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| ID | Type | Description | Link |
|---|---|---|---|
| Parsaclisib | Other Identifier | Incyte Corporation |
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The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of Sjögren's syndrome (SS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parsaclisib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parsaclisib | Drug | Parsaclisib administered orally once daily at the protocol-defined dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands | The SGUS is a combination of the scores of the 4 salivary glands (2 parotid and 2 submandibular) each gland is scored on a 5-point scale (0 to 4; 4 being more severe), with the maximum total score being 16. | Week 4 and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Salivary CXCL13 Levels | To assess the impact of parsaclisib on salivary CXCL13. | Baseline, Week 4 and Week 12 |
| Number of Participants With Treatment-emergent Adverse Events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Butler, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Pharma CR | Miami | Florida | 33147 | United States | ||
| North Georgia Rheumatology Group |
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Ten participants were enrolled and treated. Seven participants completed treatment. Three participants discontinued treatment and withdrew from the study.
Approximately 12 participants were planned. Ten participants were enrolled and analyzed for efficacy and safety.
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| ID | Title | Description |
|---|---|---|
| FG000 | Parsaclisib | parsaclisib was administered orally once a day. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Parsaclisib | parsaclisib was administered orally once a day for up to 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With a 1 Point or Greater Change on the Salivary Gland Ultrasound (SGUS) Score for Parotid and Submandibular Glands | The SGUS is a combination of the scores of the 4 salivary glands (2 parotid and 2 submandibular) each gland is scored on a 5-point scale (0 to 4; 4 being more severe), with the maximum total score being 16. | Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Week 4 and Week 12 |
|
|
Up to 21 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parsaclisib | parsaclisib was administered orally once a day. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Incyte Corporation | 1-855-463-3463 | medinfo@incyte.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2018 | Dec 7, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 25, 2019 | Dec 7, 2020 | SAP_000.pdf |
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| ID | Term |
|---|---|
| C000656179 | parsaclisib |
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Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
| Up to 21 weeks |
| Change in Whole Salivary Flow | Defined as change in stimulated and unstimulated whole salivary flow from baseline | Baseline, Weeks 4, 8, and 12 |
| Change in EULAR Sjögren's Syndrome Disease Activity Index | Defined as change in ESSDAI. The ESSDAI is a physician-assessed disease activity index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of 44 items in 12 organ-specific 'domains' contributing to disease activity (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score is then calculated as the sum of all individual weighted domain scores. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). | Week 12 |
| Change in EULAR Sjögren's Syndrome Patient Reported Index | Defined as Change in ESSPRI. EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. | Weeks 4, 8, and 12 |
| Change in Symptom Scores for Dryness | Defined as change in symptom scores for dryness of eyes, mouth, and vagina. The dryness questionnaire will ask participants to rate the dryness of eyes, mouth, or vagina (female participants only) with 24-hour recall using an 11-point numerical rating system ranging from 0 (no dryness) to 10 | Weeks 4, 8, and 12. |
| Patient Global Impression of Change Questionnaire | Defined as proportions of participants in each PGIC category. The PGIC asks a single question regarding how the patient is feeling since beginning new therapy. The questionnaire uses a 7-point scale (from 1 to 7), ranging from "very much improved, 1" to "very much worse, 7 | Baseline, Weeks 4, 8, and 12 |
| Change in PROMIS Fatigue Short Form | Defined as change in PROMIS Fatigue short form. The PROMIS fatigue short form includes 7 items with a rating scale of 1 to 5, 1 being no fatigue and 5 being severe fatigue. The recall period is 7 days. | Weeks 4, 8, and 12 |
| Female Participants Only : Change in Female Sexual Function Index | Defined as change in FSFI. The FSFI is a brief, self-report measure of female sexual function (female participants only). The questionnaire contains 19 item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported. | Weeks 4, 8, and 12 |
| Change in European Quality of Life 5 Dimensions Questionnaire | Defined as change in EQ-5D. The EQ-5D is a standardized measure of health status. It consists of 5 questions, each with a 5-item rating scale plus a visual analog scale rating from 1 to 100 for overall health status. Higher score represents more severe symptoms. | Weeks 4, 8, and 12 |
| Percentage Change in Whole Salivary Flow | Defined as change and percent change in stimulated and unstimulated whole salivary flow from baseline | Baseline, Weeks 4, 8, and 12 |
| Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index | Defined as percent change in ESSDAI. The ESSDAI is a physician-assessed disease activity index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of 44 items in 12 organ-specific 'domains' contributing to disease activity (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score is then calculated as the sum of all individual weighted domain scores. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). | Week 12 |
| Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index | Defined as percentage change in ESSPRI. EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. | Weeks 4, 8, and 12 |
| Percentage Change in Symptom Scores for Dryness | Defined as percent change in symptom scores for dryness of eyes, mouth, and vagina. The dryness questionnaire will ask participants to rate the dryness of eyes, mouth, or vagina (female participants only) with 24-hour recall using an 11-point numerical rating system ranging from 0 (no dryness) to 10 | Weeks 4, 8, and 12. |
| Percentage Change in PROMIS Fatigue Short Form | Defined as percent change in PROMIS Fatigue short form. The PROMIS fatigue short form includes 7 items with a rating scale of 1 to 5, 1 being no fatigue and 5 being severe fatigue. The recall period is 7 days. | Weeks 4, 8, and 12 |
| Female Participants Only : Percentage Change in Female Sexual Function Index | Defined as percent change in FSFI. The FSFI is a brief, self-report measure of female sexual function (female participants only). The questionnaire contains 19 item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported. | Weeks 4, 8, and 12 |
| Percentage Change in European Quality of Life 5 Dimensions Questionnaire | Defined as percent change in EQ-5D. The EQ-5D is a standardized measure of health status. It consists of 5 questions, each with a 5-item rating scale plus a visual analog scale rating from 1 to 100 for overall health status. Higher score represents more severe symptoms. | Weeks 4, 8, and 12 |
| Lawrenceville |
| Georgia |
| 30046 |
| United States |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | United States |
| Ramesh C. Gupta, MD | Memphis | Tennessee | 38119-5208 | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change From Baseline in Salivary CXCL13 Levels | To assess the impact of parsaclisib on salivary CXCL13. | Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug, and detectable levels of CXCL13. | Posted | Mean | Standard Deviation | L/h | Baseline, Week 4 and Week 12 |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug. | The full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 21 weeks |
|
|
|
| Secondary | Change in Whole Salivary Flow | Defined as change in stimulated and unstimulated whole salivary flow from baseline | The full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | g/min | Baseline, Weeks 4, 8, and 12 |
|
|
|
| Secondary | Change in EULAR Sjögren's Syndrome Disease Activity Index | Defined as change in ESSDAI. The ESSDAI is a physician-assessed disease activity index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of 44 items in 12 organ-specific 'domains' contributing to disease activity (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score is then calculated as the sum of all individual weighted domain scores. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). | Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Index | Week 12 |
|
|
|
| Secondary | Change in EULAR Sjögren's Syndrome Patient Reported Index | Defined as Change in ESSPRI. EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. | Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Index | Weeks 4, 8, and 12 |
|
|
|
| Secondary | Change in Symptom Scores for Dryness | Defined as change in symptom scores for dryness of eyes, mouth, and vagina. The dryness questionnaire will ask participants to rate the dryness of eyes, mouth, or vagina (female participants only) with 24-hour recall using an 11-point numerical rating system ranging from 0 (no dryness) to 10 | Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 4, 8, and 12. |
|
|
|
| Secondary | Patient Global Impression of Change Questionnaire | Defined as proportions of participants in each PGIC category. The PGIC asks a single question regarding how the patient is feeling since beginning new therapy. The questionnaire uses a 7-point scale (from 1 to 7), ranging from "very much improved, 1" to "very much worse, 7 | Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Baseline, Weeks 4, 8, and 12 |
|
|
|
| Secondary | Change in PROMIS Fatigue Short Form | Defined as change in PROMIS Fatigue short form. The PROMIS fatigue short form includes 7 items with a rating scale of 1 to 5, 1 being no fatigue and 5 being severe fatigue. The recall period is 7 days. | Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 4, 8, and 12 |
|
|
|
| Secondary | Female Participants Only : Change in Female Sexual Function Index | Defined as change in FSFI. The FSFI is a brief, self-report measure of female sexual function (female participants only). The questionnaire contains 19 item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported. | Full analysis set included all female participants enrolled in the study who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Index | Weeks 4, 8, and 12 |
|
|
|
| Secondary | Change in European Quality of Life 5 Dimensions Questionnaire | Defined as change in EQ-5D. The EQ-5D is a standardized measure of health status. It consists of 5 questions, each with a 5-item rating scale plus a visual analog scale rating from 1 to 100 for overall health status. Higher score represents more severe symptoms. | Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Scores on a scale | Weeks 4, 8, and 12 |
|
|
|
| Secondary | Percentage Change in Whole Salivary Flow | Defined as change and percent change in stimulated and unstimulated whole salivary flow from baseline | The full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Percentage Change | Baseline, Weeks 4, 8, and 12 |
|
|
|
