NCT01456416

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

1.6 years

First QC Date

August 19, 2011

Last Update Submit

April 2, 2013

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

RRMSMultiple SclerosisGlatiramer AcetateAutoimmune ComorbiditiesPsoriasisAutoimmune ThyroiditisVasculitisRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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.

    Comparison of CGI-1 score pre- and post-treatment.at 6 months.

Secondary Outcomes (3)

  • Secondary objectives include Visual Analog Scale (VAS).

    Secondary objective will be done at Baseline, Mo 3, Mo 6.

  • Secondary objectives include Expanded Disability Status Scale (EDSS)

    Secondary objective will be done at Baseline, Mo 3, Mo 6.

  • Secondary objectives include concomitant medication review.

    Secondary objective will be done at Baseline, Mo 3, Mo 6.

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All Subjects meeting inclusion/exclusion criteria.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC MS Comprehensive Care Center & Research Group

Los Angeles, California, 90033, United States

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple SclerosisPsoriasisThyroiditis, AutoimmuneVasculitisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesThyroiditisThyroid DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue Diseases

Study Officials

  • Regina Berkovich, M.D.Ph.D

    LAC+USC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2011

First Posted

October 20, 2011

Study Start

September 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

US(1)