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A Pilot Study of Etanercept in Dermatomyositis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00112385
Recruitment Status : Completed
First Posted : June 3, 2005
Results First Posted : June 21, 2011
Last Update Posted : June 21, 2011
Sponsor:
Collaborator:
Amgen
Information provided by:
Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dermatomyositis
Interventions Drug: Etanercept
Drug: Placebo
Enrollment 16

Recruitment Details

153 patients were screened and we enrolled and randomized 16 subjects (F 10, M 6) from until February 2006 to May 2009. Of these, 5 were new DM patients and 11 were refractory dermatomyositis patients.

Etanercept: 11 subjects (New 3, Refractory 8) Placebo: 5 subjects (New 2, Refractory 3)

Pre-assignment Details

Most patient were initially ineligible because they were not new dermatomyositis patients.

Due to slow recruitment, we modified the protocol. We allowed enrollment of refractory dermatomyositis patients receiving prednisone for greater than 2 months. These subjects could also receive second line agents, as long as they were on a stable dose.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks Subjects will be given syringes containing placebo
Period Title: Overall Study
Started 11 5
Completed 10 4
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             0
Withdrawal by Subject             0             1
Arm/Group Title Etanercept Placebo Total
Hide Arm/Group Description Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks Subjects will be given syringes containing placebo Total of all reporting groups
Overall Number of Baseline Participants 11 5 16
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 5 participants 16 participants
< 18 years 0 0 0
Between 18 and 65 years 11 5 16
>=65 years 0 0 0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 5 participants 16 participants
43.36  (14.8) 44.2  (11.9) 43.6  (13.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 5 participants 16 participants
Female
6
  54.5%
4
  80.0%
10
  62.5%
Male
5
  45.5%
1
  20.0%
6
  37.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 5 participants 16 participants
Canada 0 1 1
United States 11 4 15
1.Primary Outcome
Title Occurrence of at Least One Adverse Event
Hide Description

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;

Time Frame at each visit during the 12 month study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention- to -Treat (ITT)
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
Mild AE 1 1
Moderate AE 5 1
Severe AE 5 3
2.Primary Outcome
Title Tolerability
Hide Description The reported tolerability measure was defined as the number of participants that completed the entire 52 week study on their originally assigned treatment.
Time Frame At any point between Baseline (week 0) and the end of the study (Week 52)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: Participants
10 4
3.Primary Outcome
Title Average Change in Oral Temperature From Baseline to Week 52
Hide Description

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.

Time Frame At Baseline (Week 0) and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 9 4
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
0.16  (0.64) 0.20  (0.22)
4.Primary Outcome
Title Average Change in Respiration Rate From Baseline to Week 52
Hide Description

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.

Time Frame At Baseline (Week0) and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 9 4
Mean (Standard Deviation)
Unit of Measure: breaths per minute
-2.44  (3.17) -2.00  (4.32)
5.Primary Outcome
Title Average Change in Systolic Blood Pressure From Baseline to Week 52
Hide Description

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.

Time Frame At Baseline (Week0) and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: mmHg
-13.3  (16.3) -3.0  (14.72)
6.Primary Outcome
Title Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52.
Hide Description

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.

Time Frame At Baseline (Week0) and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: mmHg
-6.10  (9.52) 1.00  (7.39)
7.Primary Outcome
Title Average Change in Pulse Comparing Baseline to Week 52
Hide Description

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.

Time Frame At Baseline (Week0) and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: beats per minute
-4.40  (10.19) -7.25  (14.43)
8.Primary Outcome
Title Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52.
Hide Description

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.

Time Frame At Baseline (Week0) and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: Kilograms
4.59  (26.63) 3.77  (9.49)
9.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52
Hide Description

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.

Time Frame At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
1 2
10.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52
Hide Description

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.

Time Frame At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
1 1
11.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52
Hide Description

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 GGT value if during the course of the study, they had at least one clinically significant GGT result that was not present at baseline. Subjects had GGT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.

Time Frame Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
0 1
12.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52
Hide Description

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 Aldolase value if during the course of the study, they had at least one clinically significant Aldolase result that was not present at baseline. Subjects had Aldolase labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.

Time Frame Screening, Baseline (Week0), Week 4, 8,12, 16, 20, 24, 32, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
1 2
13.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52
Hide Description

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 Glucose value if during the course of the study, they had at least one clinically significant Glucose result that was not present at baseline. Subjects had Glucose labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.

Time Frame At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
0 1
14.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52
Hide Description

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 Potassium value if during the course of the study, they had at least one clinically significant Potassium result that was not present at baseline. Subjects had Potassium labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.

