Trial Outcomes & Findings for A Pilot Study of Etanercept in Dermatomyositis (NCT NCT00112385)

NCT ID: NCT00112385

Last Updated: 2011-06-21

Results Overview

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;

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 16 participants
• Primary outcome timeframe: at each visit during the 12 month study
• Results posted on: 2011-06-21

Participant Flow

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)

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.

Participant milestones

Measure	Etanercept Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo Subjects will be given syringes containing placebo
Overall Study STARTED	11	5
Overall Study COMPLETED	10	4
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Etanercept Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo Subjects will be given syringes containing placebo
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

A Pilot Study of Etanercept in Dermatomyositis

Baseline characteristics by cohort

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo	Total n=16 Participants Total of all reporting groups
Age Categorical < 18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age Categorical Between 18 and 65 years	11 participants n=5 Participants	5 participants n=7 Participants	16 participants n=5 Participants
Age Categorical >=65 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age Continuous	43.36 years STANDARD_DEVIATION 14.8 • n=5 Participants	44.2 years STANDARD_DEVIATION 11.9 • n=7 Participants	43.6 years STANDARD_DEVIATION 13.39 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Canada	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	4 participants n=7 Participants	15 participants n=5 Participants

PRIMARY outcome

Timeframe: at each visit during the 12 month study

Population: Intention- to -Treat (ITT)

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;

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Occurrence of at Least One Adverse Event Mild AE	1 participants	1 participants
Occurrence of at Least One Adverse Event Moderate AE	5 participants	1 participants
Occurrence of at Least One Adverse Event Severe AE	5 participants	3 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Tolerability	10 Participants	4 Participants

PRIMARY outcome

Timeframe: At Baseline (Week 0) and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=9 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Average Change in Oral Temperature From Baseline to Week 52	0.16 degrees Celsius Standard Deviation 0.64	0.20 degrees Celsius Standard Deviation 0.22

PRIMARY outcome

Timeframe: At Baseline (Week0) and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=9 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Average Change in Respiration Rate From Baseline to Week 52	-2.44 breaths per minute Standard Deviation 3.17	-2.00 breaths per minute Standard Deviation 4.32

PRIMARY outcome

Timeframe: At Baseline (Week0) and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=10 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Average Change in Systolic Blood Pressure From Baseline to Week 52	-13.3 mmHg Standard Deviation 16.3	-3.0 mmHg Standard Deviation 14.72

PRIMARY outcome

Timeframe: At Baseline (Week0) and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=10 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52.	-6.10 mmHg Standard Deviation 9.52	1.00 mmHg Standard Deviation 7.39

PRIMARY outcome

Timeframe: At Baseline (Week0) and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=10 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Average Change in Pulse Comparing Baseline to Week 52	-4.40 beats per minute Standard Deviation 10.19	-7.25 beats per minute Standard Deviation 14.43

PRIMARY outcome

Timeframe: At Baseline (Week0) and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=10 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52.	4.59 Kilograms Standard Deviation 26.63	3.77 Kilograms Standard Deviation 9.49

PRIMARY outcome

Timeframe: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52	1 participants	2 participants

PRIMARY outcome

Timeframe: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52	1 participants	1 participants

PRIMARY outcome

Timeframe: Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52	0 participants	1 participants

PRIMARY outcome

Timeframe: Screening, Baseline (Week0), Week 4, 8,12, 16, 20, 24, 32, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52	1 participants	2 participants

PRIMARY outcome

Timeframe: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52	0 participants	1 participants

PRIMARY outcome

Timeframe: Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52	0 participants	0 participants

PRIMARY outcome

Timeframe: Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52	0 participants	1 participants

PRIMARY outcome

Timeframe: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52	0 participants	0 participants

PRIMARY outcome

Timeframe: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52	0 participants	0 participants

PRIMARY outcome

Timeframe: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52	0 participants	0 participants

PRIMARY outcome

Timeframe: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52	0 participants	0 participants

PRIMARY outcome

Timeframe: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52	1 participants	1 participants

PRIMARY outcome

Timeframe: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52	0 participants	1 participants

PRIMARY outcome

Timeframe: At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52	0 participants	0 participants

PRIMARY outcome

Timeframe: Screening visit and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing 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	0 participants	0 participants

PRIMARY outcome

Timeframe: At Screening, Week 12, 24, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52	1 participants	0 participants

