Trial record 1 of 2 for:    Abatacept in Adults with Relapsing-remitting Multiple Sclerosis
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A Cooperative Clinical Study of Abatacept in Multiple Sclerosis (ACCLAIM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01116427
First received: May 3, 2010
Last updated: August 13, 2014
Last verified: August 2014

May 3, 2010
August 13, 2014
September 2010
June 2014   (final data collection date for primary outcome measure)
Number of New Inflammatory MRI Lesions on Monthly Scans [ Time Frame: Weeks 8-24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01116427 on ClinicalTrials.gov Archive Site
  • Absolute Number of New Inflammatory Lesions by MRI [ Time Frame: each monthly MRI ] [ Designated as safety issue: No ]
  • Lesion Volume Accumulation on T2-weighted MRI scans [ Time Frame: over 24 weeks ] [ Designated as safety issue: No ]
  • Change in Brain Parenchymal Fraction [ Time Frame: 0-24 weeks ] [ Designated as safety issue: No ]
  • New Inflammatory Lesions [ Time Frame: 8-week intervals ] [ Designated as safety issue: No ]
  • Proportion of Patients Progressing on the EDSS Scale by 1 Point [ Time Frame: general ] [ Designated as safety issue: No ]
    EDSS = Expanded Disability Status Scale -- http://www.nationalmssociety.org/for-professionals/researchers/clinical-study-measures/fss-and-edss/index.aspx
  • Annualized Relapse Rate [ Time Frame: annual ] [ Designated as safety issue: No ]
  • Mean Change in MSFC [ Time Frame: over 24 weeks ] [ Designated as safety issue: No ]
    MSFC = Multiple Sclerosis Functional Composite -- http://www.nationalmssociety.org/for-professionals/researchers/clinical-study-measures/msfc/index.aspx
  • Adverse Events (AEs) [ Time Frame: all ] [ Designated as safety issue: Yes ]
  • Multiple Laboratory Results [ Time Frame: all ] [ Designated as safety issue: Yes ]
  • Absolute number of new inflammatory MRI lesions [ Time Frame: each monthly MRI ] [ Designated as safety issue: No ]
  • lesion volume accumulation on T2-weighted MRI scans [ Time Frame: over 24 weeks ] [ Designated as safety issue: No ]
  • change in brain parenchymal fraction [ Time Frame: 0-24 weeks ] [ Designated as safety issue: No ]
  • new inflammatory lesions [ Time Frame: 8-week intervals ] [ Designated as safety issue: No ]
  • proportion of patients progressing on the EDSS scale by 1 point [ Time Frame: general ] [ Designated as safety issue: No ]
    EDSS = Expanded Disability Status Scale -- http://www.nationalmssociety.org/for-professionals/researchers/clinical-study-measures/fss-and-edss/index.aspx
  • Annualized relapse rate [ Time Frame: annual ] [ Designated as safety issue: No ]
  • Mean change in MSFC [ Time Frame: over 24 weeks ] [ Designated as safety issue: No ]
    MSFC = Multiple Sclerosis Functional Composite -- http://www.nationalmssociety.org/for-professionals/researchers/clinical-study-measures/msfc/index.aspx
  • adverse events [ Time Frame: all ] [ Designated as safety issue: Yes ]
  • various laboratory tests [ Time Frame: all ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Cooperative Clinical Study of Abatacept in Multiple Sclerosis
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
  • Biological: 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; Dosing: less than 60 kg, 500 mg; 60-100 kg, 750 mg; or greater than 100 kg, 1 gram
    Other Names:
    • Orencia®
    • CTLA4Ig
  • Drug: Placebo
    In core/extension phase: administered IV at weeks 0/28, 2/30, and 4/32, and then every 4 weeks until week 24/52
    Other Name: placebo abatacept
  • Experimental: Abatacept
    Receives abatacept during first course of treatment, switching to placebo during extension phase.
    Interventions:
    • Biological: abatacept
    • Drug: Placebo
  • Placebo Comparator: Placebo, followed by abatacept
    Receives a placebo for first course of treatment, switching to abatacept in the extension phase.
    Interventions:
    • Biological: abatacept
    • Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
65
July 2015
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinically definite RRMS meeting McDonald's criteria
  • 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
  • PPD (purified protein derivative)-tuberculin skin test result greater than 5 mm induration
  • Hemoglobin less than 10.5 gm/dL
  • Platelets less than100K/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 15GPL 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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01116427
DAIT ITN035AI
Yes
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Principal Investigator: Samia Khoury, MD Brigham and Women's Hospital
National Institute of Allergy and Infectious Diseases (NIAID)
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP