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

• Sponsor: Dinesh Khanna, MD, MS (Other)
• Overall Status: Completed
• CT.gov ID: NCT02161406
• Collaborator: Bristol-Myers Squibb (Industry), National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 88
• Locations: 27
• Arms: 2
• Actual Duration (Months): 49.5
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The study hypothesis is that SC abatacept is safe and shows evidence of efficacy (improvement in modified Rodnan score [mRSS]) in patients with diffuse cutaneous systemic sclerosis (dcScc) compared to matching placebo.

Condition or Disease	Intervention/Treatment	Phase
Diffuse Cutaneous Systemic Sclerosis	Drug: Abatacept; Drug: Placebo	Phase 2

Detailed Description

This study is a randomized placebo-controlled double-blind phase 2 trial of patients with dcSSc. Eligible participants will be randomized in a 1:1 ratio to either 125 mg SC abatacept or matching placebo, stratified by duration of dcSSc disease duration (<18 months vs >18 to </=36 months). Study participants will be treated for 12 months on double-blind study medication, followed by an additional 24 weeks of open-label SC abatacept therapy. 86 patients will be randomized in approximately 35 centers in the US, Canada and Europe, with the goal of analyzing 74 participants. The investigators study will test whether abatacept is statistically superior to placebo in reducing the MRSS at month 12 and explore the ability of abatacept to prevent or reverse progression in patients with early disease duration and lower MRSS scores, and reverse established disease in patients with longer disease duration and higher MRSS scores.

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study to Evaluate Subcutaneous Abatacept vs. Placebo in Diffuse Cutaneous Systemic Sclerosis- a Double-blind, Placebo-controlled, Randomized Controlled Trial.
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Sep 12, 2018
• Actual Study Completion Date: Oct 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Abatacept 125 mg SC abatacept vs SC placebo administered weekly for 12 months, with a 24-week open-label extension	Drug: Abatacept; Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks; Other Names: Orencia
Placebo Comparator: Placebo 125mg Placebo	Drug: Placebo; 125 mg of Placebo

Outcome Measures

Primary Outcome Measures

1. Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year [52 weeks]

   Safety is measured using AEs, including clinical significant changes in vital signs, laboratory test abnormalities and clinical tolerability of abatacept, and using serious AEs

2. Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12 [Baseline and 52 weeks]

   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).

Secondary Outcome Measures

1. Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease [Baseline and Week 52]

   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.

2. Change From Baseline to Month 12 in Physician Global Assessment for Overall Disease [Baseline and Week 52]

   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.

3. Change in % Predicted FVC [Baseline and 52 weeks]

   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.

4. Change From Baseline to Month 12 in FVC (in ml) [Baseline and Week 52]

   FVC = forced vital capacity, a measure of lung function

5. Change From Baseline to Month 12 in HAQ-DI - Overall [Baseline and Week 52]

   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.

6. Change From Baseline to Month 12 in SHAQ-DI VAS - Overall Disease [Baseline and Week 52]

   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.

7. Change From Baseline to Month 12 in SHAQ-DI VAS - Breathing [Baseline and Week 52]

   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.

8. Change From Baseline to Month 12 in SHAQ-DI VAS - Raynaud's [Baseline and Week 52]

   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.

9. Change From Baseline to Month 12 in SHAQ-DI VAS - Burden of Digital Ulcers [Baseline and Week 52]

   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.

10. Change From Baseline to Month 12 in SHAQ-DI VAS - GI Involvement [Baseline and Week 52]

    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.

11. Change From Baseline to Month 12 in Swollen Joint Count [Baseline and 52 weeks]

    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.

12. Change From Baseline to Month 12 in Tender Joint Counts [Baseline and 52 weeks]

    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.

13. Change From Baseline to Month 12 in PROMIS-29 - Physical Function [Baseline and Week 52]

    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).

14. Change From Baseline to Month 12 in PROMIS-29 - Anxiety [Baseline and Week 52]

    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).

15. Change From Baseline to Month 12 in PROMIS-29 - Depression [Baseline and Week 52]

    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).

