A Study to Evaluate the Efficacy and Safety of PF-0648060... | NCT04090411 | Trialant
NCT04090411
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Dec 16, 2025Actual
Enrollment
246Actual
Phase
Phase 2
Conditions
Moderate to Severe Ulcerative Colitis
Interventions
Induction- PF-06480605 50 mg SC Q4W
Induction- PF-06480605 150 mg SC Q4W
Induction- PF-06480605 450 mg SC Q4W
Induction- Placebo SC Q4W
Chronic- PF-06480605 50 mg SC Q4W
Chronic- PF-06480605 150 mg SC Q4W
Chronic- PF-06480605 450 mg SC Q4W
Countries
United States
Australia
Belgium
Bulgaria
Colombia
France
Germany
Hungary
India
Italy
Japan
Mexico
Poland
Romania
Russia
Serbia
Slovakia
South Africa
Spain
Thailand
Turkey (Türkiye)
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04090411
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
XA45397
Secondary IDs
ID
Type
Description
Link
TL1A
Other Identifier
Alias Study Number
Tuscany 2
Other Identifier
Alias Study Number
2019-002698-74
EudraCT Number
B7541007
Other Identifier
Previous Study ID
Brief Title
A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis
Official Title
A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate The Efficacy, Safety, and Pharmacokinetics of PF-06480605 in Adult Participants With Moderate To Severe Ulcerative Colitis
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 19, 2019Actual
Primary Completion Date
Oct 25, 2022Actual
Completion Date
Oct 25, 2022Actual
First Submitted Date
Sep 12, 2019
First Submission Date that Met QC Criteria
Sep 12, 2019
First Posted Date
Sep 16, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Oct 22, 2025
Results First Submitted that Met QC Criteria
Nov 27, 2025
Results First Posted Date
Dec 16, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 23, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Dec 16, 2025Actual
Last Update Submitted Date
Nov 27, 2025
Last Update Posted Date
Dec 16, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Name
Class
Pfizer
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.
Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
At Week 14
Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
Induction Period: Number of Participants With Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
Secondary Outcomes
Measure
Description
Time Frame
Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1)
Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
A diagnosis of UC for >=3 months.
Participants with moderate to severe active UC as defined by a Total Mayo Score of >=6, and an endoscopic subscore of >=2.
Active disease beyond the rectum (>15 cm of active disease from the anal verge at the screening endoscopy).
Must have failed or been intolerant to at least one of the following class of medications: steroids, immunosuppressants, anti-TNFs, anti-integrin inhibitors, anti- IL-12/23 inhibitors, or JAK inhibitors.
Exclusion Criteria:
Participants with a diagnosis of ischemic colitis, infectious colitis, radiation colitis, microscopic colitis, indeterminate colitis, or findings suggestive of Crohn's disease (eg, skip lesions, fistulae/perianal disease, non-necrotizing granulomas, etc.).
Participants with an imminent need for surgery or with elective surgery scheduled to occur during the study
Chest Radiograph showing abnormalities: The study will accept a Chest x-ray or computed tomography scan of the chest examination performed up to 12 weeks prior to screening if available.
12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
Infected with tuberculosis, (TB): Any evidence of untreated latent or active TB infection.
Infected with human immunodeficiency virus, (HIV), Hepatitis B or C viruses
Danese S, Allegretti JR, Schreiber S, Peyrin-Biroulet L, Jairath V, D'Haens G, Kierkus J, Leong RW, Yarur AJ, Vincent MS, Banerjee A, Chandra DE, Peeva E, Neelakantan S, Hung KE, McBride JM, Bojic D, Lasch K, Schiffman C, Feagan BG. Anti-TL1A antibody, afimkibart, in moderately-to-severely active ulcerative colitis (TUSCANY-2): a multicentre, double-blind, treat-through, multi-dose, randomised, placebo-controlled, phase 2b trial. Lancet Gastroenterol Hepatol. 2025 Oct;10(10):882-895. doi: 10.1016/S2468-1253(25)00129-3. Epub 2025 Jul 21.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Participants were randomized in 2:2:2:2:2:3:1:1:1 to 1 of 9 treatment sequences to receive PF-06480605 50 milligrams (mg), 150 mg, 450 mg or a matched placebo during the induction and chronic therapy periods. One participant in the PF-06480605 450 mg arm was enrolled but did not receive any treatment.
Recruitment Details
A total of 246 participants with moderate to severe ulcerative colitis (UC) took part in the study at 114 investigative sites across 23 countries from 19 December 2019 to 25 October 2022. The study consisted of a 12-week induction period and a 40-week chronic therapy period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Induction Period: Placebo
Participants received PF-06480605 matching placebo, as a subcutaneous (SC) injection, every 4 weeks (Q4W) up to Week 12.
From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
Chronic Period: Number of Participants With TEAEs
TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
Chronic Period: Number of Participants With SAEs
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
Induction Period: At Week 14; Chronic Period: At Week 56
Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2)
Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 (1 or 2 more stools than normal), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
Induction Period: At Week 14; Chronic Period: At Week 56
Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement
Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease [erythema, decreased vascular pattern, mild friability]) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number.
Induction Period: At Week 14; Chrnoic Period: At Week 56
Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission
Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number.
Induction Period: At Week 14; Chronic Period: At Week 56
Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605
Induction Period: 30 mins postdose on Day 1, Weeks 4, 8, 12 and 14; Chronic Period: 30 mins postdose on Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48; End of Treatment (EOT) (Week 52) and Follow-up (FU) Visits 1 (Week 56), 2 (Week 60) and 3 (Week 64)
Induction Period: Change From Baseline in Fecal Calprotectin
Baseline, Weeks 4, 8, and 12
Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
Baseline, Weeks 4, 8, and 12
Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A)
Baseline, Weeks 4, 8, and 12
Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605
Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was < 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was < 5.
Baseline, Weeks 4, 8, 12, 14
Chronic Period: Percentage of Participants Who Achieved Clinical Remission
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
At Week 56
Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
At Weeks 14 and 56
Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1)
Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
At Weeks 14 and 56
Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2)
Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 = 1 or 2 more stools than normal, and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
At Weeks 14 and 56
Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement
Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease [erythema, decreased vascular pattern, mild friability]) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic improvement were defined as those who achieved improvement at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
At Weeks 14 and 56
Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission
Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic remission were defined as those who achieved endoscopic remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
At Weeks 14 and 56
Chronic Period: Change From Week 16 in Fecal Calprotectin
Chronic Period: Number of Participants With ADA and NAbs to PF-06480605
Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was < 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was < 5.
King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University
Pathum Wan
Bangkok
10330
Thailand
Songklanagarind Hospital, Prince of Songkla University
Hat Yai
Changwat Songkhla
90110
Thailand
Phramongkutklao Hospital
Bangkok
10400
Thailand
Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi
Istanbul
34093
Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul
34093
Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi, Ic Hastaliklari Anabilim Dali
Kocaeli
41380
Turkey (Türkiye)
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin
33110
Turkey (Türkiye)
Bulent Ecevit Universitesi Tip Fakultesi
Zonguldak
67600
Turkey (Türkiye)
Municipal non-profit enterprise of Kharkiv regional council "Regional clinical hospital"
Kharkiv
61024
Ukraine
Municipal non-profit enterprise "City clinical hospital #2 named after O.O.Shalimov"
Kharkiv
61037
Ukraine
Medical Centre Medical Clinic Blagomed LLC
Kyiv
01023
Ukraine
Municipal Non-profit Enterprise "Kyiv City Clinical Hospital #1"
Kyiv
02091
Ukraine
Municipal Non-profit enterprise of Kyiv Regional Council "Kyiv regional hospital"
Kyiv
04078
Ukraine
Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"
Kyiv
04107
Ukraine
Medical center of Limited Liability Company "Health Clinic", medical clinical research center
Vinnytsia
21009
Ukraine
Medical Centre "DIACENTER" LLC
Zaporizhzhia
69076
Ukraine
Endoscopy Facility - Spire Little Aston Hospital
Sutton Coldfield
Birmingham
B74 3UP
United Kingdom
MeDiNova North London Quality Research Site
Northwood
Middlesex
HA6 2RN
United Kingdom
MeDiNova Northamptonshire Quality Research Site
Corby
NN18 9EZ
United Kingdom
Egin Research Ltd
High Wycombe
HP11 2QW
United Kingdom
Chest X-ray Facility - BMI Bishops Wood Hospital
Northwood
HA6 2JW
United Kingdom
Spire Nottingham Hospital
Nottingham
NG12 4GA
United Kingdom
Endoscopy Facility - Orpington Endoscopy Centre
Orpington
BR5 3TW
United Kingdom
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
FG002
Induction Period: PF-06480605 150 mg
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
FG003
Induction Period: PF-06480605 450 mg
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
FG004
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
FG005
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
FG006
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
FG007
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
FG008
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
FG009
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
FG010
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
FG011
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
FG012
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
FG00045 subjects
FG00147 subjects
FG00262 subjects
FG00392 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG00040 subjects
FG00146 subjects
FG00258 subjects
FG00384 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG0005 subjects
FG0011 subjects
FG0024 subjects
FG0038 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0035 subjects
FG004
Chronic Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00412 subjects
FG00514 subjects
FG00614 subjects
FG00746 subjects
FG00827 subjects
FG00930 subjects
FG01026 subjects
FG01126 subjects
FG01229 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety analysis population included all participants who received at least one dose of investigational product (IP). Participants were analyzed according to the product they received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Induction Period: Placebo
Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.
