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A Cooperative Clinical Study of Abatacept in Multiple Sclerosis (ACCLAIM)

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
abatacept
Placebo
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring MS, multiple sclerosis, relapsing-remitting multiple sclerosis, RRMS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically definite Relapsing-remitting Multiple Sclerosis (RRMS) meeting McDonald's criteria
  • Expanded Disability Status Scale (EDSS) scores between 0 and 5

  • Active disease as defined by at least one of the following criteria:

    1. One or more documented clinical exacerbations in the past year prior to visit -2
    2. One or more gadolinium (Gd)-enhanced MRI lesions in the past year
  • Willingness to forego available MS therapies
  • Ability and willingness to provide informed consent and comply with study requirements and procedures

Exclusion Criteria:

  • Normal brain MRI at week -5 scan
  • Females who are pregnant, intending pregnancy, or lactating, and unwilling to undergo pregnancy testing
  • Females who are unwilling to use approved methods of contraception for the duration of the study
  • Any chronic medical disease, other than MS, that compromises organ function
  • Active infection
  • Diagnosis of secondary or primary progressive MS
  • Previous treatment with cyclophosphamide, mitoxantrone, cladribine, or rituximab at any time
  • Previous treatment with abatacept within the last 52 weeks prior to visit -2
  • Previous treatment with systemic steroids, interferon, Copaxone, mycophenolate, or other immunosuppressive medications within the last 4 weeks prior to visit -2
  • Previous treatment with Natalizumab within the last 26 weeks prior to visit -2
  • Previous vaccination with live vaccine, or previous treatment with fingolimod, within the last 8 weeks prior to visit-2
  • Diagnosis of malignancy other than basal cell carcinoma or cervical carcinoma in situ
  • Claustrophobia or other contraindications to Gd-enhanced MRI
  • Positive for human immunodeficiency virus (HIV) serology
  • Positive for hepatitis B surface antigen (HBsAg)
  • Positive for hepatitis C virus (HCV) serology
  • Purified protein derivative (PPD)-tuberculin skin test result greater than 5 mm induration
  • Hemoglobin less than 10.5 gm/dL
  • Platelets less than 100K/µL
  • Absolute lymphocyte count less than 700 cells/μL
  • Serum creatinine greater than 1.20 mg/dL
  • eGFR (estimated glomerular filtration rate) less than 60 mL/min/1.73 m^2
  • IgG anti-cardiolipin antibody greater than 15 GPL U/mL
  • Previous participation in another interventional clinical trial within the past 4 weeks prior to visit -2
  • Allergy or sensitivity to any component of abatacept
  • The presence of any medical condition that the investigator deems incompatible with participation in the trial

Sites / Locations

  • St. Josephs Hospital and Medical Center - Barrow Neurology
  • Jordan Research and Education Institute (REDI): Alta Bates Summit Medical Center
  • University of Southern California - Keck School of Medicine
  • Newport Beach Clinical Research Associates, Inc.
  • University of California, Davis
  • University of Miami
  • South Suburban Neurology
  • Norton Neuroscience Institute - Norton Neurology Services MS Center
  • Louisiana State University
  • University of Maryland
  • Brigham & Women's Hospital
  • University of Minnesota
  • Judith Jaffe Multiple Sclerosis Center: Weill Cornell Medical College
  • University of North Carolina
  • Neurology Specialists, Inc.
  • Providence St. Vincent Medical Center
  • University of Pennsylvania
  • The Neurology Foundation, Inc.
  • Advanced Neurosciences Institute
  • Benaroya Research Institute at Virginia Mason
  • Ottawa Hospital Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Abatacept

Placebo, followed by abatacept

Arm Description

Receives abatacept during first course of treatment, switching to placebo during extension phase.

Receives a placebo for first course of treatment, switching to abatacept in the extension phase.

Outcomes

Primary Outcome Measures

Mean Number of New Inflammatory MRI Lesions Per Monthly Scans
The mean number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week -1 MRI scan . An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.

Secondary Outcome Measures

Absolute Number of New Inflammatory MRI Lesions on Monthly Scans
The absolute number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.
Lesion Volume Accumulation on T2-weighted MRI Scans Over 24 Weeks
Difference in total volume of all T2 lesions detected at Week 24 MRI scan compared to Week -1 MRI scan. A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.
Percent Brain Volume Change
Percent Brain Volume Change is a measure of brain atrophy. Brain volume was calculated from a MRI scan at Week -1 and a MRI scan at Week 24 then the percent change from Week -1 to Week 24 was calculated. A negative change score means volume decreased. A decrease in volume indicates progression of multiple sclerosis severity.
Mean Number of New Inflammatory Lesions in 8-week Intervals
The mean number of new inflammatory MRI lesions obtained on scans every 8 weeks from Week 8 to Week 24. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.
Number of Participants Progressing on the EDSS Scale by at Least 1 Point
The Expanded Disability Status Scale (EDSS) is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments. Baseline EDSS score was the lowest score observed at either visit -2 (Wk -5) or visit -1 (Wk -1). EDSS progression is defined as an increase of at least 1 point on the EDSS compared to baseline if the baseline was greater than 1.0, or 1.5 points on EDSS if baseline was less than or equal to 1.0, which persisted for a minimum of 12 weeks or was found on three consecutive EDSS assessments starting at Visit 3 (Wk 8).
Annualized Relapse Rate
The rate of multiple sclerosis relapse by year. Annualized relapse rate is calculated by dividing the total number of relapse events in the core phase in each treatment group by the total number of days participants participated in the study during the core phase. This number is then multiplied by 365.25 to get an annualized rate.
Mean Change in the MSFC Over 24 Weeks of Treatment
The Multiple Sclerosis Functional Composite (MSFC) is a three-part, standardized, quantitative assessment instrument to measure severity of multiple sclerosis. The MSFC combines three component measures to create a composite measure. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Mean change in MSFC scores from baseline to Week 24 were assessed. Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates improvement in the severity of multiple sclerosis symptoms while negative scores indicate decline in multiple sclerosis symptoms.
Mean Number of New Inflammatory MRI Lesions Per Scan During the Extension Phase
The mean number of new inflammatory MRI lesions obtained on scans at Weeks 36 and 52, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week 24 MRI scan. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.
Lesion Volume Accumulation on T2-Weighted MRI Scans Between 24 Weeks and 52 Weeks
Difference in total volume of all T2 lesions detected at Week 52 MRI scan compared to Week 24 MRI scan. A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.
Percent Brain Volume Change Between 24 Weeks and 52 Weeks
Percent Brain Volume Change is a measure of brain atrophy. Brain volume was calculated from a MRI scan at Week 24 and a MRI scan at Week 25 then the percent change from Week 24 to Week 52 was calculated. A negative change score means volume decreased. A decrease in volume indicates progression of multiple sclerosis severity.
Number of Participants Progressing on the EDSS Scale by at Least 1 Point
The Expanded Disability Status Scale (EDSS) is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments. Extension baseline EDSS score was the most recent non-missing value on or before Week 28. Only participants who scored between a 0 and a 5 at baseline were analyzed for this outcome measure. EDSS progression is defined as an increase of at least 1 point on the EDSS compared to baseline if the baseline was greater than 1.0, or 1.5 points on EDSS if baseline was less than or equal to 1.0, which persisted for a minimum of 12 weeks or was found on three consecutive EDSS assessments starting at Visit 3 (Wk 8).
Annualized Relapse in Extension Phase
The rate of multiple sclerosis relapse by year. Annualized relapse rate is calculated by dividing the total number of relapse events in the extension and follow-up phases in each treatment group by the total number of days participants participated in the study during the extension and follow-up phases. This number is then multiplied by 365.25 to get an annualized rate.
Mean Change in the MSFC in Extension Phase
The Multiple Sclerosis Functional Composite (MSFC) is a three-part, standardized, quantitative assessment instrument to measure severity of multiple sclerosis. The MSFC combines three component measures to create a composite measure. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Mean change in MSFC scores from Week 24 to Week 52 were assessed. Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates improvement in the severity of multiple sclerosis symptoms while negative scores indicate decline in multiple sclerosis symptoms.

Full Information

First Posted
May 3, 2010
Last Updated
August 3, 2016
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Immune Tolerance Network (ITN)
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1. Study Identification