Time Frame Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
0 0
15.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52
Hide Description

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 White Blood Cell (WBC) value if during the course of the study, they had at least one clinically significant WBC result that was not present at baseline. Subjects had WBC labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.

Time Frame Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
0 1
16.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52
Hide Description

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 Hemoglobin value if during the course of the study, they had at least one clinically significant Hemoglobin result that was not present at baseline. Subjects had hemoglobin labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.

Time Frame At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
0 0
17.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52
Hide Description

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 hematocrit value if during the course of the study, they had at least one clinically significant hematocrit result that was not present at baseline. Subjects had hematocrit labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.

Time Frame At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
0 0
18.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52
Hide Description

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 platelet value if during the course of the study, they had at least one clinically significant platelet result that was not present at baseline. Subjects had platelet labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.

Time Frame At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
0 0
19.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52
Hide Description

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 value if during the course of the study, they had at least 1 clinically significant urine leukocyte result that was not present at baseline. Subjects had urine leukocyte labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.

Time Frame At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
0 0
20.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52
Hide Description

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 value if during the course of the study, they had at least one clinically significant urine protein result that was not present at baseline. Subjects had urine protein labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.

Time Frame At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
1 1
21.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52
Hide Description

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 value if during the course of the study, they had at least one clinically significant urine glucose result that was not present at baseline. Subjects had urine glucose labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.

Time Frame At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
0 1
22.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52
Hide Description

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 value if during the course of the study, they had at least one clinically significant urine ketone result that was not present at baseline. Subjects had urine ketone labs collected at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.

Time Frame At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
0 0
23.Primary Outcome
Title 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
Hide Description

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 value if during the course of the study, they had at least one clinically significant serum 25-hydroxyvitamin D (25-OH VitD) result that was not present at baseline. Subjects had 25-OH VitD labs collected at Screening and at the Week 52 visit.

Time Frame Screening visit and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
0 0
24.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52
Hide Description

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 value if during the course of the study, they had at least one clinically significant Antinuclear Antibody Test (ANA) result that was not present at baseline. Subjects had ANA labs collected at Screening, Week 12, 24, 40, and 52.

Time Frame At Screening, Week 12, 24, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
1 0
25.Primary Outcome
Title Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Monoclonal Protein Detection by Serum Protein Electrophoresis (SPEP) From the Screening Visit to Week 52
Hide Description

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 value if during the course of the study, they had at least one clinically significant monoclonal protein value that was not present at baseline. Subjects had monoclonal protein labs collected at Screening, Week 12, 24, 40, and 52.

Time Frame Screening visit, Week 12, 24, 40, and 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.

Data may also be missing due to the subject's refusal to complete an assessment or examiner error.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
0 0
26.Primary Outcome
Title Average Cumulative Dosage of Prednisone Over the One Year Study Period
Hide Description The average cumulative dosage of prednisone over the one year period of the study was calculated. The results are presented by treatment group.
Time Frame Baseline until week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Mean (Standard Deviation)
Unit of Measure: mg
5907.09  (3482.85) 9917.65  (4762.09)
27.Secondary Outcome
Title Average Prednisone Dosage After Week 24
Hide Description We calculated the average dosage of prednisone from the week 24 visit until the end of the study (week 52).
Time Frame from week 24 to 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Median (Inter-Quartile Range)
Unit of Measure: mg
1.2
(0 to 14.31)
29.2
(12.65 to 31.39)
28.Secondary Outcome
Title Average Daily Dose of Prednisone From Baseline to Week 52
Hide Description The average daily dose of prednisone from baseline to week 52 was calculated by treatment group.
Time Frame Baseline through Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Mean (Standard Deviation)
Unit of Measure: mg
17.00  (9.92) 36.40  (21.37)
29.Other Pre-specified Outcome
Title The Number of Participants Who Were Classified as Treatment Failures
Hide Description Treatment failures were determined based on criteria from the study protocol using objective and subjective ratings from the study physician. If the study physician felt that the rate of prednisone taper needed to be reduced, the prednisone dose needed to be increased or restarted, or a second-line agent added, the patient will be considered to be a treatment failure.
Time Frame At any point during the 52 week study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 11 5
Measure Type: Number
Unit of Measure: participants
6 5
30.Other Pre-specified Outcome
Title Change in the Average Manual Muscle Testing (MMT) Score From Baseline to Week 52
Hide Description

The Manual Muscle Test (MMT) assesses 26 muscle groups. The muscle strength of each muscle group is graded. The score for each muscle group ranges from 0 (No contraction palpable) to 5 (normal strength). The minimum total MMT score is a 0. The maximum total MMT score is a 130.

