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A Study of Subcutaneous Abatacept to Treat Diffuse Cutaneous Systemic Sclerosis (ASSET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02161406
Recruitment Status : Completed
First Posted : June 11, 2014
Results First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborators:
Bristol-Myers Squibb
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Dinesh Khanna, MD, MS, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diffuse Cutaneous Systemic Sclerosis
Interventions Drug: Abatacept
Drug: Placebo
Enrollment 88
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Period Title: Overall Study
Started 44 44
Completed 34 35
Not Completed 10 9
Reason Not Completed
Death             2             1
Lost to Follow-up             2             1
Withdrawal by Subject             2             4
investigator withdrew subject             3             1
Lack of Efficacy             1             1
relocation             0             1
Arm/Group Title Abatacept Placebo Total
Hide Arm/Group Description

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Total of all reporting groups
Overall Number of Baseline Participants 44 44 88
Hide Baseline Analysis Population Description
Safety population includes all of the randomized participants who received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 44 participants 88 participants
50  (12) 49  (13) 49  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Female
31
  70.5%
35
  79.5%
66
  75.0%
Male
13
  29.5%
9
  20.5%
22
  25.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
Hispanic or Latino
4
   9.1%
7
  15.9%
11
  12.5%
Not Hispanic or Latino
40
  90.9%
36
  81.8%
76
  86.4%
Unknown or Not Reported
0
   0.0%
1
   2.3%
1
   1.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   4.5%
3
   6.8%
5
   5.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   6.8%
3
   6.8%
6
   6.8%
White
35
  79.5%
37
  84.1%
72
  81.8%
More than one race
4
   9.1%
0
   0.0%
4
   4.5%
Unknown or Not Reported
0
   0.0%
1
   2.3%
1
   1.1%
Disease Duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 44 participants 88 participants
1.66  (0.84) 1.52  (0.79) 1.59  (0.81)
[1]
Measure Description: Disease duration for this outcome is defined as the disease duration since the first non-Raynaud's sign or symptom until the screening visit.
dcSSc Disease Duration <= 18 months   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
26
  59.1%
27
  61.4%
53
  60.2%
[1]
Measure Description: dcSSc disease duration is defined as the time from the diagnosis of diffuse cutaneous systemic sclerosis (dcSSc) until screening.
mRSS   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants 44 participants 88 participants
23.34  (7.947) 21.57  (7.328) 22.45  (7.652)
[1]
Measure Description: modified Rodnan skin scores (mRSS) have a range from 0 to 51, with higher score indicating greater severity of systemic scleroderma
FVC% Predicted   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent predicted
Number Analyzed 44 participants 44 participants 88 participants
84.19  (13.504) 86.49  (16.597) 85.34  (15.087)
[1]
Measure Description: FVC is Forced vital capacity, a measure of lung function. FVC % Predicted is calculated using equations from Hankinson [Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999;159(1):179-87], incorporating age, gender, and race. It is calculated as the (FVC Observed / FVC predicted) * 100, where FVC predicted is calculated relative to a reference population.
DLCO% Predicted, Corrected for Hemoglobin   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent predicted
Number Analyzed 44 participants 44 participants 88 participants
79.57  (18.117) 76.45  (18.439) 78.01  (18.241)
[1]
Measure Description: Percent predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin (Hb), is reported. For adult males, the equation (expressing Hb in gm•dL-1) is DLCO predicted × (1.7*Hb / (10.22+Hb)). In adult women, the equation is DLCO predicted × (1.7*Hb / (9.38+Hb)). Percent predicted DLCO was entered directly into the eCRFs, based on equipment and testing techniques meeting ATS/ERS requirements (Crapo RO, Morris AH. Standardized single breath normal values for carbon monoxide diffusing capacity. Am.Rev.Respir.Dis 1981;123:185-189).
Patient Global Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants 44 participants 88 participants
3.88  (2.206) 4.31  (2.561) 4.09  (2.384)
[1]
Measure Description: Patient global assessment for overall disease represents the patient’s assessment of the patient’s global scleroderma on a 0 (excellent) -10 (extremely poor) Likert scale.
HAQ-DI   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants 44 participants 88 participants
1.14  (0.716) 0.97  (0.701) 1.05  (0.710)
[1]
Measure Description: HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient’s functional ability. The HAQ-DI overall score ranges from 0 (no disability) to 3 (severe disability).
Physician Global Assessment   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 44 participants 44 participants 88 participants
4.77  (1.669) 4.76  (1.665) 4.77  (1.657)
[1]
Measure Description: Physician global assessment for overall disease: This assessment represents the physician’s assessment of the patient’s current disease activity on a 0 (excellent) -10 (extremely poor) Likert scale.
Proportion of Participants with >= 1 Tendon Friction Rubs   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
19
  43.2%
13
  29.5%
32
  36.4%
[1]
Measure Description: Tendon friction rubs in systemic sclerosis have been associated with diffuse cutaneous skin disease, increased disability and poor survival. They were considered present if palpable on physical exam in the shoulder, elbow, wrist, metacarpophalangeal (MCP) joint, knee, and ankle. We report the proportion of subjects with at least one tendon friction rub.
Proportion of Participants with >= 1 Large Joint Contractures   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
31
  70.5%
32
  72.7%
63
  71.6%
[1]
Measure Description: Joint contractures are recognized by the loss of joint motion upon physical exam. We report the proportion of subjects with at least one large joint contracture.
Swollen Joint Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of swollen joints
Number Analyzed 44 participants 44 participants 88 participants
3.64  (5.620) 3.86  (5.849) 3.75  (5.704)
[1]
Measure Description: 28 joints are assessed for swelling (positive or negative). The number of swollen joint count ranges from 0 to 28.
Proportion of Participants with >= 1 Swollen Joint Count   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
21
  47.7%
21
  47.7%
42
  47.7%
[1]
Measure Description: 28 joints are assessed for swelling (positive or negative). The number of swollen joint count ranges from 0 to 28. We report the proportion of participants with >= 1 swollen joint.
Proportion of Participants with Previous Use of Immunosuppressives  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
12
  27.3%
5
  11.4%
17
  19.3%
