Multiple SclerosisNCT02419638
Comparison of Rebif Compared to Tecifdera on Six-month Outcomes in Patients With Relapsing-remitting MS
An observational study of Multiple Sclerosis, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month… 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?
- Rebif (IFN β-1a subcutaneous three times per week) and Tecifdera (dimethyl fumarate)
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Feb 2016
- Phase
- Observational
- 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
Study population: This is a single center study conducted at the Partners Multiple Sclerosis Center. Patients who are planning to start a new disease modifying treatment for relapsing-remitting MS will be offered enrollment in this study of two commonly used MS treatments by their treating physician. Potential subjects will undergo inclusion/exclusion review by the study nurse. Those meeting criteria will be enrolled by overall study PI or treating physician. Subjects will be identified from the Partners MS Center at the Brigham and Women's Hospital. Potential subjects will initially be approached by their treating physician concerning the study.
Who may be able to join
- Male and female subjects aged 18-65 years old, inclusive.
- A diagnosis of MS as defined by the McDonald 2010 criteria for MS.
- Relapsing form of MS, defined as at least one relapse in the prior 5 years.
- Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive.
- English language skills adequate for the completion of questionnaires and cognitive measures.
Who cannot join
- Subjects with progressive MS.
- Subjects with a contraindications for standard treatment with Rebif or Tecfidera including GI disease, needle phobia, liver disease.
- Subjects treated with:
- High dose intravenous immunoglobulin within 2 months prior to study entry
- Natalizumab within 3 months prior to study entry
- Immunosuppressive/immunomodulatory medications including cyclophosphamide, mitoxantrone, azathioprine, methotrexate, rituximab, ofatumumab, ocrelizumab, or alemtuzumab at any time.
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- Subjects with absolute lymphocyte count < 800 cells (mm3).
- Subjects with any of the following neurologic/psychiatric disorder:
- Severe depression during the past 12 months before screening;
- History of substance abuse (treatment or alcohol) or any other factor (i.e., serious psychiatric condition) that may interfere with the subject's ability to cooperate and comply with the study procedures;
- Subjects unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA.
- Pregnant or nursing females, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG laboratory test.
- Female subjects of childbearing potential, defined as all females physiologically capable of becoming pregnant, unless they agree to abstinence or, if sexually active, the use of contraception.
- History of hypersensitivity to any of the study treatments or to treatments of similar chemical classes.
- Subjects with abnormal Liver Function Test (LFT) levels
Trial locations and contacts
1 site in 1 country.
United States1 site
Partners MS Center, 1 Brookline Place Suite 225
Brookline, Massachusetts, 02445
About this study
To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month MRI scan as standard of care.
Read the detailed description
Primary objective To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month MRI scan as standard of care.
Key secondary objective To compare Rebif vs. Tecfidera in reducing the T2 lesion volume, number of T1 black holes, gadolinium-enhancing lesions, brain parenchymal fraction, brain white matter fraction and brain gray matter fraction on the 6 month MRI.
Other secondary objectives
- To compare the two treatments on the following clinical efficacy measures which are routinely obtained as part of our clinical practice: Expanded disability status score (EDSS), ambulation index (AI), disease steps and number of relapses. In addition we will obtain the MSFC-4, which in addition to the AI which is routinely done, will include the symbol digit modalities test (SDMT), low contrast visual acuity, and 9 hole peg test.
- To compare adherence to the two treatments using an adherence question.
Tertiary objectives
- To compare the two treatments on optical coherence tomography (OCT) and visual acuity measures.
- To compare the following patient reported outcomes: MSQOL-54 (MSQOL54), Modified MOS Social Support Survey (MSSS), Modified Fatigue Impact Scale (MFIS), Center for Epidemiological Studies Depression Scale (CES-D).
- To compare cognitive function using the brief repeatable battery of neuropsychological tests in Multiple Sclerosis (BRB) which includes the following cognitive measures: Symbol Digit Modalities Test (SDMT), Selective Reminding Test (SRT), 10/36 Spatial Recall Test (10/36), Controlled Oral Word Association Test (COWAT).
- To compare the following Pharmacoeconomic outcomes: Healthcare Utilization and Costs, QUALY, Unscheduled visits (office, ER, hospital), out-of-pocket expenses (e.g., durable medical equipment, copays), Work Productivity and Activity Impairment (WPAI), Treatment satisfaction questionnaire (Treatment Satisfaction for Medication Questionnaire (TSQM))
Design: The study is a single center, 6-month, randomized, parallel-group, single blind study to compare two FDA approved treatments for MS (Rebif and Tecfidera) in adults with relapsing-remitting MS. 120 subjects will be treated with each medication (total 240 patients). Randomization will ensure balanced patient groups and prevent bias. Patients will be prescribed the medication by their treating physician who will follow the patient in a open fashion as part of standard of care for MS including obtaining MRI imaging at 6 months. At 6 months, patients will have a neurologic exam by an independent examining physician and administration of questionaires by study staff blinded to their treatment.
Methods: Relapsing-remitting patients beginning medication and deemed suitable for treatment with Rebif or Tecfidera as part of standard of care for MS will be explained the nature of the study, after which informed consent will be obtained. They will undergo a baseline visit and then randomized to one of the two treatments. Blood samples for biomarker studies will be collected at the baseline visit and at 6 months. MRI is obtained prior to therapy and at 6 months as part of standard of care. Following the completion of the 6 month study period, subjects are able to continue on either of the two treatments or switch to another agent according to their own preference and following discussions with their treating MS neurologist.
Subjects who discontinue treatments prior to the 6 month period are free to begin another therapy. Upon discontinuation of treatment, subjects will complete the end of study (EOS) visit as soon as possible and will be followed for the duration of the 6-month treatment phase.
- Conditions
- Multiple Sclerosis
- Being tested
- Rebif (IFN β-1a subcutaneous three times per week), Tecifdera (dimethyl fumarate)
- Keywords
- relapsing-remitting MS, lesions, treatment
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebif (IFN β-1a subcutaneous three times per week)Drug
Tecifdera (dimethyl fumarate)Drug
| Study group | Role | What they receive |
|---|---|---|
| Randomized Treatment Arm: Rebif | 120 patients treated with Rebif (IFN β-1a subcutaneous three times per week) Receives: Drug: Rebif (IFN β-1a subcutaneous three times per week) | |
| Randomized Treatment Arm: Tecfidera | 120 patients treated with Tecfidera (dimethyl fumarate) Receives: Drug: Tecifdera (dimethyl fumarate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
T2 lesion load: Rebif v. Tecfidera
To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month MRI scan as standard of care.
Measured: 6 months
Secondary outcomes (1)
Reducing lesion load and MRI characteristics: Rebif v. Tecfidera
To compare Rebif vs. Tecfidera in reducing the T2 lesion volume, number of T1 black holes, gadolinium-enhancing lesions, brain parenchymal fraction, brain white matter fraction and brain gray matter fraction on the 6 month MRI.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionFeb 2016
Why it stopped: Collaborative decision between study PI and sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- EMD Serono
- Responsible party
- Principal investigator, Tanuja Chitnis, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419638
- Sponsor's protocol ID
- 2015P000242
- Status last verified
- Feb 2016
- First submitted
- 14 Apr 2015
- Last updated
- 29 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Klawiter EC, Cross AH, Naismith RT. The present efficacy of multiple sclerosis therapeutics: Is the new 66% just the old 33%? Neurology. 2009 Sep 22;73(12):984-90. doi: 10.1212/WNL.0b013e3181b9c8f7.
PubMed 19770475Freedman MS, Hughes B, Mikol DD, Bennett R, Cuffel B, Divan V, LaVallee N, Al-Sabbagh A. Efficacy of disease-modifying therapies in relapsing remitting multiple sclerosis: a systematic comparison. Eur Neurol. 2008;60(1):1-11. doi: 10.1159/000127972. Epub 2008 Apr 25.
PubMed 18437041Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Lancet. 1998 Nov 7;352(9139):1498-504.
PubMed 9820297Kappos L, Gold R, Miller DH, Macmanus DG, Havrdova E, Limmroth V, Polman CH, Schmierer K, Yousry TA, Yang M, Eraksoy M, Meluzinova E, Rektor I, Dawson KT, Sandrock AW, O'Neill GN; BG-12 Phase IIb Study Investigators. Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study. Lancet. 2008 Oct 25;372(9648):1463-72. doi: 10.1016/S0140-6736(08)61619-0.
PubMed 18970976Fox RJ, Miller DH, Phillips JT, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, Viglietta V, Dawson KT; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1087-97. doi: 10.1056/NEJMoa1206328.
PubMed 22992072Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Meltzer L, Kurukulasuriya NC. Efficacy and safety of delayed-release dimethyl fumarate in patients newly diagnosed with relapsing-remitting multiple sclerosis (RRMS). Mult Scler. 2015 Jan;21(1):57-66. doi: 10.1177/1352458514537013. Epub 2014 Jul 2.
PubMed 24990854Gold R, Kappos L, Arnold DL, Bar-Or A, Giovannoni G, Selmaj K, Tornatore C, Sweetser MT, Yang M, Sheikh SI, Dawson KT; DEFINE Study Investigators. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1098-107. doi: 10.1056/NEJMoa1114287.
PubMed 22992073Rudick RA, Lee JC, Simon J, Ransohoff RM, Fisher E. Defining interferon beta response status in multiple sclerosis patients. Ann Neurol. 2004 Oct;56(4):548-55. doi: 10.1002/ana.20224.
PubMed 15389896Wei X, Warfield SK, Zou KH, Wu Y, Li X, Guimond A, Mugler JP 3rd, Benson RR, Wolfson L, Weiner HL, Guttmann CR. Quantitative analysis of MRI signal abnormalities of brain white matter with high reproducibility and accuracy. J Magn Reson Imaging. 2002 Feb;15(2):203-9. doi: 10.1002/jmri.10053.
PubMed 11836778Liu L, Meier D, Polgar-Turcsanyi M, Karkocha P, Bakshi R, Guttmann CR. Multiple sclerosis medical image analysis and information management. J Neuroimaging. 2005;15(4 Suppl):103S-117S. doi: 10.1177/1051228405282864.
PubMed 16385023
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rebif Compared to Tecifdera on Six-month Outcomes in Patients With Relapsing-remitting MS
- ClinicalTrials.gov ID
- NCT02419638
- Acronym / sponsor ID
- 2015P000242
- Conditions
- Multiple Sclerosis
- Keywords
- relapsing-remitting MS, lesions, treatment
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Collaborative decision between study PI and sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- EMD Serono
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 Apr 2015 (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.
To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month MRI scan as standard of care.
Detailed description
Primary objective To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month MRI scan as standard of care.
Key secondary objective To compare Rebif vs. Tecfidera in reducing the T2 lesion volume, number of T1 black holes, gadolinium-enhancing lesions, brain parenchymal fraction, brain white matter fraction and brain gray matter fraction on the 6 month MRI.
Other secondary objectives
- To compare the two treatments on the following clinical efficacy measures which are routinely obtained as part of our clinical practice: Expanded disability status score (EDSS), ambulation index (AI), disease steps and number of relapses. In addition we will obtain the MSFC-4, which in addition to the AI which is routinely done, will include the symbol digit modalities test (SDMT), low contrast visual acuity, and 9 hole peg test.
- To compare adherence to the two treatments using an adherence question.
Tertiary objectives
- To compare the two treatments on optical coherence tomography (OCT) and visual acuity measures.
- To compare the following patient reported outcomes: MSQOL-54 (MSQOL54), Modified MOS Social Support Survey (MSSS), Modified Fatigue Impact Scale (MFIS), Center for Epidemiological Studies Depression Scale (CES-D).