16. Change From Baseline to Month 12 in PROMIS 29 - Fatigue [Baseline and Week 52]

    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).

17. Change From Baseline to Month 12 in PROMIS-29 - Sleep Disturbance [Baseline and Week 52]

    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).

18. Change From Baseline to Month 12 in PROMIS-29 - Pain Interference [Baseline and Week 52]

    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).

19. Change From Baseline to Month 12 in PROMIS-29 - Ability to Participate in Social Roles & Activities [Baseline and Week 52]

    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).

20. Change From Baseline to Month 12 in PROMIS-29 - Pain Intensity [Baseline and Week 52]

    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).

21. Change From Baseline to Month 12 in SCTC GIT - Composite Score [Baseline and Week 52]

    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.

22. ACR CRISS at 12 Months [Week 52]

    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.

23. Change From Baseline to Month 12 in PROMIS - Fatigue [Baseline and Week 52]

    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).

24. Change From Baseline to Month 12 in PROMIS - Sleep Disturbance [Baseline and Week 52]

    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).

25. Change From Baseline to Month 12 in PROMIS - Sleep Impairment [Baseline and Week 52]

    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).

26. Change From Baseline to Month 12 in HAQ-DI - Dressing and Grooming [Baseline and Week 52]

    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.

27. Change From Baseline to Month 12 in HAQ-DI - Hygiene [Baseline and Week 52]

    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.

28. Change From Baseline to Month 12 in HAQ-DI - Arising [Baseline and Week 52]

    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.

29. Change From Baseline to Month 12 in HAQ-DI - Reach [Baseline and Week 52]

    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.

30. Change From Baseline to Month 12 in HAQ-DI - Eating [Baseline and Week 52]

    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.

31. Change From Baseline to Month 12 in HAQ-DI - Grip [Baseline and Week 52]

    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.

32. Change From Baseline to Month 12 in HAQ-DI - Walking [Baseline and Week 52]

    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.

33. Change From Baseline to Month 12 in HAQ-DI - Common Daily Activities [Baseline and Week 52]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Diagnosis of Systematic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/ European Union League Against Rheumatism classification of SSc

2. Diffuse Systemic Sclerosis (dcSSc) as defined by LeRoy and Medsger

3. Disease duration of ≤ 36 months (defined as time from the first non-Raynaud phenomenon manifestation)

4. For disease duration of ≤ 18 months: ≥ 10 and ≤ 35 mRSS units at the screening visit

5. For disease duration of >18-36 months: ≥ 15 and ≤ 45 mRSS units at the screening visit and one of the following:

• Increase ≥ 3 in mRSS units compared with the last visit within previous 1-6 months

• Involvement of one new body area with ≥ 2 mRSS units compared with the last visit within the previous 1-6 months

• Involvement of two new body areas with ≥ 1 mRSS units compared with the last visit within the previous 1-6 months

• Presence of 1 or more Tendon Friction Rub

1. Age ≥ 18 years at the screening visit

2. If female of childbearing potential, the patient must have a negative pregnancy test at screening and baseline visits

3. Oral corticosteroids (≤ 10 mg/day of prednisone or equivalent) and NSAIDs are permitted if the patient is on a stable dose regimen for

• 2 weeks prior to and including the baseline visit.

1. ACE inhibitors, calcium-channel blockers, proton-pump inhibitors, and/or oral vasodilators are permitted if the patient is on a stable dose for ≥ 2 weeks prior to and including the baseline visit.

Exclusion Criteria:

1. Rheumatic disease other than dcSSc; it is acceptable to include patients with fibromyalgia and scleroderma-associated myopathy

2. Limited cutaneous systemic sclerosis or sine scleroderma at the screening visit

3. Major surgery (including joint surgery) within 8 weeks prior to screening visit

4. Infected ulcer prior to randomization

5. Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the baseline visit

6. Previous treatment with cell-depleting therapies, including investigational agents, including but not limited to, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, and ABA