Proportion of Participants with Previous Use of Prednisone  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 44 participants 88 participants
12
  27.3%
5
  11.4%
17
  19.3%
1.Primary Outcome
Title Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year
Hide Description Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of abatacept, and using serious AEs
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Measure Type: Count of Participants
Unit of Measure: Participants
35
  79.5%
40
  90.9%
2.Primary Outcome
Title Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12
Hide Description The efficacy of treatment on skin fibrosis will be measured by changes from baseline to month 12 in mRSS, a measure of skin thickness. mRSS scores have a range from 0 to 51, with higher score indicating greater severity of SSc (worse outcome).
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.24  (1.14) -4.49  (1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease
Hide Description Patient global assessment for overall disease represents the patient’s assessment of the patient’s global scleroderma on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.31  (0.423) -0.09  (0.457)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Month 12 in Physician Global Assessment for Overall Disease
Hide Description This assessment represents the physician’s assessment of the patient’s current disease activity on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.3  (0.290) -0.35  (0.318)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title Change in % Predicted FVC
Hide Description FVC is Forced vital capacity, a measure of lung function. FVC % Predicted is calculated using equations from Hankinson [Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999;159(1):179-87], incorporating age, gender, and race. It is calculated as the (FVC Observed / FVC predicted) * 100, where FVC predicted is calculated relative to a reference population.
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: percent predicted
-1.34  (1.24) -4.13  (1.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to Month 12 in FVC (in ml)
Hide Description FVC = forced vital capacity, a measure of lung function
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: ml
-36.39  (43.82) -121.6  (46.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to Month 12 in HAQ-DI - Overall
Hide Description The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI overall score ranges from 0 (no disability) to 3 (severe disability). Higher score means worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.17  (0.07) 0.11  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline to Month 12 in SHAQ-DI VAS - Overall Disease
Hide Description Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud’s, gastrointestinal involvement, breathing, and overall disease. The VAS scale for disease severity ranges from 0 (no disease) to 150 (very severe). A higher score means a worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-7.42  (5.638) 3.52  (6.045)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to Month 12 in SHAQ-DI VAS - Breathing
Hide Description Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud’s, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much breathing problems interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
9.30  (5.51) 16.95  (5.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline to Month 12 in SHAQ-DI VAS - Raynaud's
Hide Description Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud’s, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much Raynaud’s interfered with daily activities ranges from 0 (does not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
7.58  (6.60) -3.64  (7.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline to Month 12 in SHAQ-DI VAS - Burden of Digital Ulcers
Hide Description Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud’s, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much finger ulcers interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-3.18  (5.13) 8.67  (5.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline to Month 12 in SHAQ-DI VAS - GI Involvement
Hide Description Scleroderma-Health Assessment Question Disability Index visual analogue scales (VAS) assess the burden of digital ulcers, Raynaud’s, gastrointestinal involvement, breathing, and overall disease. The VAS scale for how much intestinal problems interfered with daily activities ranges from 0 (do not limit activities) to 150 (very severe limitation). A higher score means a worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
9.98  (6.00) 8.01  (6.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline to Month 12 in Swollen Joint Count
Hide Description 28 joints are assessed for swelling (positive or negative). The number of swollen joint count ranges from 0 to 28. A higher number indicates worse outcome.
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: number of swollen joints
-0.11  (0.595) -0.86  (0.601)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline to Month 12 in Tender Joint Counts
Hide Description 28 joints are assessed for tenderness (positive or negative). The number of tender joint counts ranges from 0 to 28. A higher number indicates worse outcome.
Time Frame Baseline and 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: number of tender joints
-0.71  (0.90) -1.47  (0.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline to Month 12 in PROMIS-29 - Physical Function
Hide Description The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the physical function domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.54  (0.65) -0.17  (0.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline to Month 12 in PROMIS-29 - Anxiety
Hide Description The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the anxiety domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-3.5  (1.31) -1.09  (1.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline to Month 12 in PROMIS-29 - Depression
Hide Description The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the depression domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.02  (1.13) -0.41  (1.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline to Month 12 in PROMIS 29 - Fatigue
Hide Description The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the fatigue domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.65  (1.29) -0.98  (1.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline to Month 12 in PROMIS-29 - Sleep Disturbance
Hide Description The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the sleep disturbance domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e.,worse outcome).
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.31  (0.57) -0.21  (0.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline to Month 12 in PROMIS-29 - Pain Interference
Hide Description The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain interference domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-4.10  (1.13) -1.56  (1.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline to Month 12 in PROMIS-29 - Ability to Participate in Social Roles & Activities
