Dermatomyositis
Conditions
Keywords
dermatomyositis, etanercept, tumor necrosis factor alpha
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.
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.
Interventions
DRUGEtanercept
Etanercept 50 mg will be injected subcutaneously once per week for 52 weeks
DRUGPlacebo
Placebo, contained in 50mg syringes, will be injected subcutaneously once per week for 52 weeks.
Sponsors
Amgen
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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) 1. Subjects must have symmetric proximal greater than distal weakness 2. Characteristic DM rash consisting of any or all of the following: heliotrope, shawl sign, V-sign, Gottron's sign, Gottron's papules, periungual telangiectasias 3. 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. 4. 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 2. Newly diagnosed subjects should be able to walk independently 30 feet (cane, walkers, orthoses allowed). However, subjects with refractory dermatomyositis may be non-ambulatory. 3. Age \> 18 years 4. Patients must not use topical skin ointments for treatment of the dermatological manifestations as it will interfere with skin assessment. 5. Men and women of childbearing age must be willing to use a method of birth control. 6. Able to give informed consent 7. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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; |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
Countries
United States
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 details
Most patient were initially ineligible because they were not new dermatomyositis patients. Due to slow recruitment, we modified the protocol. We allowed enrollment of refractory dermatomyositis patients receiving prednisone for greater than 2 months. These subjects could also receive second line agents, as long as they were on a stable dose.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks | 11 |
| Placebo Subjects will be given syringes containing placebo | 5 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Etanercept | Placebo | Total |
|---|---|---|---|
| Age Categorical < 18 years | 0 participants | 0 participants | 0 participants |
| Age Categorical >=65 years | 0 participants | 0 participants | 0 participants |
| Age Categorical Between 18 and 65 years | 11 participants | 5 participants | 16 participants |
| Age Continuous | 43.36 years STANDARD_DEVIATION 14.8 | 44.2 years STANDARD_DEVIATION 11.9 | 43.6 years STANDARD_DEVIATION 13.39 |
| Region of Enrollment Canada | 0 participants | 1 participants | 1 participants |
| Region of Enrollment United States | 11 participants | 4 participants | 15 participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 1 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 11 | 5 / 5 |
| serious Total, serious adverse events | 3 / 11 | 3 / 5 |
Outcome results
Primary
Average Change in Body Weight in Kilograms (kg) Comparing Baseline to 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.
Time frame: At Baseline (Week0) and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52. | 4.59 Kilograms | Standard Deviation 26.63 |
| Placebo | Average Change in Body Weight in Kilograms (kg) Comparing Baseline to Week 52. | 3.77 Kilograms | Standard Deviation 9.49 |
Primary
Average Change in Diastolic Blood Pressure Comparing Baseline to 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.
Time frame: At Baseline (Week0) and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52. | -6.10 mmHg | Standard Deviation 9.52 |
| Placebo | Average Change in Diastolic Blood Pressure Comparing Baseline to Week 52. | 1.00 mmHg | Standard Deviation 7.39 |
Primary
Average Change in Oral Temperature From Baseline to 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.
Time frame: At Baseline (Week 0) and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Oral Temperature From Baseline to Week 52 | 0.16 degrees Celsius | Standard Deviation 0.64 |
| Placebo | Average Change in Oral Temperature From Baseline to Week 52 | 0.20 degrees Celsius | Standard Deviation 0.22 |
Primary
Average Change in Pulse Comparing Baseline to 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.
Time frame: At Baseline (Week0) and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Pulse Comparing Baseline to Week 52 | -4.40 beats per minute | Standard Deviation 10.19 |
| Placebo | Average Change in Pulse Comparing Baseline to Week 52 | -7.25 beats per minute | Standard Deviation 14.43 |
Primary
Average Change in Respiration Rate From Baseline to 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.
Time frame: At Baseline (Week0) and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Respiration Rate From Baseline to Week 52 | -2.44 breaths per minute | Standard Deviation 3.17 |
| Placebo | Average Change in Respiration Rate From Baseline to Week 52 | -2.00 breaths per minute | Standard Deviation 4.32 |
Primary
Average Change in Systolic Blood Pressure From Baseline to 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.