BG001
Induction Period: PF-06480605 50 mg
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
BG002
Induction Period: PF-06480605 150 mg
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
BG003
Induction Period: PF-06480605 450 mg
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00045
BG00147
BG00262
BG00391
BG004245
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00039.9± 12.90
BG00137.8± 13.91
BG00242.2± 13.02
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00021
BG00119
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Induction Period: Percentage of Participants Who Achieved Clinical Remission at Week 14
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
Evaluable population ITT included all participants randomly assigned to IP and who took at least one dose of IP in induction period. Participants were analyzed according to the product they received. Overall number analyzed is the number of participants with data available for analysis.
Posted
Number
90% Confidence Interval
percentage of participants
At Week 14
ID
Title
Description
OG000
Induction Period: Placebo
Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.
OG001
Induction Period: PF-06480605 50 mg
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
OG002
Induction Period: PF-06480605 150 mg
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
OG003
Induction Period: PF-06480605 450 mg
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
Units
Counts
Participants
OG00043
OG00147
OG00260
OG003
Title
Denominators
Categories
Title
Measurements
OG00011.6(5.77 to 22.88)
OG00125.5(15.44 to 37.19)
OG00223.3(14.98 to 33.98)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Chan and Zhang Method
0.0545
One-sided P-value
Risk Difference (RD)
13.90
2-Sided
90
-0.20
27.65
Superiority
OG000
OG002
Chan and Zhang Method
Primary
Induction Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
Safety analysis population included all participants who received at least one dose of IP during the induction period. Participants were analyzed according to the product they received.
Posted
Count of Participants
Participants
From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
ID
Title
Description
OG000
Induction Period: Placebo
Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.
OG001
Induction Period: PF-06480605 50 mg
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
Primary
Induction Period: Number of Participants With Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
Safety analysis population included all participants who received at least one dose of IP during the induction period. Participants were analyzed according to the product they received.
Posted
Count of Participants
Participants
From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
ID
Title
Description
OG000
Induction Period: Placebo
Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.
OG001
Induction Period: PF-06480605 50 mg
Primary
Induction Period: Number of Participants With AEs or SAEs Leading to Discontinuation
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
Safety analysis population included all participants who received at least one dose of IP during the induction period. Participants were analyzed according to the product they received.
Posted
Count of Participants
Participants
From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.)
ID
Title
Description
OG000
Induction Period: Placebo
Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.
OG001
Induction Period: PF-06480605 50 mg
Primary
Chronic Period: Number of Participants With TEAEs
TEAEs was defined as all events that started on or after the first dosing day and time, but before the last dose plus the lag time. An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
Evaluable population modified intent-to-treat (mITT) included all participants randomly assigned to IP who took at least one dose of IP in CPT. Participants were analyzed according to the treatment sequence they were randomized.
Posted
Count of Participants
Participants
From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
ID
Title
Description
OG000
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG001
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Primary
Chronic Period: Number of Participants With SAEs
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
Evaluable population mITT included all participants randomly assigned to IP who took at least one dose of IP in CPT. Participants were analyzed according to the treatment sequence they were randomized.
Posted
Count of Participants
Participants
From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
ID
Title
Description
OG000
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG001
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Primary
Chronic Period: Number of Participants With AEs or SAEs Leading to Discontinuation
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; or is a congenital anomaly/birth defect. Participants who had an AE/SAE that led to study discontinuation have been reported here. Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
Evaluable population mITT included all participants randomly assigned to IP who took at least one dose of IP in CPT. Participants were analyzed according to the treatment sequence they were randomized.
Posted
Count of Participants
Participants
From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
ID
Title
Description
OG000
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG001
Secondary
Induction and Chronic: Percentage of Participants Who Achieved Remission as Per Food and Drug Administration (FDA) Definition 1 (Modified Remission 1)
Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
Evaluable ITT and mITT populations included all participants randomly assigned to IP and who took at least one dose of IP in induction and chronic, respectively. Overall number analyzed is the number of participants with data available for analysis.
Posted
Number
90% Confidence Interval
percentage of participants
Induction Period: At Week 14; Chronic Period: At Week 56
ID
Title
Description
OG000
Induction Period: Placebo
Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.
