This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Abituzumab in SSc-ILD (NCT02745145), a randomized phase 2 study. The primary outcome is Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02745145 |
| Phase | Phase 2 |
| Condition | Systemic Sclerosis-associated Interstitial Lung Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 24 |
| Arms in the primary outcome | 3 |
| Lead sponsor | EMD Serono Research & Development Institute, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD) who, according to the registry summary, already received constant doses of mycophenolate. The primary endpoint population is described as the modified intent-to-treat population: randomized participants who received at least one dose of study drug, including placebo. For the outcome, the registry says the analyzed number signifies participants evaluable for that measure.
Intervention
Abituzumab at 500 mg or 1500 mg. The registry describes the trial purpose as comparing both doses with placebo in relation to efficacy, safety, tolerability, and immune response.
Comparator
Placebo. The trial is described as randomized, placebo controlled, and parallel group. The registry lists three arms: placebo, abituzumab 500 mg, and abituzumab 1500 mg.
Primary question
What was the change from baseline in absolute forced vital capacity (FVC) at Week 52 in each arm, and can the posted results support a comparison of either abituzumab dose with placebo? FVC is reported in milliliters. The available arm results do not provide an estimable two-arm comparison.
The clinical question is framed around change in FVC, a measure of the amount of air exhaled after the deepest breath possible. The registry says FVC assessments used spirometry. A change-from-baseline endpoint asks how the recorded measure at follow-up differs from the participant’s starting value; it does not, by itself, show how the treatment arms differ from one another. That requires arm-level results sufficient to estimate a contrast and its uncertainty.
The record also lists secondary questions involving dyspnea, respiratory questionnaire scores, skin involvement, lung fibrosis, survival, and clinically meaningful progression of systemic sclerosis. Those outcomes broaden the scope of the trial, but they do not replace the primary FVC question. The posted primary results are notably sparse: the 500 mg arm has no evaluable participants recorded, and no two-arm continuous-outcome comparison is estimable from the reported results. Thus, the registry record does not establish a comparative answer to the primary question.
3. Trial Design
The registry describes NCT02745145 as a Phase II randomized, placebo-controlled, parallel-group trial of abituzumab for SSc-ILD. The planned arms were placebo, abituzumab 500 mg, and abituzumab 1500 mg. The official title calls the trial double-blind, while the registry’s masking classification is quadruple. The record does not explain which people were masked or how the different masking descriptions relate.
The registry lists an enrollment of 24. That is the recorded enrollment field, not the number analyzed for the primary endpoint. For the primary outcome, the posted analyzed counts are 2 for placebo, 0 for abituzumab 500 mg, and 1 for abituzumab 1500 mg. These outcome-specific counts are the basis for interpreting the reported means; they should not be confused with the trial’s enrollment field or the safety group counts.
The registry gives a start date of 2016-05-31 and a primary completion date of 2018-05-30. The status is TERMINATED. The reason for termination is not reported in the registry record, and the dates alone do not establish why the trial ended or whether it ended as planned.
The primary endpoint was change from baseline in absolute FVC at Week 52, expressed in milliliters. The record lists mean and standard deviation as the summary measures. It gives a placebo mean change of -130.0 with a standard deviation of 56.6, based on 2 participants. For abituzumab 1500 mg, the mean change is -50.0 based on 1 participant, with no standard deviation posted. The 500 mg arm has no reported analyzed value. These arm summaries do not constitute a complete comparative analysis.
The record lists 10 outcome measures and 9 posted secondary outcomes. It reports no analyses in the analysis count. This does not describe a prespecified analysis plan; statistical details such as covariate adjustment, handling of repeated measurements, and any interim analyses are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: The study enrolled 24 participants and was early terminated due to the difficulties experienced in identifying participants who meet the eligibility criteria of the trial.
Overall Study
| Stage | Placebo | Abituzumab 500 Milligrams (mg) | Abituzumab 1500 mg |
|---|---|---|---|
| STARTED | 10 | 5 | 9 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 10 | 5 | 9 |
Reasons for not completing this period:
| Reason | Placebo | Abituzumab 500 Milligrams (mg) | Abituzumab 1500 mg |
|---|---|---|---|
| Adverse Event | 1 | 0 | 0 |
| Death | 0 | 1 | 0 |
| Progressive disease | 0 | 0 | 1 |
| Withdrew consent | 1 | 1 | 1 |
| Study Termination | 8 | 3 | 7 |
Analysis population for the primary outcome, as defined in the registry: Modified intent-to-treat (mITT) population was defined as all randomized participants who received at least 1 dose of study drug (including placebo). Here, "Overall Number of Participants Analyzed" signified participants evaluable for the outcome measure. All participants for abituzumab 500 mg arm dropped out before the analysis was conducted.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The safety analysis set (SAF) included all participants who received at least 1 dose of abituzumab (including placebo) and have at least 1 post dose safety assessment.