7. Anti-CD20, and cyclophosphamide within 12 months prior to baseline visit.

8. Use of Intravenous Immunoglobulin (IVIG) within 12 weeks prior to baseline visit

9. Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation

10. Immunization with a live/attenuated vaccine within ≤ 4 weeks prior to the baseline visit

11. Treatment with methotrexate, hydroxychloroquine, cyclosporine A, azathioprine, mycophenolate mofetil rapamycin, colchicine, or D-penicillamine, within≤ 4 weeks prior to the baseline visit

12. Treatment with etanercept within ≤ 2 weeks, infliximab, certolizumab, golimumab, ABA or adalimumab within ≤ 8 weeks, anakinra within ≤ 1 week prior to the baseline visit

13. Pulmonary disease with FVC ≤ 50% of predicted, or DLCO (uncorrected for hemoglobin ) ≤ 40% of predicted at the screening visit

14. Pulmonary arterial hypertension (PAH) as determined by right heart catheterization or on PAH approved medications for PAH. It is acceptable to use PDFE-5 inhibitors for Raynaud's and digital ulcers.

15. Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be participants with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).

16. Positive for hepatitis B surface antigen prior to the baseline visit

17. Positive for hepatitis C antigen, if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay prior to baseline visit

18. Subjects at risk for tuberculosis (TB). Specifically excluded from this study will be participants with a history of active TB within the last 3 years, even if it was treated; a history of active TB greater than 3 years ago, unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; current clinical, radiographic, or laboratory evidence of active TB; and latent TB that was not successfully treated (≥ 4 weeks).

19. Any of the following at the screening visit: Hemoglobin <8.5 g/dL; WBC < 3,000/mm3 (<3 x 109/L); platelets < 100,000/mm3 (<3 x 109/L); serum creatinine > 2 x ULN; serum ALT or AST > 2 x ULN

20. Severe skin thickening (mRSS 3) on the inner aspects of thighs, upper arms, or abdomen

21. Patients with a history of anaphylaxis to abatacept

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arthritis Associates of Southern California	Los Angeles	California	United States	90045
2	University of California- Los Angeles	Los Angeles	California	United States	90095
3	Stanford University	Redwood City	California	United States	94063
4	Georgetown University	Washington	District of Columbia	United States	20009
5	Northwestern University	Chicago	Illinois	United States	60611
6	Harvard Mass General	Boston	Massachusetts	United States	02116
7	Boston University	Boston	Massachusetts	United States	02118
8	University of Michigan	Ann Arbor	Michigan	United States	48109
9	University of Minnesota	Minneapolis	Minnesota	United States	55455
10	Mayo Clinic	Rochester	Minnesota	United States	55905
11	Rutgers University Clinical Research Center	New Brunswick	New Jersey	United States	08831
12	Steffens Scleroderma Center	Albany	New York	United States	12203
13	NorthWell Health	Great Neck	New York	United States	11021
14	Hospital for Special Surgery	New York	New York	United States	10021
15	Columbia University	New York	New York	United States	10032
16	Cleveland Clinic	Cleveland	Ohio	United States	44195
17	Ohio State University Medical Center	Columbus	Ohio	United States	43221
18	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
19	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15261
20	Medical University of South Carolina	Charleston	South Carolina	United States	29425
21	University of Texas Health Center at Houston	Houston	Texas	United States	77030
22	University of Utah	Salt Lake City	Utah	United States	84132
23	Swedish Health Services	Seattle	Washington	United States	98122
24	St. Joseph Health Care London	London	Ontario	Canada	N6A4V2
25	Mount Sinai Hospital	Toronto	Ontario	Canada	M5T 3L9
26	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
27	Royal Free Hospital	London		United Kingdom	NW3 2QG

Sponsors and Collaborators

• Dinesh Khanna, MD, MS
• Bristol-Myers Squibb
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Dinesh Khanna, MD, MS, University of Michigan

Study Documents (Full-Text)

• Study Protocol - Dec 8, 2015
• Statistical Analysis Plan - Apr 6, 2018

More Information

Additional Information:

• To learn more about the Scleroderma program at the University of Michigan
• Study Website

Publications

None provided.

