Relapsing Remitting Multiple SclerosisNCT01456416
Glatiramer Acetate for Multiple Sclerosis With Autoimmune Comorbidities
An observational study of Relapsing Remitting Multiple Sclerosis, run by University of Southern California at 1 site in United States.
Trial summary
The incidence of autoimmune conditions is at least 2-3 times higher in Multiple Sclerosis population than in general population. These MS patients category response unfavorably to the Interferon. The investigators suggest that autoimmune co morbidity can serve as a biological marker predicting good response to GA. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Apr 2013
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: All Subjects meeting inclusion/exclusion criteria.
Who may be able to join
- Clinically definite multiple sclerosis defined by McDonald Criteria.
- Between 18-60 years of age.
- Subject must able to understand and sign the IRB- approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol.
- Subjects who are women of childbearing potential, must have a negative serum pregnancy test at the screening visit, and must be willing to practice a reliable birth-control method.
- Subjects must have officially diagnosed and documented co-morbid, other than MS, autoimmune condition (psoriasis, vasculitis, thyroiditis or rheumatoid arthritis).
- At the time of enrollment patients were on beta IFN (Avonex, Betaseron or Rebif) treatment for at least 3 months.
Who cannot join
- Women who are either pregnant or breastfeeding, and women of child-bearing potential (defined as not surgically sterile or at least two years postmenopausal) who are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
- Any clinically significant general health conditions that may interfere with the trial participation.
- Subject has a history of drug or alcohol abuse within the past year.
- Subject had corticosteroid treatment within last 90 days.
- Subject started new medication within last 30 days.
- Subject is a participant in another research project.
- Subject has contraindications for GA treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC MS Comprehensive Care Center & Research Group
Los Angeles, California, 90033
About this study
Official title: Pilot Study for Evaluation of Glatiramer Acetate in RRMS Patients With Comorbid Autoimmune Conditions
The incidence of autoimmune conditions is at least 2-3 times higher in Multiple Sclerosis population than in general population. These MS patients category response unfavorably to the Interferon. The investigators suggest that autoimmune co morbidity can serve as a biological marker predicting good response to GA.
Read the detailed description
Multiple Sclerosis (MS) is an auto-immune neurodegenerative disease that affects more than 400,000 individuals in the United States, and 2.5 million worldwide (www.nationalmssociety.org). The main pathogenic mechanism in MS involves an inflammatory condition that damages the myelin of the central nervous system (CNS), resulting in axonal damage and neurological impairment, often leading to severe disability. MS is one of the most common causes of neurological disability in young and middle-aged adult individuals, and as such has a tremendous physical, psychological and social impact on patients' lives. MS is a complex disease diagnosed by McDonald criteria with different clinical and pathological phenotypes. Several forms of MS have been described: Relapsing-Remitting (RRMS), Secondary-Progressive MS (SPMS), Progressive-Relapsing MS (PRMS), and Primary-Progressive MS (PPMS).
Glatiramer Acetate (GA) and Beta-Interferons (β-IFNs) are well established first-line immunomodulating treatment options for relapsing remitting multiple sclerosis (RRMS) with excellent safety profiles. The mechanisms of action of GA and IFNs are different. It is well known that in general Disease-Modifying Treatments (DMTs) reduce relapse rate in more than half of the multiple sclerosis (MS) patients who receive DMT, while having little if any effect on the rest. It has been speculated that the response to beta-interferons or GA may have genetic basis. As Axtell RC et al. indicated the experimental autoimmune encephalomyeilits (EAE) in mouse caused by TH1 cells generally respond well to interferon-beta, while EAE caused by TH17 cells get worse with interferon-beta.
Autoimmune disease is an extreme situation where the autoimmune response overshoots and goes out of control. The other extreme is a degenerative disorder, where the autoimmune response is not strong enough for effective protection, and degeneration therefore continues. GA being an immunomodulator may provide both properly regulated immune suppression (in the case of autoimmune disease) and properly regulated immune activation (in the case of the neurodegenerative disease).
