A Pilot Study of Etanercept in Dermatomyositis

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00112385
• Collaborator: Amgen (Industry)
• Enrollment: 16
• Location: 1
• Arms: 2
• Duration (Months): 51
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of the study is to obtain preliminary data regarding the safety and tolerability of etanercept in DM. In addition, we will use the study to assess the variability, reliability, and responsiveness of the core set of outcome measures recommended by IMACS. The study will be performed under the aegis of the Muscle Study Group (MSG), consisting of experienced investigators with an avid interest in myopathies. The ultimate goal of this pilot study will be to obtain necessary, prerequisite information important in designing future therapeutic trials of etanercept and other agents in patients with DM. The specific aims of the study are:

Aim 1: To preliminarily assess the safety and tolerability of etanercept in patients with DM.

Aim 2: To assess the safety and tolerability of prednisone in the dosing schedule we propose to use.

Aim 3: To evaluate outcome measures recommended by IMACS and assess their variability, reliability, and responsiveness in order to facilitate the design of future therapeutic trials in the inflammatory myopathies.

Condition or Disease	Intervention/Treatment	Phase
Dermatomyositis	Drug: Etanercept; Drug: Placebo	Phase 1

Detailed Description

Dermatomyositis (DM) is one of the major subtypes of idiopathic inflammatory myopathy. Prednisone is the initial treatment of choice in most patients with DM. However, because of the high rate of patients with disabling weakness despite treatment with prednisone, the long-term side effects of prednisone, and the many side effects associated with other second-line immunosuppressive agents (e.g., methotrexate, azathioprine), better treatment options are needed. There is evidence that tumor necrosis factor-a (TNF-a) plays a role in the pathogenesis of DM. Thus, etanercept, which blocks TNF-a, is a logical drug to assess in DM. Etanercept has been associated with a number of side effects including an increased risk of infection, inducing other autoimmune diseases, and perhaps cancer. These risks may be further enhanced in DM in which the frequency of other autoimmune disorders (e.g., connective tissue disease) and malignancy are already increased.

The goal of this pilot study will be to assess the safety and tolerability of etanercept in DM.We will perform a double-blind, placebo-controlled pilot study of etanercept in 40 patients with DM randomized in a 3:1 ratio to receive etanercept or placebo. All newly diagnosed and untreated patients will be started on a standard dose of prednisone and tapering schedule. Refractory patients who have been or are currently being treated with prednisone, IVIG, or methotrexate can also participate. Subjects will be followed for 1 year and we will assess various outcome variables recommended by the The International Myositis Assessment Clinical Study Group (IMACS). The primary aim of the study is to preliminarily assess the safety and tolerability of etanercept in patients with DM. We hypothesize that etanercept will be safe and well tolerated in this population. The second aim is to assess the safety and tolerability of prednisone in the dosing schedule we propose to use. We hypothesize that most patients will be able to tolerate the reduction of the prednisone dosage but most will not be able to be completely weaned off the medication. We believe we will find a relationship between prednisone dosage and its related side effects. The third aim of the study is to assess the variability, reliability, and responsiveness of the outcome measures recommended by IMACS using this pilot study of etanercept as the vehicle. The information gained from this study is necessary in order to design larger therapeutic trials of etanercept and other drugs in dermatomyositis.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Etanercept in Dermatomyositis
• Study Start Date: Mar 1, 2006
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Etanercept Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected subcutaneously once a week for 52 weeks.	Drug: Etanercept; Etanercept 50 mg will be injected subcutaneously once per week for 52 weeks
Placebo Comparator: Placebo Subjects will be given syringes containing placebo. Injections will be given subcutaneously, one time per week for 52 weeks.	Drug: Placebo; Placebo, contained in 50mg syringes, will be injected subcutaneously once per week for 52 weeks.; Other Names: Saline

Outcome Measures

Primary Outcome Measures

1. Occurrence of at Least One Adverse Event [at each visit during the 12 month study]

   Adverse events (AEs) were assessed using the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE). The grade of "mild", "moderate" or "severe" matches with the descriptions from the CTCAE dictionary. In general, a "Mild" AE is asymptomatic; clinical or diagnostic observations only; intervention not indicated. A "Moderate" AE is minimal, local or noninvasive intervention indicated; limiting activities of daily living. A "Severe" AE is medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling;

2. Tolerability [At any point between Baseline (week 0) and the end of the study (Week 52)]

   The reported tolerability measure was defined as the number of participants that completed the entire 52 week study on their originally assigned treatment.