Hide Description The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the ability to participate in social roles and activities domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-1.11  (1.07) -1.26  (1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline to Month 12 in PROMIS-29 - Pain Intensity
Hide Description The Patient-Reported Outcomes Measurement Information System (PROMIS) 29-item short-form health-reported quality of life measures (PROMIS-29) were administered. The transformed score (T-score) for the pain intensity domain was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.72  (0.32) -0.18  (0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline to Month 12 in SCTC GIT - Composite Score
Hide Description The SCTC GIT is the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Instrument. It assesses scleroderma-related gastrointestinal symptoms. The composite score ranges from 0 to 2.83; 0 indicates better health and higher score indicates worse health.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.07  (0.047) -0.05  (0.050)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
24.Secondary Outcome
Title ACR CRISS at 12 Months
Hide Description The American College of Rheumatology Combined Response Index in Systemic Sclerosis is a composite endpoint. It is determined in a 2-step process. The first step assesses whether the patient has had a significant decline in renal or cardiopulmonary involvement. If none of these apply, the second step assesses the probability of improvement by measuring changes in five outcomes and integrating them into a single number using an equation described in Khanna D, Berrocal VJ, et al. [The American College of Rheumatology Provisional Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis. Arthritis and Rheumatology. 2016; 68(2):299-311.]. It incorporates changes in the modified Rodnan skin score, percent predicted forced vital capacity (FVC), patient and physician global assessments, and SHAQ-DI over 1 year. The score ranges from 0 to 1; a higher score indicates better outcome.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
0.72
(.005 to .994)
0.02
(0 to 0.750)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method van Elteren test
Comments The van Elteren test adjusted for duration of dcSSc. Multiple imputation was used to address missing follow-up data in 5 components of CRISS.
25.Secondary Outcome
Title Change From Baseline to Month 12 in PROMIS - Fatigue
Hide Description The Patient-Reported Outcomes Measurement Information System (PROMIS) 8-question short-form health-reported quality of life measure fatigue domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-2.44  (1.209) -0.05  (1.285)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1769
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline to Month 12 in PROMIS - Sleep Disturbance
Hide Description The Patient-Reported Outcomes Measurement Information System (PROMIS) 4-question short-form health-reported quality of life measure sleep disturbance domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., better outcome).
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat population includes all of the randomized participants who received at least one dose of study medication
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.31  (0.573) -0.21  (0.620)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9075
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
27.Secondary Outcome
Title Change From Baseline to Month 12 in PROMIS - Sleep Impairment
Hide Description The Patient-Reported Outcomes Measurement Information System (PROMIS) 8-question short-form health-reported quality of life measure sleep impairment domain was administered. The transformed score (T-score) was used, where 50 (10) is the mean (standard deviation) of a relevant reference population. Higher scores equals more of the concept being measured (i.e., worse outcome).
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat population includes all of the randomized participants who received at least one dose of study medication
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
0.46  (1.267) -0.54  (1.320)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5831
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
28.Secondary Outcome
Title Change From Baseline to Month 12 in HAQ-DI - Dressing and Grooming
Hide Description The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.25  (0.115) 0.14  (0.119)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0193
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
29.Secondary Outcome
Title Change From Baseline to Month 12 in HAQ-DI - Hygiene
Hide Description The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.08  (0.125) 0.40  (0.132)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0097
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
30.Secondary Outcome
Title Change From Baseline to Month 12 in HAQ-DI - Arising
Hide Description The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.23  (0.103) 0.04  (0.109)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0751
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
31.Secondary Outcome
Title Change From Baseline to Month 12 in HAQ-DI - Reach
Hide Description The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.12  (0.176) 0.03  (0.127)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4927
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
32.Secondary Outcome
Title Change From Baseline to Month 12 in HAQ-DI - Eating
Hide Description The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.22  (0.118) 0.02  (0.122)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1604
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
33.Secondary Outcome
Title Change From Baseline to Month 12 in HAQ-DI - Grip
Hide Description The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.29  (0.142) -0.22  (0.149)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7281
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
34.Secondary Outcome
Title Change From Baseline to Month 12 in HAQ-DI - Walking
Hide Description The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.02  (0.100) 0.18  (0.106)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1679
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
35.Secondary Outcome
Title Change From Baseline to Month 12 in HAQ-DI - Common Daily Activities
Hide Description The HAQ-DI is the Health Assessment Question Disability Index that assesses the extent of a patient's functional ability. The HAQ-DI subscore ranges from 0 (no disability) to 3 (severe disability). A higher score means worse outcome.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population includes all of the randomized participants who received at least one dose of study medication.
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description:

