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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 has been completed.
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 3, 2016
Last verified: August 2016
Results First Received: December 15, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Multiple Sclerosis, Relapsing-Remitting
Interventions: Biological: abatacept
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants with relapsing-remitting multiple sclerosis were recruited from 21 sites in the US and Canada between November 2010 and November 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Abatacept First, Then Placebo Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
Placebo First, Then Abatacept Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.

Participant Flow for 2 periods

Period 1:   Core Phase
    Abatacept First, Then Placebo     Placebo First, Then Abatacept  
STARTED     44     21  
COMPLETED     39     20  
NOT COMPLETED     5     1  
Adverse Event                 0                 1  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 3                 0  
Worsening Multiple Sclerosis                 1                 0  

Period 2:   Extension Phase
    Abatacept First, Then Placebo     Placebo First, Then Abatacept  
STARTED     38 [1]   20  
COMPLETED     29     18  
NOT COMPLETED     9     2  
Adverse Event                 1                 1  
Lost to Follow-up                 2                 0  
Withdrawal by Subject                 5                 1  
Not using appropriate birth control                 1                 0  
[1] One participant that completed core phase did not meet eligibility for Extension Phase



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Abatacept First, Then Placebo Subjects received abatacept IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows: Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
Placebo First, Then Abatacept Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
Total Total of all reporting groups

Baseline Measures
    Abatacept First, Then Placebo     Placebo First, Then Abatacept     Total  
Number of Participants  
[units: participants]
  44     21     65  
Age  
[units: years]
Mean (Standard Deviation)
  40.5  (9.7)     42.7  (11.0)     41.2  (10.1)  
Gender  
[units: participants]
     
Female     32     18     50  
Male     12     3     15  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     2     1     3  
Not Hispanic or Latino     41     20     61  
Unknown or Not Reported     1     0     1  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     7     5     12  
White     35     16     51  
More than one race     1     0     1  
Unknown or Not Reported     1     0     1  
Region of Enrollment  
[units: participants]
     
Canada     41     19     60  
United States     3     2     5  
Baseline Expanded Disability Status Scale (EDSS) Score [1]
[units: units on a scale]
Mean (Standard Deviation)
  2.0  (1.3)     2.4  (1.2)     2.1  (1.3)  
Baseline Multiple Sclerosis Functional Composite (MSFC) Score [2]
[units: Scores on a scale]
Mean (Standard Deviation)
  -0.01  (0.68)     0.03  (0.81)     0.00  (0.72)  
Baseline Gd-enhanced Lesions [3]
[units: Lesions]
Mean (Standard Deviation)
  0.7  (1.4)     3.8  (10.7)     1.7  (6.3)  
Baseline T2 Lesion Volume [4]
[units: cm^3]
Mean (Standard Deviation)
  6.7  (8.1)     9.6  (9.0)     7.7  (8.5)  
[1] Baseline EDSS score was the lowest score observed at either visit -2 (Wk -5) or visit -1 (Wk -1). The EDSS is an assessment for severity of multiple sclerosis. The EDSS an ordinal clinical rating scale ranging from 0 (normal neurological examination) to 10 (death due to multiple sclerosis) in half-point increments.
[2] Baseline MSFC score was the most recent score on or before Randomization. The three component measures of the MSFC include the 1) Time 25-foot Walk (a measure of lower extremity function), 2) 9-hole Peg Test (a measure of upper extremity function), and 3) Paced Auditory Serial Addition Test (a measure of cognitive function). Scores from all three components are combined then are converted into a Z-score for analyses, with a range from -1 to 1. A positive score indicates less severity of multiple sclerosis while negative scores indicate more severe multiple sclerosis symptoms.
[3] Number of gadolinium (Gd)-enhancing lesions detected during an MRI scan. Baseline MRI evaluations were obtained at Visit -1 (Wk -1). Gd-enhancing lesions are measured on T1 weighted images after injection of 0.1 mM/kg of gadolinium pentate. A higher score indicates more severe multiple sclerosis.
[4] Total volume of all T2 lesions detected during an MRI scan. Baseline MRI evaluations were obtained at Visit -1 (Wk -1). A T2 lesion is defined as an abnormal, hyperintense white-matter area visible on T2 weighted images. A higher score indicates more severe multiple sclerosis.



  Outcome Measures
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1.  Primary:   Mean Number of New Inflammatory MRI Lesions Per Monthly Scans   [ Time Frame: Weeks 8-24 ]

2.  Secondary:   Absolute Number of New Inflammatory MRI Lesions on Monthly Scans   [ Time Frame: Weeks 4-24 ]

3.  Secondary:   Lesion Volume Accumulation on T2-weighted MRI Scans Over 24 Weeks   [ Time Frame: Week -1 to Week 24 ]

4.  Secondary:   Percent Brain Volume Change   [ Time Frame: Week -1 to Week 24 ]

5.  Secondary:   Mean Number of New Inflammatory Lesions in 8-week Intervals   [ Time Frame: Week 8 to Week 24 ]

6.  Secondary:   Number of Participants Progressing on the EDSS Scale by at Least 1 Point   [ Time Frame: Week -1 to Week 24 ]

7.  Secondary:   Annualized Relapse Rate   [ Time Frame: Week -1 to Week 24 ]

8.  Secondary:   Mean Change in the MSFC Over 24 Weeks of Treatment   [ Time Frame: Week -1 to Week 24 ]

9.  Secondary:   Mean Number of New Inflammatory MRI Lesions Per Scan During the Extension Phase   [ Time Frame: Weeks 36 and 52 ]

10.  Secondary:   Lesion Volume Accumulation on T2-Weighted MRI Scans Between 24 Weeks and 52 Weeks   [ Time Frame: Week 24 to Week 52 ]

11.  Secondary:   Percent Brain Volume Change Between 24 Weeks and 52 Weeks   [ Time Frame: Week 24 to Week 52 ]

12.  Secondary:   Number of Participants Progressing on the EDSS Scale by at Least 1 Point   [ Time Frame: Week 24 to Week 64 ]

13.  Secondary:   Annualized Relapse in Extension Phase   [ Time Frame: Week 24 to Week 64 ]

14.  Secondary:   Mean Change in the MSFC in Extension Phase   [ Time Frame: Week 24 to Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsGov@niaid.nih.gov


Publications of Results:
Other Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01116427     History of Changes
Other Study ID Numbers: DAIT ITN035AI
Study First Received: May 3, 2010
Results First Received: December 15, 2015
Last Updated: August 3, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government