Overview

This trial is active, not recruiting.

Condition multiple sclerosis, relapsing-remitting
Treatments abatacept, placebo
Phase phase 2
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator Immune Tolerance Network (ITN)
Start date September 2010
End date June 2014
Trial size 65 participants
Trial identifier NCT01116427, DAIT ITN035AI

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Receives abatacept during first course of treatment, switching to placebo during extension phase.
abatacept Orencia®
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
placebo 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
(Placebo Comparator)
Receives a placebo for first course of treatment, switching to abatacept in the extension phase.
abatacept Orencia®
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
placebo 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

Primary Outcomes

Measure
Number of New Inflammatory MRI Lesions on Monthly Scans
time frame: Weeks 8-24

Secondary Outcomes

Measure
Absolute Number of New Inflammatory Lesions by MRI
time frame: each monthly MRI
Lesion Volume Accumulation on T2-weighted MRI scans
time frame: over 24 weeks
Change in Brain Parenchymal Fraction
time frame: 0-24 weeks
New Inflammatory Lesions
time frame: 8-week intervals
Proportion of Patients Progressing on the EDSS Scale by 1 Point
time frame: general
Annualized Relapse Rate
time frame: annual
Mean Change in MSFC
time frame: over 24 weeks
Adverse Events (AEs)
time frame: all
Multiple Laboratory Results
time frame: all

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

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
Principal investigator Samia Khoury, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID).