Multiple Sclerosis, Relapsing-RemittingPhase 2ACCLAIMNCT01116427
A Cooperative Clinical Study of Abatacept in Multiple Sclerosis
A Phase 2 study testing abatacept in people with Multiple Sclerosis, Relapsing-Remitting, run by National Institute of Allergy and Infectious Diseases (NIAID) at 21 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Sep 2010to Feb 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
United States20 sites
University of Maryland
Baltimore, Maryland, 21201
Jordan Research and Education Institute (REDI): Alta Bates Summit Medical Center
Berkeley, California, 94705
Brigham & Women's Hospital
Boston, Massachusetts, 02115
University of North Carolina
Chapel Hill, North Carolina, 27514
Neurology Specialists, Inc.
Dayton, Ohio, 45417
South Suburban Neurology
Flossmoor, Illinois, 60422
Advanced Neurosciences Institute
Franklin, Tennessee, 37064
University of Southern California - Keck School of Medicine
Los Angeles, California, 90033
Norton Neuroscience Institute - Norton Neurology Services MS Center
Louisville, Kentucky, 40207
University of Miami
Miami, Florida, 33136
University of Minnesota
Minneapolis, Minnesota, 55414
Judith Jaffe Multiple Sclerosis Center: Weill Cornell Medical College
New York, New York, 10065
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, 92663
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
St. Josephs Hospital and Medical Center - Barrow Neurology
Phonix, Arizona, 85013
Providence St. Vincent Medical Center
Portland, Oregon, 97225
The Neurology Foundation, Inc.
Providence, Rhode Island, 02905
University of California, Davis
Sacramento, California, 95817
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101
Louisiana State University
Shreveport, Louisiana, 71130
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- abatacept, Placebo
- Keywords
- MS, multiple sclerosis, relapsing-remitting multiple sclerosis, RRMS
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abataceptBiological
Also called Orencia®, CTLA4-Ig
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
PlaceboDrug
Also called placebo abatacept
In core/extension phase: administered IV at weeks 0/28, 2/30, and 4/32, and then every 4 weeks until week 24/52
| Study group | Role | What they receive |
|---|---|---|
| Abatacept | Experimental | Receives abatacept during first course of treatment, switching to placebo during extension phase. Receives: Biological: abatacept; Drug: Placebo |
| Placebo, followed by abatacept | Placebo comparator | Receives a placebo for first course of treatment, switching to abatacept in the extension phase. Receives: Biological: abatacept; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weeks 8-24
Secondary outcomes (13)
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.
Measured: Weeks 4-24
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.
Measured: Week -1 to Week 24
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.
Measured: Week -1 to Week 24
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.
Measured: Week 8 to Week 24
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).
Measured: Week -1 to Week 24
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.
Measured: Week -1 to Week 24
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.
Measured: Week -1 to Week 24
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.
Measured: Weeks 36 and 52
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.
Measured: Week 24 to Week 52
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.
Measured: Week 24 to Week 52
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).
Measured: Week 24 to Week 64
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.
Measured: Week 24 to Week 64
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.
Measured: Week 24 to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Responsible party
- Sponsor
- Investigators
- Samia Khoury, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116427
- Sponsor's protocol ID
- DAIT ITN035AI
- Acronym
- ACCLAIM
- Status last verified
- Aug 2016
- First submitted
- 3 May 2010
- Last updated
- 15 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 18794494Khoury 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.
PubMed 27481207
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01116427
- Acronym / sponsor ID
- ACCLAIM / DAIT ITN035AI
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- MS, multiple sclerosis, relapsing-remitting multiple sclerosis, RRMS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN)
- Study start
- Sep 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Posted 8 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abatacept | Experimental | Biological: abatacept, Drug: PlaceboReceives abatacept during first course of treatment, switching to placebo during extension phase. |
| Placebo, followed by abatacept | Placebo comparator | Biological: abatacept, Drug: PlaceboReceives a placebo for first course of treatment, switching to abatacept in the extension phase. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Willingness to forego available MS therapies
- Ability and willingness to provide informed consent and comply with study requirements and procedures
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abataceptAlso: Orencia®, CTLA4-IgIn 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 | Biological | Abatacept, Placebo, followed by abatacept |
| PlaceboAlso: placebo abataceptIn core/extension phase: administered IV at weeks 0/28, 2/30, and 4/32, and then every 4 weeks until week 24/52 | Drug | Abatacept, Placebo, followed by abatacept |
Primary outcome
Mean Number of New Inflammatory MRI Lesions Per Monthly Scans
Time frame: Weeks 8-24
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.
13 secondary outcomes
Absolute Number of New Inflammatory MRI Lesions on Monthly Scans
Time frame: Weeks 4-24
Lesion Volume Accumulation on T2-weighted MRI Scans Over 24 Weeks
Time frame: Week -1 to Week 24
Percent Brain Volume Change
Time frame: Week -1 to Week 24
Mean Number of New Inflammatory Lesions in 8-week Intervals
Time frame: Week 8 to Week 24
Number of Participants Progressing on the EDSS Scale by at Least 1 Point
Time frame: Week -1 to Week 24
Annualized Relapse Rate
Time frame: Week -1 to Week 24
Mean Change in the MSFC Over 24 Weeks of Treatment
Time frame: Week -1 to Week 24
Mean Number of New Inflammatory MRI Lesions Per Scan During the Extension Phase
Time frame: Weeks 36 and 52
Lesion Volume Accumulation on T2-Weighted MRI Scans Between 24 Weeks and 52 Weeks
Time frame: Week 24 to Week 52
Percent Brain Volume Change Between 24 Weeks and 52 Weeks
Time frame: Week 24 to Week 52
Number of Participants Progressing on the EDSS Scale by at Least 1 Point
Time frame: Week 24 to Week 64
Annualized Relapse in Extension Phase
Time frame: Week 24 to Week 64
Mean Change in the MSFC in Extension Phase
Time frame: Week 24 to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18794494Viglietta 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 publication: PubMed 27481207Khoury 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.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Immune Tolerance Network (ITN)Link provided by the sponsor.
- ITN TrialShare: open public access to study level informationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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.
Samia Khoury, MD principal investigator
Brigham and Women's Hospital
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing abatacept in people with Multiple Sclerosis, Relapsing-Remitting, run by National Institute of Allergy and Infectious Diseases (NIAID) at 21 sites in 2 countries.
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 7 inclusion and 26 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 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Number of New Inflammatory MRI Lesions Per Monthly Scans (time frame: Weeks 8-24). 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 NCT01116427, which also lists 2 linked publications.
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 15 Sep 2016; AzTrials last refreshed its copy on 7 Nov 2026.