- To compare cognitive function using the brief repeatable battery of neuropsychological tests in Multiple Sclerosis (BRB) which includes the following cognitive measures: Symbol Digit Modalities Test (SDMT), Selective Reminding Test (SRT), 10/36 Spatial Recall Test (10/36), Controlled Oral Word Association Test (COWAT).
- To compare the following Pharmacoeconomic outcomes: Healthcare Utilization and Costs, QUALY, Unscheduled visits (office, ER, hospital), out-of-pocket expenses (e.g., durable medical equipment, copays), Work Productivity and Activity Impairment (WPAI), Treatment satisfaction questionnaire (Treatment Satisfaction for Medication Questionnaire (TSQM))
Design: The study is a single center, 6-month, randomized, parallel-group, single blind study to compare two FDA approved treatments for MS (Rebif and Tecfidera) in adults with relapsing-remitting MS. 120 subjects will be treated with each medication (total 240 patients). Randomization will ensure balanced patient groups and prevent bias. Patients will be prescribed the medication by their treating physician who will follow the patient in a open fashion as part of standard of care for MS including obtaining MRI imaging at 6 months. At 6 months, patients will have a neurologic exam by an independent examining physician and administration of questionaires by study staff blinded to their treatment.
Methods: Relapsing-remitting patients beginning medication and deemed suitable for treatment with Rebif or Tecfidera as part of standard of care for MS will be explained the nature of the study, after which informed consent will be obtained. They will undergo a baseline visit and then randomized to one of the two treatments. Blood samples for biomarker studies will be collected at the baseline visit and at 6 months. MRI is obtained prior to therapy and at 6 months as part of standard of care. Following the completion of the 6 month study period, subjects are able to continue on either of the two treatments or switch to another agent according to their own preference and following discussions with their treating MS neurologist.
Subjects who discontinue treatments prior to the 6 month period are free to begin another therapy. Upon discontinuation of treatment, subjects will complete the end of study (EOS) visit as soon as possible and will be followed for the duration of the 6-month treatment phase.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized Treatment Arm: Rebif | – | Drug: Rebif (IFN β-1a subcutaneous three times per week)120 patients treated with Rebif (IFN β-1a subcutaneous three times per week) |
| Randomized Treatment Arm: Tecfidera | – | Drug: Tecifdera (dimethyl fumarate)120 patients treated with Tecfidera (dimethyl fumarate) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a single center study conducted at the Partners Multiple Sclerosis Center. Patients who are planning to start a new disease modifying treatment for relapsing-remitting MS will be offered enrollment in this study of two commonly used MS treatments by their treating physician. Potential subjects will undergo inclusion/exclusion review by the study nurse. Those meeting criteria will be enrolled by overall study PI or treating physician. Subjects will be identified from the Partners MS Center at the Brigham and Women's Hospital. Potential subjects will initially be approached by their treating physician concerning the study.
Key inclusion criteria (5 listed)
- Male and female subjects aged 18-65 years old, inclusive.
- A diagnosis of MS as defined by the McDonald 2010 criteria for MS.
- Relapsing form of MS, defined as at least one relapse in the prior 5 years.
- Expanded Disability Status Scale (EDSS) score of 0 to 5.5, inclusive.
- English language skills adequate for the completion of questionnaires and cognitive measures.
Key exclusion criteria (15 listed)
- Subjects with progressive MS.
- Subjects with a contraindications for standard treatment with Rebif or Tecfidera including GI disease, needle phobia, liver disease.
- Subjects treated with:
- Subjects with absolute lymphocyte count < 800 cells (mm3).
- Subjects with any of the following neurologic/psychiatric disorder:
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 (IFN β-1a subcutaneous three times per week) | Drug | Randomized Treatment Arm: Rebif |
| Tecifdera (dimethyl fumarate) | Drug | Randomized Treatment Arm: Tecfidera |
Primary outcome
T2 lesion load: Rebif v. Tecfidera
Time frame: 6 months
To compare two commonly used MS medications, IFN β-1a subcutaneous three times per week (Rebif) and oral twice daily dimethyl fumarate (Tecfidera), on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month MRI scan as standard of care.
