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Study to Evaluate Early Glatiramer Acetate Treatment in Delaying Conversion to CDMS of Subjects Presenting With CIS (PreCISe)
This study has been completed.

First Received on April 22, 2008.   Last Updated on April 4, 2011   History of Changes
Sponsor: Teva Pharmaceutical Industries
Information provided by: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT00666224
  Purpose

The primary objective is to assess the effect of treatment with glatiramer acetate (GA) compared to placebo on the time to conversion to CDMS, as determined by Poser criteria (the occurrence of the second clinical attack) during the double-blind phase. The secondary objective is to assess, within the time frame of the up to 3-year placebo-controlled study period, the effect of GA on clinical and MRI parameters. The long-term objective of the study is to assess, within the time frame of 5 years, the neuroprotective effect of early versus delayed treatment with GA as reflected by clinical and MRI parameters measuring the accumulated irreversible brain tissue damage.


Condition Intervention Phase
Multiple Sclerosis
Drug: Glatiramer Acetate
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Effect of Early Glatiramer Acetate Treatment in Delaying the Conversion to CDMS of Subjects Presenting With CIS

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • The primary objective is to assess the effect of treatment with glatiramer acetate (GA) compared to placebo on the time to conversion to CDMS, as determined by Poser criteria (the occurrence of the second clinical attack) during the double-blind phase. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objective is to assess, within the time frame of the up to 3-year placebo-controlled study period, the effect of GA on clinical and MRI parameters. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Enrollment: 482
Study Start Date: January 2004
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Glatiramer acetate 20 mg once daily by subcutaneous route injection.
Drug: Glatiramer Acetate
Injection, 20mg, once daily,for 36 months
Placebo Comparator: 2
Matching placebo once daily by subcutaneous route injection.
Drug: Placebo
injection, once daily,for 36 months or until conversion to CDMS

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject must have undergone a single clinical attack.
  2. The subject must have a unifocal clinical presentation.
  3. The subject should be enrolled within the period of 90 days after onset of a single unifocal clinical attack (index attack).
  4. There must be 2 or more cerebral lesions highly suspicious of MS on the screening MRI, measuring 6mm or more in diameter.
  5. Subjects must be between the ages of 18 and 45 years inclusive.
  6. Subjects must not have taken corticosteroids (IV, IM and/or PO) within the 30 days prior to the MRI at the baseline visit.
  7. Subjects may be male or female. Women of child-bearing potential must practice a medically acceptable method of birth control. Acceptable methods include oral contraceptive, contraceptive patch, long-acting injectable contraceptive, or double-barrier method (condom or IUD with spermicide).
  8. The subjects must be willing and able to give written informed consent, prior to entering the study.

Exclusion Criteria:

  1. Multifocal clinical presentation.
  2. Diseases other than MS responsible for the clinical/MRI presentation. The following laboratory tests must be part of the subject's medical history for differential diagnosis of CIS: ESR, ANA, complement (C3, C4) and anticardiolipin IgG - IgM. In the event that the results of these tests are inconclusive, the following additional tests may be requested by the Eligibility Evaluation Committee: syphilis screening, vitamin B12 and folic acid. In the case of spinal cord CIS presentation, a spinal cord MRI is required for confirmation of diagnosis in the medical history of the subject.
  3. Use of experimental or investigational drugs, including IV immunoglobulin, and/or participation in an investigational drug study within 6 months prior to study entry.
  4. Use of interferon agents within 6 months prior to the screening visit.
  5. Chronic corticosteroid (IV, IM and/or PO) treatment (more than 30 consecutive days) in the 6 months prior to study entry.
  6. Pregnancy or breast feeding.
  7. Subjects who experience a relapse between the screening (month -1) and baseline (month 0) visits.
  8. Life-threatening or other clinically significant disease.
  9. A medical or psychiatric condition that affects the subject's ability to give informed consent, or to complete the study, or if the subject is considered by the treating neurologist/physician to be, for any other reason, an unsuitable candidate for this study.
  10. A known history of sensitivity to mannitol.
  11. A known history of sensitivity to gadolinium.
  12. Inability to successfully undergo MRI scanning.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666224

  Show 97 Study Locations
Sponsors and Collaborators
Teva Pharmaceutical Industries
  More Information

Publications:
Responsible Party: Siyu Liu, Vice President, North American IR&D and Head of Global Clinical Operations, Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT00666224     History of Changes
Other Study ID Numbers: GA 9010
Study First Received: April 22, 2008
Last Updated: April 4, 2011
Health Authority: United States: Food and Drug Administration;   European Union: European Medicines Agency

Keywords provided by Teva Pharmaceutical Industries:
Clinically Definite Multiple Sclerosis
Clinically Isolated Syndrome
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 09, 2012