• Responsible Party: Dinesh Khanna, MD, MS, Associate Professor of Rheumatology/ Internal Medicine, University of Michigan
• ClinicalTrials.gov Identifier: NCT02161406
• Other Study ID Numbers: IM101-344; 1UM1AI110557
• First Posted: Jun 11, 2014
• Last Update Posted: Feb 17, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dinesh Khanna, MD, MS, Associate Professor of Rheumatology/ Internal Medicine, University of Michigan: Scleroderma
• Additional relevant MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis; Abatacept

Study Results

Participant Flow

Arm/Group Title	Abatacept	Placebo
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

Baseline Characteristics

Arm/Group Title	Abatacept	Placebo	Total
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 Participants	44	44	88
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50 (12)	49 (13)	49 (13)
Sex: Female, Male (Count of Participants)
Female	31 70.5%	35 79.5%	66 75%
Male	13 29.5%	9 20.5%	22 25%
Ethnicity (NIH/OMB) (Count of 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%	1 2.3%	1 1.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	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%
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%	4 4.5%
Unknown or Not Reported	0 0%	1 2.3%	1 1.1%
Disease Duration (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	1.66 (0.84)	1.52 (0.79)	1.59 (0.81)
dcSSc Disease Duration <= 18 months (Count of Participants)
Count of Participants [Participants]	26 59.1%	27 61.4%	53 60.2%
mRSS (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	23.34 (7.947)	21.57 (7.328)	22.45 (7.652)
FVC% Predicted (percent predicted) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent predicted]	84.19 (13.504)	86.49 (16.597)	85.34 (15.087)
DLCO% Predicted, Corrected for Hemoglobin (percent predicted) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent predicted]	79.57 (18.117)	76.45 (18.439)	78.01 (18.241)
Patient Global Assessment (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	3.88 (2.206)	4.31 (2.561)	4.09 (2.384)
HAQ-DI (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.14 (0.716)	0.97 (0.701)	1.05 (0.710)
Physician Global Assessment (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.77 (1.669)	4.76 (1.665)	4.77 (1.657)
Proportion of Participants with >= 1 Tendon Friction Rubs (Count of Participants)
Count of Participants [Participants]	19 43.2%	13 29.5%	32 36.4%
Proportion of Participants with >= 1 Large Joint Contractures (Count of Participants)
Count of Participants [Participants]	31 70.5%	32 72.7%	63 71.6%
Swollen Joint Count (number of swollen joints) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of swollen joints]	3.64 (5.620)	3.86 (5.849)	3.75 (5.704)
Proportion of Participants with >= 1 Swollen Joint Count (Count of Participants)
Count of Participants [Participants]	21 47.7%	21 47.7%	42 47.7%
Proportion of Participants with Previous Use of Immunosuppressives (Count of Participants)
Count of Participants [Participants]	12 27.3%	5 11.4%	17 19.3%
Proportion of Participants with Previous Use of Prednisone (Count of Participants)
Count of Participants [Participants]	12 27.3%	5 11.4%	17 19.3%

Outcome Measures

1. Primary Outcome

Title	Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year
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

Outcome Measure Data

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
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
Measure Participants	44	44
Count of Participants [Participants]	35 79.5%	40 90.9%

2. Primary Outcome

Title	Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [units on a scale]	-6.24 (1.14)	-4.49 (1.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.28
	Comments
	Method	Mixed Models Analysis
	Comments

3. Secondary Outcome

Title	Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.31 (0.423)	-0.09 (0.457)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.73
	Comments
	Method	Mixed Models Analysis
	Comments

4. Secondary Outcome

Title	Change From Baseline to Month 12 in Physician Global Assessment for Overall Disease
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-1.3 (0.290)	-0.35 (0.318)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Mixed Models Analysis
	Comments

5. Secondary Outcome

Title	Change in % Predicted FVC
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [percent predicted]	-1.34 (1.24)	-4.13 (1.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.11
	Comments
	Method	Mixed Models Analysis
	Comments

6. Secondary Outcome

Title	Change From Baseline to Month 12 in FVC (in ml)
Description	FVC = forced vital capacity, a measure of lung function
Time Frame	Baseline and Week 52

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [ml]	-36.39 (43.82)	-121.6 (46.39)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	Mixed Models Analysis
	Comments

