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Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)

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ClinicalTrials.gov Identifier: NCT01963611
Recruitment Status : Terminated (Study was terminated based on sponsor discretion.)
First Posted : October 16, 2013
Results First Posted : May 11, 2016
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
EMD Serono

Brief Summary:
This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: Plovamer acetate 0.5 milligram (mg) Drug: Copaxone 20 mg Drug: Plovamer acetate 3 mg Drug: Plovamer acetate 10 mg Drug: Plovamer acetate 20 mg Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Multi-center, Parallel-group, Rater-blinded Study to Evaluate the Efficacy, Safety and Tolerability of 0.5 mg, 3 mg, 10 mg and 20 mg Plovamer Acetate Doses Compared to Copaxone in Patients With Relapsing Remitting Multiple Sclerosis
Study Start Date : October 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Plovamer acetate 0.5 milligram (mg)
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Drug: Plovamer acetate 0.5 milligram (mg)
Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

Experimental: Plovamer acetate 3 mg
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Drug: Plovamer acetate 3 mg
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

Experimental: Plovamer acetate 10 mg
Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
Drug: Plovamer acetate 10 mg
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.

Experimental: Plovamer acetate 20 mg
Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
Drug: Plovamer acetate 20 mg
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.

Active Comparator: Copaxone 20 mg
Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
Drug: Copaxone 20 mg
Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.




Primary Outcome Measures :
  1. Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan [ Time Frame: Baseline , Week 12, 24, 28, 32, 36, 40 ]
    Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions per Subject and Scan was calculated using 5 serial magnetic resonance imaging (MRI) scans.


Secondary Outcome Measures :
  1. Mean Annualized Relapse Rate (ARR) [ Time Frame: Baseline up to Week 40 ]
    Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0. Annualized Relapse Rate was calculated as = 365.25 x (Number of relapses during Treatment Period) per (Number of days on treatment during Treatment Period).

  2. Percentage of Subjects Remaining Relapse-Free [ Time Frame: Baseline up to Week 40 ]
    Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.

  3. Mean Number of New T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan [ Time Frame: Weeks 12, 24, 28, 32, 36, 40 ]
    T1 Gd-enhancing lesions per subject and scan was measured using 5 serial MRI scans.

  4. Mean Number of New or Enlarging Time Constant 2 (T2) Lesions Per Subject and Scan [ Time Frame: Weeks 12, 24, 28, 32, 36,40 ]
    New or enlarging Time Constant 2 (T2) lesions per subject and scan was calculated using 5 serial MRI scans.

  5. Mean Number of New, Unenhancing T1 Lesions (Black Holes) Per Subject and Scan [ Time Frame: Weeks 12, 24, 28, 32, 36, 40 ]
    New, unenhancing T1 lesions (Black Holes) per subject and scan was calculated using 5 Serial MRIs.

  6. Mean Change From Baseline in Volume of T1 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan [ Time Frame: Baseline, Weeks 12, 24, 28, 32, 36, 40 ]
    Change from baseline in volume of T1 Gd-enhancing lesions per subject was calculated using 5 Serial MRI Scans.

  7. Mean Change From Baseline in Volume of T2 Gadolinium (Gd)-Enhancing Lesions Per Subject and Scan [ Time Frame: Baseline, Weeks 12, 24, 28, 32, 36, 40 ]
    Change from baseline per subjects in volume of T2 Gd-enhancing lesions was calculated using 5 series MRI scan.

  8. Time to First Relapse [ Time Frame: Baseline up to Week 40 ]
    Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by the patient and must be accompanied by at least one of the following: An increase of greater than or equal to (>=) 1 grade in >=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of >=2 grades in 1 functional scale of the EDSS or an increase of >= 0.5 or an increase of >=1.0 in EDSS if the previous EDSS was 0.

  9. Mean Change From Baseline in Brain Volume Per Subject [ Time Frame: Baseline, Weeks 24, 28, 32, 36, 40 ]
    Change from baseline in brain volume per subject was calculated using 5 series MRI scan.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, between the ages of 18 and 60 years
  • Subject is able to learn and self-administer subcutaneous injections (a care-giver may be trained to inject the subject)
  • Subjects must have a current diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS) (according to the 2010 McDonald MS diagnostic criteria)
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Any multiple sclerosis categorized as primary progressive, secondary progressive or progressive relapsing
  • Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for MRI
  • Any requirement for continuous systemic glucocorticoid administration during the trial period. (Note: Treatment with interferons such as Avonex®, Rebif®, or Betaseron® will be allowed until the baseline visit, as no wash-out period is needed)
  • Contraindication to Copaxone use
  • Other protocol defined exclusion criteria could apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963611


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Sponsors and Collaborators
EMD Serono
Investigators
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Study Director: Medical Responsible EMD Serono, Inc., Billerica MA, a subsidiary of Merck KGaA, Darmstadt, Germany

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Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01963611     History of Changes
Other Study ID Numbers: EMR200575-001
2013-002283-25 ( EudraCT Number )
First Posted: October 16, 2013    Key Record Dates
Results First Posted: May 11, 2016
Last Update Posted: May 11, 2016
Last Verified: April 2016

Keywords provided by EMD Serono:
Multiple Sclerosis
Relapsing Remitting
Plovamer acetate
Copaxone

Additional relevant MeSH terms:
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Glatiramer Acetate
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
(T,G)-A-L
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents