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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000420-15 | EudraCT Number | ||
| BUTTERFLY | Other Identifier | Alias Study Number |
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The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mg of PF-04236921 | Other |
| |
| 50 mg of PF-04236921 | Other |
| |
| 200 mg of PF-04236921 | Other |
| |
| Placebo | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04236921 | Biological | subcutaneous injection; administered at day 1, weeks 8, 16. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24 | SRI components include:Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),British Isles Lupus Assessment Group(BILAG) 2004,Physician's Global Assessment(PhGA).Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: greater than or equal to(>=) 4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (less than [<] 0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]). | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20 | SRI components include:SLEDAI-2K ,BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anniston Medical Clinic, PC | Anniston | Alabama | 36207 | United States | ||
| Pinnacle Research Group, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29776017 | Derived | Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25. | |
| 27672124 | Derived | Wallace DJ, Strand V, Merrill JT, Popa S, Spindler AJ, Eimon A, Petri M, Smolen JS, Wajdula J, Christensen J, Li C, Diehl A, Vincent MS, Beebe J, Healey P, Sridharan S. Efficacy and safety of an interleukin 6 monoclonal antibody for the treatment of systemic lupus erythematosus: a phase II dose-ranging randomised controlled trial. Ann Rheum Dis. 2017 Mar;76(3):534-542. doi: 10.1136/annrheumdis-2016-209668. Epub 2016 Sep 26. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Due to safety reason, dosing in 200 mg reporting arm was prematurely terminated and the participants were discontinued from it. Therefore, the statistical analysis plan was amended after it and 200 mg reporting arm was not included in efficacy data analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-04236921 10 Milligram (10 mg) | Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| FG001 | PF-04236921 50 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| PF-04236921 | Biological | subcutaneous injection; administered at day 1, weeks 8, 16. |
|
| PF-04236921 | Biological | subcutaneous injection; administered at day 1, weeks 8, 16. |
|
| PF-04236921 | Biological | subcutaneous injection; administered at day 1, weeks 8, 16 |
|
| Week 4, 8, 12, 16, 20 |
| Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24 | SRI components include: modified SLEDAI-2K (SLEDAI-2K without standard parameters "Low complement" and "Leukopenia"), BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. Modified SLEDAI-2K: assesses improvement in disease activity (range: 0 to 102; higher score = higher severity). BILAG: assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant's general health status (range: 0[none] to 3[severe]). | Week 4, 8, 12, 16, 20, 24 |
| Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24 | BICLA include: BILAG-2004, SLEDAI-2K, PhGA of disease activity. Participants classified as responder if they did not meet the definition of treatment failure and met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (<10 percent [%] worsening) in analogue PhGA. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]). | Week 4, 8, 12, 16, 20, 24 |
| Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24 | SRI components include: SLEDAI-2K, BILAG 2004 and PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening(<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity(range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity (range: A[severe] to E [no disease]). PhGA: assesses worsening in participant's general health status (range: 0[none] to 3[severe]). Model percent estimates reported only for 'Reduction in SLEDAI Score','No Worsening in PhGA' categories; for remaining categories, raw percentages reported | Week 24 |
| Number of Participants With Clinically Significant Laboratory Tests Results | Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Laboratory values included Alanine Aminotransferase (ALT) [>5.0 - 10.0*Upper limit of normal range (ULN)], Albumin [<26-20 gram per liter (g/L)/ <20 g/L], Amylase [>2.0 - 5.0*ULN], Aspartate Aminotransferase (AST) [>5.0 - 10.0*ULN], Creatine Kinase (CK) [>5.0 - 10.0* ULN/ >10.0*ULN], Glucose (Hyperglycemia) [>13.9 - 27.8 millimoles/liter (mmol/L)], Hemoglobin (HGB) [<80 - 65 g/L/ <65 g/L], Lipase [>2.0 - 5.0*ULN], Lymphocytes (Lymph.)(Absolute [Abs]) [<0.5 - 0.2*10^3/microliter (UL)/ <0.2*10^3/UL], Platelets [<50-25*10^3/UL/ <25*10^3/UL], potassium (low) [<3.0 - 2.5 mmol/L], Sodium (low) [<130 - 120 mmol/L], Total Neutrophils (TN) (Abs) [<1.0 - 0.5*10^3/UL/ <0.5*10^3/UL], Triglycerides [>5.7 - 11.4 mmol/L], White Blood Cell Count (WBC) [<2.0 - 1.0*10^3/UL/ <1.0*10^3/UL]. | Baseline up to Week 52 |