Autoimmune conditions cluster in families with high risk for multiple sclerosis than in general population which suggests that the disease might arise on a background of a generalized susceptibility to autoimmunity. Occurrence of psoriasis, autoimmune thyroiditis, vasculitis, rheumatoid arthritis, scleroderma, lupus are seen more commonly in MS patients. Many of these patients initially get started on beta-IFNs, and usually do not do well on them. According to Investigator's and the USC MS Comprehensive Care Center experience, autoimmune co-morbidity associated with MS can serve as a biological marker predicting good response to GA and unfavorable response to the IFNs.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- RRMS, Multiple Sclerosis, Glatiramer Acetate, Autoimmune Comorbidities, Psoriasis, Autoimmune Thyroiditis, Vasculitis, Rheumatoid Arthritis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Psoriasis, Thyroiditis, Autoimmune, Vasculitis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glatiramer Acetate | GA administered SQ daily in MS patients who met all Inclusion-Exclusion Criteria and were approved by their Health Care Plans for GA treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Clinical Global Impression Scale (CGI-1).
The primary objective is to determine whether daily GA injections do not aggravate comorbid autoimmune conditions.
Measured: Comparison of CGI-1 score pre- and post-treatment.at 6 months.
Secondary outcomes (3)
Secondary objectives include Visual Analog Scale (VAS).
Comparison of VAS data pre- and post-treatment (Baseline, Mo 3, Mo 6).
Measured: Secondary objective will be done at Baseline, Mo 3, Mo 6.
Secondary objectives include Expanded Disability Status Scale (EDSS)
Comparison of EDSS score pre- and post-treatment (Baseline, Mo 3, Mo 6).
Measured: Secondary objective will be done at Baseline, Mo 3, Mo 6.
Secondary objectives include concomitant medication review.
Comparison/review of Concomitant Medications used for co-morbid condition treatment (Baseline, Mo 3, Mo 6).
Measured: Secondary objective will be done at Baseline, Mo 3, Mo 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Responsible party
- Sponsor
- Investigators
- Regina Berkovich, M.D.Ph.D, Principal investigator, LAC+USC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456416
- Sponsor's protocol ID
- GAforMS with AutoimmuneComor
- Status last verified
- Apr 2013
- First submitted
- 19 Aug 2011
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1. McDonald, W.I., et al., 2001. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol, 2001. 50(1): p. 121-7. 2. Axtell RC, de Jong BA, Raman C,et al. T helper type 1 and 17 cells determine efficacy of interferon beta in multiple sclerosis and experimental encephalomyelitis. Nat Med 2010; 16(4):406-412. E-pub 2010 Mar 28. 3. Howard L. Weiner, MD, Multiple Sclerosis Is an Inflammatory T-Cell-Mediated Autoimmune Disease, Arch Neurol. 2004; 61:1613-1615. 4. Teitelbaum, D., A. Meshorer, T. Hirshfeld, R. Arnon, and M. Sela. 1971. Suppression of experimental allergic encephalomyelitis by a synthetic polypeptide. Eur. J. Immunol. 1:242. 5. Ben-Nun, A., I. Mendel, R. Bakimer, M. Fridkis-Hareli, D. Teitelbaum, R. Arnon, M. Sela, and N. Kerlero de Rosbo. 1996. The autoimmune reactivity to myelin oligodendrocyte glycoprotein (MOG) in multiple sclerosis is potentially pathogenic: effect of copolymer 1 on MOG-induced disease. J. Neurol.243:S14. 6. Jonathan Kipnis and Michal Schwartz, Dual action of glatiramer acetate (Cop-1) in the treatment of CNS autoimmune and neurodegenerative disorders, Trends in Molecular Medicine, Volume 8, Issue 7, 319-323, 1 July 2002, doi:10.1016/S1471-4914(02)02373-0 7. Lisa F Barcellos, Brinda B Kamdar, Patricia P Ramsay, Cari DeLoa, Robin R Lincoln, Stacy Caillier, Silke Schmidt, Jonathan L Haines, Margaret A Pericak-Vance, Jorge R Oksenberg, Stephen L Hause, Clustering of autoimmune diseases in families with a high-risk for multiple sclerosis: a descriptive study, Lancet Neurol 2006; 5: 924-31
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Evaluation of Glatiramer Acetate in RRMS Patients With Comorbid Autoimmune Conditions
- ClinicalTrials.gov ID
- NCT01456416
- Acronym / sponsor ID
- GAforMS with AutoimmuneComor
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- RRMS, Multiple Sclerosis, Glatiramer Acetate, Autoimmune Comorbidities, Psoriasis, Autoimmune Thyroiditis, Vasculitis, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Teva Pharmaceuticals USA
- Study start
- Sep 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 Oct 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.