1 secondary outcome
Reducing lesion load and MRI characteristics: Rebif v. Tecfidera
Time frame: 6 months
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 29 Feb 2016.
- Background: PubMed 19770475Klawiter EC, Cross AH, Naismith RT. The present efficacy of multiple sclerosis therapeutics: Is the new 66% just the old 33%? Neurology. 2009 Sep 22;73(12):984-90. doi: 10.1212/WNL.0b013e3181b9c8f7.
- Background: PubMed 18437041Freedman MS, Hughes B, Mikol DD, Bennett R, Cuffel B, Divan V, LaVallee N, Al-Sabbagh A. Efficacy of disease-modifying therapies in relapsing remitting multiple sclerosis: a systematic comparison. Eur Neurol. 2008;60(1):1-11. doi: 10.1159/000127972. Epub 2008 Apr 25.
- Background: PubMed 9820297Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis. PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) Study Group. Lancet. 1998 Nov 7;352(9139):1498-504.
- Background: PubMed 18970976Kappos L, Gold R, Miller DH, Macmanus DG, Havrdova E, Limmroth V, Polman CH, Schmierer K, Yousry TA, Yang M, Eraksoy M, Meluzinova E, Rektor I, Dawson KT, Sandrock AW, O'Neill GN; BG-12 Phase IIb Study Investigators. Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study. Lancet. 2008 Oct 25;372(9648):1463-72. doi: 10.1016/S0140-6736(08)61619-0.
- Background: PubMed 22992072Fox RJ, Miller DH, Phillips JT, Hutchinson M, Havrdova E, Kita M, Yang M, Raghupathi K, Novas M, Sweetser MT, Viglietta V, Dawson KT; CONFIRM Study Investigators. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1087-97. doi: 10.1056/NEJMoa1206328.
- Background: PubMed 24990854Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Meltzer L, Kurukulasuriya NC. Efficacy and safety of delayed-release dimethyl fumarate in patients newly diagnosed with relapsing-remitting multiple sclerosis (RRMS). Mult Scler. 2015 Jan;21(1):57-66. doi: 10.1177/1352458514537013. Epub 2014 Jul 2.
- Background: PubMed 22992073Gold R, Kappos L, Arnold DL, Bar-Or A, Giovannoni G, Selmaj K, Tornatore C, Sweetser MT, Yang M, Sheikh SI, Dawson KT; DEFINE Study Investigators. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med. 2012 Sep 20;367(12):1098-107. doi: 10.1056/NEJMoa1114287.
- Background: PubMed 15389896Rudick RA, Lee JC, Simon J, Ransohoff RM, Fisher E. Defining interferon beta response status in multiple sclerosis patients. Ann Neurol. 2004 Oct;56(4):548-55. doi: 10.1002/ana.20224.
- Background: PubMed 11836778Wei X, Warfield SK, Zou KH, Wu Y, Li X, Guimond A, Mugler JP 3rd, Benson RR, Wolfson L, Weiner HL, Guttmann CR. Quantitative analysis of MRI signal abnormalities of brain white matter with high reproducibility and accuracy. J Magn Reson Imaging. 2002 Feb;15(2):203-9. doi: 10.1002/jmri.10053.
- Background: PubMed 16385023Liu L, Meier D, Polgar-Turcsanyi M, Karkocha P, Bakshi R, Guttmann CR. Multiple sclerosis medical image analysis and information management. J Neuroimaging. 2005;15(4 Suppl):103S-117S. doi: 10.1177/1051228405282864.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Brigham and Women's Hospital 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 5 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: withdrawn, as of the sponsor's last update on 29 Feb 2016. 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.
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?
T2 lesion load: Rebif v. Tecfidera (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02419638, which also lists 10 linked publications.
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 29 Feb 2016.