join
- History or presence of progressive multifocal leukoencephalopathy (PML).
- Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Secondary Progressive Multiple Sclerosis (SPMS).
- Immune-compromised in the judgment of the Investigator.
- History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator or Sponsor, would preclude participation in the study.
- Concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, etc).
- Previous history of severe disc edema, hemorrhage, or > 1 confirmed optic neuritis (ON) with the most recent ON symptom onset being less than 12 months ago.
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- Previous treatment with > 1 Disease Modifying Therapy (DMT).
- Previous treatment with investigational products for MS, immunosuppressant or cytotoxic therapy.
- Previous treatment with TYSABRI®
- Women who are not postmenopausal, surgically sterile, or willing to practice contraception.
- Women pregnant, breast feeding, or planning to become pregnant.
- Involved with other study protocol simultaneously without prior approval.
- Determined not suitable for study participation by Investigator and/or Sponsor.
About this study
Official title: Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a
Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRI®) or Interferon beta-1a (AVONEX®) treatments initiated at the time of acute optic neuritis (AON) as measured by RNFL thickness from Optical Coherence Tomography in patients with Relapsing Remitting Multiple Sclerosis (RRMS).
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- TYSABRI and AVONEX
- 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.
TYSABRI and AVONEXDrug
TYSABRI and AVONEX treatment per package insert.
| Study group | Role | What they receive |
|---|---|---|
| TYSABRI | Experimental | Not described Receives: Drug: TYSABRI and AVONEX |
| AVONEX | Experimental | Not described Receives: Drug: TYSABRI and AVONEX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups.
Measured: Between week 4 and weeks 36
Secondary outcomes (1)
Changes in average RNFL thickness of affected eyes (corrected by fellow eyes) across treatment groups.
Measured: Between week 4 and weeks 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study start1 Nov 2008
- Primary completion1 Aug 2009 (estimated)
- Study completion1 Jun 2010 (estimated)
Why it stopped: Sponsor decision to withdraw study at this time.
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771043
- Sponsor's protocol ID
- US 010-07-NAT
- Acronym
- PRTOECT
- Status last verified
- May 2024
- First submitted
- 7 Oct 2008
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a
- ClinicalTrials.gov ID
- NCT00771043
- Acronym / sponsor ID
- PRTOECT / US 010-07-NAT
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision to withdraw study at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2008 (actual)
- Primary completion
- 1 Aug 2009 (estimated)
- Study completion
- 1 Jun 2010 (estimated)
- First posted
- 10 Oct 2008 (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.
Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRI®) or Interferon beta-1a (AVONEX®) treatments initiated at the time of acute optic neuritis (AON) as measured by RNFL thickness from Optical Coherence Tomography in patients with Relapsing Remitting Multiple Sclerosis (RRMS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TYSABRI | Experimental | Drug: TYSABRI and AVONEX |
| AVONEX | Experimental | Drug: TYSABRI and AVONEX |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of RRMS.
- Patients with unilateral AON consistent with Multiple Sclerosis (MS).
- Treatment with intravenous methylprednisolone (IVMP) at 1gm daily for three days after the onset of AON, without a taper, and completed within 14 days of the AON symptom onset.
- Age 18-55 years.
- Expanded Disability Status Scale (EDSS) 0 to 5.0.
Key exclusion criteria (13 listed)
- History or presence of progressive multifocal leukoencephalopathy (PML).
- Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Secondary Progressive Multiple Sclerosis (SPMS).
- Immune-compromised in the judgment of the Investigator.
- History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator or Sponsor, would preclude participation in the study.
- Concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, etc).
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 |
|---|---|---|
| TYSABRI and AVONEXTYSABRI and AVONEX treatment per package insert. | Drug | AVONEX, TYSABRI |
Primary outcome
Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups.
Time frame: Between week 4 and weeks 36
1 secondary outcome
Changes in average RNFL thickness of affected eyes (corrected by fellow eyes) across treatment groups.
Time frame: Between week 4 and weeks 36
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 3 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TYSABRI and AVONEX in people with Relapsing-remitting 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 6 inclusion and 13 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 3 Jun 2024. 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?
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?
Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups. (time frame: Between week 4 and weeks 36). 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 3 Jun 2024.