7. Secondary Outcome

Title	Change From Baseline to Month 12 in HAQ-DI - Overall
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.17 (0.07)	0.11 (0.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Mixed Models Analysis
	Comments

8. Secondary Outcome

Title	Change From Baseline to Month 12 in SHAQ-DI VAS - Overall Disease
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-7.42 (5.638)	3.52 (6.045)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	Mixed Models Analysis
	Comments

9. Secondary Outcome

Title	Change From Baseline to Month 12 in SHAQ-DI VAS - Breathing
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	9.30 (5.51)	16.95 (5.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.34
	Comments
	Method	Mixed Models Analysis
	Comments

10. Secondary Outcome

Title	Change From Baseline to Month 12 in SHAQ-DI VAS - Raynaud's
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	7.58 (6.60)	-3.64 (7.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	Mixed Models Analysis
	Comments

11. Secondary Outcome

Title	Change From Baseline to Month 12 in SHAQ-DI VAS - Burden of Digital Ulcers
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-3.18 (5.13)	8.67 (5.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	Mixed Models Analysis
	Comments

12. Secondary Outcome

Title	Change From Baseline to Month 12 in SHAQ-DI VAS - GI Involvement
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	9.98 (6.00)	8.01 (6.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.82
	Comments
	Method	Mixed Models Analysis
	Comments

13. Secondary Outcome

Title	Change From Baseline to Month 12 in Swollen Joint Count
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [number of swollen joints]	-0.11 (0.595)	-0.86 (0.601)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.37
	Comments
	Method	Mixed Models Analysis
	Comments

14. Secondary Outcome

Title	Change From Baseline to Month 12 in Tender Joint Counts
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [number of tender joints]	-0.71 (0.90)	-1.47 (0.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.55
	Comments
	Method	Mixed Models Analysis
	Comments

15. Secondary Outcome

Title	Change From Baseline to Month 12 in PROMIS-29 - Physical Function
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-1.54 (0.65)	-0.17 (0.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments
	Method	Mixed Models Analysis
	Comments

16. Secondary Outcome

Title	Change From Baseline to Month 12 in PROMIS-29 - Anxiety
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-3.5 (1.31)	-1.09 (1.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	Mixed Models Analysis
	Comments

17. Secondary Outcome

Title	Change From Baseline to Month 12 in PROMIS-29 - Depression
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.02 (1.13)	-0.41 (1.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.81
	Comments
	Method	Mixed Models Analysis
	Comments

18. Secondary Outcome

Title	Change From Baseline to Month 12 in PROMIS 29 - Fatigue
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.65 (1.29)	-0.98 (1.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.86
	Comments
	Method	Mixed Models Analysis
	Comments

19. Secondary Outcome

Title	Change From Baseline to Month 12 in PROMIS-29 - Sleep Disturbance
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.31 (0.57)	-0.21 (0.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.91
	Comments
	Method	Mixed Models Analysis
	Comments

20. Secondary Outcome

Title	Change From Baseline to Month 12 in PROMIS-29 - Pain Interference
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-4.10 (1.13)	-1.56 (1.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	Mixed Models Analysis
	Comments

21. Secondary Outcome

Title	Change From Baseline to Month 12 in PROMIS-29 - Ability to Participate in Social Roles & Activities
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-1.11 (1.07)	-1.26 (1.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.92
	Comments
	Method	Mixed Models Analysis
	Comments

22. Secondary Outcome

Title	Change From Baseline to Month 12 in PROMIS-29 - Pain Intensity
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.72 (0.32)	-0.18 (0.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.24
	Comments
	Method	Mixed Models Analysis
	Comments

23. Secondary Outcome

Title	Change From Baseline to Month 12 in SCTC GIT - Composite Score
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	0.07 (0.047)	-0.05 (0.050)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.07
	Comments
	Method	Mixed Models Analysis
	Comments

24. Secondary Outcome

Title	ACR CRISS at 12 Months
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

Outcome Measure Data

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
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
Measure Participants	44	44
Median (Inter-Quartile Range) [units on a scale]	0.72	0.02

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	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
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-2.44 (1.209)	-0.05 (1.285)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1769
	Comments
	Method	Mixed Models Analysis
	Comments

26. Secondary Outcome

Title	Change From Baseline to Month 12 in PROMIS - Sleep Disturbance
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.31 (0.573)	-0.21 (0.620)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.9075
	Comments
	Method	Mixed Models Analysis
	Comments

27. Secondary Outcome

Title	Change From Baseline to Month 12 in PROMIS - Sleep Impairment
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	0.46 (1.267)	-0.54 (1.320)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.5831
	Comments
	Method	Mixed Models Analysis
	Comments

28. Secondary Outcome

Title	Change From Baseline to Month 12 in HAQ-DI - Dressing and Grooming
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.25 (0.115)	0.14 (0.119)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0193
	Comments
	Method	Mixed Models Analysis
	Comments

29. Secondary Outcome

Title	Change From Baseline to Month 12 in HAQ-DI - Hygiene
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.08 (0.125)	0.40 (0.132)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0097
	Comments
	Method	Mixed Models Analysis
	Comments

30. Secondary Outcome

Title	Change From Baseline to Month 12 in HAQ-DI - Arising
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.23 (0.103)	0.04 (0.109)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0751
	Comments
	Method	Mixed Models Analysis
	Comments

31. Secondary Outcome

Title	Change From Baseline to Month 12 in HAQ-DI - Reach
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.12 (0.176)	0.03 (0.127)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.4927
	Comments
	Method	Mixed Models Analysis
	Comments

32. Secondary Outcome

Title	Change From Baseline to Month 12 in HAQ-DI - Eating
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.22 (0.118)	0.02 (0.122)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1604
	Comments
	Method	Mixed Models Analysis
	Comments

33. Secondary Outcome

Title	Change From Baseline to Month 12 in HAQ-DI - Grip
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.29 (0.142)	-0.22 (0.149)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.7281
	Comments
	Method	Mixed Models Analysis
	Comments

34. Secondary Outcome

Title	Change From Baseline to Month 12 in HAQ-DI - Walking
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.02 (0.100)	0.18 (0.106)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1679
	Comments
	Method	Mixed Models Analysis
	Comments

35. Secondary Outcome

Title	Change From Baseline to Month 12 in HAQ-DI - Common Daily Activities
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

Outcome Measure Data

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
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
Measure Participants	44	44
Least Squares Mean (Standard Error) [score on a scale]	-0.09 (0.113)	0.08 (0.121)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abatacept, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2906
	Comments
	Method	Mixed Models Analysis
	Comments