| Secondary | Percentage Change in EULAR Sjögren's Syndrome Disease Activity Index | Defined as percent change in ESSDAI. The ESSDAI is a physician-assessed disease activity index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of 44 items in 12 organ-specific 'domains' contributing to disease activity (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. An overall score is then calculated as the sum of all individual weighted domain scores. Overall score is calculated as sum of all individual weighted domain scores (ranges from 0 (best) to 123 (worst activity). | Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Percentage Change | Week 12 |
|
|
|
| Secondary | Percentage Change in EULAR Sjögren's Syndrome Patient Reported Index | Defined as percentage change in ESSPRI. EULAR Sjogren's Syndrome Patient-Reported Index (ESSPRI) Score is defined as the change in score between baseline (Week -1) and Week 12. The ESSPRI is a patient-reported, subjective symptom index for primary Sjögren's syndrome developed by the EULAR consortium. It consists of three questions covering the cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain (articular and/or muscular). Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. | Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Percentage Change | Weeks 4, 8, and 12 |
|
|
|
| Secondary | Percentage Change in Symptom Scores for Dryness | Defined as percent change in symptom scores for dryness of eyes, mouth, and vagina. The dryness questionnaire will ask participants to rate the dryness of eyes, mouth, or vagina (female participants only) with 24-hour recall using an 11-point numerical rating system ranging from 0 (no dryness) to 10 | Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Percentage Change | Weeks 4, 8, and 12. |
|
|
|
| Secondary | Percentage Change in PROMIS Fatigue Short Form | Defined as percent change in PROMIS Fatigue short form. The PROMIS fatigue short form includes 7 items with a rating scale of 1 to 5, 1 being no fatigue and 5 being severe fatigue. The recall period is 7 days. | Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Percentage Change | Weeks 4, 8, and 12 |
|
|
|
| Secondary | Female Participants Only : Percentage Change in Female Sexual Function Index | Defined as percent change in FSFI. The FSFI is a brief, self-report measure of female sexual function (female participants only). The questionnaire contains 19 item sexual functioning questionnaire to rate sexual function between 2.0 and 36.0, where 2.0 is low sexual function and 36.0 is high sexual function. Difference in FSFI scores are reported. | Full analysis set included all female participants enrolled in the study who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Percentage Change | Weeks 4, 8, and 12 |
|
|
|
| Secondary | Percentage Change in European Quality of Life 5 Dimensions Questionnaire | Defined as percent change in EQ-5D. The EQ-5D is a standardized measure of health status. It consists of 5 questions, each with a 5-item rating scale plus a visual analog scale rating from 1 to 100 for overall health status. Higher score represents more severe symptoms. | Full analysis set included all participants enrolled in the study who received at least 1 dose of study drug. | Posted | Mean | Standard Deviation | Percentage Change | Weeks 4, 8, and 12 |
|
|
|
| 10 |
| 0 |
| 10 |
| 4 |
| 10 |
| Dental caries | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
Clinical Study Agreement
|
| Mean change in stimulated salivary flow Week 12 |
|
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| Mean change in unstimulated salivary flow Week 4 |
|
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| Mean change in unstimulated salivary flow Week 8 |
|
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| Mean change in unstimulated salivary flow Week 12 |
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| Mean Change at Week 12 |
|
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| Mean Change at Week 12 |
|
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| Change in Symptom Score for eye dryness at Week 12 |
|
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| Change in Symptom Score for mouth dryness at Week 4 |
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| Change in Symptom Score for mouth dryness at Week 8 |
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| Change in Symptom Score for mouth dryness at Week 12 |
|
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| Change in Symptom Score for vaginal dryness at Week 4 |
|
|
| Change in Symptom Score for vaginal dryness at Week 8 |
|
|
| Change in Symptom Score for vaginal dryness at Week 12 |
|
|
| Somewhat Worse |
|
| No Change |
|
| Somewhat Improved |
|
| Improved |
|
| Very much Improved |
|
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
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| Change in Score at Week 12 |
|
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| Change in Functional Index at Week 12 |
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|
|
| Change in EQ5D at week 12 |
|
|
|
| Percent change in stimulated salivary flow Week 12 |
|
|
| Percent change in unstimulated salivary flow Week 4 |
|
|
| Percent change in unstimulated salivary flow Week 8 |
|
|
| Percent change in unstimulated salivary flow Week 12 |
|
|
|
| Percent Change at Week 12 |
|
|
|
| Percent Change at Week 12 |
|
|
|
| Percent change in Symptom Score for eye dryness at Week 12 |
|
|
| Percent change in Symptom Score for mouth dryness at Week 4 |
|
|
| Percent change in Symptom Score for mouth dryness at Week 8 |
|
|
| Percent change in Symptom Score for mouth dryness at Week 12 |
|
|
| Percent change in Symptom Score for vaginal dryness at Week 4 |
|
|
| Percent change in Symptom Score for vaginal dryness at Week 8 |
|
|
| Percent change in Symptom Score for vaginal dryness at Week 12 |
|
|
|
| Percent change in Score at Week 12 |
|
|
|
| Percent change in Functional Index at Week 12 |
|
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| Percent Change in EQ5D at week 12 |
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