Diffuse Cutaneous Systemic Sclerosis
Conditions
Keywords
Scleroderma
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.
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.
Interventions
DRUGAbatacept
Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks
DRUGPlacebo
125 mg of Placebo
Sponsors
Bristol-Myers Squibb
National Institute of Allergy and Infectious Diseases (NIAID)
Dinesh Khanna, MD, MS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 6. Age ≥ 18 years at the screening visit 7. If female of childbearing potential, the patient must have a negative pregnancy test at screening and baseline visits 8. 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. 9. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Change From Baseline to Month 12 in FVC (in ml) | Baseline and Week 52 | FVC = forced vital capacity, a measure of lung function |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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. |
| 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). |
| 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). |
| 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. |
| 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. |
| 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). |
| 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). |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
Countries
Canada, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Abatacept 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 | 44 |
| Placebo 125mg Placebo
Placebo: 125 mg of Placebo | 44 |
| Total | 88 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | investigator withdrew subject | 3 | 1 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | relocation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 4 |
Baseline characteristics
| Characteristic | Abatacept | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 12 | 49 years STANDARD_DEVIATION 13 | 49 years STANDARD_DEVIATION 13 |
| dcSSc Disease Duration <= 18 months | 26 Participants | 27 Participants | 53 Participants |
| Disease Duration | 1.66 years STANDARD_DEVIATION 0.84 | 1.52 years STANDARD_DEVIATION 0.79 | 1.59 years STANDARD_DEVIATION 0.81 |
| DLCO% Predicted, Corrected for Hemoglobin | 79.57 percent predicted STANDARD_DEVIATION 18.117 | 76.45 percent predicted STANDARD_DEVIATION 18.439 | 78.01 percent predicted STANDARD_DEVIATION 18.241 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 7 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 36 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| FVC% Predicted | 84.19 percent predicted STANDARD_DEVIATION 13.504 | 86.49 percent predicted STANDARD_DEVIATION 16.597 | 85.34 percent predicted STANDARD_DEVIATION 15.087 |
| HAQ-DI | 1.14 units on a scale STANDARD_DEVIATION 0.716 | 0.97 units on a scale STANDARD_DEVIATION 0.701 | 1.05 units on a scale STANDARD_DEVIATION 0.71 |
| mRSS | 23.34 units on a scale STANDARD_DEVIATION 7.947 | 21.57 units on a scale STANDARD_DEVIATION 7.328 | 22.45 units on a scale STANDARD_DEVIATION 7.652 |
| Patient Global Assessment | 3.88 units on a scale STANDARD_DEVIATION 2.206 | 4.31 units on a scale STANDARD_DEVIATION 2.561 | 4.09 units on a scale STANDARD_DEVIATION 2.384 |
| Physician Global Assessment | 4.77 units on a scale STANDARD_DEVIATION 1.669 | 4.76 units on a scale STANDARD_DEVIATION 1.665 | 4.77 units on a scale STANDARD_DEVIATION 1.657 |
| Proportion of Participants with >= 1 Large Joint Contractures | 31 Participants | 32 Participants | 63 Participants |
| Proportion of Participants with >= 1 Swollen Joint Count | 21 Participants | 21 Participants | 42 Participants |
| Proportion of Participants with >= 1 Tendon Friction Rubs | 19 Participants | 13 Participants | 32 Participants |
| Proportion of Participants with Previous Use of Immunosuppressives | 12 Participants | 5 Participants | 17 Participants |
| Proportion of Participants with Previous Use of Prednisone | 12 Participants | 5 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 35 Participants | 37 Participants | 72 Participants |
| Sex: Female, Male Female | 31 Participants | 35 Participants | 66 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 22 Participants |
| Swollen Joint Count | 3.64 number of swollen joints STANDARD_DEVIATION 5.62 | 3.86 number of swollen joints STANDARD_DEVIATION 5.849 | 3.75 number of swollen joints STANDARD_DEVIATION 5.704 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 44 | 1 / 44 |
| other Total, other adverse events | 35 / 44 | 40 / 44 |
| serious Total, serious adverse events | 9 / 44 | 12 / 44 |
Outcome results
Primary
Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12 | -6.24 units on a scale | Standard Error 1.14 |
| Placebo | Change From Baseline in the Modified Rodnan Skin Score (mRSS) to Month 12 | -4.49 units on a scale | Standard Error 1.14 |
p-value: 0.28Mixed Models Analysis
Primary
Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Abatacept | Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year | 35 Participants |
| Placebo | Proportion of Participants With at Least One Adverse Events (AEs) or Serious AEs (SAEs) in 1 Year | 40 Participants |
Secondary
ACR CRISS at 12 Months
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Abatacept | ACR CRISS at 12 Months | 0.72 units on a scale |
| Placebo | ACR CRISS at 12 Months | 0.02 units on a scale |
p-value: 0.03van Elteren test
Secondary
Change From Baseline to Month 12 in FVC (in ml)
FVC = forced vital capacity, a measure of lung function
Time frame: Baseline and Week 52
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in FVC (in ml) | -36.39 ml | Standard Error 43.82 |
| Placebo | Change From Baseline to Month 12 in FVC (in ml) | -121.6 ml | Standard Error 46.39 |