The average change in the average Manual Muscle Testing (MMT)from Baseline to Week 52 was calculated. The average score is composed of 26 muscle groups that were tested. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).

Time Frame At Baseline (Week 0) and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.24  (0.29) 0.30  (0.21)
31.Other Pre-specified Outcome
Title Average Change in Time to Rise From a Chair From Baseline to Week 52
Hide Description

The Average change in time to rise from a chair comparing Baseline performance to Week 52.The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).

This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40.

Time Frame At Baseline (Week0) and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: Seconds
-.05  (2.64) -1.22  (1.98)
32.Other Pre-specified Outcome
Title Average Change in Time (Seconds) to Walk 30 Feet Comparing Performance at Baseline to Week 52
Hide Description

Average change in time to walk 30 feet comparing Baseline performance to Week 52.The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).

This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40.

Time Frame At Baseline (Week0) and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: Seconds
-2.26  (4.81) -0.55  (1.44)
33.Other Pre-specified Outcome
Title Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Femur From the Screening Visit to Week 52
Hide Description

The average change in z-score for Dual-emission X-ray absorptiometry (DEXA) of the femur from the Screening visit to the Week 52 visit was calculated. The average change was determined by subtracting the Screening Visit test results from the Week 52 results (Week 52- Screening visit).

The Screening visit was conducted within 8 weeks of the Baseline visit.

Time Frame Screening and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 7 4
Mean (Standard Deviation)
Unit of Measure: Z-score
0.17  (0.48) -0.57  (0.90)
34.Other Pre-specified Outcome
Title Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Lumbar Spine From the Screening Visit to Week 52
Hide Description The average change in z-score for Dual-emission X-ray absorptiometry (DEXA) of the lumbar spine was calculated comparing the results from the Screening visit to Week 52. The average change was determined by subtracting the Screening Visit (Week <8)test results from the Week 52 results (Week 52- screening Visit). The Screening visit occurred within 8 weeks of the Baseline visit.
Time Frame Screening visit and Week 52.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 7 4
Mean (Standard Deviation)
Unit of Measure: Z-Score
-0.10  (0.57) 0.07  (1.01)
35.Other Pre-specified Outcome
Title Average Change in Physician Global Activity Assessment From Baseline to Week 52
Hide Description

Average change in Physician Global Activity Assessment score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's global (overall) disease activity. A score of 0 cm indicated no evidence of disease activity. A score of 10.0 cm indicated extremely active disease. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).

This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40.

Time Frame At Baseline (Week0) and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: cm
-2.36  (2.12) -1.32  (2.41)
36.Other Pre-specified Outcome
Title Average Change in Patient Global Activity Assessment Score From Baseline to Week 52
Hide Description

Average change in Patient Global Activity Assessment score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's perceived global (overall) disease activity. A score of 0 cm indicated no evidence of disease activity. A score of 10.0 cm indicated extremely active disease.

This measure was also collected as part of the study protocol at Week 12, 24, 32 and 40.

Time Frame At Baseline (Week0) and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: cm
-2.34  (2.97) -0.38  (2.76)
37.Other Pre-specified Outcome
Title Average Change in Cutaneous Disease Activity and Severity Index (CDASI) Score From Week 52 to Baseline
Hide Description

Average change in Cutaneous Disease Activity and Severity Index (CDASI) score from Baseline to Week 52. The assessment graded the severity of the subject's rash. The rash was rated using a a 4-point scale with a score of 0 indicating no rash. The score was added together using all 13 anatomical locations included on the assessment. The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).

This measure was also collected as part of the study protocol at Week 4, 8, 12, 16, 20, 24, 32 and 40.

Time Frame At Baseline (Week0) and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-3.05  (4.84) -0.25  (4.84)
38.Other Pre-specified Outcome
Title Change in Pruritis Rating From Baseline to Week 52
Hide Description

This is the average change in pruritis score from Baseline to Week 52. The assessment used a Visual Analog Scale to rate the subject's perceived level of pruritis (itchiness). A score of 0 cm indicated "Not itchy at all". A score of 10.0 cm indicated "Extremely itchy".

This assessment was also completed at Week 4, 8, 12, 16, 20, 24, 32 and 40.

Time Frame At Baseline (Week0), and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: cm
0.33  (2.63) -1.64  (1.69)
39.Other Pre-specified Outcome
Title Change in Health Assessment Questionnaire (HAQ) Score From Baseline to Week 52
Hide Description

The Health Assessment Questionnaire (HAQ)was completed by subjects to assess the affects of their illness on the ability to function in daily life. The HAQ consists of 8 sections. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do).The 8 scores of the 8 sections are summed and divided by 8. A higher score indicates more impairment.

