Trial · NCT04837131
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment-emergent Adverse Event (AE) | 7 months | The number of participants with at least one treatment-emergent adverse event. Defined as any of the following: Treatment-emergent AEs; Treatment-emergent serious adverse events (SAEs); Treatment-emergent treatment-related AEs; or Treatment-emergent treatment-related SAEs. |
| Primary | Adverse Events Leading to Ixazomib Dose Modifications | 7 months | Number of participants with treatment-emergent AEs leading to ixazomib dose modifications. |
| Primary | Adverse Events Leading to Ixazomib Early Discontinuation | 7 months | Number of participants with treatment-emergent AEs leading to ixazomib early discontinuation. |
| Primary | Change in the UCLA Scleroderma Clinical Trials Consortium Gastrointestinal 2.0 (UCLA SCTC GIT 2.0) Questionnaire Score | Baseline, 7 months | The UCLA SCTC GIT 2.0 is a self-administered survey consisting of 34 questions (Reflux 1 to 8, Distention/Bloating 9 to 12, Fecal Soilage 13, Diarrhea 14 to 15, Social functioning 16 to 21, Emotional well-being 22 to 30, Constipation 31 to 34). The items are scored on a scale from 0 to 3, where 0 indicates better health and 3 indicates worse health, except for questions 15 and 31, which are scored as 0 (better health) and 1 (worse health). Scores from all scales except the constipation scale are averaged to form a total GIT score from 0 (no gastrointestinal problems) to 3 (most severe) that captures overall burden of severity of scleroderma-associated gastrointestinal involvement. |
| Secondary | Change From Baseline in Modified Rodnan Skin Score (MRSS) | Baseline, 24 weeks | MRSS is a validated clinical semiquantitative assessment of scleroderma skin thickness at 17 prespecified sites on the body, with thickness at each site scored from 0 (uninvolved) to 3 (severe thickening) that are tabulated for a total numerical skin score ranging 0-51. Lower scores indicate less involvement, and higher scores indicate more severe thickening. |
| Secondary | Change From Baseline in High Resolution Chest CT Scan Goh Score | Baseline, 24 weeks | Staging extent of scleroderma lung involvement on high resolution chest CT scan by the application of Goh criteria which identified a severity extent threshold of 20% lung involvement yields two cohorts with significantly different 10 year survivorship. Goh scores range 0-100% with a higher score indicating greater extent of lung involvement. |
| Secondary | Change in Forced Vital Capacity (FVC) % Predicted. | Baseline, 7 months | FVC is the maximum amount of air a person can forcefully exhale from their lungs after taking a deep breath. |
| Secondary | Change in Total Lung Capacity (TLC) % Predicted | Baseline, 24 weeks | TLC is the total maximum amount of air that lungs can hold. |
| Secondary | Severity of Dyspnea at Baseline (Mahler Baseline Dyspnea Index) | Baseline | Severity of dyspnea at baseline is measured with the Mahler Baseline Dyspnea Index (BDI). BDI includes 5 grades of severity from 0 (severe impairment) to 4 (no impairment ) for each of 3 categories (functional impairment; magnitude of task; magnitude of effort) yielding a summation focal score (0-12). Higher scores indicate lower impairment. |
| Secondary | Dyspnea Status Rating (Mahler Transitional Dyspnea Index) | 12 weeks, 24 weeks | Mahler Transitional Dyspnea Index (TDI) rates a participant's dyspnea status relative to baseline. TDI scores range from -3 (major deterioration) to +3 (major improvement) including 0 to indicate no change in status for each of the 3 BDI categories (functional impairment; magnitude of task; magnitude of effort) yielding a summation focal score (-9 to +9). Higher scores indicate major improvement. |
| Secondary | Change in Scleroderma Health Assessment Questionnaire (SHAQ) Score | Baseline, 24 weeks | SHAQ self-assesses function in 8 domains of the Health Assessment Questionnaire Disability Index (HAQ-DI): dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Highest domain scores 0 (no difficulty) to 3 (unable to do) are summed and divided by 8 to yield Disability Index score as a continuous variable ranging 0 to 3. SHAQ has:1) a 15-cm Visual Analog Scale (VAS) rating pain with anchors "No Pain" and "Very Severe Pain"; 2) four 15-cm VAS assessing Raynaud phenomenon, digital ulcers, gastrointestinal and lung symptoms with anchors "Does Not Interfere" and "Very Severe Limitation"; and 3) overall disease severity 15-cm VAS with anchors "No Disease" and "Very Severe Disease" |
| Secondary | Change in Patient Global Assessment of Disease Activity (PtGA) | Baseline, 24 weeks | Patient-reported outcome that represents the participant's assessment of his or her current overall health (Question: How was your overall health in the last week?) rated on an 11-point numeric scale anchored at 0 (excellent) to 10 (extremely poor) with higher scores indicating worse disease in terms of severity and damage. |
| Secondary | Change in Physician Global Assessment of Disease Activity (MDGA) | Baseline, 24 weeks | Physician-reported outcome that represents an assessment of the participant's current overall health rated on an 11-point numeric scale anchored at 0 (excellent) to 10 (extremely poor) with higher scores indicating worse disease in terms of severity and damage. |
| Secondary | Change in American College of Rheumatology Composite Response Index for Clinical Trials in Early Diffuse Cutaneous Systemic Sclerosis (ACR CRISS) | Baseline, 24 weeks | ACR CRISS calculates the predicted probability of improvement in a 2-step process. Four possible outcomes in Step 1 include worsening of FVC % predicted by at least 15%, new decline of left ventricular ejection fraction to 45% or less attributable to scleroderma and needing treatment, new onset pulmonary arterial hypertension attributable to scleroderma and scleroderma renal crisis. If any one of these outcomes develops as a change from baseline, the participant is classified as not improved (score = 0) regardless of changes in other parameters. Step 2 calculates change from baseline in the predicted probability of improvement based on combined changes in the mRSS, FVC % predicted, patient global assessment, physician global assessment, and HAQ-DI. The calculated probability ranges from 0 (not improved) to 1.0 where a higher score indicates improvement. |
| Secondary | Change in Diffusion Capacity (DLCO) % Predicated | Baseline, 7 months | DLCO is the amount of carbon monoxide (CO) that moves from the lungs to the blood |
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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