p-value: 0.19Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in HAQ-DI - Arising
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in HAQ-DI - Arising | -0.23 score on a scale | Standard Error 0.103 |
| Placebo | Change From Baseline to Month 12 in HAQ-DI - Arising | 0.04 score on a scale | Standard Error 0.109 |
p-value: 0.0751Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in HAQ-DI - Common Daily Activities
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in HAQ-DI - Common Daily Activities | -0.09 score on a scale | Standard Error 0.113 |
| Placebo | Change From Baseline to Month 12 in HAQ-DI - Common Daily Activities | 0.08 score on a scale | Standard Error 0.121 |
p-value: 0.2906Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in HAQ-DI - Dressing and Grooming
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in HAQ-DI - Dressing and Grooming | -0.25 score on a scale | Standard Error 0.115 |
| Placebo | Change From Baseline to Month 12 in HAQ-DI - Dressing and Grooming | 0.14 score on a scale | Standard Error 0.119 |
p-value: 0.0193Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in HAQ-DI - Eating
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in HAQ-DI - Eating | -0.22 score on a scale | Standard Error 0.118 |
| Placebo | Change From Baseline to Month 12 in HAQ-DI - Eating | 0.02 score on a scale | Standard Error 0.122 |
p-value: 0.1604Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in HAQ-DI - Grip
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in HAQ-DI - Grip | -0.29 score on a scale | Standard Error 0.142 |
| Placebo | Change From Baseline to Month 12 in HAQ-DI - Grip | -0.22 score on a scale | Standard Error 0.149 |
p-value: 0.7281Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in HAQ-DI - Hygiene
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in HAQ-DI - Hygiene | -0.08 score on a scale | Standard Error 0.125 |
| Placebo | Change From Baseline to Month 12 in HAQ-DI - Hygiene | 0.40 score on a scale | Standard Error 0.132 |
p-value: 0.0097Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in HAQ-DI - Overall
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in HAQ-DI - Overall | -0.17 score on a scale | Standard Error 0.07 |
| Placebo | Change From Baseline to Month 12 in HAQ-DI - Overall | 0.11 score on a scale | Standard Error 0.07 |
p-value: 0.005Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in HAQ-DI - Reach
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in HAQ-DI - Reach | -0.12 score on a scale | Standard Error 0.176 |
| Placebo | Change From Baseline to Month 12 in HAQ-DI - Reach | 0.03 score on a scale | Standard Error 0.127 |
p-value: 0.4927Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in HAQ-DI - Walking
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in HAQ-DI - Walking | -0.02 score on a scale | Standard Error 0.1 |
| Placebo | Change From Baseline to Month 12 in HAQ-DI - Walking | 0.18 score on a scale | Standard Error 0.106 |
p-value: 0.1679Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease | -0.31 score on a scale | Standard Error 0.423 |
| Placebo | Change From Baseline to Month 12 in Patient Global Assessment for Overall Disease | -0.09 score on a scale | Standard Error 0.457 |
p-value: 0.73Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in 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. Higher score means worse outcome.
Time frame: Baseline and Week 52
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in Physician Global Assessment for Overall Disease | -1.3 score on a scale | Standard Error 0.29 |
| Placebo | Change From Baseline to Month 12 in Physician Global Assessment for Overall Disease | -0.35 score on a scale | Standard Error 0.318 |
p-value: 0.03Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in PROMIS-29 - Ability to Participate in Social Roles & Activities
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in PROMIS-29 - Ability to Participate in Social Roles & Activities | -1.11 score on a scale | Standard Error 1.07 |
| Placebo | Change From Baseline to Month 12 in PROMIS-29 - Ability to Participate in Social Roles & Activities | -1.26 score on a scale | Standard Error 1.14 |
p-value: 0.92Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in PROMIS-29 - Anxiety
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in PROMIS-29 - Anxiety | -3.5 score on a scale | Standard Error 1.31 |
| Placebo | Change From Baseline to Month 12 in PROMIS-29 - Anxiety | -1.09 score on a scale | Standard Error 1.37 |
p-value: 0.21Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in PROMIS-29 - Depression
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in PROMIS-29 - Depression | -0.02 score on a scale | Standard Error 1.13 |
| Placebo | Change From Baseline to Month 12 in PROMIS-29 - Depression | -0.41 score on a scale | Standard Error 1.2 |
p-value: 0.81Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in PROMIS 29 - Fatigue
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in PROMIS 29 - Fatigue | -0.65 score on a scale | Standard Error 1.29 |
| Placebo | Change From Baseline to Month 12 in PROMIS 29 - Fatigue | -0.98 score on a scale | Standard Error 1.36 |
p-value: 0.86Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in PROMIS-29 - Pain Intensity
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in PROMIS-29 - Pain Intensity | -0.72 score on a scale | Standard Error 0.32 |
| Placebo | Change From Baseline to Month 12 in PROMIS-29 - Pain Intensity | -0.18 score on a scale | Standard Error 0.33 |
p-value: 0.24Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in PROMIS-29 - Pain Interference