The average change was determined by subtracting the Baseline test results from the Week 52 results (Week 52- Baseline).

This measure was also collected as part of the study protocol at Week 12, 24, 32 and 40.

Time Frame At Baseline (Week0) and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 10 4
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.33  (0.45) -0.34  (0.68)
40.Other Pre-specified Outcome
Title Forced Vital Capacity (FVC) Average Change in Percent Predicted From Screening to Week 52.
Hide Description

The average change in percent predicted Forced Vital Capacity (FVC) from the Screening Visit to Week 52 was calculated. The average change was determined by subtracting the Screening Visit results from the Week 52 results (Week 52- Screening Visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.

This assessment was also completed at the Week 24 visit.

Time Frame Screening Visit and Week 52.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 9 4
Mean (Standard Deviation)
Unit of Measure: Percent predicted
-2.56  (8.93) -1.00  (16.47)
41.Other Pre-specified Outcome
Title Average Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) From the Screening Visit to Week 52
Hide Description

The average change in percent predicted Forced Expiratory Volume in 1 second (FEV1) from Screening to Week 52 was calculated. The average change was determined by subtracting the Screening Visit results from the Week 52 results (Week 52- Screening visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.

This assessment was also completed during the Week 24 visit.

Time Frame Screening Visit and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 9 4
Mean (Standard Deviation)
Unit of Measure: Percent predicted
-0.67  (11.92) -4.25  (14.80)
42.Other Pre-specified Outcome
Title Average Change in Percent Predicted Diffusion Capacity (DLCO)From the Screening Visit to Week 52
Hide Description

Average change in percent predicted Diffusion Capacity (DLCO)from the Screening Visit to Week 52 was calculate. The average change was determined by subtracting the Screening test results from the Week 52 results (Week 52- Screening Visit). The Screening visit occurred within 8 weeks prior to the Baseline visit.

This assessment was also completed during the Week 24 visit.

Time Frame Screening visit and Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Etanercept Placebo
Hide Arm/Group Description:
Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
Subjects will be given syringes containing placebo
Overall Number of Participants Analyzed 8 3
Mean (Standard Deviation)
Unit of Measure: Percent predicted
-4.50  (14.34) -14.67  (8.33)
Time Frame from screening to one month after completion of the study (at least 56 wks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etanercept Placebo
Hide Arm/Group Description Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks Subjects will be given syringes containing placebo
All-Cause Mortality
Etanercept Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/11 (27.27%)      3/5 (60.00%)    
General disorders     
Fever * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Infections and infestations     
Urinary Tract Infection * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Viral Gastroenteritis * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Ovarian Cancer * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Nervous system disorders     
Post Herpetic Neuralgia * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Dermatomyositis Flare * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Pregnancy, puerperium and perinatal conditions     
Partner Pregnant * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Psychiatric disorders     
Acute Psychosis * 1  1/11 (9.09%)  2 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etanercept Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/11 (100.00%)      5/5 (100.00%)    
Blood and lymphatic system disorders     
Bleeding- Vaginal * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Elevated WBC * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Low WBC Count * 1  2/11 (18.18%)  2 0/5 (0.00%)  0
Cardiac disorders     
Cardiomegaly * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Chest tightness * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Tachycardia * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Transient Cardiac Arrhythmia * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Ear and labyrinth disorders     
Auditory/Ear-Other- Tingling in ear * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Pain- Ear * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Eye disorders     
Blurred Vision * 1  2/11 (18.18%)  2 1/5 (20.00%)  1
Cataracts * 1  1/11 (9.09%)  2 0/5 (0.00%)  0
Dryness inner eyelids * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Subconjuctival haemorrhage * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Gastrointestinal disorders     
Abdominal Ascites * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Abdominal Distention * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Abdominal Pain * 1  0/11 (0.00%)  0 2/5 (40.00%)  2
Constipation * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Dental/Teeth * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Diarrhea * 1  3/11 (27.27%)  4 3/5 (60.00%)  3
Difficulty Swallowing * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Fecal Urgency * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Heartburn * 1  3/11 (27.27%)  4 0/5 (0.00%)  0
Inguinal Hernia * 1  0/0  0 1/5 (20.00%)  1
Nausea * 1  3/11 (27.27%)  5 2/5 (40.00%)  4
Stomach Cramps * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Toothache * 1  3/11 (27.27%)  4 0/5 (0.00%)  0
Vomiting * 1  2/11 (18.18%)  2 1/5 (20.00%)  3
General disorders     
Chest tightness * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Chills * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Fatigue * 1  1/11 (9.09%)  1 1/5 (20.00%)  1
Fever * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Injection Site Reaction * 1  2/11 (18.18%)  2 2/5 (40.00%)  2
Hepatobiliary disorders     
Fatty liver * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Infections and infestations     
Bladder Infection * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Infection- Sacral area * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Infection NOS (Viral Syndrome) * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Infection Upper Airway * 1  5/11 (45.45%)  8 1/5 (20.00%)  1
Infection with Normal ANC - Conjunctiva * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Infection with Normal - ANC - UTI * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Infection- Conjuctiva * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Infection - Lip * 1  1/11 (9.09%)  1 1/5 (20.00%)  1
Infection - Other (Gastrointestinal) * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Periungal Finger Infections * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Skin/Cellulitus Right Great Toe * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
UTI * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Viral Gastroenteritis * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Viral Hepatitis * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Injury, poisoning and procedural complications     
Fall; Right Scalp Abrasion & Hematoma, R Chest Wall Bruising * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Skin Burn Left Forearm Vent Surface * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Investigations     
Cholesterol High * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Elevated Aldolase * 1  1/11 (9.09%)  1 1/5 (20.00%)  1
Elevated ALT * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Elevated AST * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Elevated CK * 1  2/11 (18.18%)  2 1/5 (20.00%)  1
Elevated GGT * 1  1/11 (9.09%)  1 1/5 (20.00%)  1
Laboratory/Other- Abnormal PAP Smear * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Increased Vit D Level * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Urine Glucose Pos. * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Urine Protein Pos. * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Vitamin D Low * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Metabolism and nutrition disorders     
Elevated Glucose * 1  0/11 (0.00%)  0 2/5 (40.00%)  2
Hypercalcemia * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders     
Edema: Left Knee Swelling * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Increased Muscle Weakness * 1  1/11 (9.09%)  1 1/5 (20.00%)  2
Increased weakness right lower leg * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Musculoskeletal Pains * 1  6/11 (54.55%)  27 3/5 (60.00%)  4
Syndromes- Other (Sicca) * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Left Kidney Cyst * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Endometrial polyp * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Nervous system disorders     
Burning sensation right foot * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Dizziness * 1  2/11 (18.18%)  3 1/5 (20.00%)  1
Headache * 1  3/11 (27.27%)  3 4/5 (80.00%)  5
Neuropathy * 1  3/11 (27.27%)  3 1/5 (20.00%)  1
Ear numbness * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Post herpetic neuralgia * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Spinal Headache * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Worsening of Dermato * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Psychiatric disorders     
Anxiety/Mood Alternation * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Depression * 1  2/11 (18.18%)  2 0/5 (0.00%)  0
Insomnia * 1  1/11 (9.09%)  1 1/5 (20.00%)  1
Renal and urinary disorders     
Cystitis * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Atelectasis * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Bronchospasm * 1  0/11 (0.00%)  0 1/5 (20.00%)  2
Dyspnea * 1  1/11 (9.09%)  1 2/5 (40.00%)  2
Interstital Lung Disease * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Pain- Throat/Pharynx * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Pleural Effusion * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Pneumonitis * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Shortness of Breath * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Skin and subcutaneous tissue disorders     
Decubitus Ulcer * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Left Antecubital Fossa Scab- Wound Complication - Noninfectious * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Mechanics Hand on Right Index Finger- Hand/Foot * 1  1/11 (9.09%)  1 0/5 (0.00%)  0
Pruritus * 1  5/11 (45.45%)  6 1/5 (20.00%)  1
Skin Rash * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Worsening Skin Rash * 1  5/11 (45.45%)  7 1/5 (20.00%)  1
Surgical and medical procedures     
Replacement of pacemaker * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
Vascular disorders     
Hypertension * 1  3/11 (27.27%)  3 1/5 (20.00%)  1
Increased Edema * 1  0/11 (0.00%)  0 1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: A Pilot Study of Etanercept in Dermatomyositis
Organization: Brigham and Women's Hospital
Phone: 617-732-8046
Responsible Party: Anthony A. Amato, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00112385     History of Changes
Obsolete Identifiers: NCT00282880
Other Study ID Numbers: 1R01NS049639-01A2 ( U.S. NIH Grant/Contract )
1R01NS049639-01A2 ( U.S. NIH Grant/Contract )
First Submitted: June 2, 2005
First Posted: June 3, 2005
Results First Submitted: April 25, 2011
Results First Posted: June 21, 2011
Last Update Posted: June 21, 2011