| Number of Participants Who Discontinued Due to Adverse Events | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants who discontinued due to adverse events were reported. | Baseline up to Week 52 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent AEs or SAEs (excluding infectious AEs or SAEs and injection site reactions) were reported. AEs include both SAEs and non-SAEs. | Baseline up to Week 52 |
| Number of Participants With Treatment-Emergent Infectious Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent infectious AEs or SAEs were reported. AEs include both SAEs and non-SAEs. | Baseline up to Week 52 |
| Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings | Criteria for potentially clinically important (PCI) findings in ECG were defined as: heart rate <=40 beats per minute (bpm) or >=120 bpm; PR interval >=220 millisecond (msec); QT interval >=480 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) >=500msec; no sinus rhythm. | Baseline up to Week 52 |
| Number of Participants With Potentially Clinically Important Vital Signs Findings | Criteria for PCI findings in vital signs were defined as: sitting systolic blood pressure (Increase from baseline >=20 millimeter of mercury (mm Hg) and >=160 mm Hg or a decrease from baseline >=20 mm Hg and <=90 mm Hg) and sitting diastolic blood pressure (increase from baseline >=15 mm Hg and >=90 mm Hg or decrease from baseline >=15 mm Hg and <=60 mm Hg), pulse rate (increase from baseline >=15 beats/min and >=120 beats/min or decrease from baseline >=15 beats/min and <=50 beats /min), body temperature (increase of >=2 degree Fahrenheit (F) and temperature >=101 degree F) and weight (change of >=7% in body weight) | Baseline up to Week 52 |
| Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs) | Human serum samples were analyzed for the presence or absence of anti-PF-04236921 antibodies. A positive ADA sample was further tested for neutralizing antibodies using a validated assay. | Baseline up to Week 52 |
| Serum Concentration of PF-04236921 | Serum PF-04236921 concentrations over time were summarized. | Day 1, Week 2, 4, 6, 8, 12, 16, 20, 24 |
| Percentage of Participants With Corticosteroid Dose Reduced by Both Greater Than or Equal to (>=) 25 Percent (%) From Baseline and Less Than or Equal to (<=) 7.5 Milligrams Per Day (mg/Day) | Participants were given supplemental corticosteroids at baseline to control disease activity, if necessary. The steroid taper was based on participant's symptoms. Participants recorded their steroid usage on a diary card. Least Observation Carried Forward (LOCF) method was used to impute missing data. | Week 12, 16, 20, 24 |
| Percentage of Participants With Normalized Serological Activity | Serologic activity was to be assessed in the subgroup of participants who had positive serologic activity at baseline. | Baseline up to Week 24 |
| Patient Global Visual Analog Scale (VAS) Scores at Baseline | Participants assessed their disease activity using a 100 millimeter (mm) VAS. Participants answered the following question "Considering all the ways your disease affects you, how are you feeling today?" Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad). | Baseline |
| Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24 | Participants assessed their disease activity using a 100 mm VAS. Participants answered the following question "Considering all the ways your disease affects you, how are you feeling today?" Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad). | Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24 |
| Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24 | EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point VAS (0= worst imaginable health state, 100= best imaginable health state). | Baseline, Week 4, 8, 12, 16, 20, 24 |
| Thirty Six-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Baseline | SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and mental component score MCS. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values. | Baseline |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values. | Baseline, Week 4, 8, 12, 16, 20, 24 |
| Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Vitality sub-score is a component of SF-36 Health Survey Questionnaire and assesses energy and fatigue. The vitality score ranged from 0-100 (100=highest level of functioning). LOCF method was used to impute missing values. | Baseline, Week 4, 8, 12, 16, 20, 24 |
| Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24 | The SF-6D focuses on seven of the eight health domains covered by the SF-36 Health Survey: physical functioning, role participation (combined role-physical and role-emotional), social functioning, bodily pain, mental health, and vitality. The SF-6D is an attempt to derive a single index from the SF-36 Health Survey for use in economic evaluation studies. As such, it represents a summary score based on a subset of the SF-36 data. Consequently, in lieu of the SF-6D, PCS and MCS SF-36 results are being provided. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values. | Baseline, Week 4, 8, 12, 16, 20, 24 |
| Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's 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). | Baseline |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24 | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's 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). LOCF method was used to impute missing values. | Baseline, Week 4, 8, 12, 16, 20, 24 |
| Anniston |
| Alabama |
| 36207 |
| United States |
| Achieve Clinical Research, LLC | Birmingham | Alabama | 35216 | United States |
| Med Investigations, Inc. | Fair Oaks | California | 95628 | United States |
| Premier Clinical Research, LLC | Lakewood | California | 90712 | United States |
| Novo Research | Long Beach | California | 90813 | United States |
| St Mary Medical Center | Long Beach | California | 90813 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Wallace Rheumatic Study Center | Los Angeles | California | 90048 | United States |
| UCLA Division of Rheumatology | Los Angeles | California | 90095-1670 | United States |
| UCLA Rheumatology Clinical Research Center | Los Angeles | California | 90095-1670 | United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095-6984 | United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Inland Rheumatology and Osteoporosis Medical Group | Upland | California | 91786 | United States |
| Inland Rheumatology Clinical Trials, Inc. | Upland | California | 91786 | United States |
| Asthma, Allergy, Arthritis and Lung Center | Daytona Beach | Florida | 32114 | United States |
| Southeastern Arthritis Center | Gainesville | Florida | 32607 | United States |
| Southeastern Community Pharmacy | Gainesville | Florida | 32607 | United States |
| Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute | Gainesville | Florida | 32607 | United States |
| Southeastern lmaging & Diagnostics | Gainesville | Florida | 32607 | United States |
| New Horizon Research Center | Miami | Florida | 33175 | United States |
| Arthritis Associates | Orlando | Florida | 32804 | United States |
| Millennium Research | Ormond Beach | Florida | 32174 | United States |
| The Arthritis Center | Palm Harbor | Florida | 34684 | United States |
| Advent Clinical Research Centers, Inc. | Pinellas Park | Florida | 33781 | United States |
| Burnette & Silverfield, MDS PLC | Tampa | Florida | 33614 | United States |
| Emory University | Atlanta | Georgia | 30303 | United States |
| Grady Health Systems | Atlanta | Georgia | 30303 | United States |
| Idaho Arthritis Center | Meridian | Idaho | 83642 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Beacon Medical Group Rheumatology | Granger | Indiana | 46530 | United States |
| Indiana CTSI Clinical Research Center | Indianapolis | Indiana | 46202 | United States |
| Investigational Drug Services | Indianapolis | Indiana | 46202 | United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | United States |
| Johns Hopkins Outpatient Center | Baltimore | Maryland | 21287 | United States |
| Johns Hopkins Outpatient Express Testing Center | Baltimore | Maryland | 21287 | United States |
| Tufts Medical Center/ Center for Arthritis and Rheumatic Diseases | Boston | Massachusetts | 02111 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109-5008 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109-5422 | United States |
| University of Michigan Health System, | Ann Arbor | Michigan | 48109-5872 | United States |
| Henry Ford Health System (Henry Ford Medical Center) | Detroit | Michigan | 48201-3450 | United States |
| Shores Rheumatology P.C | Saint Clair Shores | Michigan | 48081 | United States |
| University of Nevada School of Medicine | Las Vegas | Nevada | 89102 | United States |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | United States |
| Arthritis and Osteoporosis Medical Associates, PLLC | Brooklyn | New York | 11201 | United States |
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | United States |
| NYU Center for Musculoskeletal Care | New York | New York | 10016 | United States |
| Allergy/Immunology and Rheumatology | Rochester | New York | 14623 | United States |
| The University of North Carolina Clinical and Translational Research Center | Chapel Hill | North Carolina | 27514 | United States |
| The University of North Carolina Hospitals Investigational Drug Services | Chapel Hill | North Carolina | 27514 | United States |
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Joint and Muscle Medical Care | Charlotte | North Carolina | 28204 | United States |
