A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:

A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550446
• Other study ID #: A3921035
• Status: Completed
• Phase: Phase 2
• First received: October 25, 2007
• Last updated: November 29, 2012
• Start date: September 2007
• Est. completion date: January 2009

Study information

• Verified date: November 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must have active rheumatoid arthritis

• Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD)

• Subjects must not be currently taking any DMARD other than an antimalarial

Exclusion Criteria:

• Subjects who discontinued any previous TNF inhibitor therapy for either lack of benefit or safety.

• Subjects who previously received adalimumab (Humira®) therapy for any reason.

• Subjects with evidence of blood disorders, chronic infections or untreated tuberculosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Adalimumab
40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.
• CP-690-550
15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
• CP-690-550
10 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
• CP-690-550
5 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
• CP-690,550
3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
• CP-690,550
1 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
• Placebo
Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)

Locations

Country	Name	City	State
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Bulgaria	Pfizer Investigational Site	Pleven
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia 1606
Chile	Pfizer Investigational Site	Providencia	Santiago, RM
Chile	Pfizer Investigational Site	Santiago	RM
Chile	Pfizer Investigational Site	Santiago	RM
Croatia	Pfizer Investigational Site	Split
Croatia	Pfizer Investigational Site	Zagreb
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Praha 11 - Chodov
Czech Republic	Pfizer Investigational Site	Praha 2
Czech Republic	Pfizer Investigational Site	Praha 4
Czech Republic	Pfizer Investigational Site	Zlin
Germany	Pfizer Investigational Site	Dresden
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Hildesheim
Germany	Pfizer Investigational Site	Leipzig
Greece	Pfizer Investigational Site	Goudi	Athens
Greece	Pfizer Investigational Site	Thessaloniki
Hungary	Pfizer Investigational Site	Szolnok
Italy	Pfizer Investigational Site	Firenze
Italy	Pfizer Investigational Site	Genova
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Mexico	Pfizer Investigational Site	Cuernavaca	Morelos
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Metepec	Estado de Mexico
Mexico	Pfizer Investigational Site	Mexico	D.f.
Romania	Pfizer Investigational Site	Bucuresti
Romania	Pfizer Investigational Site	Constanta
Romania	Pfizer Investigational Site	Iasi
Slovakia	Pfizer Investigational Site	Piestany
Slovakia	Pfizer Investigational Site	Zilina
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Lviv
Ukraine	Pfizer Investigational Site	Vinnitsa
Ukraine	Pfizer Investigational Site	Zaporizhzhia
United States	Pfizer Investigational Site	Cedar Rapids	Iowa
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	Duncansville	Pennsylvania
United States	Pfizer Investigational Site	Hickory	North Carolina
United States	Pfizer Investigational Site	Hickory	North Carolina
United States	Pfizer Investigational Site	Knoxville	Tennessee
United States	Pfizer Investigational Site	Little Rock	Arkansas
United States	Pfizer Investigational Site	Mesa	Arizona
United States	Pfizer Investigational Site	Mesquite	Texas
United States	Pfizer Investigational Site	Morton Grove	Illinois
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	Northridge	California
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Palo Alto	California
United States	Pfizer Investigational Site	Rockford	Illinois
United States	Pfizer Investigational Site	Stanford	California
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tarzana	California
United States	Pfizer Investigational Site	Upland	California
United States	Pfizer Investigational Site	Wichita	Kansas
United States	Pfizer Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Brazil,  Bulgaria,  Chile,  Croatia,  Czech Republic,  Germany,  Greece,  Hungary,  Italy,  Korea, Republic of,  Mexico,  Romania,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels	Blood samples for immunoglobulin assessments were obtained to determine IgG, IgM, and IgA levels in serum.	Baseline, Week 24/ ET	No
Other	Change From Baseline in Serum Immunoglobulin G (IgG), Immunoglobulin M (IgM) and Immunoglobulin A (IgA) Levels at Week 24	Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG, IgM, and IgA levels.	Baseline, Week 24/ ET	No
Other	Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers	The following biomarkers were assessed: Cluster of Differentiation 3 (CD3), CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.	Baseline, Week 24/ ET	No
Other	Change From Baseline in Fluorescence Activated Cell Sorting (FACS) Lymphocyte Biomarkers at Week 24	The following biomarkers were assessed: CD3, CD4, CD8, CD19 and CD56. FACS analysis for lymphocyte subset markers were used to assess the effects of repeated doses of CP-690,550.	Baseline, Week 24/ ET	No
Other	Medical Outcome Study- Sleep Scale (MOS-SS)	Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 sub scales: sleep disturbance (SD), snoring (Sno), awakened short of breath (ASOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range:0-100); sleep quantity (Qua)(range:0-24), and optimal (Opt) sleep (yes: 1, no: 0)and nine item index measures of sleep disturbance were constructed to provide composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute.	Baseline, Week 2, 12, 24/ ET	No
Other	Change From Baseline in Medical Outcome Study- Sleep Scale (MOS-SS) at Week 2, 12 and 24/ET	Participant-rated questionnaire to assess key constructs of sleep over the past week. Consists of a 12-item based on 7 subscales: sleep disturbance (SD), snoring (Sno), awakened short of breath (A SOB) or with headache, sleep adequacy (Ade), and somnolence (Som) (range: 0-100); sleep quantity (Qua) (range: 0-24), and optimal (Opt) sleep (yes: 1, no: 0) and 9 item index measures of sleep disturbance were constructed to provide 2 composite scores: sleep problem summary (SPS) and overall sleep problems (OSP). Except sleep adequacy, optimal sleep and quantity, higher scores=greater impairment. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range*100); total score range: 0 to 100; higher score = greater intensity of attribute.	Baseline, Week 2, 12, 24/ ET	No
Other	Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale	FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.	Baseline, Week 2, 12, 24/ ET	No
Other	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Week 2, 12 and 24/ET	FACIT-Fatigue is a 13-item questionnaire. Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.	Baseline, Week 2, 12, 24/ ET	No
Primary	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12	ACR20 response: greater than or equal to (>=) 20 % improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).	Week 12	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	ACR20 response: 20% improvement in TJC; >=20% improvement in SJC; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.	Week 2, 4, 6, 8, 10, 16, 20 and 24/Early Termination (ET)	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 50%(ACR50) Response	ACR50 response: >= 50% improvement in TJC or SJC and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.	Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	ACR70 response: >= 70% improvement in TJC or SJC and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.	Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET	No
Secondary	Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Response	ACR90 response: >= 90% improvement in TJC or SJC and 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.	Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET	No
Secondary	Area Under the Numeric Index of American College of Rheumatology Response (ACR-n) Curve	ACR-n = calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening. Area under the curve (AUC) for ACR-n is the measure of the area under the curve of the mean change from baseline in ACR-n. The trapezoidal rule was used to compute the AUC.	Baseline up to Week 2, 4, 6, 8, 10, 12	No
Secondary	Tender Joint Count (TJC)	Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET	No
Secondary	Change From Baseline in Tender Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24 or ET	Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from baseline indicated an improvement.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET	No
Secondary	Swollen Joint Counts (SJC)	Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET	No
Secondary	Change From Baseline in Swollen Joint Count at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24	Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling = 1. A negative value in change from baseline indicated an improvement.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET	No
Secondary	Patient Assessment of Arthritis Pain	Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET	No
Secondary	Change From Baseline in Patient Assessment of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET	Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET	No
Secondary	Patient Global Assessment (PtGA) of Arthritis Pain	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.	Baseline, 2, 4, 6, 8, 10, 12, 16, 20, 24/ET	No
Secondary	Change From Baseline in Patient Global Assessment (PtGA) of Arthritis at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET	No
Secondary	Physician Global Assessment (PGA) of Arthritis	Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET	No
Secondary	Change From Baseline in Physician's Global Assessment (PGA) of Arthritis Pain at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET	Physician global assessment of arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET	No
Secondary	C-Reactive Protein (CRP)	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 milligram per liter (mg/L) to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET	No
Secondary	Change From Baseline in C-reactive Protein (CRP) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is 0 mg/L to 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET	No
Secondary	Health Assessment Questionnaire-Disability Index (HAQ-DI)	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET	No
Secondary	Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET	No
Secondary	Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])	DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and less than (<) 2.6 = remission.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET	No
Secondary	Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 2, 4, 6, 8, 10, 12, 16, 20 and 24/ET	DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and > 3.2 to 5.1 implied moderate to high disease activity, and < 2.6 = remission.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET	No
Secondary	Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])	DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implies low disease activity and > 3.2 to 5.1 implies moderate to high disease activity, and < 2.6 = remission.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET	No
Secondary	Change From Baseline in Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 2, 4, 6, 8, 12, 16, 20 and 24/ET	DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR [mm/hour] and PtGA of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implies low disease activity and > 3.2 to 5.1 implies moderate to high disease activity, and < 2.6 = remission.	Baseline, Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET	No
Secondary	Percentage of Participants With Disease Improvement Based on DAS28-4 (ESR)	Disease improvement was classified as good, moderate, and none based on improvement in DAS28-4 (ESR) from baseline and present DAS28-4 (ESR) score. Good: an improvement from baseline of >1.2 and a present score of <=3.2; none: an improvement of <=0.6 or >0.6 to <=1.2 with a present score of >5.1; remaining participants were classified as having moderate (Mod) improvement. Scores of good and moderate were considered to have therapeutic response.	Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ET	No
Secondary	Percentage of Participants With Disease Remission Based on Normal C-reactive Protein (CRP)	CRP value less than or equal to upper limit of normal (ULN) implied disease remission (ULN=4.9 mg/L).	Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET	No
Secondary	Percentage of Participants With Disease Remission Based on DAS28-3 (CRP)	DAS28-3 (CRP) defined remission was classified as a score of <2.6.	Week 2, 4, 6, 8, 10, 12, 16, 20, 24/ ET	No
Secondary	36-Item Short-Form Health Survey (SF-36)	SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).	Baseline, Week 12, 24/ ET	No
Secondary	Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 12 and 24/ET	SF-36 is a standardized survey evaluating 8 domains (of 2 components [C]; physical [Ph] and mental [Mn]) of functional health and well being: physical and social (So) functioning (Fn), physical and emotional role (role-physical [R-P], role-emotional [R-E]) limitations, bodily pain (BP), general health (GH), vitality (Vit), mental health (MnH). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).	Baseline, Week 12, 24/ ET	No
Secondary	Euro Quality of Life 5 Dimension (EQ-5D)-Health State Profile Utility Score	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Baseline, Week 12, 24/ ET	No
Secondary	Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D)- Health State Profile Utility Score at Week 12 and 24/ET	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.	Baseline, Week 12, 24/ ET	No

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