| Characteristic | Unit | Placebo | Abituzumab 500 Milligrams (mg) | Abituzumab 1500 mg | Total |
|---|---|---|---|---|---|
| Participants analysed | 10 | 5 | 9 | 24 | |
| Age, Continuous | Years | 51 (SD 10.6) | 60 (SD 7.5) | 55 (SD 7.8) | 55 (SD 9.3) |
| Sex: Female, Male: Female | Participants | 8 | 4 | 7 | 19 |
| Sex: Female, Male: Male | Participants | 2 | 1 | 2 | 5 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 3 | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 9 | 5 | 6 | 20 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 10 | 5 | 9 | 24 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52, measured over Baseline, Week 52.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | milliliters |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in absolute forced vital capacity (FVC) at Week 52. FVC is defined in the registry as the maximum amount of air exhaled from the lungs after taking the deepest breath possible. The record says the assessments were made using spirometry and reports the outcome in milliliters.
Change from baseline describes the follow-up value in relation to the starting value. In a randomized trial, comparing such changes across groups can help assess whether the groups’ observed trajectories differ, provided that sufficient outcome data are available and the comparison method is specified. A within-group mean change alone does not tell whether that change differs from the change under placebo. The between-group contrast, together with a measure of uncertainty, is needed to interpret the comparative result.
FVC is used as the primary measure of lung function in the trial’s evaluation of SSc-ILD. The endpoint’s stated timeframe is baseline and Week 52. The registry reports the mean and standard deviation as its summary measures. It does not post a standard deviation for the 1500 mg arm, any endpoint value for the 500 mg arm, or a confidence interval or test result for a dose-versus-placebo contrast. The small outcome-specific analyzed counts make the available arm summaries especially limited as evidence about the comparative endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome data are incomplete for comparing abituzumab with placebo. The placebo arm has a reported mean change in FVC of -130.0 milliliters, with a standard deviation of 56.6 and an analyzed count of 2. The 1500 mg arm has a reported mean change of -50.0 milliliters and an analyzed count of 1, but no standard deviation. The 500 mg arm has an analyzed count of 0 and no reported mean or spread.
These summaries describe only the recorded values in the available outcome groups. They are not a complete treatment comparison. In particular, the registry does not provide the 500 mg arm’s endpoint estimate, a measure of variability for the 1500 mg arm, a confidence interval for either dose comparison, or a p-value for the primary endpoint. The record explicitly indicates that values are missing or not estimable for a two-arm continuous endpoint comparison. Accordingly, there is no supported comparative estimate to interpret as evidence for a difference between either dose and placebo.
A mean is a summary of observed measurements, while a standard deviation describes variation among those measurements. A confidence interval would convey uncertainty around an estimated quantity, such as a between-arm difference. With only the posted summaries, and especially with no endpoint value in one arm, the precision of a comparative effect cannot be assessed. The single analyzed observation in the 1500 mg arm also cannot characterize that arm’s participant-to-participant variation in the way a group standard deviation would.
The registry’s enrollment field is 24, whereas the outcome-specific analyzed counts are much smaller. These are different quantities: enrollment describes the trial record, while the analyzed counts refer to participants evaluable for this endpoint. The record does not explain why the primary outcome counts are limited, whether this reflects missing measurements, exclusions from the endpoint analysis, or another process. The reasons are not reported in the registry record.
The safety summaries are separate from the primary endpoint results. They include serious adverse events, other adverse events, and deaths by safety group. They should not be used to fill the missing efficacy comparison, and the small numbers should not be treated as precise estimates of comparative safety. The record’s terminated status is also not an outcome finding: the reason for termination is not reported in the registry record.
Overall, the posted data give a limited description of observed FVC change in two arms and no estimable two-arm comparison. They do not establish the size or precision of a treatment effect. No conclusion about efficacy, lack of efficacy, or comparative safety follows from the incomplete primary endpoint summaries alone.
9. Statistical Methods Explained
What does a mean change describe?
The primary outcome is a continuous measure: change in FVC from baseline to Week 52, with results expressed in milliliters. A mean summarizes the observed changes in an arm by averaging them. The placebo mean is -130.0, based on 2 analyzed participants. The 1500 mg mean is -50.0, based on 1 analyzed participant. These are arm-specific summaries, not the estimated difference between an abituzumab arm and placebo.