Time frame: At Baseline (Week0) and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Systolic Blood Pressure From Baseline to Week 52 | -13.3 mmHg | Standard Deviation 16.3 |
| Placebo | Average Change in Systolic Blood Pressure From Baseline to Week 52 | -3.0 mmHg | Standard Deviation 14.72 |
Primary
Average Cumulative Dosage of Prednisone Over the One Year Study Period
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Cumulative Dosage of Prednisone Over the One Year Study Period | 5907.09 mg | Standard Deviation 3482.85 |
| Placebo | Average Cumulative Dosage of Prednisone Over the One Year Study Period | 9917.65 mg | Standard Deviation 4762.09 |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52 | 1 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Alanine Aminotransferase (ALT) Laboratory Values From Baseline to Week 52 | 1 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52 | 1 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Aldolase Laboratory Values From Baseline to Week 52 | 2 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52 | 1 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Antinuclear Antibody Test (ANA) Values From the Screening Visit to Week 52 | 0 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52 | 1 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Creatine Kinase (CK) Laboratory Values From Baseline to Week 52 | 2 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52 | 0 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Gamma-glutamyl Transpeptidase (GGT) Laboratory Values From Baseline to Week 52 | 1 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52 | 0 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Glucose Laboratory Values From Baseline to Week 52 | 1 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52 | 0 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hematocrit Laboratory Values From Baseline to Week 52 | 0 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52 | 0 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Hemoglobin Laboratory Values From Baseline to Week 52 | 0 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Monoclonal Protein Detection by Serum Protein Electrophoresis (SPEP) From the Screening Visit to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Monoclonal Protein Detection by Serum Protein Electrophoresis (SPEP) From the Screening Visit to Week 52 | 0 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Monoclonal Protein Detection by Serum Protein Electrophoresis (SPEP) From the Screening Visit to Week 52 | 0 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52 | 0 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Platelet Counts From Baseline to Week 52 | 0 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52 | 0 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Potassium Laboratory Values From Baseline to Week 52 | 0 participants |
Primary
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
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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Serum 25-hydroxyvitamin D (25-OH VitD) Laboratory Values From the Screening Visit to Week 52 | 0 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Serum 25-hydroxyvitamin D (25-OH VitD) Laboratory Values From the Screening Visit to Week 52 | 0 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52 | 0 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Glucose Laboratory Values From Baseline to Week 52 | 1 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52 | 0 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Ketone Laboratory Values From Baseline to Week 52 | 0 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52 | 0 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Leukocyte Values From Baseline to Week 52 | 0 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52 | 1 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal Urine Protein Laboratory Values From Baseline to Week 52 | 1 participants |
Primary
Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to 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 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
Population: Data for all subjects in the trial are not available for this assessment at all time points. One subject in the placebo group left the study before week 52. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~Data may also be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52 | 0 participants |
| Placebo | Frequency of Subjects With Treatment Emergent, Clinically Significant, Abnormal White Blood Cell Count (WBC) Values From Baseline to Week 52 | 1 participants |
Primary
Occurrence of at Least One Adverse Event
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
Population: Intention- to -Treat (ITT)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept | Occurrence of at Least One Adverse Event | Mild AE | 1 participants |
| Etanercept | Occurrence of at Least One Adverse Event | Moderate AE | 5 participants |
| Etanercept | Occurrence of at Least One Adverse Event | Severe AE | 5 participants |
| Placebo | Occurrence of at Least One Adverse Event | Mild AE | 1 participants |
| Placebo | Occurrence of at Least One Adverse Event | Moderate AE | 1 participants |
| Placebo | Occurrence of at Least One Adverse Event | Severe AE | 3 participants |
Primary
Tolerability
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)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | Tolerability | 10 Participants |
| Placebo | Tolerability | 4 Participants |
Secondary
Average Daily Dose of Prednisone From Baseline to Week 52
The average daily dose of prednisone from baseline to week 52 was calculated by treatment group.
Time frame: Baseline through Week 52
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Daily Dose of Prednisone From Baseline to Week 52 | 17.00 mg | Standard Deviation 9.92 |
| Placebo | Average Daily Dose of Prednisone From Baseline to Week 52 | 36.40 mg | Standard Deviation 21.37 |
Secondary
Average Prednisone Dosage After Week 24
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Etanercept | Average Prednisone Dosage After Week 24 | 1.2 mg |
| Placebo | Average Prednisone Dosage After Week 24 | 29.2 mg |
Other Pre-specified
Average Change in Cutaneous Disease Activity and Severity Index (CDASI) Score From Week 52 to Baseline
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
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Cutaneous Disease Activity and Severity Index (CDASI) Score From Week 52 to Baseline | -3.05 Units on a scale | Standard Deviation 4.84 |
| Placebo | Average Change in Cutaneous Disease Activity and Severity Index (CDASI) Score From Week 52 to Baseline | -0.25 Units on a scale | Standard Deviation 4.84 |
Other Pre-specified
Average Change in Patient Global Activity Assessment Score From Baseline to 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.
Time frame: At Baseline (Week0) and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Patient Global Activity Assessment Score From Baseline to Week 52 | -2.34 cm | Standard Deviation 2.97 |
| Placebo | Average Change in Patient Global Activity Assessment Score From Baseline to Week 52 | -0.38 cm | Standard Deviation 2.76 |
Other Pre-specified
Average Change in Percent Predicted Diffusion Capacity (DLCO)From the Screening Visit to 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.
Time frame: Screening visit and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Percent Predicted Diffusion Capacity (DLCO)From the Screening Visit to Week 52 | -4.50 Percent predicted | Standard Deviation 14.34 |
| Placebo | Average Change in Percent Predicted Diffusion Capacity (DLCO)From the Screening Visit to Week 52 | -14.67 Percent predicted | Standard Deviation 8.33 |
Other Pre-specified
Average Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) From the Screening Visit to 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.
Time frame: Screening Visit and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) From the Screening Visit to Week 52 | -0.67 Percent predicted | Standard Deviation 11.92 |
| Placebo | Average Change in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) From the Screening Visit to Week 52 | -4.25 Percent predicted | Standard Deviation 14.8 |
Other Pre-specified
Average Change in Physician Global Activity Assessment From Baseline to 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.
Time frame: At Baseline (Week0) and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Physician Global Activity Assessment From Baseline to Week 52 | -2.36 cm | Standard Deviation 2.12 |
| Placebo | Average Change in Physician Global Activity Assessment From Baseline to Week 52 | -1.32 cm | Standard Deviation 2.41 |
Other Pre-specified
Average Change in Time (Seconds) to Walk 30 Feet Comparing Performance at Baseline to 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.
Time frame: At Baseline (Week0) and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Time (Seconds) to Walk 30 Feet Comparing Performance at Baseline to Week 52 | -2.26 Seconds | Standard Deviation 4.81 |
| Placebo | Average Change in Time (Seconds) to Walk 30 Feet Comparing Performance at Baseline to Week 52 | -0.55 Seconds | Standard Deviation 1.44 |
Other Pre-specified
Average Change in Time to Rise From a Chair From Baseline to 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.
Time frame: At Baseline (Week0) and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Time to Rise From a Chair From Baseline to Week 52 | -.05 Seconds | Standard Deviation 2.64 |
| Placebo | Average Change in Time to Rise From a Chair From Baseline to Week 52 | -1.22 Seconds | Standard Deviation 1.98 |
Other Pre-specified
Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Femur From the Screening Visit to Week 52
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
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Femur From the Screening Visit to Week 52 | 0.17 Z-score | Standard Deviation 0.48 |
| Placebo | Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Femur From the Screening Visit to Week 52 | -0.57 Z-score | Standard Deviation 0.9 |
Other Pre-specified
Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Lumbar Spine From the Screening Visit to Week 52
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.
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject left the study early and one subject was lost to follow-up before the Week 52 visit. In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Lumbar Spine From the Screening Visit to Week 52 | -0.10 Z-Score | Standard Deviation 0.57 |
| Placebo | Average Change in Z-score for Dual-emission X-ray Absorptiometry (DEXA) of the Lumbar Spine From the Screening Visit to Week 52 | 0.07 Z-Score | Standard Deviation 1.01 |
Other Pre-specified
Change in Health Assessment Questionnaire (HAQ) Score From Baseline to 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.
Time frame: At Baseline (Week0) and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Change in Health Assessment Questionnaire (HAQ) Score From Baseline to Week 52 | -0.33 Units on a scale | Standard Deviation 0.45 |
| Placebo | Change in Health Assessment Questionnaire (HAQ) Score From Baseline to Week 52 | -0.34 Units on a scale | Standard Deviation 0.68 |
Other Pre-specified
Change in Pruritis Rating From Baseline to 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.
Time frame: At Baseline (Week0), and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Change in Pruritis Rating From Baseline to Week 52 | 0.33 cm | Standard Deviation 2.63 |
| Placebo | Change in Pruritis Rating From Baseline to Week 52 | -1.64 cm | Standard Deviation 1.69 |
Other Pre-specified
Change in the Average Manual Muscle Testing (MMT) Score From Baseline to 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).
Time frame: At Baseline (Week 0) and Week 52
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Change in the Average Manual Muscle Testing (MMT) Score From Baseline to Week 52 | 0.24 Units on a scale | Standard Deviation 0.29 |
| Placebo | Change in the Average Manual Muscle Testing (MMT) Score From Baseline to Week 52 | 0.30 Units on a scale | Standard Deviation 0.21 |
Other Pre-specified
Forced Vital Capacity (FVC) Average Change in Percent Predicted From Screening to 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.
Time frame: Screening Visit and Week 52.
Population: Data for all subjects enrolled in the trial are not available for this assessment. One subject in the placebo group left the study before the Week 52 visit. One subject in the etanercept group was lost to follow-up before the Week 52 visit.~In addition, data may be missing due to the subject's refusal to complete an assessment or examiner error.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept | Forced Vital Capacity (FVC) Average Change in Percent Predicted From Screening to Week 52. | -2.56 Percent predicted | Standard Deviation 8.93 |
| Placebo | Forced Vital Capacity (FVC) Average Change in Percent Predicted From Screening to Week 52. | -1.00 Percent predicted | Standard Deviation 16.47 |
Other Pre-specified
The Number of Participants Who Were Classified as Treatment Failures
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept | The Number of Participants Who Were Classified as Treatment Failures | 6 participants |
| Placebo | The Number of Participants Who Were Classified as Treatment Failures | 5 participants |