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in PROMIS-29 - Pain Interference | -4.10 score on a scale | Standard Error 1.13 |
| Placebo | Change From Baseline to Month 12 in PROMIS-29 - Pain Interference | -1.56 score on a scale | Standard Error 1.22 |
p-value: 0.13Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in PROMIS-29 - Physical Function
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in PROMIS-29 - Physical Function | -1.54 score on a scale | Standard Error 0.65 |
| Placebo | Change From Baseline to Month 12 in PROMIS-29 - Physical Function | -0.17 score on a scale | Standard Error 0.69 |
p-value: 0.15Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in PROMIS-29 - Sleep Disturbance
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in PROMIS-29 - Sleep Disturbance | -0.31 score on a scale | Standard Error 0.57 |
| Placebo | Change From Baseline to Month 12 in PROMIS-29 - Sleep Disturbance | -0.21 score on a scale | Standard Error 0.62 |
p-value: 0.91Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in PROMIS - Fatigue
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in PROMIS - Fatigue | -2.44 score on a scale | Standard Error 1.209 |
| Placebo | Change From Baseline to Month 12 in PROMIS - Fatigue | -0.05 score on a scale | Standard Error 1.285 |
p-value: 0.1769Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in PROMIS - Sleep Disturbance
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
Population: Modified Intent-to-Treat population includes all of the randomized participants who received at least one dose of study medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in PROMIS - Sleep Disturbance | -0.31 score on a scale | Standard Error 0.573 |
| Placebo | Change From Baseline to Month 12 in PROMIS - Sleep Disturbance | -0.21 score on a scale | Standard Error 0.62 |
p-value: 0.9075Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in PROMIS - Sleep Impairment
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
Population: Modified Intent-to-Treat population includes all of the randomized participants who received at least one dose of study medication
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in PROMIS - Sleep Impairment | 0.46 score on a scale | Standard Error 1.267 |
| Placebo | Change From Baseline to Month 12 in PROMIS - Sleep Impairment | -0.54 score on a scale | Standard Error 1.32 |
p-value: 0.5831Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in SCTC GIT - Composite Score
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in SCTC GIT - Composite Score | 0.07 score on a scale | Standard Error 0.047 |
| Placebo | Change From Baseline to Month 12 in SCTC GIT - Composite Score | -0.05 score on a scale | Standard Error 0.05 |
p-value: 0.07Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in SHAQ-DI VAS - Breathing
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in SHAQ-DI VAS - Breathing | 9.30 score on a scale | Standard Error 5.51 |
| Placebo | Change From Baseline to Month 12 in SHAQ-DI VAS - Breathing | 16.95 score on a scale | Standard Error 5.85 |
p-value: 0.34Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in SHAQ-DI VAS - Burden of Digital Ulcers
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in SHAQ-DI VAS - Burden of Digital Ulcers | -3.18 score on a scale | Standard Error 5.13 |
| Placebo | Change From Baseline to Month 12 in SHAQ-DI VAS - Burden of Digital Ulcers | 8.67 score on a scale | Standard Error 5.52 |
p-value: 0.12Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in SHAQ-DI VAS - GI Involvement
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in SHAQ-DI VAS - GI Involvement | 9.98 score on a scale | Standard Error 6 |
| Placebo | Change From Baseline to Month 12 in SHAQ-DI VAS - GI Involvement | 8.01 score on a scale | Standard Error 6.42 |
p-value: 0.82Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in SHAQ-DI VAS - Overall Disease
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in SHAQ-DI VAS - Overall Disease | -7.42 score on a scale | Standard Error 5.638 |
| Placebo | Change From Baseline to Month 12 in SHAQ-DI VAS - Overall Disease | 3.52 score on a scale | Standard Error 6.045 |
p-value: 0.19Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in SHAQ-DI VAS - Raynaud's
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in SHAQ-DI VAS - Raynaud's | 7.58 score on a scale | Standard Error 6.6 |
| Placebo | Change From Baseline to Month 12 in SHAQ-DI VAS - Raynaud's | -3.64 score on a scale | Standard Error 7.17 |
p-value: 0.25Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in Swollen Joint Count
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in Swollen Joint Count | -0.11 number of swollen joints | Standard Error 0.595 |
| Placebo | Change From Baseline to Month 12 in Swollen Joint Count | -0.86 number of swollen joints | Standard Error 0.601 |
p-value: 0.37Mixed Models Analysis
Secondary
Change From Baseline to Month 12 in Tender Joint Counts
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change From Baseline to Month 12 in Tender Joint Counts | -0.71 number of tender joints | Standard Error 0.9 |
| Placebo | Change From Baseline to Month 12 in Tender Joint Counts | -1.47 number of tender joints | Standard Error 0.91 |
p-value: 0.55Mixed Models Analysis
Secondary
Change in % Predicted FVC
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
Population: mITT population includes all of the randomized participants who received at least one dose of study medication.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Abatacept | Change in % Predicted FVC | -1.34 percent predicted | Standard Error 1.24 |
| Placebo | Change in % Predicted FVC | -4.13 percent predicted | Standard Error 1.22 |
p-value: 0.11Mixed Models Analysis