The incidence of autoimmune conditions is at least 2-3 times higher in Multiple Sclerosis population than in general population. These MS patients category response unfavorably to the Interferon. The investigators suggest that autoimmune co morbidity can serve as a biological marker predicting good response to GA.
Detailed description
Multiple Sclerosis (MS) is an auto-immune neurodegenerative disease that affects more than 400,000 individuals in the United States, and 2.5 million worldwide (www.nationalmssociety.org). The main pathogenic mechanism in MS involves an inflammatory condition that damages the myelin of the central nervous system (CNS), resulting in axonal damage and neurological impairment, often leading to severe disability. MS is one of the most common causes of neurological disability in young and middle-aged adult individuals, and as such has a tremendous physical, psychological and social impact on patients' lives. MS is a complex disease diagnosed by McDonald criteria with different clinical and pathological phenotypes. Several forms of MS have been described: Relapsing-Remitting (RRMS), Secondary-Progressive MS (SPMS), Progressive-Relapsing MS (PRMS), and Primary-Progressive MS (PPMS).
Glatiramer Acetate (GA) and Beta-Interferons (β-IFNs) are well established first-line immunomodulating treatment options for relapsing remitting multiple sclerosis (RRMS) with excellent safety profiles. The mechanisms of action of GA and IFNs are different. It is well known that in general Disease-Modifying Treatments (DMTs) reduce relapse rate in more than half of the multiple sclerosis (MS) patients who receive DMT, while having little if any effect on the rest. It has been speculated that the response to beta-interferons or GA may have genetic basis. As Axtell RC et al. indicated the experimental autoimmune encephalomyeilits (EAE) in mouse caused by TH1 cells generally respond well to interferon-beta, while EAE caused by TH17 cells get worse with interferon-beta.
Autoimmune disease is an extreme situation where the autoimmune response overshoots and goes out of control. The other extreme is a degenerative disorder, where the autoimmune response is not strong enough for effective protection, and degeneration therefore continues. GA being an immunomodulator may provide both properly regulated immune suppression (in the case of autoimmune disease) and properly regulated immune activation (in the case of the neurodegenerative disease).
Autoimmune conditions cluster in families with high risk for multiple sclerosis than in general population which suggests that the disease might arise on a background of a generalized susceptibility to autoimmunity. Occurrence of psoriasis, autoimmune thyroiditis, vasculitis, rheumatoid arthritis, scleroderma, lupus are seen more commonly in MS patients. Many of these patients initially get started on beta-IFNs, and usually do not do well on them. According to Investigator's and the USC MS Comprehensive Care Center experience, autoimmune co-morbidity associated with MS can serve as a biological marker predicting good response to GA and unfavorable response to the IFNs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glatiramer Acetate | – | –GA administered SQ daily in MS patients who met all Inclusion-Exclusion Criteria and were approved by their Health Care Plans for GA treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All Subjects meeting inclusion/exclusion criteria.
Key inclusion criteria (6 listed)
- Clinically definite multiple sclerosis defined by McDonald Criteria.
- Between 18-60 years of age.
- Subject must able to understand and sign the IRB- approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol.