3. Average Change in Oral Temperature From Baseline to Week 52 [At Baseline (Week 0) and Week 52]

   The subject's oral temperature was measured in degrees Celsius. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40.

4. Average Change in Respiration Rate From Baseline to Week 52 [At Baseline (Week0) and Week 52]

   The subject's respiration rate was measured as number of breaths per minute. The average change was determined by subtracting the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40.

5. Average Change in Systolic Blood Pressure From Baseline to Week 52 [At Baseline (Week0) and Week 52]

   The subject's systolic blood pressure was measured in millimeters of mercury (mmHg). The average value was calculated per treatment group for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40.

6. Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52. [At Baseline (Week0) and Week 52]

   The subject's diastolic blood pressure was measured in millimeters of mercury (mm Hg). The average value was calculated for the Baseline and Week 52 visit based on treatment group. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4,8,12,16,20,24,32 and 40.

7. Average Change in Pulse Comparing Baseline to Week 52 [At Baseline (Week0) and Week 52]

   The subject's pulse was measured in beats per minute (BPM). The average value was calculated per treatment group for the Baseline and Week 52 visit. The average change was determined by subtracting the average value Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40.

8. Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52. [At Baseline (Week0) and Week 52]

   The subject's body weight was measured in kilograms(kg). The average value was calculated for each treatment group for the Baseline and Week 52 visits. The average change was determined by subtracting the average value at the Baseline Visit (Week 0) results from the Week 52 results (Week 52- Baseline (Week 0)). This measure was also collected as part of the study protocol at the Screening visit and Week 4, 8, 12, 16, 20, 24, 32 and 40.

9. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52 [At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52]

   The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant creatine kinase (CK) value if during the course of the study, they had at least one clinically significant CK result that was not present at baseline. Subjects had CK labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.

10. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52 [At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant ALT value if during the course of the study, they had at least one clinically significant ALT result that was not present at baseline. Subjects had ALT labs drawn at Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52.

11. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52 [Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

12. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52 [Screening, Baseline (Week0), Week 4, 8,12, 16, 20, 24, 32, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

13. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52 [At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

14. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52 [Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

15. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52 [Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

16. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52 [At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

17. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52 [At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

18. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52 [At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

19. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52 [At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

20. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52 [At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

21. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52 [At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

22. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52 [At Screening, Baseline (Week0), Week 4, 8, 12, 16, 20, 24, 32, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

23. 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 [Screening visit and Week 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

24. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52 [At Screening, Week 12, 24, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

25. Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Monoclonal Protein Detection by Serum Protein Electrophoresis (SPEP) From the Screening Visit to Week 52 [Screening visit, Week 12, 24, 40, and 52]

    The site investigators used the reference ranges provided by the lab that completed the testing of the sample to determine if the value was abnormal. If a value was abnormal, the site investigator would determine if the value was clinically significant or not. A subject was considered to have a treatment emergent, clinically significant 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.

26. Average Cumulative Dosage of Prednisone Over the One Year Study Period [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.

Secondary Outcome Measures

1. Average Prednisone Dosage After Week 24 [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).

2. Average Daily Dose of Prednisone From Baseline to Week 52 [Baseline through Week 52]

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

Other Outcome Measures

1. The Number of Participants Who Were Classified as Treatment Failures [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.

2. Change in the Average Manual Muscle Testing (MMT) Score From Baseline to Week 52 [At Baseline (Week 0) and Week 52]

   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).

3. Average Change in Time to Rise From a Chair From Baseline to Week 52 [At Baseline (Week0) and Week 52]

   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.

4. Average Change in Time (Seconds) to Walk 30 Feet Comparing Performance at Baseline to Week 52 [At Baseline (Week0) and Week 52]

   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.

5. Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Femur From the Screening Visit to Week 52 [Screening and Week 52]

   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.

6. Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Lumbar Spine From the Screening Visit to Week 52 [Screening visit and Week 52.]

   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.

7. Average Change in Physician Global Activity Assessment From Baseline to Week 52 [At Baseline (Week0) and Week 52]

   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.

8. Average Change in Patient Global Activity Assessment Score From Baseline to Week 52 [At Baseline (Week0) and Week 52]

   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.

9. Average Change in Cutaneous Disease Activity and Severity Index (CDASI) Score From Week 52 to Baseline [At Baseline (Week0) and Week 52]

   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.