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

Overall Number of Participants Analyzed 44 44
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.09  (0.113) 0.08  (0.121)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abatacept, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2906
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 52 weeks
Adverse Event Reporting Description Coding of adverse events into body system was performed by the study chair for adverse events and by the medical monitors for serious adverse events.
 
Arm/Group Title Abatacept Placebo
Hide Arm/Group Description

125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension

Abatacept: Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks

125mg Placebo

Placebo: 125 mg of Placebo

All-Cause Mortality
Abatacept Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/44 (4.55%)      1/44 (2.27%)    
Show Serious Adverse Events Hide Serious Adverse Events
Abatacept Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/44 (20.45%)      12/44 (27.27%)    
Blood and lymphatic system disorders     
GAVE   0/44 (0.00%)  0 1/44 (2.27%)  1
Cardiac disorders     
Acute coronary syndrome   1/44 (2.27%)  1 0/44 (0.00%)  0
Atrial Flutter   0/44 (0.00%)  0 1/44 (2.27%)  1
Cardiac arrest   0/44 (0.00%)  0 1/44 (2.27%)  1
Congestive Heart Failure   0/44 (0.00%)  0 1/44 (2.27%)  1
Digital Ischemia   0/44 (0.00%)  0 1/44 (2.27%)  1
NSTEMI Myocardial Infarction   0/44 (0.00%)  0 1/44 (2.27%)  1
Pulmonary Arterial Hypertension   0/44 (0.00%)  0 1/44 (2.27%)  1
Pulmonary Arterial Hypertension and Pericardial Effusion   0/44 (0.00%)  0 1/44 (2.27%)  1
Worsening AV block   0/44 (0.00%)  0 1/44 (2.27%)  1
Gastrointestinal disorders     
Anemia   0/44 (0.00%)  0 1/44 (2.27%)  1
Cholecystitis   0/44 (0.00%)  0 1/44 (2.27%)  1
Dysphagia due to GI dysmotility   0/44 (0.00%)  0 1/44 (2.27%)  1
Dysphagia from myositis and prolonged hospitalization   1/44 (2.27%)  1 0/44 (0.00%)  0
Erosive esophagitis   0/44 (0.00%)  0 1/44 (2.27%)  1
GAVE; Severe anemia   0/44 (0.00%)  0 1/44 (2.27%)  1
Melena   1/44 (2.27%)  1 0/44 (0.00%)  0
Pseudo obstruction of the small bowel, paralytic ileus   1/44 (2.27%)  1 0/44 (0.00%)  0
Infections and infestations     
Cellulitis of right elbow   1/44 (2.27%)  1 0/44 (0.00%)  0
Healthcare associated pneumonia (HCAP)   0/44 (0.00%)  0 1/44 (2.27%)  1
Left side mastoiditis/ abrythnitis   1/44 (2.27%)  1 0/44 (0.00%)  0
Paronychia   0/44 (0.00%)  0 1/44 (2.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma (BCC)   0/44 (0.00%)  0 1/44 (2.27%)  1
Squamous Cell Carcinoma In-situ Left Anterior Ear   1/44 (2.27%)  1 0/44 (0.00%)  0
Psychiatric disorders     
Depression with Suicidal Ideation   0/44 (0.00%)  0 1/44 (2.27%)  1
Renal and urinary disorders     