For a treatment comparison, the quantity of interest would generally be a contrast between arms. A contrast describes how the outcome in one assigned group differs from the outcome in another, according to the chosen statistical method. The registry does not report such an estimate for the primary endpoint. It also does not post an analyzed value for the 500 mg arm. The two reported means cannot substitute for a complete randomized comparison.
What does the standard deviation contribute?
General statistical explanation: the standard deviation describes how spread out individual observations are around their group mean. It is not the same as the uncertainty of the mean or the uncertainty of a treatment contrast. The placebo standard deviation is 56.6. No standard deviation is reported for the 1500 mg arm, and no endpoint values are reported for the 500 mg arm. Without adequate arm-level information, the variation relevant to a comparative estimate cannot be established from the posted results.
What would a confidence interval show?
General statistical explanation: a confidence interval presents a range of values compatible with an estimate under the method’s assumptions, and communicates the estimate’s precision. A narrow interval indicates greater precision than a wide interval, while an interval spanning a broad range indicates substantial uncertainty. The registry record does not report a confidence interval for a dose-versus-placebo FVC comparison. Since no such comparison is estimable from the available data, no interval can be interpreted as the precision of a treatment effect.
Why does the analysis population matter?
The registry defines the modified intent-to-treat population as randomized participants who received at least one dose of study drug, including placebo. It further says that the “Overall Number of Participants Analyzed” signifies participants evaluable for the outcome measure. That definition distinguishes the population description from the endpoint-specific count. The record reports analyzed counts of 2 for placebo, 0 for 500 mg, and 1 for 1500 mg. The reasons for the difference between enrollment and these endpoint counts are not reported in the registry record.
General statistical explanation: restricting an analysis to participants with evaluable endpoint data can affect how well the analyzed groups represent the randomized groups, particularly if missingness is related to outcomes or treatment. To assess that possibility, readers would need information on missing observations, reasons for missingness, and the analysis method used to address it. Those details are not reported in the registry record. The available numbers do not establish why observations were absent.
What does an unadjusted recalculation mean?
General statistical explanation: a recalculated comparison based on posted summary statistics is an unadjusted calculation, not necessarily the trial sponsor’s primary analysis. Such a calculation depends on having suitable summaries for each group and on assumptions about the data and comparison method. Here, the record states that a two-arm continuous endpoint comparison is not estimable. No recalculated treatment contrast is therefore available to interpret, and the registry does not post a sponsor comparison for the primary outcome.
Any sample-size illustration based on an observed effect is a planning exercise, not a description of trial power after the fact. It asks how many participants per arm might be needed under the stated assumptions to detect a chosen fraction of an effect. The registry’s planning assumptions specify a two-sided significance level of 0.05, equal allocation, and a normal approximation; the effect to detect is described as a fraction of the observed effect. Such illustrations do not demonstrate that the trial had a particular probability of finding a result, and do not repair missing endpoint data. Sample-size calculations are not observed power.
General statistical explanation: continuous outcomes may have more variability than a simple model assumes. Over-dispersion refers broadly to variability greater than a model’s assumed level; when present, it can make standard errors and uncertainty estimates too small if the model does not accommodate the extra variation. The registry record does not identify an over-dispersion model or provide enough endpoint data to assess this issue. This is a general consideration, not a claim that over-dispersion occurred in this trial.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures and 9 posted secondary outcomes, in addition to the primary FVC endpoint. The secondary outcomes cover dyspnea, respiratory health status, skin score, quantitative lung fibrosis, overall survival, and criteria for clinically meaningful systemic sclerosis progression. Testing or estimating many outcomes can raise multiplicity concerns: in general, more statistical comparisons create more opportunities for apparently notable findings by chance. The registry record does not report a multiplicity adjustment, a hierarchy for testing outcomes, or a statistical analysis plan. It is therefore not possible to determine how multiple outcomes were handled.
The record reports no analyses in the analysis count and no p-value or confidence interval for the primary comparison. This absence should not be interpreted as a null result. It means the registry does not provide those inferential results for the primary endpoint. Reasons for non-reporting or non-estimability are not reported in the registry record.
Missingness is a central limitation for the primary endpoint: the analyzed count is 0 in the 500 mg arm, and the other arms have analyzed counts of 2 and 1. The registry describes the modified intent-to-treat population and says that the analyzed number refers to participants evaluable for the outcome. It does not report how many endpoint measurements were missing, why they were missing, or whether any imputation or sensitivity analysis was performed. No assumptions about those procedures can be made from the posted record.
