Phase 2 Completed N=65 Randomized Triple-blind Treatment

A Cooperative Clinical Study of Abatacept in Multiple Sclerosis

Multiple Sclerosis, Relapsing-Remitting

Source: ClinicalTrials.gov NCT01116427 ↗

Enrolled (actual)

Serious AEs

5.4%

Results posted

Apr 2016

Primary outcomePrimary: Mean Number of New Inflammatory MRI Lesions Per Monthly Scans — 0.4; 1.7 New Lesions — p=0.87

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Number of New Inflammatory MRI Lesions Per Monthly Scans	0.4; 1.7	0.87
SECONDARY Absolute Number of New Inflammatory MRI Lesions on Monthly Scans	2.3; 9.1	0.36
SECONDARY Lesion Volume Accumulation on T2-weighted MRI Scans Over 24 Weeks	-0.05; -0.18	0.93
SECONDARY Percent Brain Volume Change	-0.09; -0.25	0.68
SECONDARY Mean Number of New Inflammatory Lesions in 8-week Intervals	0.5; 2.2	0.21
SECONDARY Number of Participants Progressing on the EDSS Scale by at Least 1 Point	1; 2	0.29
SECONDARY Annualized Relapse Rate	0.13; 0.09	—
SECONDARY Mean Change in the MSFC Over 24 Weeks of Treatment	0.10; -0.04	0.13
SECONDARY Mean Number of New Inflammatory MRI Lesions Per Scan During the Extension Phase	1.3; 0.6	0.06
SECONDARY Lesion Volume Accumulation on T2-Weighted MRI Scans Between 24 Weeks and 52 Weeks	0.47; 0.07	0.07
SECONDARY Percent Brain Volume Change Between 24 Weeks and 52 Weeks	-0.28; -0.31	0.88
SECONDARY Number of Participants Progressing on the EDSS Scale by at Least 1 Point	1; 2	0.29
SECONDARY Annualized Relapse in Extension Phase	0.38; 0.16	—
SECONDARY Mean Change in the MSFC in Extension Phase	0.06; -0.01	0.67

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01116427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.