Trial · NCT00112385
A Pilot Study of Etanercept in Dermatomyositis
NCT00112385, Phase 1, Completed, Brigham and Women's Hospital; results first posted 2011-06-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Pilot Study of Etanercept in Dermatomyositis. Trials, record NCT00112385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00112385
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study of Etanercept in Dermatomyositis
- NCT number
- NCT00112385
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 16 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Dermatomyositis
- Interventions
- Etanercept, Placebo
- First posted
- 2005-06-03
- Last updated
- 2011-06-21
- Results first posted
- 2011-06-21
Source ClinicalTrials.gov
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of at Least One Adverse Event | at each visit during the 12 month study | Adverse events (AEs) were assessed using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). The grade of "mild", "moderate" or "severe" matches with the descriptions from the CTCAE dictionary. In general, a "Mild" AE is asymptomatic; clinical or diagnostic observations only; intervention not indicated. A "Moderate" AE is minimal, local or noninvasive intervention indicated; limiting activities of daily living. A "Severe" AE is medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; |
| Primary | Tolerability | At any point between Baseline (week 0) and the end of the study (Week 52) | The reported tolerability measure was defined as the number of participants that completed the entire 52 week study on their originally assigned treatment. |
| Primary | Average Change in Oral Temperature From Baseline to Week 52 | At Baseline (Week 0) and Week 52 | The subject's oral temperature was measured in degrees Celsius. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. |
| Primary | Average Change in Respiration Rate From Baseline to Week 52 | At Baseline (Week0) and Week 52 | The subject's respiration rate was measured as number of breaths per minute. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. |
| Primary | Average Change in Systolic Blood Pressure From Baseline to Week 52 | At Baseline (Week0) and Week 52 | The subject's systolic blood pressure was measured in millimeters of mercury (mmHg). The average value was calculated per treatment group for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. |
| Primary | Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52. | At Baseline (Week0) and Week 52 | The subject's diastolic blood pressure was measured in millimeters of mercury (mm Hg). The average value was calculated for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40. |
| Primary | Average Change in Pulse Comparing Baseline to Week 52 | At Baseline (Week0) and Week 52 | The subject's pulse was measured in beats per minute (BPM). The average value was calculated per treatment group for the Baseline and Week 52 visit. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40. |
| Primary | Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52. | At Baseline (Week0) and Week 52 | The subject's body weight was measured in kilograms(kg). The average value was calculated for each treatment group for the Baseline and Week 52 visits. The average change was determined by subtracting the average value at the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40. |
| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52 | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant creatine kinase (CK) value if during the course of the study, they had at least one clinically significant CK result that was not present at baseline. Subjects had CK labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. |
| Primary | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52 | At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52 | The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant ALT value if during the course of the study, they had at least one clinically significant ALT result that was not present at baseline. Subjects had ALT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52. |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 registered outcomesOutcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Occurrence of at Least One Adverse Event | at each visit during the 12 month study | Intention- to -Treat (ITT) | participants | NUMBER |
| OTHER_PRE_SPECIFIED | The Number of Participants Who Were Classified as Treatment Failures | At any point during the 52 week study | participants | NUMBER | |
| SECONDARY | Average Prednisone Dosage After Week 24 | from week 24 to 52 | mg | MEDIAN | |
| OTHER_PRE_SPECIFIED | Change in the Average Manual Muscle Testing (MMT) Score From Baseline to Week 52 | At Baseline (Week 0) and Week 52 | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Units on a scale | MEAN |
| PRIMARY | Tolerability | At any point between Baseline (week 0) and the end of the study (Week 52) | Participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Average Change in Time to Rise From a Chair From Baseline to Week 52 | At Baseline (Week0) and Week 52 | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Seconds | MEAN |
| OTHER_PRE_SPECIFIED | Average Change in Time (Seconds) to Walk 30 Feet Comparing Performance at Baseline to Week 52 | At Baseline (Week0) and Week 52 | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | Seconds | MEAN |
| OTHER_PRE_SPECIFIED | Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Femur From the Screening Visit to Week 52 | Screening and Week 52 | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error. | Z-score | MEAN |
| OTHER_PRE_SPECIFIED | Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Lumbar Spine From the Screening Visit to Week 52 | Screening visit and Week 52. | Data for all subjects enrolled in the trial are not available for this assessment. One subject left the study early and one subject was lost to follow-up before the Week 52 visit. In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error. | Z-Score | MEAN |
| OTHER_PRE_SPECIFIED | Average Change in Physician Global Activity Assessment From Baseline to Week 52 | At Baseline (Week0) and Week 52 | Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit. | cm | MEAN |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 outcomesResults by group88
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Occurrence of at Least One Adverse Event | Etanercept | Mild AE | 1 | participants | |
| Occurrence of at Least One Adverse Event | Placebo | Mild AE | 1 | participants | |
| Occurrence of at Least One Adverse Event | Etanercept | Moderate AE | 5 | participants | |
| Occurrence of at Least One Adverse Event | Placebo | Moderate AE | 1 | participants | |
| Occurrence of at Least One Adverse Event | Etanercept | Severe AE | 5 | participants | |
| Occurrence of at Least One Adverse Event | Placebo | Severe AE | 3 | participants | |
| The Number of Participants Who Were Classified as Treatment Failures | Etanercept | 6 | participants | ||
| The Number of Participants Who Were Classified as Treatment Failures | Placebo | 5 | participants | ||
| Average Prednisone Dosage After Week 24 | Etanercept | 1.2 | Inter-Quartile Range 0 to 14.31 | mg | |
| Average Prednisone Dosage After Week 24 | Placebo | 29.2 | Inter-Quartile Range 12.65 to 31.39 | mg |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Etanercept | 11 | |
| Overall Study | STARTED | Placebo | 5 | |
| Overall Study | COMPLETED | Etanercept | 10 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | Etanercept | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events212
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Ascites | Gastrointestinal disorders | Etanercept | 0 | 11 | 0 |
| other | Abdominal Ascites | Gastrointestinal disorders | Placebo | 1 | 5 | 1 |
| other | Abdominal Distention | Gastrointestinal disorders | Etanercept | 0 | 11 | 0 |
| other | Abdominal Distention | Gastrointestinal disorders | Placebo | 1 | 5 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Etanercept | 0 | 11 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 2 | 5 | 2 |
| other | Anxiety/Mood Alternation | Psychiatric disorders | Etanercept | 1 | 11 | 1 |
| other | Anxiety/Mood Alternation | Psychiatric disorders | Placebo | 0 | 5 | 0 |
| other | Atelectasis | Respiratory, thoracic and mediastinal disorders | Etanercept | 0 | 11 | 0 |
| other | Atelectasis | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 5 | 1 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Etanercept | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Etanercept | 11 | 11 |
| Total, other adverse events | Placebo | 5 | 5 |
| Total, serious adverse events | Etanercept | 3 | 11 |
| Total, serious adverse events | Placebo | 3 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21688301 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01NS049639 | A Pilot Study of Etanercept in Dermatomyositis | AMATO, ANTHONY ARNOLD | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2005 to 2007 |
Source NIH RePORTER
Trial comparisons20
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Etanercept vs Placebo: Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52 | Trial comparisons |
| Etanercept vs Placebo: Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Serum 25-hydroxyvitamin D (25-OH VitD) Laboratory Values From the Screening Visit to Week 52 | Trial comparisons |
| Etanercept vs Placebo: Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52 | Trial comparisons |
| Etanercept vs Placebo: Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52 | Trial comparisons |
| Etanercept vs Placebo: Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52 | Trial comparisons |
| Etanercept vs Placebo: Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52 | Trial comparisons |
| Etanercept vs Placebo: Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52 | Trial comparisons |
| Etanercept vs Placebo: Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52 | Trial comparisons |
| Etanercept vs Placebo: Tolerability | Trial comparisons |
| Etanercept vs Placebo: Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52 | Trial comparisons |
1 to 10 of 20
See all 20 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00112385
GET https://conductscience.org/api/trials/v1/NCT00112385/registered?page=2