Unique Protocol Identification Number
NCT01116427
Brief Title
A Cooperative Clinical Study of Abatacept in Multiple Sclerosis
Acronym
ACCLAIM
Official Title
A Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Abatacept in Adults With Relapsing-remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Immune Tolerance Network (ITN)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The ACCLAIM study is testing whether the medication "abatacept" can be of benefit to patients with relapsing-remitting multiple sclerosis (MS). Although abatacept is an investigational medication for MS, it is not a new drug. Abatacept has been approved by the FDA to treat rheumatoid arthritis.
Detailed Description
MS is a chronic autoimmune disease in which blood cells that are supposed to protect the body from infection mistakenly attack the body's own tissue. In MS, the target of this attack is a protein called myelin that coats nerves throughout the body. Damage to this protective layer can lead to loss of neurologic function. There are a number of treatments available to MS patients. Interferon beta, Copaxone, and other drugs can delay the worsening of the disease in some patients. For other patients, more aggressive treatment with chemotherapy drugs such as cyclophosphamide or azathioprine are needed. These drugs attempt to slow the disease by limiting the activity of the entire immune system. Because of this, they can often have serious side effects. This study evaluates the efficacy of abatacept in the treatment of relapsing-remitting MS. In the first phase of the study, all participants will receive 8 intravenous treatments over a period of 24 weeks. Then, if a participant remains eligible, they will enter the second phase of the study and will receive another 8 treatments over the following 24 weeks. Two-thirds (2 out of 3) of participants will receive the study drug abatacept in the first phase, and then an inactive form (placebo) of the drug in the second phase. The remaining one-third (1 in 3) will get the placebo first, then the study drug in the second phase if they remain eligible. Therefore, all participants in the ACCLAIM trial will have the opportunity to receive the study drug abatacept if they remain healthy during the study. Participants will be asked to return for a follow-up visit 12 weeks after all treatments have been completed. Regular appointments scheduled during the trial will be used to monitor participants' health and progress in the study. These appointments will include: physical and neurological exams, blood tests and motor function assessments. A total of 11 magnetic resonance imaging (MRI) procedures are scheduled during the study. The study medication and procedures related to the study will be provided at no expense to the participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
MS, multiple sclerosis, relapsing-remitting multiple sclerosis, RRMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abatacept
Arm Type
Experimental
Arm Description
Receives abatacept during first course of treatment, switching to placebo during extension phase.
Arm Title
Placebo, followed by abatacept
Arm Type
Placebo Comparator
Arm Description
Receives a placebo for first course of treatment, switching to abatacept in the extension phase.
Intervention Type
Biological
Intervention Name(s)
abatacept
Other Intervention Name(s)
Orencia®, CTLA4-Ig
Intervention Description
In core/extension phase: administered IV at weeks 0/28, 2/30, and 4/32, and then every 4 weeks until week 24/52; Dosing: less than 60 kg, 500 mg; 60-100 kg, 750 mg; or greater than 100 kg, 1 gram
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
placebo abatacept
Intervention Description
In core/extension phase: administered IV at weeks 0/28, 2/30, and 4/32, and then every 4 weeks until week 24/52
Primary Outcome Measure Information:
Title
Mean Number of New Inflammatory MRI Lesions Per Monthly Scans
Description
The mean number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week -1 MRI scan . An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.
Time Frame
Weeks 8-24
Secondary Outcome Measure Information:
Title
Absolute Number of New Inflammatory MRI Lesions on Monthly Scans
Description
The absolute number of new inflammatory MRI lesions obtained on scans every 4 weeks from Week 8 to Week 24. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.
Time Frame
Weeks 4-24
Title
Lesion Volume Accumulation on T2-weighted MRI Scans Over 24 Weeks
Description
Difference in total volume of all T2 lesions detected at Week 24 MRI scan compared to Week -1 MRI scan. A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.
Time Frame
Week -1 to Week 24
Title
Percent Brain Volume Change
Description
Percent Brain Volume Change is a measure of brain atrophy. Brain volume was calculated from a MRI scan at Week -1 and a MRI scan at Week 24 then the percent change from Week -1 to Week 24 was calculated. A negative change score means volume decreased. A decrease in volume indicates progression of multiple sclerosis severity.
Time Frame
Week -1 to Week 24
Title
Mean Number of New Inflammatory Lesions in 8-week Intervals
Description
The mean number of new inflammatory MRI lesions obtained on scans every 8 weeks from Week 8 to Week 24. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.
Time Frame
Week 8 to Week 24
Title