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	2/44 (4.5%)		1/44 (2.3%)
Serious Adverse Events
	Abatacept		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/44 (20.5%)		12/44 (27.3%)
Blood and lymphatic system disorders
GAVE	0/44 (0%)	0	1/44 (2.3%)	1
Cardiac disorders
Acute coronary syndrome	1/44 (2.3%)	1	0/44 (0%)	0
Atrial Flutter	0/44 (0%)	0	1/44 (2.3%)	1
Cardiac arrest	0/44 (0%)	0	1/44 (2.3%)	1
Congestive Heart Failure	0/44 (0%)	0	1/44 (2.3%)	1
Digital Ischemia	0/44 (0%)	0	1/44 (2.3%)	1
NSTEMI Myocardial Infarction	0/44 (0%)	0	1/44 (2.3%)	1
Pulmonary Arterial Hypertension	0/44 (0%)	0	1/44 (2.3%)	1
Pulmonary Arterial Hypertension and Pericardial Effusion	0/44 (0%)	0	1/44 (2.3%)	1
Worsening AV block	0/44 (0%)	0	1/44 (2.3%)	1
Gastrointestinal disorders
Anemia	0/44 (0%)	0	1/44 (2.3%)	1
Cholecystitis	0/44 (0%)	0	1/44 (2.3%)	1
Dysphagia due to GI dysmotility	0/44 (0%)	0	1/44 (2.3%)	1
Dysphagia from myositis and prolonged hospitalization	1/44 (2.3%)	1	0/44 (0%)	0
Erosive esophagitis	0/44 (0%)	0	1/44 (2.3%)	1
GAVE; Severe anemia	0/44 (0%)	0	1/44 (2.3%)	1
Melena	1/44 (2.3%)	1	0/44 (0%)	0
Pseudo obstruction of the small bowel, paralytic ileus	1/44 (2.3%)	1	0/44 (0%)	0
Infections and infestations
Cellulitis of right elbow	1/44 (2.3%)	1	0/44 (0%)	0
Healthcare associated pneumonia (HCAP)	0/44 (0%)	0	1/44 (2.3%)	1
Left side mastoiditis/ abrythnitis	1/44 (2.3%)	1	0/44 (0%)	0
Paronychia	0/44 (0%)	0	1/44 (2.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma (BCC)	0/44 (0%)	0	1/44 (2.3%)	1
Squamous Cell Carcinoma In-situ Left Anterior Ear	1/44 (2.3%)	1	0/44 (0%)	0
Psychiatric disorders
Depression with Suicidal Ideation	0/44 (0%)	0	1/44 (2.3%)	1
Renal and urinary disorders
Renal crisis	3/44 (6.8%)	3	1/44 (2.3%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory Failure	1/44 (2.3%)	1	0/44 (0%)	0
Other (Not Including Serious) Adverse Events
	Abatacept		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/44 (79.5%)		40/44 (90.9%)
Blood and lymphatic system disorders
Other Non-serious Adverse Events	0/44 (0%)	0	3/44 (6.8%)	3
Anemia	4/44 (9.1%)	4	2/44 (4.5%)	3
Cardiac disorders
Other Non-serious Adverse Events	3/44 (6.8%)	4	5/44 (11.4%)	5
Ear and labyrinth disorders
Other Non-serious Adverse Events	2/44 (4.5%)	2	1/44 (2.3%)	1
Endocrine disorders
Other Non-serious Adverse Events	3/44 (6.8%)	3	1/44 (2.3%)	1
Gastrointestinal disorders
Other Non-serious Adverse Events	11/44 (25%)	17	13/44 (29.5%)	18
Diarrhea	4/44 (9.1%)	4	6/44 (13.6%)	6
Dysphagia	3/44 (6.8%)	3	2/44 (4.5%)	2
Nausea	4/44 (9.1%)	4	4/44 (9.1%)	5
Vomiting (Emesis)	3/44 (6.8%)	3	2/44 (4.5%)	2
General disorders
Other Non-serious Adverse Events	13/44 (29.5%)	23	12/44 (27.3%)	16
Fatigue	2/44 (4.5%)	2	6/44 (13.6%)	7
Weight Loss	3/44 (6.8%)	3	2/44 (4.5%)	2
Hepatobiliary disorders
Other Non-serious Adverse Events	1/44 (2.3%)	1	4/44 (9.1%)	4
Infections and infestations
Other Non-serious Adverse Events	17/44 (38.6%)	24	22/44 (50%)	39
Upper Respiratory Infection	3/44 (6.8%)	3	9/44 (20.5%)	11
Urinary Tract Infection	2/44 (4.5%)	2	4/44 (9.1%)	4
Musculoskeletal and connective tissue disorders
Other Non-serious Adverse Events	18/44 (40.9%)	25	17/44 (38.6%)	23
Nervous system disorders
Other Non-serious Adverse Events	7/44 (15.9%)	7	7/44 (15.9%)	9
Headache	1/44 (2.3%)	1	6/44 (13.6%)	8
Renal and urinary disorders
Other Non-serious Adverse Events	1/44 (2.3%)	1	5/44 (11.4%)	6
Respiratory, thoracic and mediastinal disorders
Other Non-serious Adverse Events	5/44 (11.4%)	6	13/44 (29.5%)	15
Skin and subcutaneous tissue disorders
Other Non-serious Adverse Events	7/44 (15.9%)	8	7/44 (15.9%)	12
Pruritis (Itching)	4/44 (9.1%)	4	1/44 (2.3%)	1
Rash	3/44 (6.8%)	3	2/44 (4.5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.