PRIMARY outcome

Timeframe: Screening visit, Week 12, 24, 40, and 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Monoclonal Protein Detection by Serum Protein Electrophoresis (SPEP) From the Screening Visit to Week 52	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline until week 52

The average cumulative dosage of prednisone over the one year period of the study was calculated. The results are presented by treatment group.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Average Cumulative Dosage of Prednisone Over the One Year Study Period	5907.09 mg Standard Deviation 3482.85	9917.65 mg Standard Deviation 4762.09

SECONDARY outcome

Timeframe: from week 24 to 52

We calculated the average dosage of prednisone from the week 24 visit until the end of the study (week 52).

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Average Prednisone Dosage After Week 24	1.2 mg Interval 0.0 to 14.31	29.2 mg Interval 12.65 to 31.39

SECONDARY outcome

Timeframe: Baseline through Week 52

The average daily dose of prednisone from baseline to week 52 was calculated by treatment group.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
Average Daily Dose of Prednisone From Baseline to Week 52	17.00 mg Standard Deviation 9.92	36.40 mg Standard Deviation 21.37

OTHER_PRE_SPECIFIED outcome

Timeframe: At any point during the 52 week study

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.

Outcome measures

Measure	Etanercept n=11 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 Participants Subjects will be given syringes containing placebo
The Number of Participants Who Were Classified as Treatment Failures	6 participants	5 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At Baseline (Week 0) and Week 52

Population: 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.

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).

Outcome measures

Measure	Etanercept n=10 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Change in the Average Manual Muscle Testing (MMT) Score From Baseline to Week 52	0.24 Units on a scale Standard Deviation 0.29	0.30 Units on a scale Standard Deviation 0.21

OTHER_PRE_SPECIFIED outcome

Timeframe: At Baseline (Week0) and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=10 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Average Change in Time to Rise From a Chair From Baseline to Week 52	-.05 Seconds Standard Deviation 2.64	-1.22 Seconds Standard Deviation 1.98

OTHER_PRE_SPECIFIED outcome

Timeframe: At Baseline (Week0) and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=10 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Average Change in Time (Seconds) to Walk 30 Feet Comparing Performance at Baseline to Week 52	-2.26 Seconds Standard Deviation 4.81	-0.55 Seconds Standard Deviation 1.44

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=7 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Femur From the Screening Visit to Week 52	0.17 Z-score Standard Deviation 0.48	-0.57 Z-score Standard Deviation 0.90

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening visit and Week 52.

Population: 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.

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.

Outcome measures

Measure	Etanercept n=7 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Lumbar Spine From the Screening Visit to Week 52	-0.10 Z-Score Standard Deviation 0.57	0.07 Z-Score Standard Deviation 1.01

OTHER_PRE_SPECIFIED outcome

Timeframe: At Baseline (Week0) and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=10 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Average Change in Physician Global Activity Assessment From Baseline to Week 52	-2.36 cm Standard Deviation 2.12	-1.32 cm Standard Deviation 2.41

OTHER_PRE_SPECIFIED outcome

Timeframe: At Baseline (Week0) and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=10 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Average Change in Patient Global Activity Assessment Score From Baseline to Week 52	-2.34 cm Standard Deviation 2.97	-0.38 cm Standard Deviation 2.76

OTHER_PRE_SPECIFIED outcome

Timeframe: At Baseline (Week0) and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=10 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Average Change in Cutaneous Disease Activity and Severity Index (CDASI) Score From Week 52 to Baseline	-3.05 Units on a scale Standard Deviation 4.84	-0.25 Units on a scale Standard Deviation 4.84

OTHER_PRE_SPECIFIED outcome

Timeframe: At Baseline (Week0), and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=10 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Change in Pruritis Rating From Baseline to Week 52	0.33 cm Standard Deviation 2.63	-1.64 cm Standard Deviation 1.69

OTHER_PRE_SPECIFIED outcome

Timeframe: At Baseline (Week0) and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=10 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Change in Health Assessment Questionnaire (HAQ) Score From Baseline to Week 52	-0.33 Units on a scale Standard Deviation 0.45	-0.34 Units on a scale Standard Deviation 0.68

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening Visit and Week 52.

Population: 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.

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.

