Trial · NCT02161406
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 35
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Change From Baseline to Month 12 in FVC (in ml) | Baseline and Week 52 | FVC = forced vital capacity, a measure of lung function |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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