| Box Arthritis & Rheumatology of the Carolinas, PLLC | Charlotte | North Carolina | 28210 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Paramount Medical Research and Consulting, LLC | Middleburg Heights | Ohio | 44130 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| Clinical Research Center of Reading, LLP | Wyomissing | Pennsylvania | 19610 | United States |
| Low Country Rheumatology, PA/Low Country Research | Charleston | South Carolina | 29406 | United States |
| Arthritis Clinic | Jackson | Tennessee | 38305 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390-8577 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Rheumatic Disease Clinical Research Center, LLC | Houston | Texas | 77004 | United States |
| Accurate Clinical Research, Inc. | Houston | Texas | 77034 | United States |
| Southwest Rheumatology Research, LLC | Mesquite | Texas | 75150 | United States |
| The Seattle Arthritis Clinic | Seattle | Washington | 98133 | United States |
| Tacoma Center for Arthritis Research, PS | Tacoma | Washington | 98405 | United States |
| Mountain State Clinical Research | Clarksburg | West Virginia | 26301 | United States |
| Framingham Centro Medico | La Plata | Buenos Aires | B1902COS | Argentina |
| Instituto CAICI S.R.L. | Rosario | Santa Fe Province | S2000PBJ | Argentina |
| Centro Medico Privado de Reumatologia | San Miguel de Tucumán | Tucumán Province | T4000AXL | Argentina |
| Centro de Educación Medica e Investigaciones Clinicas "Norberto Quirno" CEMIC | C.a.b.a | C1431FWO | Argentina |
| Centro Polivalente de Asistencia e Investigación ClÃnica - CER- San Juan | San Juan | J5402DIL | Argentina |
| Centro de Estudios Reumatologicos | Santiago | RM | 7501126 | Chile |
| Centro Medico Prosalud | Santiago | RM | Chile |
| Sociedad Medica del Aparato Locomotor S.A. (SOMEAL) | Santiago | Santiago Metropolitan | 7510186 | Chile |
| Centro Integral de Reumatologia REUMALAB S.A.S. | Envigado | Antioquia | Colombia |
| Hospital Pablo Tobon Uribe | MedellÃn | Antioquia | 0 | Colombia |
| Mix Supplier S.A. | Envigado | Antioquia, Colombia | Colombia |
| Centro Integral de ReumatologÃa del Caribe CIRCARIBE SAS | Barranquilla | Atlántico | Colombia |
| Congregacion de Hermanas Franciscanas Misioneras de Maria Auxiliadora- Clinica Asunción | Barranquilla | Atlántico | Colombia |
| Organizacion Clinica General del Norte S.A. | Barranquilla | Atlántico | Colombia |
| Farmamix Ltda. | Bogota, Distrito Capital | Cundimarca | Colombia |
| Centro Integral de Reumatologia e Inmunologia S.A.S.- CIREI S.A.S. | Bogota | Cundinamarca | Colombia |
| Riesgo De Fractura S.A | Bogota | Cundinamarca | Colombia |
| Servimed E.U | Bucaramanga | Santander Department | Colombia |
| Farmamix Ltda. | Bogotá | Colombia |
| Charité - Universitaetsmedizin Berlin | Berlin | 10117 | Germany |
| Charité University Medicine Berlin. Schlosspark-Klinik | Berlin | 14059 | Germany |
| Universitaetsklinikum Koeln | Cologne | 50937 | Germany |
| Universitaetsklinikum Erlangen | Erlangen | 91054 | Germany |
| CIRI am Klinikum der Goethe-Universitaet | Frankfurt am Main | 60528 | Germany |
| Universitaetsklinikum Leipzig AoeR, Department fuer Innere Medizin | Leipzig | 04103 | Germany |
| Qualiclinic Kft. | Budapest | 1036 | Hungary |
| Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum | Debrecen | H-4032 | Hungary |
| Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz Infektologia, Hepatologia es Immunologia | Gyula | 5700 | Hungary |
| Spitalul Clinic Republican | Chisinau | Md-2025 | 2025 | Moldova |
| Centro de Investigacion REUMED, Clinica Anglo Americana | San Isidro | Lima region | Lima 27 | Peru |
| Investigaciones ClÃnicas SAC | Santiago de Surco | Lima region | Lima 33 | Peru |
| Investigaciones Clinicas SAC | Surco | Lima region | Lima 33 | Peru |
| Unidad de Investigación en Medicina Interna y Enfermedades CrÃticas | Arequipa | AQ 54 | Peru |
| NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek.med. Barbara Bazela | Elblag | 82-300 | Poland |
| Medyczne Centrum Hetmanska - Indywidualna Specjalistyczna Praktyka Lekarska - | Poznan | 60-218 | Poland |
| Prywatna Praktyka Lekarska Prof. UM Dr hab. med. Pawel Hrycaj | Poznan | 61-397 | Poland |
| Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych | Warsaw | 02-507 | Poland |
| University of Puerto Rico | Rio Piedras | 00935 | Puerto Rico |
| Division of Rheumatology, Allergy and Immunology | San Juan | 00935 | Puerto Rico |
| Spitalul Clinic Sf. Maria | Bucharest | 11172 | Romania |
| Spitalul Clinic Colentina | Bucharest | 20125 | Romania |
| Spitalul Clinic Jedetean de urgenta Cluj, Reumatologie | Cluj-Napoca | 400006 | Romania |
| Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" | Galati | 800578 | Romania |
| Dong-A University Medical Center 1 | Busan | 602-715 | South Korea |
| National Taiwan University Hospital | Taipei TOC | 100 | Taiwan |