10. Change in Pruritis Rating From Baseline to Week 52 [At Baseline (Week0), and Week 52]

    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.

11. Change in Health Assessment Questionnaire (HAQ) Score From Baseline to Week 52 [At Baseline (Week0) and Week 52]

    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.

12. Forced Vital Capacity (FVC) Average Change in Percent Predicted From Screening to Week 52. [Screening Visit and Week 52.]

    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.

13. Average Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) From the Screening Visit to Week 52 [Screening Visit and Week 52]

    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.

14. Average Change in Percent Predicted Diffusion Capacity (DLCO)From the Screening Visit to Week 52 [Screening visit and Week 52]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Study subjects must meet the following criteria:

1. Meet the diagnostic criteria for DM (a-c; a,b,d; or a,c,d)

2. Subjects must have symmetric proximal greater than distal weakness

3. Characteristic DM rash consisting of any or all of the following: heliotrope, shawl sign, V-sign, Gottron's sign, Gottron's papules, periungual telangiectasias

4. Laboratory evidence of myopathy with at least one of the following: an elevated serum CK or aldolase level, myositis-specific antibody, electromyography (EMG) demonstrating myopathic features (e.g., muscle membrane instability, myopathic units, or early recruitment), or an abnormal skeletal muscle MRI showing diffuse or patchy edema within the muscles.

5. A muscle biopsy will be optional if the patient fulfills criteria a-c. The subject must demonstrate symmetric proximal weakness (criteria a) for entry into the study. If the subject does not have a definite rash (criteria b) or laboratory evidence of a myopathy (criteria c), a muscle biopsy will be required. The muscle biopsy must demonstrate one of the following: perifascicular atrophy, expression of MHC 1 on perifascicular muscle fibers, MAC deposition on small blood vessels, tubuloreticular inclusions in endothelial cells on EM, or MXA expression on muscle fibers of blood vessels

6. Newly diagnosed subjects should be able to walk independently 30 feet (cane, walkers, orthoses allowed). However, subjects with refractory dermatomyositis may be non-ambulatory.

7. Age > 18 years

8. Patients must not use topical skin ointments for treatment of the dermatological manifestations as it will interfere with skin assessment.

9. Men and women of childbearing age must be willing to use a method of birth control.

10. Able to give informed consent

11. Subject or designee must have the ability to self-inject investigational product or have a care giver at home who can administer subcutaneous injections

Exclusion Criteria

The presence of any of the following excludes subject participation in the study:

1. Presence of any one of the following medical conditions: active infection, uncontrolled diabetes mellitus, MI, CVA or TIA within 3 months of screening visit, symptomatic cardiomyopathy (congestive heart failure), symptomatic coronary artery disease, uncontrolled hypertension (sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg), oxygen-dependent severe pulmonary disease, systemic lupus erythematosus (SLE), cancer (other than basal cell skin cancer) less than 5 years previously, HIV or other immunosuppressing disease, positive PPD test or any history of mycobacterial disease, chronic hepatitis B or hepatitis C, history of multiple sclerosis, transverse myelitis, optic neuritis, chronic inflammatory demyelinating neuropathy, epilepsy, or other chronic serious medical illnesses

2. Presence of any of the following on routine blood screening: WBC<3000, Platelets < 100,000, hematocrit < 30%, BUN > 30 mg %, symptomatic liver disease with serum albumin < 3 G/DL, PT or PTT > upper range of control values

3. Forced Vital Capacity < 50% of predicted

4. History of non-compliance with other therapies

5. Any prior or concurrent cyclophosphamide, or current use of any immunosuppressive agent besides methotrexate (e.g., azathioprine, mycophenolate, or cyclosporine)

6. Coexistence of other neuromuscular disease that may complicate interpretation of the results of the study

7. Drug or alcohol abuse within last 3 months

8. Pregnancy or breast feeding

9. Juvenile DM

10. Subjects who have known hypersensitivity to Enbrel or any of its components or who is known to have antibodies to etanercept

11. Use of a live vaccine 90 days prior to, or during this study.

12. Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.