Outcome measures

Measure	Etanercept n=9 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Forced Vital Capacity (FVC) Average Change in Percent Predicted From Screening to Week 52.	-2.56 Percent predicted Standard Deviation 8.93	-1.00 Percent predicted Standard Deviation 16.47

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening Visit and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=9 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=4 Participants Subjects will be given syringes containing placebo
Average Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) From the Screening Visit to Week 52	-0.67 Percent predicted Standard Deviation 11.92	-4.25 Percent predicted Standard Deviation 14.80

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening visit and Week 52

Population: 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.

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.

Outcome measures

Measure	Etanercept n=8 Participants Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=3 Participants Subjects will be given syringes containing placebo
Average Change in Percent Predicted Diffusion Capacity (DLCO)From the Screening Visit to Week 52	-4.50 Percent predicted Standard Deviation 14.34	-14.67 Percent predicted Standard Deviation 8.33

Adverse Events

Etanercept

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Etanercept n=11 participants at risk Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 participants at risk Subjects will be given syringes containing placebo
Pregnancy, puerperium and perinatal conditions Partner Pregnant	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Urinary Tract Infection	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
General disorders Fever	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Nervous system disorders Post Herpetic Neuralgia	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Psychiatric disorders Acute Psychosis	9.1% 1/11 • Number of events 2 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Viral Gastroenteritis	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Nervous system disorders Dermatomyositis Flare	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cancer	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)

