ACCLAIM
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Mean Number of New Inflammatory MRI Lesions Per Monthly Scans | 0.87 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Abatacept
T-lymphocyte activation antigen CD80 inhibitor|T-lymphocyte activation antigen CD86 inhibitor
Placebo or sham
- Placebo
Results by group
Mean Number of New Inflammatory MRI Lesions Per Monthly Scans
Weeks 8-24
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Abatacept First, Then Placebo | 0.4 New Lesions | 0.9 (Standard Deviation) | 42 |
| Placebo First, Then Abatacept | 1.7 New Lesions | 3.6 (Standard Deviation) | 20 |
Abatacept First, Then Placebo
Placebo First, Then Abatacept
p = 0.87
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Core Phase: Abatacept -> Placebo | 44 | 2 (4.5%) | |
| Core Phase: Placebo -> Abatacept | 21 | 0 (0.0%) | |
| Extension Phase: Abatacept -> Placebo | 37 | 2 (5.4%) | |
| Extension Phase: Placebo -> Abatacept | 19 | 0 (0.0%) | |
| Follow-up Phase: Abatacept -> Placebo | 29 | 4 (13.8%) | |
| Follow-up Phase: Placebo -> Abatacept | 18 | 1 (5.6%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Mean Number of New Inflammatory MRI Lesions Per Monthly Scans
Weeks 8-24
MRI lesions
Other measures (13)
Absolute Number of New Inflammatory MRI Lesions on Monthly Scans
Weeks 4-24
MRI lesionsLesion Volume Accumulation on T2-weighted MRI Scans Over 24 Weeks
Week -1 to Week 24
MRI lesionsPercent Brain Volume Change
Week -1 to Week 24
MRI lesionsBrain volume lossMean Number of New Inflammatory Lesions in 8-week Intervals
Week 8 to Week 24
MRI lesionsNumber of Participants Progressing on the EDSS Scale by at Least 1 Point
Week -1 to Week 24
Disability progressionAnnualized Relapse Rate
Week -1 to Week 24
RelapsesMean Change in the MSFC Over 24 Weeks of Treatment
Week -1 to Week 24
Disability progressionThinking and memoryWalking and mobilityArm and hand functionMean Number of New Inflammatory MRI Lesions Per Scan During the Extension Phase
Weeks 36 and 52
MRI lesionsLesion Volume Accumulation on T2-Weighted MRI Scans Between 24 Weeks and 52 Weeks
Week 24 to Week 52
MRI lesionsPercent Brain Volume Change Between 24 Weeks and 52 Weeks
Week 24 to Week 52
MRI lesionsBrain volume loss
Who could take part
Relapsing MS · 18 to 65
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Abatacept Targets T Follicular Helper and Regulatory T Cells, Disrupting Molecular Pathways That Regulate Their Proliferation and Maintenance.J Immunol · 2019
Results
ACCLAIM: A randomized trial of abatacept (CTLA4-Ig) for relapsing-remitting multiple sclerosis.Mult Scler · 2017
Background
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.
Loading reviews and guidelines…
Related trials
- LTS18002
Phase 3 · Not yet recruiting
Still running
- FREXALT
Phase 3 · Running, not recruiting
Still running
- LITMUS
Not a drug-phase study · Completed (inferred)
Results posted, no main test reported
- Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with RMS
Phase 2 · Stopped early
Stopped early
- SUSTAIN
Phase 3 · Stopped early
Stopped early
- ZEUS
Not a drug-phase study · Stopped
Stopped early
History
Started
Sept 2010
Main results due
Jun 2014
Finished
Feb 2015
Results posted
Apr 2016
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error