- Subjects who are women of childbearing potential, must have a negative serum pregnancy test at the screening visit, and must be willing to practice a reliable birth-control method.
- Subjects must have officially diagnosed and documented co-morbid, other than MS, autoimmune condition (psoriasis, vasculitis, thyroiditis or rheumatoid arthritis).
Key exclusion criteria (7 listed)
- Women who are either pregnant or breastfeeding, and women of child-bearing potential (defined as not surgically sterile or at least two years postmenopausal) who are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner.
- Any clinically significant general health conditions that may interfere with the trial participation.
- Subject has a history of drug or alcohol abuse within the past year.
- Subject had corticosteroid treatment within last 90 days.
- Subject started new medication within last 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in Clinical Global Impression Scale (CGI-1).
Time frame: Comparison of CGI-1 score pre- and post-treatment.at 6 months.
The primary objective is to determine whether daily GA injections do not aggravate comorbid autoimmune conditions.
3 secondary outcomes
Secondary objectives include Visual Analog Scale (VAS).
Time frame: Secondary objective will be done at Baseline, Mo 3, Mo 6.
Secondary objectives include Expanded Disability Status Scale (EDSS)
Time frame: Secondary objective will be done at Baseline, Mo 3, Mo 6.
Secondary objectives include concomitant medication review.
Time frame: Secondary objective will be done at Baseline, Mo 3, Mo 6.
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 4 Apr 2013.
- Background1. McDonald, W.I., et al., 2001. Recommended diagnostic criteria for multiple sclerosis: guidelines from the International Panel on the diagnosis of multiple sclerosis. Ann Neurol, 2001. 50(1): p. 121-7. 2. Axtell RC, de Jong BA, Raman C,et al. T helper type 1 and 17 cells determine efficacy of interferon beta in multiple sclerosis and experimental encephalomyelitis. Nat Med 2010; 16(4):406-412. E-pub 2010 Mar 28. 3. Howard L. Weiner, MD, Multiple Sclerosis Is an Inflammatory T-Cell-Mediated Autoimmune Disease, Arch Neurol. 2004; 61:1613-1615. 4. Teitelbaum, D., A. Meshorer, T. Hirshfeld, R. Arnon, and M. Sela. 1971. Suppression of experimental allergic encephalomyelitis by a synthetic polypeptide. Eur. J. Immunol. 1:242. 5. Ben-Nun, A., I. Mendel, R. Bakimer, M. Fridkis-Hareli, D. Teitelbaum, R. Arnon, M. Sela, and N. Kerlero de Rosbo. 1996. The autoimmune reactivity to myelin oligodendrocyte glycoprotein (MOG) in multiple sclerosis is potentially pathogenic: effect of copolymer 1 on MOG-induced disease. J. Neurol.243:S14. 6. Jonathan Kipnis and Michal Schwartz, Dual action of glatiramer acetate (Cop-1) in the treatment of CNS autoimmune and neurodegenerative disorders, Trends in Molecular Medicine, Volume 8, Issue 7, 319-323, 1 July 2002, doi:10.1016/S1471-4914(02)02373-0 7. Lisa F Barcellos, Brinda B Kamdar, Patricia P Ramsay, Cari DeLoa, Robin R Lincoln, Stacy Caillier, Silke Schmidt, Jonathan L Haines, Margaret A Pericak-Vance, Jorge R Oksenberg, Stephen L Hause, Clustering of autoimmune diseases in families with a high-risk for multiple sclerosis: a descriptive study, Lancet Neurol 2006; 5: 924-31
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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.
Regina Berkovich, M.D.Ph.D principal investigator
LAC+USC
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 Relapsing Remitting Multiple Sclerosis, run by University of Southern California 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 6 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 4 Apr 2013. 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 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?
Change from Baseline in Clinical Global Impression Scale (CGI-1). (time frame: Comparison of CGI-1 score pre- and post-treatment.at 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 NCT01456416, which also lists 1 linked publication.
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 4 Apr 2013.