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
| FG002 | PF-04236921 200 mg | Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| FG003 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PF-04236921 10 Milligram (10 mg) | Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| BG001 | PF-04236921 50 mg | Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| BG002 | PF-04236921 200 mg | Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| BG003 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24 | SRI components include:Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K),British Isles Lupus Assessment Group(BILAG) 2004,Physician's Global Assessment(PhGA).Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: greater than or equal to(>=) 4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (less than [<] 0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]). | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants who completed through the Week 24 visit. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20 | SRI components include:SLEDAI-2K ,BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG:assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]). | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Number | Percentage of participants | Week 4, 8, 12, 16, 20 |
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| Secondary | Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24 | SRI components include: modified SLEDAI-2K (SLEDAI-2K without standard parameters "Low complement" and "Leukopenia"), BILAG 2004, PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening (<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. Modified SLEDAI-2K: assesses improvement in disease activity (range: 0 to 102; higher score = higher severity). BILAG: assesses disease extent, severity (range: A [severe] to E [no disease]). PhGA: assesses worsening in participant's general health status (range: 0[none] to 3[severe]). | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Number | Percentage of participants | Week 4, 8, 12, 16, 20, 24 |
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| Secondary | Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24 | BICLA include: BILAG-2004, SLEDAI-2K, PhGA of disease activity. Participants classified as responder if they did not meet the definition of treatment failure and met all the following criteria: BILAG-2004 improvement (all A scores at baseline improved to B/C/D and all B scores improved to C or D); no worsening in disease activity (no new BILAG-2004 A scores or =<1 new B score); no worsening of total SLEDAI-2K score; no significant deterioration (<10 percent [%] worsening) in analogue PhGA. Treatment failure: any new/increased use of corticosteroids,immunosuppressants/antimalarial, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. BILAG:assesses disease extent, severity (range: A[severe] to E[no disease]). SLEDAI-2K:assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). PhGA: assesses worsening in participant's general health status(range: 0[none] to 3[severe]). | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Number | Percentage of participants | Week 4, 8, 12, 16, 20, 24 |
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| Secondary | Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24 | SRI components include: SLEDAI-2K, BILAG 2004 and PhGA. Participants classified as responder if they did not meet definition of treatment failure and met all the following criteria: >=4 point reduction in SLEDAI-2K score; no new BILAG A organ domain score or 2 new BILAG B organ domain scores; no worsening(<0.3 point increase) in PhGA score. Treatment failure: any new/increased use of corticosteroids, immunosuppressants/antimalarial drug, any death, hospitalization/treatment discontinuation due to SLE, any flare of lupus interfering with participation in study. SLEDAI-2K: assesses improvement in disease activity(range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity (range: A[severe] to E [no disease]). PhGA: assesses worsening in participant's general health status (range: 0[none] to 3[severe]). Model percent estimates reported only for 'Reduction in SLEDAI Score','No Worsening in PhGA' categories; for remaining categories, raw percentages reported | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants who completed through the Week 24 visit. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Number | Percentage of participants | Week 24 |
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| Secondary | Number of Participants With Clinically Significant Laboratory Tests Results | Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. Laboratory values included Alanine Aminotransferase (ALT) [>5.0 - 10.0*Upper limit of normal range (ULN)], Albumin [<26-20 gram per liter (g/L)/ <20 g/L], Amylase [>2.0 - 5.0*ULN], Aspartate Aminotransferase (AST) [>5.0 - 10.0*ULN], Creatine Kinase (CK) [>5.0 - 10.0* ULN/ >10.0*ULN], Glucose (Hyperglycemia) [>13.9 - 27.8 millimoles/liter (mmol/L)], Hemoglobin (HGB) [<80 - 65 g/L/ <65 g/L], Lipase [>2.0 - 5.0*ULN], Lymphocytes (Lymph.)(Absolute [Abs]) [<0.5 - 0.2*10^3/microliter (UL)/ <0.2*10^3/UL], Platelets [<50-25*10^3/UL/ <25*10^3/UL], potassium (low) [<3.0 - 2.5 mmol/L], Sodium (low) [<130 - 120 mmol/L], Total Neutrophils (TN) (Abs) [<1.0 - 0.5*10^3/UL/ <0.5*10^3/UL], Triglycerides [>5.7 - 11.4 mmol/L], White Blood Cell Count (WBC) [<2.0 - 1.0*10^3/UL/ <1.0*10^3/UL]. | Safety population defined as all participants who had at least one dose of investigational product. Here, "number analyzed" signifies those participants who were evaluable at specified time points. | Posted | Number | Participants | Baseline up to Week 52 |
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| Secondary | Number of Participants Who Discontinued Due to Adverse Events | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants who discontinued due to adverse events were reported. | Safety population defined as all participants who had at least one dose of investigational product. | Posted | Number | Participants | Baseline up to Week 52 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent AEs or SAEs (excluding infectious AEs or SAEs and injection site reactions) were reported. AEs include both SAEs and non-SAEs. | Safety population defined as all participants who had at least one dose of investigational product. | Posted | Number | Participants | Baseline up to Week 52 |
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| Secondary | Number of Participants With Treatment-Emergent Infectious Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 52 that were absent before treatment or that worsened relative to pretreatment state. Number of participants with treatment-emergent infectious AEs or SAEs were reported. AEs include both SAEs and non-SAEs. | Safety population defined as all participants who had at least one dose of investigational product. | Posted | Number | Participants | Baseline up to Week 52 |
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| Secondary | Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings | Criteria for potentially clinically important (PCI) findings in ECG were defined as: heart rate <=40 beats per minute (bpm) or >=120 bpm; PR interval >=220 millisecond (msec); QT interval >=480 msec; QRS interval >=120 msec; QT interval corrected using the Fridericia formula (QTcF) >=500msec; no sinus rhythm. | Safety population defined as all participants who had at least one dose of investigational product. Here, N (Number of participants analyzed) signifies participants evaluable for this outcome measure for each group respectively. | Posted | Number | Participants | Baseline up to Week 52 |
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| Secondary | Number of Participants With Potentially Clinically Important Vital Signs Findings | Criteria for PCI findings in vital signs were defined as: sitting systolic blood pressure (Increase from baseline >=20 millimeter of mercury (mm Hg) and >=160 mm Hg or a decrease from baseline >=20 mm Hg and <=90 mm Hg) and sitting diastolic blood pressure (increase from baseline >=15 mm Hg and >=90 mm Hg or decrease from baseline >=15 mm Hg and <=60 mm Hg), pulse rate (increase from baseline >=15 beats/min and >=120 beats/min or decrease from baseline >=15 beats/min and <=50 beats /min), body temperature (increase of >=2 degree Fahrenheit (F) and temperature >=101 degree F) and weight (change of >=7% in body weight) | Safety population defined as all participants who had at least one dose of investigational product. | Posted | Number | Participants | Baseline up to Week 52 |
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| Secondary | Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs) | Human serum samples were analyzed for the presence or absence of anti-PF-04236921 antibodies. A positive ADA sample was further tested for neutralizing antibodies using a validated assay. | Safety population defined as all participants who had at least one dose of investigational product. | Posted | Number | Participants | Baseline up to Week 52 |
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| Secondary | Serum Concentration of PF-04236921 | Serum PF-04236921 concentrations over time were summarized. | Pharmacokinetic analysis set was the subset of participants from safety analysis set (all participants who received at least 1 dose of investigational product) who provided at least 1 pharmacokinetic concentration. Here, "number analyzed" signifies those participants who were evaluable at specified time points. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Day 1, Week 2, 4, 6, 8, 12, 16, 20, 24 |
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| Secondary | Percentage of Participants With Corticosteroid Dose Reduced by Both Greater Than or Equal to (>=) 25 Percent (%) From Baseline and Less Than or Equal to (<=) 7.5 Milligrams Per Day (mg/Day) | Participants were given supplemental corticosteroids at baseline to control disease activity, if necessary. The steroid taper was based on participant's symptoms. Participants recorded their steroid usage on a diary card. Least Observation Carried Forward (LOCF) method was used to impute missing data. | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants evaluable for this outcome measure at specified timepoints. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Number | Percentage of Participants | Week 12, 16, 20, 24 |
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| Secondary | Percentage of Participants With Normalized Serological Activity | Serologic activity was to be assessed in the subgroup of participants who had positive serologic activity at baseline. | Consistent with the protocol which pre-specified that if the number of participants with abnormal serological activity at baseline were <25% of overall population, data for this outcome measure was not available. | Posted | Baseline up to Week 24 |
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| Secondary | Patient Global Visual Analog Scale (VAS) Scores at Baseline | Participants assessed their disease activity using a 100 millimeter (mm) VAS. Participants answered the following question "Considering all the ways your disease affects you, how are you feeling today?" Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad). | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Mean | Standard Error | mm | Baseline |
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| Secondary | Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24 | Participants assessed their disease activity using a 100 mm VAS. Participants answered the following question "Considering all the ways your disease affects you, how are you feeling today?" Response was recorded by placing a mark on the scale between 0 (very well) and 100 (extremely bad). | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Least Squares Mean | 95% Confidence Interval | mm | Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24 |
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| Secondary | Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24 | EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point VAS (0= worst imaginable health state, 100= best imaginable health state). | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 4, 8, 12, 16, 20, 24 |
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| Secondary | Thirty Six-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Baseline | SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and mental component score MCS. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values. | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Number of participants analyzed= participants evaluable for this outcome measure at specified timepoint. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Mean | Standard Error | Units on a scale | Baseline |
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| Secondary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values. | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 4, 8, 12, 16, 20, 24 |
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| Secondary | Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. Vitality sub-score is a component of SF-36 Health Survey Questionnaire and assesses energy and fatigue. The vitality score ranged from 0-100 (100=highest level of functioning). LOCF method was used to impute missing values. | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 4, 8, 12, 16, 20, 24 |
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| Secondary | Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24 | The SF-6D focuses on seven of the eight health domains covered by the SF-36 Health Survey: physical functioning, role participation (combined role-physical and role-emotional), social functioning, bodily pain, mental health, and vitality. The SF-6D is an attempt to derive a single index from the SF-36 Health Survey for use in economic evaluation studies. As such, it represents a summary score based on a subset of the SF-36 data. Consequently, in lieu of the SF-6D, PCS and MCS SF-36 results are being provided. The score for each aspect and PCS/MCS is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). LOCF method was used to impute missing values. | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 4, 8, 12, 16, 20, 24 |
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| Secondary | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's 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). | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Mean | Standard Deviation | Units on a scale | Baseline |
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| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24 | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's 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). LOCF method was used to impute missing values. | Full Analysis Set= all randomized participants who received at least 1 dose of study drug. Here, "number analyzed" signifies those participants who were evaluable at specified time points. As per sponsor's decision, dosing in "PF-04236921 200 mg" arm was prematurely terminated and hence it was not included in efficacy analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline, Week 4, 8, 12, 16, 20, 24 |
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Not provided
An AE may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. SAEs consist of all the SAEs including infectious SAEs; non-SAEs consist of all the non-SAEs including infectious non-SAEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-04236921 10 Milligram (10 mg) | Participants received 10 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. | 4 | 45 | 20 | 45 | ||
| EG001 | PF-04236921 50 mg | Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. | 3 | 47 | 24 | 47 | ||
| EG002 | PF-04236921 200 mg | Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. | 7 | 46 | 32 | 46 | ||
| EG003 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. | 8 | 45 | 26 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Cardio | Cardiac disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Ovarian haemorrhage | Reproductive system and breast disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Umbilical hernia, obstructive | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Vasculitis cerebral | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Arthroscopy | Investigations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.1 | Non-systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA v16.1 | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Disseminated tuberculosis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Latent tuberculosis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pyelonephritis chronic | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v16.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000620303 | PF-04236921 |
Not provided
Not provided
Not provided
| Male |
|
Point estimates of the ORs as well as their confidence intervals were calculated from the generalized linear mix model that included fixed factors of the stratification factors, treatment, visit and treatment by visit. |
| Mixed Models Analysis |
| 0.528 |
P-value was displayed without adjusting for multiplicity. |
| Odds Ratio (OR) |
| 0.96 |
| 2-Sided |
| 90 |
| 0.38 |
| 2.41 |
| Superiority |
| PF-04236921 50 mg |
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| OG002 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
|
| OG001 | PF-04236921 50 mg | Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| OG002 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
|
| OG001 | PF-04236921 50 mg | Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| OG002 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
|
| OG001 | PF-04236921 50 mg | Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| OG002 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
|
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| OG002 | PF-04236921 200 mg | Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| OG003 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
| OG003 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
| OG002 |
| PF-04236921 200 mg |
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| OG003 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
| PF-04236921 200 mg |
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| OG003 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
| OG003 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
Participants received 200 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
| OG003 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
| Counts |
|---|
| Participants |
|
|
|
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
|
|
|
| Placebo |
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
|
| OG002 |
| Placebo |
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
| OG002 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
|
| Placebo |
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
|
Participants received 50 mg dose of PF-04236921 subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16.
| OG002 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
|
Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
| OG002 | Placebo | Placebo matching to PF-04236921 administered subcutaneously in the anterolateral right and left thighs at Week 0, Week 8 and Week 16. |
|
|
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