13. Concurrent sulfasalazine therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital
• Amgen

Investigators

• Principal Investigator: Anthony A Amato, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

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• ClinicalTrials.gov Identifier: NCT00112385
• Other Study ID Numbers: 1R01NS049639-01A2; 1R01NS049639-01A2; NCT00282880
• First Posted: Jun 3, 2005
• Last Update Posted: Jun 21, 2011
• Last Verified: May 1, 2011

• Keywords provided by , ,: dermatomyositis; etanercept; tumor necrosis factor alpha
• Additional relevant MeSH terms: Dermatomyositis; Etanercept

Study Results

Participant Flow

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 Detail	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
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

Baseline Characteristics

Arm/Group Title	Etanercept	Placebo	Total
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 Participants	11	5	16
Age (participants) [Number]
< 18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	11 100%	5 100%	16 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.36 (14.8)	44.2 (11.9)	43.6 (13.39)
Sex: Female, Male (Count of Participants)
Female	6 54.5%	4 80%	10 62.5%
Male	5 45.5%	1 20%	6 37.5%
Region of Enrollment (participants) [Number]
Canada	0 0%	1 20%	1 6.3%
United States	11 100%	4 80%	15 93.8%

Outcome Measures

1. Primary Outcome

Title	Occurrence of at Least One Adverse Event
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

Outcome Measure Data

Analysis Population Description

Intention- to -Treat (ITT)

Arm/Group Title	Etanercept	Placebo
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
Measure Participants	11	5
Mild AE	1 9.1%	1 20%
Moderate AE	5 45.5%	1 20%
Severe AE	5 45.5%	3 60%

2. Other Pre-specified Outcome

Title	The Number of Participants Who Were Classified as Treatment Failures
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etanercept	Placebo
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
Measure Participants	11	5
Number [participants]	6 54.5%	5 100%

3. Secondary Outcome

Title	Average Prednisone Dosage After Week 24
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etanercept	Placebo
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
Measure Participants	11	5
Median (Inter-Quartile Range) [mg]	1.2	29.2

4. Other Pre-specified Outcome

Title	Change in the Average Manual Muscle Testing (MMT) Score From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	10	4
Mean (Standard Deviation) [Units on a scale]	0.24 (0.29)	0.30 (0.21)

5. Primary Outcome

Title	Tolerability
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etanercept	Placebo
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
Measure Participants	11	5
Number [Participants]	10 90.9%	4 80%

6. Other Pre-specified Outcome

Title	Average Change in Time to Rise From a Chair From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	10	4
Mean (Standard Deviation) [Seconds]	-.05 (2.64)	-1.22 (1.98)

7. Other Pre-specified Outcome

Title	Average Change in Time (Seconds) to Walk 30 Feet Comparing Performance at Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	10	4
Mean (Standard Deviation) [Seconds]	-2.26 (4.81)	-0.55 (1.44)

8. 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
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

Outcome Measure Data

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
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
Measure Participants	7	4
Mean (Standard Deviation) [Z-score]	0.17 (0.48)	-0.57 (0.90)

9. 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
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.

Outcome Measure Data

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
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
Measure Participants	7	4
Mean (Standard Deviation) [Z-Score]	-0.10 (0.57)	0.07 (1.01)

10. Other Pre-specified Outcome

Title	Average Change in Physician Global Activity Assessment From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	10	4
Mean (Standard Deviation) [cm]	-2.36 (2.12)	-1.32 (2.41)

11. Other Pre-specified Outcome

Title	Average Change in Patient Global Activity Assessment Score From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	10	4
Mean (Standard Deviation) [cm]	-2.34 (2.97)	-0.38 (2.76)

12. Other Pre-specified Outcome

Title	Average Change in Cutaneous Disease Activity and Severity Index (CDASI) Score From Week 52 to Baseline
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

Outcome Measure Data

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
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
Measure Participants	10	4
Mean (Standard Deviation) [Units on a scale]	-3.05 (4.84)	-0.25 (4.84)

13. Other Pre-specified Outcome

Title	Change in Pruritis Rating From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	10	4
Mean (Standard Deviation) [cm]	0.33 (2.63)	-1.64 (1.69)

14. Other Pre-specified Outcome

Title	Change in Health Assessment Questionnaire (HAQ) Score From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	10	4
Mean (Standard Deviation) [Units on a scale]	-0.33 (0.45)	-0.34 (0.68)

15. Other Pre-specified Outcome

Title	Forced Vital Capacity (FVC) Average Change in Percent Predicted From Screening to Week 52.
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.

Outcome Measure Data

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
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
Measure Participants	9	4
Mean (Standard Deviation) [Percent predicted]	-2.56 (8.93)	-1.00 (16.47)

16. Other Pre-specified Outcome

Title	Average Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) From the Screening Visit to Week 52
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

Outcome Measure Data

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
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
Measure Participants	9	4
Mean (Standard Deviation) [Percent predicted]	-0.67 (11.92)	-4.25 (14.80)

17. Other Pre-specified Outcome

Title	Average Change in Percent Predicted Diffusion Capacity (DLCO)From the Screening Visit to Week 52
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

Outcome Measure Data

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
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
Measure Participants	8	3
Mean (Standard Deviation) [Percent predicted]	-4.50 (14.34)	-14.67 (8.33)

18. Primary Outcome

Title	Average Change in Oral Temperature From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	9	4
Mean (Standard Deviation) [degrees Celsius]	0.16 (0.64)	0.20 (0.22)

19. Primary Outcome

Title	Average Change in Respiration Rate From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	9	4
Mean (Standard Deviation) [breaths per minute]	-2.44 (3.17)	-2.00 (4.32)

20. Primary Outcome

Title	Average Change in Systolic Blood Pressure From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	10	4
Mean (Standard Deviation) [mmHg]	-13.3 (16.3)	-3.0 (14.72)

21. Primary Outcome

Title	Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52.
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

Outcome Measure Data

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
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
Measure Participants	10	4
Mean (Standard Deviation) [mmHg]	-6.10 (9.52)	1.00 (7.39)

22. Primary Outcome

Title	Average Change in Pulse Comparing Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	10	4
Mean (Standard Deviation) [beats per minute]	-4.40 (10.19)	-7.25 (14.43)

23. Primary Outcome

Title	Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52.
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

Outcome Measure Data

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
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
Measure Participants	10	4
Mean (Standard Deviation) [Kilograms]	4.59 (26.63)	3.77 (9.49)

24. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	1 9.1%	2 40%

25. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	1 9.1%	1 20%

26. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	0 0%	1 20%

27. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	1 9.1%	2 40%

28. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	0 0%	1 20%

29. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	0 0%	0 0%

30. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	0 0%	1 20%

31. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	0 0%	0 0%

32. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	0 0%	0 0%

33. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	0 0%	0 0%

34. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	0 0%	0 0%

35. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	1 9.1%	1 20%

36. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	0 0%	1 20%

37. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	0 0%	0 0%

38. 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
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	0 0%	0 0%

39. Primary Outcome

Title	Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	1 9.1%	0 0%

40. 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
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

Outcome Measure Data

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
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
Measure Participants	11	5
Number [participants]	0 0%	0 0%

41. Primary Outcome

Title	Average Cumulative Dosage of Prednisone Over the One Year Study Period
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etanercept	Placebo
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
Measure Participants	11	5
Mean (Standard Deviation) [mg]	5907.09 (3482.85)	9917.65 (4762.09)

42. Secondary Outcome

Title	Average Daily Dose of Prednisone From Baseline to Week 52
Description	The average daily dose of prednisone from baseline to week 52 was calculated by treatment group.
Time Frame	Baseline through Week 52

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etanercept	Placebo
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
Measure Participants	11	5
Mean (Standard Deviation) [mg]	17.00 (9.92)	36.40 (21.37)

Adverse Events

Time Frame	from screening to one month after completion of the study (at least 56 wks)
Arm/Group Title	Etanercept		Placebo
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Etanercept		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/11 (27.3%)		3/5 (60%)
General disorders
Fever	1/11 (9.1%)	1	0/5 (0%)	0
Infections and infestations
Urinary Tract Infection	1/11 (9.1%)	1	0/5 (0%)	0
Viral Gastroenteritis	0/11 (0%)	0	1/5 (20%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer	0/11 (0%)	0	1/5 (20%)	1
Nervous system disorders
Post Herpetic Neuralgia	1/11 (9.1%)	1	0/5 (0%)	0
Dermatomyositis Flare	0/11 (0%)	0	1/5 (20%)	1
Pregnancy, puerperium and perinatal conditions
Partner Pregnant	1/11 (9.1%)	1	0/5 (0%)	0
Psychiatric disorders
Acute Psychosis	1/11 (9.1%)	2	0/5 (0%)	0
Other (Not Including Serious) Adverse Events
	Etanercept		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/11 (100%)		5/5 (100%)
Blood and lymphatic system disorders
Bleeding- Vaginal	0/11 (0%)	0	1/5 (20%)	1
Elevated WBC	0/11 (0%)	0	1/5 (20%)	1
Low WBC Count	2/11 (18.2%)	2	0/5 (0%)	0
Cardiac disorders
Cardiomegaly	0/11 (0%)	0	1/5 (20%)	1
Chest tightness	0/11 (0%)	0	1/5 (20%)	1
Tachycardia	1/11 (9.1%)	1	0/5 (0%)	0
Transient Cardiac Arrhythmia	1/11 (9.1%)	1	0/5 (0%)	0
Ear and labyrinth disorders
Auditory/Ear-Other- Tingling in ear	1/11 (9.1%)	1	0/5 (0%)	0
Pain- Ear	1/11 (9.1%)	1	0/5 (0%)	0
Eye disorders
Blurred Vision	2/11 (18.2%)	2	1/5 (20%)	1
Cataracts	1/11 (9.1%)	2	0/5 (0%)	0
Dryness inner eyelids	1/11 (9.1%)	1	0/5 (0%)	0
Subconjuctival haemorrhage	0/11 (0%)	0	1/5 (20%)	1
Gastrointestinal disorders
Abdominal Ascites	0/11 (0%)	0	1/5 (20%)	1
Abdominal Distention	0/11 (0%)	0	1/5 (20%)	1
Abdominal Pain	0/11 (0%)	0	2/5 (40%)	2
Constipation	1/11 (9.1%)	1	0/5 (0%)	0
Dental/Teeth	1/11 (9.1%)	1	0/5 (0%)	0
Diarrhea	3/11 (27.3%)	4	3/5 (60%)	3
Difficulty Swallowing	1/11 (9.1%)	1	0/5 (0%)	0
Fecal Urgency	0/11 (0%)	0	1/5 (20%)	1
Heartburn	3/11 (27.3%)	4	0/5 (0%)	0
Inguinal Hernia	0/0 (NaN)	0	1/5 (20%)	1
Nausea	3/11 (27.3%)	5	2/5 (40%)	4
Stomach Cramps	0/11 (0%)	0	1/5 (20%)	1
Toothache	3/11 (27.3%)	4	0/5 (0%)	0
Vomiting	2/11 (18.2%)	2	1/5 (20%)	3
General disorders
Chest tightness	0/11 (0%)	0	1/5 (20%)	1
Chills	0/11 (0%)	0	1/5 (20%)	1
Fatigue	1/11 (9.1%)	1	1/5 (20%)	1
Fever	0/11 (0%)	0	1/5 (20%)	1
Injection Site Reaction	2/11 (18.2%)	2	2/5 (40%)	2
Hepatobiliary disorders
Fatty liver	0/11 (0%)	0	1/5 (20%)	1
Infections and infestations
Bladder Infection	0/11 (0%)	0	1/5 (20%)	1
Infection- Sacral area	1/11 (9.1%)	1	0/5 (0%)	0
Infection NOS (Viral Syndrome)	1/11 (9.1%)	1	0/5 (0%)	0
Infection Upper Airway	5/11 (45.5%)	8	1/5 (20%)	1
Infection with Normal ANC - Conjunctiva	1/11 (9.1%)	1	0/5 (0%)	0
Infection with Normal - ANC - UTI	1/11 (9.1%)	1	0/5 (0%)	0
Infection- Conjuctiva	1/11 (9.1%)	1	0/5 (0%)	0
Infection - Lip	1/11 (9.1%)	1	1/5 (20%)	1
Infection - Other (Gastrointestinal)	0/11 (0%)	0	1/5 (20%)	1
Periungal Finger Infections	0/11 (0%)	0	1/5 (20%)	1
Skin/Cellulitus Right Great Toe	1/11 (9.1%)	1	0/5 (0%)	0
UTI	1/11 (9.1%)	1	0/5 (0%)	0
Viral Gastroenteritis	1/11 (9.1%)	1	0/5 (0%)	0
Viral Hepatitis	1/11 (9.1%)	1	0/5 (0%)	0
Injury, poisoning and procedural complications
Fall; Right Scalp Abrasion & Hematoma, R Chest Wall Bruising	1/11 (9.1%)	1	0/5 (0%)	0
Skin Burn Left Forearm Vent Surface	0/11 (0%)	0	1/5 (20%)	1
Investigations
Cholesterol High	0/11 (0%)	0	1/5 (20%)	1
Elevated Aldolase	1/11 (9.1%)	1	1/5 (20%)	1
Elevated ALT	0/11 (0%)	0	1/5 (20%)	1
Elevated AST	0/11 (0%)	0	1/5 (20%)	1
Elevated CK	2/11 (18.2%)	2	1/5 (20%)	1
Elevated GGT	1/11 (9.1%)	1	1/5 (20%)	1
Laboratory/Other- Abnormal PAP Smear	1/11 (9.1%)	1	0/5 (0%)	0
Increased Vit D Level	0/11 (0%)	0	1/5 (20%)	1
Urine Glucose Pos.	0/11 (0%)	0	1/5 (20%)	1
Urine Protein Pos.	0/11 (0%)	0	1/5 (20%)	1
Vitamin D Low	0/11 (0%)	0	1/5 (20%)	1
Metabolism and nutrition disorders
Elevated Glucose	0/11 (0%)	0	2/5 (40%)	2
Hypercalcemia	0/11 (0%)	0	1/5 (20%)	1
Musculoskeletal and connective tissue disorders
Edema: Left Knee Swelling	0/11 (0%)	0	1/5 (20%)	1
Increased Muscle Weakness	1/11 (9.1%)	1	1/5 (20%)	2
Increased weakness right lower leg	1/11 (9.1%)	1	0/5 (0%)	0
Musculoskeletal Pains	6/11 (54.5%)	27	3/5 (60%)	4
Syndromes- Other (Sicca)	1/11 (9.1%)	1	0/5 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left Kidney Cyst	0/11 (0%)	0	1/5 (20%)	1
Endometrial polyp	0/11 (0%)	0	1/5 (20%)	1
Nervous system disorders
Burning sensation right foot	1/11 (9.1%)	1	0/5 (0%)	0
Dizziness	2/11 (18.2%)	3	1/5 (20%)	1
Headache	3/11 (27.3%)	3	4/5 (80%)	5
Neuropathy	3/11 (27.3%)	3	1/5 (20%)	1
Ear numbness	1/11 (9.1%)	1	0/5 (0%)	0
Post herpetic neuralgia	1/11 (9.1%)	1	0/5 (0%)	0
Spinal Headache	1/11 (9.1%)	1	0/5 (0%)	0
Worsening of Dermato	1/11 (9.1%)	1	0/5 (0%)	0
Psychiatric disorders
Anxiety/Mood Alternation	1/11 (9.1%)	1	0/5 (0%)	0
Depression	2/11 (18.2%)	2	0/5 (0%)	0
Insomnia	1/11 (9.1%)	1	1/5 (20%)	1
Renal and urinary disorders
Cystitis	1/11 (9.1%)	1	0/5 (0%)	0
Respiratory, thoracic and mediastinal disorders
Atelectasis	0/11 (0%)	0	1/5 (20%)	1
Bronchospasm	0/11 (0%)	0	1/5 (20%)	2
Dyspnea	1/11 (9.1%)	1	2/5 (40%)	2
Interstital Lung Disease	1/11 (9.1%)	1	0/5 (0%)	0
Pain- Throat/Pharynx	0/11 (0%)	0	1/5 (20%)	1
Pleural Effusion	0/11 (0%)	0	1/5 (20%)	1
Pneumonitis	0/11 (0%)	0	1/5 (20%)	1
Shortness of Breath	0/11 (0%)	0	1/5 (20%)	1
Skin and subcutaneous tissue disorders
Decubitus Ulcer	1/11 (9.1%)	1	0/5 (0%)	0
Left Antecubital Fossa Scab- Wound Complication - Noninfectious	0/11 (0%)	0	1/5 (20%)	1
Mechanics Hand on Right Index Finger- Hand/Foot	1/11 (9.1%)	1	0/5 (0%)	0
Pruritus	5/11 (45.5%)	6	1/5 (20%)	1
Skin Rash	0/11 (0%)	0	1/5 (20%)	1
Worsening Skin Rash	5/11 (45.5%)	7	1/5 (20%)	1
Surgical and medical procedures
Replacement of pacemaker	0/11 (0%)	0	1/5 (20%)	1
Vascular disorders
Hypertension	3/11 (27.3%)	3	1/5 (20%)	1
Increased Edema	0/11 (0%)	0	1/5 (20%)	1

Limitations/Caveats

[Not Specified]

More Information

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.