General statistical explanation: methods for missing data rely on assumptions about why outcomes are unavailable. Different assumptions can lead to different estimates, so reporting the missingness pattern and analysis approach is important. Here, those details are not reported in the registry record, and the primary comparative endpoint is not estimable from the posted arm summaries.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Placebo | 1 | 10 | 10.0% |
| Abituzumab 500 Milligrams (mg) | 1 | 5 | 20.0% |
| Abituzumab 1500 mg | 2 | 9 | 22.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 0 of 10 |
| Abituzumab 500 Milligrams (mg) | 1 of 5 |
| Abituzumab 1500 mg | 0 of 9 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo | 9 of 10 |
| Abituzumab 500 Milligrams (mg) | 4 of 5 |
| Abituzumab 1500 mg | 8 of 9 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | Abituzumab 500 Milligrams (mg) | Abituzumab 1500 mg |
|---|---|---|---|---|
| Pneumonia | Infections and infestations | 1 of 10 | 1 of 5 | 0 of 9 |
| Disease progression | General disorders | 0 of 10 | 1 of 5 | 0 of 9 |
| Device related infection | Infections and infestations | 0 of 10 | 1 of 5 | 0 of 9 |
| Small fibre neuropathy | Nervous system disorders | 0 of 10 | 0 of 5 | 1 of 9 |
| Skin ulcer | Skin and subcutaneous tissue disorders | 0 of 10 | 0 of 5 | 1 of 9 |
| Abdominal distension | Gastrointestinal disorders | 0 of 10 | 0 of 5 | 1 of 9 |
| Neutrophil count increased | Investigations | 0 of 10 | 1 of 5 | 0 of 9 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | Abituzumab 500 Milligrams (mg) | Abituzumab 1500 mg |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 3 of 10 | 1 of 5 | 3 of 9 |
| Cough | Respiratory, thoracic and mediastinal disorders | 3 of 10 | 0 of 5 | 3 of 9 |
| Nausea | Gastrointestinal disorders | 1 of 10 | 1 of 5 | 2 of 9 |
| Fatigue | General disorders | 1 of 10 | 1 of 5 | 2 of 9 |
| Gastroenteritis | Infections and infestations | 4 of 10 | 0 of 5 | 0 of 9 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 1 of 10 | 1 of 5 | 2 of 9 |
| Headache | Nervous system disorders | 1 of 10 | 1 of 5 | 2 of 9 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 1 of 10 | 1 of 5 | 1 of 9 |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 1 of 10 | 1 of 5 | 1 of 9 |
| Abdominal discomfort | Gastrointestinal disorders | 1 of 10 | 0 of 5 | 1 of 9 |
Serious events with the highest arm-level rate: disease progression (20.0%), device related infection (20.0%), pneumonia (20.0%), neutrophil count increased (20.0%), small fibre neuropathy (11.1%).
The registry reports safety groups separately from the primary endpoint groups. For serious adverse events, the placebo group has 1 affected participant among 10 at risk; the abituzumab 500 mg group has 1 among 5; and the abituzumab 1500 mg group has 2 among 9. Deaths are reported as 0 for placebo, 1 for abituzumab 500 mg, and 0 for abituzumab 1500 mg. Other adverse events are reported for 9 of 10, 4 of 5, and 8 of 9 participants, respectively.
These are descriptive counts within the registry’s safety groups. They do not provide an adjusted comparison, and the small group counts limit how precisely differences in event frequency can be estimated. The record does not report confidence intervals or statistical tests for these safety figures. Serious events and other adverse events are distinct categories in the registry summary; their counts should not be combined to create a new total.
The registry also lists serious adverse event terms with percentages, including Disease progression, Device related infection, Pneumonia, and Neutrophil count increased at 20.0% each, and Small fibre neuropathy and Skin ulcer at 11.1% each. These term percentages are registry entries and do not establish comparative risk between treatment groups. The record does not give enough context in these entries to infer causation or to compare event timing. The figures describe reported safety observations, not a treatment recommendation or definitive safety conclusion.
12. What the Result Does, and Does Not, Mean
The primary endpoint results show a placebo mean change of -130.0 milliliters and an abituzumab 1500 mg mean change of -50.0 milliliters. The placebo standard deviation is 56.6. The 500 mg arm has no evaluable participants recorded for this outcome, and no standard deviation is given for the 1500 mg arm. The primary endpoint is therefore not available as a complete dose-versus-placebo comparison.
These data do not quantify a treatment effect with an associated measure of precision. A difference between arm means, if calculated from the limited reported means, would not resolve the missing 500 mg result, supply the absent variability information, or provide a confidence interval or statistical test. The registry identifies the continuous endpoint comparison as not estimable. The record does not establish whether the sparse results arose from missing measurements, analysis exclusions, or another cause.
The data also do not show that there was no effect. An unreported or non-estimable comparison is different from a well-estimated comparison near zero. Likewise, the observed mean in a very small analyzed group should not be generalized to all trial participants or to people outside the trial. The registry’s enrollment field and endpoint-specific analyzed counts refer to different aspects of the record.
The safety counts are descriptive and should be read with the same caution. They record serious and other adverse events and deaths in the safety groups, but do not demonstrate that an event was caused by treatment or establish a precise comparison between groups. The trial’s terminated status does not explain the reason for termination; that reason is not reported in the registry record.
In general, randomized allocation is intended to support fair comparisons between groups, but interpretation still depends on outcome availability, analysis methods, and uncertainty reporting. In this record, the missing primary-arm result and the lack of a comparative estimate prevent a reliable statistical answer to the primary question. The posted results support describing the available observations, not asserting a treatment benefit, lack of benefit, or definitive safety profile.
13. Why This Trial Matters Statistically
This trial illustrates an important distinction between trial enrollment and the number of participants contributing to a particular endpoint. The registry records enrollment of 24, but the primary FVC results have analyzed counts of 2 for placebo, 0 for abituzumab 500 mg, and 1 for abituzumab 1500 mg. Those endpoint-specific counts determine how much information is available for interpreting the posted FVC summaries.
It also demonstrates why an arm mean is not enough to answer a comparative clinical question. The primary question concerns changes under two doses relative to placebo, yet one dose arm has no analyzed observations and the registry does not report a dose-versus-placebo estimate or its uncertainty. Without a complete contrast, the numerical means are descriptive rather than a supported test of treatment differences.
The record includes several secondary outcomes and safety summaries, but their presence does not compensate for the missing primary comparison. Multiplicity and missing-data methods matter especially when many outcomes are listed and only a subset of results are available. The statistical approach to these issues is not reported in the registry record.
For researchers and readers, the trial is a reminder to distinguish a registry’s status, enrollment, analysis population, and outcome-specific count. It also shows why confidence intervals and clear reporting of analysis methods matter: they help readers judge uncertainty and the assumptions behind an estimate. Here, the information is insufficient to determine the comparative precision of the primary outcome.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main trial-specific limitation is the incomplete primary endpoint reporting. The 500 mg group has an analyzed count of 0 and no reported mean change. The 1500 mg group has a mean based on 1 participant, without a standard deviation. Placebo has a mean and standard deviation based on 2 participants. The registry does not provide a comparative estimate, confidence interval, or test result for the primary endpoint.
The record does not explain why the endpoint-specific analyzed counts are limited relative to the enrollment field. It does not report the number or pattern of missing FVC measurements, reasons for missingness, or procedures used to address missing data. The analysis method beyond reporting means and standard deviations is not reported in the registry record.
The trial is listed as terminated, but the reason for termination is not reported. The official title describes the trial as double-blind while the registry classification indicates quadruple masking; the record does not clarify the roles covered by each description. Statistical details including interim analyses, sample-size justification, and a full prespecified analysis plan are not reported in the registry record.
The safety data are also limited as comparative evidence. They are reported as counts within groups and do not include confidence intervals or tests for between-group differences. The available entries do not establish causal attribution for adverse events. The listed secondary outcomes further create questions about multiplicity, but the record does not state how multiple outcomes were handled. These limitations restrict conclusions to a description of the posted observations.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Abituzumab in SSc-ILD — NCT02745145.
- Registry record last updated 2019-06-18; status last verified 2019-05.
- Results first posted 2019-06-18.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT02745145 is a randomized, Phase II, parallel-group, placebo-controlled trial of abituzumab for systemic sclerosis-associated interstitial lung disease. The registry lists placebo, abituzumab 500 mg, and abituzumab 1500 mg arms, enrollment of 24, and status TERMINATED. The primary outcome is change from baseline in absolute FVC at Week 52, measured in milliliters.
For that outcome, placebo has a mean change of -130.0 and standard deviation of 56.6 among 2 analyzed participants. The 1500 mg arm has a mean change of -50.0 among 1 participant, with no standard deviation reported. The 500 mg arm has an analyzed count of 0. A two-arm continuous endpoint comparison is not estimable from the posted results. The reason for termination, missing-data procedures, and full statistical analysis plan are not reported in the registry record.