CompletedPhase 2Relapsing MSNCT01116427

What it found

Missed its main goal

The main measure did not show a significant benefit.

MeasureEstimate95% CIp
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

GroupValueIntervalNumber analysed
Abatacept First, Then Placebo0.4 New Lesions0.9 (Standard Deviation)42
Placebo First, Then Abatacept1.7 New Lesions3.6 (Standard Deviation)20

Abatacept First, Then Placebo

0.4

Placebo First, Then Abatacept

1.7

p = 0.87

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Core Phase: Abatacept -> Placebo442 (4.5%)
Core Phase: Placebo -> Abatacept210 (0.0%)
Extension Phase: Abatacept -> Placebo372 (5.4%)
Extension Phase: Placebo -> Abatacept190 (0.0%)
Follow-up Phase: Abatacept -> Placebo294 (13.8%)
Follow-up Phase: Placebo -> Abatacept181 (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 lesions
  • Lesion Volume Accumulation on T2-weighted MRI Scans Over 24 Weeks

    Week -1 to Week 24

    MRI lesions
  • Percent Brain Volume Change

    Week -1 to Week 24

    MRI lesionsBrain volume loss
  • Mean Number of New Inflammatory Lesions in 8-week Intervals

    Week 8 to Week 24

    MRI lesions
  • Number of Participants Progressing on the EDSS Scale by at Least 1 Point

    Week -1 to Week 24

    Disability progression
  • Annualized Relapse Rate

    Week -1 to Week 24

    Relapses
  • Mean Change in the MSFC Over 24 Weeks of Treatment

    Week -1 to Week 24

    Disability progressionThinking and memoryWalking and mobilityArm and hand function
  • Mean Number of New Inflammatory MRI Lesions Per Scan During the Extension Phase

    Weeks 36 and 52

    MRI lesions
  • Lesion Volume Accumulation on T2-Weighted MRI Scans Between 24 Weeks and 52 Weeks

    Week 24 to Week 52

    MRI lesions
  • Percent 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

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Related trials

History

    1. Started

      Sept 2010

    2. Main results due

      Jun 2014

    3. Finished

      Feb 2015

    4. Results posted

      Apr 2016

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