Renal crisis   3/44 (6.82%)  3 1/44 (2.27%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure   1/44 (2.27%)  1 0/44 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Abatacept Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/44 (79.55%)      40/44 (90.91%)    
Blood and lymphatic system disorders     
Other Non-serious Adverse Events  [1]  0/44 (0.00%)  0 3/44 (6.82%)  3
Anemia   4/44 (9.09%)  4 2/44 (4.55%)  3
Cardiac disorders     
Other Non-serious Adverse Events  [1]  3/44 (6.82%)  4 5/44 (11.36%)  5
Ear and labyrinth disorders     
Other Non-serious Adverse Events  [1]  2/44 (4.55%)  2 1/44 (2.27%)  1
Endocrine disorders     
Other Non-serious Adverse Events  [1]  3/44 (6.82%)  3 1/44 (2.27%)  1
Gastrointestinal disorders     
Other Non-serious Adverse Events  [1]  11/44 (25.00%)  17 13/44 (29.55%)  18
Diarrhea   4/44 (9.09%)  4 6/44 (13.64%)  6
Dysphagia   3/44 (6.82%)  3 2/44 (4.55%)  2
Nausea   4/44 (9.09%)  4 4/44 (9.09%)  5
Vomiting (Emesis)   3/44 (6.82%)  3 2/44 (4.55%)  2
General disorders     
Other Non-serious Adverse Events  [1]  13/44 (29.55%)  23 12/44 (27.27%)  16
Fatigue   2/44 (4.55%)  2 6/44 (13.64%)  7
Weight Loss   3/44 (6.82%)  3 2/44 (4.55%)  2
Hepatobiliary disorders     
Other Non-serious Adverse Events  [1]  1/44 (2.27%)  1 4/44 (9.09%)  4
Infections and infestations     
Other Non-serious Adverse Events  [1]  17/44 (38.64%)  24 22/44 (50.00%)  39
Upper Respiratory Infection   3/44 (6.82%)  3 9/44 (20.45%)  11
Urinary Tract Infection   2/44 (4.55%)  2 4/44 (9.09%)  4
Musculoskeletal and connective tissue disorders     
Other Non-serious Adverse Events  [1]  18/44 (40.91%)  25 17/44 (38.64%)  23
Nervous system disorders     
Other Non-serious Adverse Events  [1]  7/44 (15.91%)  7 7/44 (15.91%)  9
Headache   1/44 (2.27%)  1 6/44 (13.64%)  8
Renal and urinary disorders     
Other Non-serious Adverse Events  [1]  1/44 (2.27%)  1 5/44 (11.36%)  6
Respiratory, thoracic and mediastinal disorders     
Other Non-serious Adverse Events  [1]  5/44 (11.36%)  6 13/44 (29.55%)  15
Skin and subcutaneous tissue disorders     
Other Non-serious Adverse Events  [1]  7/44 (15.91%)  8 7/44 (15.91%)  12
Pruritis (Itching)   4/44 (9.09%)  4 1/44 (2.27%)  1
Rash   3/44 (6.82%)  3 2/44 (4.55%)  2
Indicates events were collected by systematic assessment
[1]
Specific adverse event terms that occurred in < 5% of subjects were pooled.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Cathie Spino
Organization: University of Michigan DCC (SABER)
Phone: 734-615-5469
Responsible Party: Dinesh Khanna, MD, MS, University of Michigan
ClinicalTrials.gov Identifier: NCT02161406     History of Changes
Other Study ID Numbers: IM101-344
1UM1AI110557 ( U.S. NIH Grant/Contract )
First Submitted: June 3, 2014
First Posted: June 11, 2014
Results First Submitted: April 4, 2019
Results First Posted: June 18, 2019
Last Update Posted: June 18, 2019