Number of Participants Progressing on the EDSS Scale by at Least 1 Point
Description
The Expanded Disability Status Scale (EDSS) is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments. Baseline EDSS score was the lowest score observed at either visit -2 (Wk -5) or visit -1 (Wk -1). EDSS progression is defined as an increase of at least 1 point on the EDSS compared to baseline if the baseline was greater than 1.0, or 1.5 points on EDSS if baseline was less than or equal to 1.0, which persisted for a minimum of 12 weeks or was found on three consecutive EDSS assessments starting at Visit 3 (Wk 8).
Time Frame
Week -1 to Week 24
Title
Annualized Relapse Rate
Description
The rate of multiple sclerosis relapse by year. Annualized relapse rate is calculated by dividing the total number of relapse events in the core phase in each treatment group by the total number of days participants participated in the study during the core phase. This number is then multiplied by 365.25 to get an annualized rate.
Time Frame
Week -1 to Week 24
Title
Mean Change in the MSFC Over 24 Weeks of Treatment
Description
The Multiple Sclerosis Functional Composite (MSFC) is a three-part, standardized, quantitative assessment instrument to measure severity of multiple sclerosis. The MSFC combines three component measures to create a composite measure. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Mean change in MSFC scores from baseline to Week 24 were assessed. Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates improvement in the severity of multiple sclerosis symptoms while negative scores indicate decline in multiple sclerosis symptoms.
Time Frame
Week -1 to Week 24
Title
Mean Number of New Inflammatory MRI Lesions Per Scan During the Extension Phase
Description
The mean number of new inflammatory MRI lesions obtained on scans at Weeks 36 and 52, adjusted for differences between subjects before treatment by subtracting the number of new inflammatory lesions observed from the week 24 MRI scan. An inflammatory lesion is defined as a gadolinium (Gd)-enhancing lesion that shows hyperintensity on postcontrast but no hyperintensity on noncontrast T1 images. A new inflammatory lesion is one that was not present on the previously scheduled MRI scan. If the previously scheduled MRI scan was missing, the scan was compared to the last available MRI.
Time Frame
Weeks 36 and 52
Title
Lesion Volume Accumulation on T2-Weighted MRI Scans Between 24 Weeks and 52 Weeks
Description
Difference in total volume of all T2 lesions detected at Week 52 MRI scan compared to Week 24 MRI scan. A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.
Time Frame
Week 24 to Week 52
Title
Percent Brain Volume Change Between 24 Weeks and 52 Weeks
Description
Percent Brain Volume Change is a measure of brain atrophy. Brain volume was calculated from a MRI scan at Week 24 and a MRI scan at Week 25 then the percent change from Week 24 to Week 52 was calculated. A negative change score means volume decreased. A decrease in volume indicates progression of multiple sclerosis severity.
Time Frame
Week 24 to Week 52
Title
Number of Participants Progressing on the EDSS Scale by at Least 1 Point
Description
The Expanded Disability Status Scale (EDSS) is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments. Extension baseline EDSS score was the most recent non-missing value on or before Week 28. Only participants who scored between a 0 and a 5 at baseline were analyzed for this outcome measure. EDSS progression is defined as an increase of at least 1 point on the EDSS compared to baseline if the baseline was greater than 1.0, or 1.5 points on EDSS if baseline was less than or equal to 1.0, which persisted for a minimum of 12 weeks or was found on three consecutive EDSS assessments starting at Visit 3 (Wk 8).
Time Frame
Week 24 to Week 64
Title
Annualized Relapse in Extension Phase
Description
The rate of multiple sclerosis relapse by year. Annualized relapse rate is calculated by dividing the total number of relapse events in the extension and follow-up phases in each treatment group by the total number of days participants participated in the study during the extension and follow-up phases. This number is then multiplied by 365.25 to get an annualized rate.
Time Frame
Week 24 to Week 64
Title
Mean Change in the MSFC in Extension Phase
Description
The Multiple Sclerosis Functional Composite (MSFC) is a three-part, standardized, quantitative assessment instrument to measure severity of multiple sclerosis. The MSFC combines three component measures to create a composite measure. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Mean change in MSFC scores from Week 24 to Week 52 were assessed. Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates improvement in the severity of multiple sclerosis symptoms while negative scores indicate decline in multiple sclerosis symptoms.
Time Frame