Other adverse events

Measure	Etanercept n=11 participants at risk Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks	Placebo n=5 participants at risk Subjects will be given syringes containing placebo
Gastrointestinal disorders Abdominal Ascites	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Gastrointestinal disorders Abdominal Distention	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Gastrointestinal disorders Abdominal Pain	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	40.0% 2/5 • Number of events 2 • from screening to one month after completion of the study (at least 56 wks)
Psychiatric disorders Anxiety/Mood Alternation	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Ear and labyrinth disorders Auditory/Ear-Other- Tingling in ear	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Bladder Infection	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Blood and lymphatic system disorders Bleeding- Vaginal	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Eye disorders Blurred Vision	18.2% 2/11 • Number of events 2 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 2 • from screening to one month after completion of the study (at least 56 wks)
Nervous system disorders Burning sensation right foot	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Cardiac disorders Cardiomegaly	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Eye disorders Cataracts	9.1% 1/11 • Number of events 2 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Cardiac disorders Chest tightness	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
General disorders Chest tightness	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
General disorders Chills	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Investigations Cholesterol High	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Gastrointestinal disorders Constipation	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Renal and urinary disorders Cystitis	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Skin and subcutaneous tissue disorders Decubitus Ulcer	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Gastrointestinal disorders Dental/Teeth	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Psychiatric disorders Depression	18.2% 2/11 • Number of events 2 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Gastrointestinal disorders Diarrhea	27.3% 3/11 • Number of events 4 • from screening to one month after completion of the study (at least 56 wks)	60.0% 3/5 • Number of events 3 • from screening to one month after completion of the study (at least 56 wks)
Gastrointestinal disorders Difficulty Swallowing	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Nervous system disorders Dizziness	18.2% 2/11 • Number of events 3 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Eye disorders Dryness inner eyelids	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	40.0% 2/5 • Number of events 2 • from screening to one month after completion of the study (at least 56 wks)
Musculoskeletal and connective tissue disorders Edema: Left Knee Swelling	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Investigations Elevated Aldolase	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Investigations Elevated ALT	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Investigations Elevated AST	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Investigations Elevated CK	18.2% 2/11 • Number of events 2 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Investigations Elevated GGT	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Metabolism and nutrition disorders Elevated Glucose	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	40.0% 2/5 • Number of events 2 • from screening to one month after completion of the study (at least 56 wks)
Blood and lymphatic system disorders Elevated WBC	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Injury, poisoning and procedural complications Fall; Right Scalp Abrasion & Hematoma, R Chest Wall Bruising	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
General disorders Fatigue	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Hepatobiliary disorders Fatty liver	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Gastrointestinal disorders Fecal Urgency	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
General disorders Fever	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Nervous system disorders Headache	27.3% 3/11 • Number of events 3 • from screening to one month after completion of the study (at least 56 wks)	80.0% 4/5 • Number of events 5 • from screening to one month after completion of the study (at least 56 wks)
Gastrointestinal disorders Heartburn	27.3% 3/11 • Number of events 4 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Vascular disorders Hypertension	27.3% 3/11 • Number of events 3 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Vascular disorders Increased Edema	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Musculoskeletal and connective tissue disorders Increased Muscle Weakness	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 2 • from screening to one month after completion of the study (at least 56 wks)
Musculoskeletal and connective tissue disorders Increased weakness right lower leg	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Infection- Sacral area	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Infection NOS (Viral Syndrome)	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Infection Upper Airway	45.5% 5/11 • Number of events 8 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Infection with Normal ANC - Conjunctiva	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Infection with Normal - ANC - UTI	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Infection- Conjuctiva	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Infection - Lip	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Infection - Other (Gastrointestinal)	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Gastrointestinal disorders Inguinal Hernia	— 0/0 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
General disorders Injection Site Reaction	18.2% 2/11 • Number of events 2 • from screening to one month after completion of the study (at least 56 wks)	40.0% 2/5 • Number of events 2 • from screening to one month after completion of the study (at least 56 wks)
Psychiatric disorders Insomnia	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Respiratory, thoracic and mediastinal disorders Interstital Lung Disease	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Investigations Laboratory/Other- Abnormal PAP Smear	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Skin and subcutaneous tissue disorders Left Antecubital Fossa Scab- Wound Complication - Noninfectious	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Left Kidney Cyst	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Blood and lymphatic system disorders Low WBC Count	18.2% 2/11 • Number of events 2 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Skin and subcutaneous tissue disorders Mechanics Hand on Right Index Finger- Hand/Foot	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Musculoskeletal and connective tissue disorders Musculoskeletal Pains	54.5% 6/11 • Number of events 27 • from screening to one month after completion of the study (at least 56 wks)	60.0% 3/5 • Number of events 4 • from screening to one month after completion of the study (at least 56 wks)
Gastrointestinal disorders Nausea	27.3% 3/11 • Number of events 5 • from screening to one month after completion of the study (at least 56 wks)	40.0% 2/5 • Number of events 4 • from screening to one month after completion of the study (at least 56 wks)
Nervous system disorders Neuropathy	27.3% 3/11 • Number of events 3 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Surgical and medical procedures Replacement of pacemaker	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Nervous system disorders Ear numbness	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial polyp	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Investigations Increased Vit D Level	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Ear and labyrinth disorders Pain- Ear	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Respiratory, thoracic and mediastinal disorders Pain- Throat/Pharynx	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Periungal Finger Infections	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Nervous system disorders Post herpetic neuralgia	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Skin and subcutaneous tissue disorders Pruritus	45.5% 5/11 • Number of events 6 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Respiratory, thoracic and mediastinal disorders Shortness of Breath	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Injury, poisoning and procedural complications Skin Burn Left Forearm Vent Surface	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Skin and subcutaneous tissue disorders Skin Rash	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Skin/Cellulitus Right Great Toe	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Nervous system disorders Spinal Headache	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Gastrointestinal disorders Stomach Cramps	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Eye disorders Subconjuctival haemorrhage	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Musculoskeletal and connective tissue disorders Syndromes- Other (Sicca)	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Cardiac disorders Tachycardia	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Gastrointestinal disorders Toothache	27.3% 3/11 • Number of events 4 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Cardiac disorders Transient Cardiac Arrhythmia	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Investigations Urine Glucose Pos.	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Investigations Urine Protein Pos.	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations UTI	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Viral Gastroenteritis	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Infections and infestations Viral Hepatitis	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Investigations Vitamin D Low	0.00% 0/11 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)
Gastrointestinal disorders Vomiting	18.2% 2/11 • Number of events 2 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 3 • from screening to one month after completion of the study (at least 56 wks)
Nervous system disorders Worsening of Dermato	9.1% 1/11 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)	0.00% 0/5 • from screening to one month after completion of the study (at least 56 wks)
Skin and subcutaneous tissue disorders Worsening Skin Rash	45.5% 5/11 • Number of events 7 • from screening to one month after completion of the study (at least 56 wks)	20.0% 1/5 • Number of events 1 • from screening to one month after completion of the study (at least 56 wks)

Additional Information

A Pilot Study of Etanercept in Dermatomyositis

Brigham and Women's Hospital

Phone: 617-732-8046

Email: aamato@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place