Week 24 to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically definite Relapsing-remitting Multiple Sclerosis (RRMS) meeting McDonald's criteria Expanded Disability Status Scale (EDSS) scores between 0 and 5 Active disease as defined by at least one of the following criteria: One or more documented clinical exacerbations in the past year prior to visit -2 One or more gadolinium (Gd)-enhanced MRI lesions in the past year Willingness to forego available MS therapies Ability and willingness to provide informed consent and comply with study requirements and procedures Exclusion Criteria: Normal brain MRI at week -5 scan Females who are pregnant, intending pregnancy, or lactating, and unwilling to undergo pregnancy testing Females who are unwilling to use approved methods of contraception for the duration of the study Any chronic medical disease, other than MS, that compromises organ function Active infection Diagnosis of secondary or primary progressive MS Previous treatment with cyclophosphamide, mitoxantrone, cladribine, or rituximab at any time Previous treatment with abatacept within the last 52 weeks prior to visit -2 Previous treatment with systemic steroids, interferon, Copaxone, mycophenolate, or other immunosuppressive medications within the last 4 weeks prior to visit -2 Previous treatment with Natalizumab within the last 26 weeks prior to visit -2 Previous vaccination with live vaccine, or previous treatment with fingolimod, within the last 8 weeks prior to visit-2 Diagnosis of malignancy other than basal cell carcinoma or cervical carcinoma in situ Claustrophobia or other contraindications to Gd-enhanced MRI Positive for human immunodeficiency virus (HIV) serology Positive for hepatitis B surface antigen (HBsAg) Positive for hepatitis C virus (HCV) serology Purified protein derivative (PPD)-tuberculin skin test result greater than 5 mm induration Hemoglobin less than 10.5 gm/dL Platelets less than 100K/µL Absolute lymphocyte count less than 700 cells/μL Serum creatinine greater than 1.20 mg/dL eGFR (estimated glomerular filtration rate) less than 60 mL/min/1.73 m^2 IgG anti-cardiolipin antibody greater than 15 GPL U/mL Previous participation in another interventional clinical trial within the past 4 weeks prior to visit -2 Allergy or sensitivity to any component of abatacept The presence of any medical condition that the investigator deems incompatible with participation in the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samia Khoury, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Josephs Hospital and Medical Center - Barrow Neurology
City
Phonix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Jordan Research and Education Institute (REDI): Alta Bates Summit Medical Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
University of Southern California - Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Newport Beach Clinical Research Associates, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
South Suburban Neurology
City
Flossmoor
State/Province
Illinois
ZIP/Postal Code
60422
Country
United States
Facility Name
Norton Neuroscience Institute - Norton Neurology Services MS Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Louisiana State University
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Name
Judith Jaffe Multiple Sclerosis Center: Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Neurology Specialists, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Neurology Foundation, Inc.
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Advanced Neurosciences Institute
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Benaroya Research Institute at Virginia Mason
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The plan is to share data in: 1.)ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools that are available to researchers who register online and subsequently receive DAIT approval; and 2.)TrialShare, a clinical trials research portal developed by the Immune Tolerance Network that makes data from the consortium's clinical trials publicly available without charge.
Citations:
PubMed Identifier
18794494
Citation
Viglietta V, Bourcier K, Buckle GJ, Healy B, Weiner HL, Hafler DA, Egorova S, Guttmann CR, Rusche JR, Khoury SJ. CTLA4Ig treatment in patients with multiple sclerosis: an open-label, phase 1 clinical trial. Neurology. 2008 Sep 16;71(12):917-24. doi: 10.1212/01.wnl.0000325915.00112.61.
Results Reference
background
PubMed Identifier
27481207
Citation
Khoury SJ, Rochon J, Ding L, Byron M, Ryker K, Tosta P, Gao W, Freedman MS, Arnold DL, Sayre PH, Smilek DE; ACCLAIM Study Group. ACCLAIM: A randomized trial of abatacept (CTLA4-Ig) for relapsing-remitting multiple sclerosis. Mult Scler. 2017 Apr;23(5):686-695. doi: 10.1177/1352458516662727. Epub 2016 Aug 5.
Results Reference
result
Links:
URL
http://www.niaid.nih.gov/Pages/default.aspx
Description
National Institute of Allergy and Infectious Diseases (NIAID)
URL
http://www.immunetolerance.org
Description
Immune Tolerance Network (ITN)
URL
http://www.itntrialshare.org
Description
ITN TrialShare: open public access to study level information
Available IPD and Supporting Information:
Available IPD/Information Type
Study protocol synopsis, -navigator, -schedule of assessments, study schema, and manuscript(s) with overviews, data and reports, participant level data
Available IPD/Information URL
https://www.itntrialshare.org/project/Studies/ITN035AIPRI/Study%20Data/begin.view?
Available IPD/Information Identifier
ACCLAIM ITN035AI
Available IPD/Information Comments
ACCLAIM ITN035AI is the Study Identifier in the Immune Tolerance Network (ITN) TrialShare Clinical Trials Research Portal

Learn more about this trial

A Cooperative Clinical Study of Abatacept in Multiple Sclerosis

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