OG001
Induction Period: PF-06480605 50 mg
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
Secondary
Induction and Chronic: Percentage of Participants Who Achieved Remission as Per FDA Definition 2 (Modified Remission 2)
Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 (1 or 2 more stools than normal), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
Evaluable ITT and mITT populations included all participants randomly assigned to IP and who took at least one dose of IP in induction and chronic, respectively. Overall number analyzed is the number of participants with data available for analysis.
Posted
Number
90% Confidence Interval
percentage of participants
Induction Period: At Week 14; Chronic Period: At Week 56
ID
Title
Description
OG000
Induction Period: Placebo
Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.
OG001
Induction Period: PF-06480605 50 mg
Secondary
Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Improvement
Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease [erythema, decreased vascular pattern, mild friability]) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number.
Evaluable ITT and mITT populations included all participants randomly assigned to IP and who took at least one dose of IP in induction and chronic, respectively. Overall number analyzed is the number of participants with data available for analysis.
Posted
Number
90% Confidence Interval
percentage of participants
Induction Period: At Week 14; Chrnoic Period: At Week 56
ID
Title
Description
OG000
Induction Period: Placebo
Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.
OG001
Induction Period: PF-06480605 50 mg
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
Secondary
Induction and Chronic: Percentage of Participants Who Achieved Endoscopic Remission
Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Percentages have been rounded off to the nearest whole number.
Evaluable ITT and mITT populations included all participants randomly assigned to IP and who took at least one dose of IP in induction and chronic, respectively. Overall number analyzed is the number of participants with data available for analysis.
Posted
Number
90% Confidence Interval
percentage of participants
Induction Period: At Week 14; Chronic Period: At Week 56
ID
Title
Description
OG000
Induction Period: Placebo
Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.
OG001
Induction Period: PF-06480605 50 mg
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
OG002
Induction Period: PF-06480605 150 mg
Secondary
Induction and Chronic: Trough Concentration (Ctrough) of PF-06480605
Pharmacokinetic (PK) population included all participants randomly assigned to IP and received at least one dose of PF-06480605 for whom at least one concentration value was reported. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Induction Period: 30 mins postdose on Day 1, Weeks 4, 8, 12 and 14; Chronic Period: 30 mins postdose on Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48; End of Treatment (EOT) (Week 52) and Follow-up (FU) Visits 1 (Week 56), 2 (Week 60) and 3 (Week 64)
ID
Title
Description
OG000
Induction Period: PF-06480605 50 mg
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
OG001
Induction Period: PF-06480605 150 mg
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
OG002
Induction Period: PF-06480605 450 mg
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
Secondary
Induction Period: Change From Baseline in Fecal Calprotectin
Biomarker analysis population included all participants randomly assigned to IP and who took at least one dose of PF-06480605 and in whom at least one measurement of biomarker of interest was reported. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Mean
Standard Deviation
micrograms per gram (µg/g)
Baseline, Weeks 4, 8, and 12
ID
Title
Description
OG000
Induction Period: Placebo
Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.
OG001
Induction Period: PF-06480605 50 mg
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
OG002
Induction Period: PF-06480605 150 mg
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
OG003
Induction Period: PF-06480605 450 mg
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
Secondary
Induction Period: Change From Baseline in High Sensitivity C-reactive Protein (hsCRP)
Biomarker analysis population included all participants randomly assigned to IP and who took at least one dose of PF-06480605 and in whom at least one measurement of biomarker of interest was reported. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Mean
Standard Deviation
milligrams per deciliter (mg/dL)
Baseline, Weeks 4, 8, and 12
ID
Title
Description
OG000
Induction Period: Placebo
Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.
OG001
Induction Period: PF-06480605 50 mg
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
OG002
Induction Period: PF-06480605 150 mg
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
OG003
Induction Period: PF-06480605 450 mg
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
Secondary
Induction Period: Change From Baseline in Serum Soluble TL1A (sTL1A)
Biomarker analysis population included all participants randomly assigned to IP and who took at least one dose of PF-06480605 and in whom at least one measurement of biomarker of interest was reported. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Mean
Standard Deviation
picograms per milliliter (pg/mL)
Baseline, Weeks 4, 8, and 12
ID
Title
Description
OG000
Induction Period: Placebo
Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.
OG001
Induction Period: PF-06480605 50 mg
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
OG002
Induction Period: PF-06480605 150 mg
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
OG003
Induction Period: PF-06480605 450 mg
Secondary
Induction Period: Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) to PF-06480605
Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was < 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was < 5.
Evaluation of NAb is generally relevant only in participants who are positive for ADA. Immunogenicity analysis population included all participants randomly assigned to IP and who took at least one dose of PF-06480605 and in whom at least one post-treatment ADA determination was reported. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Count of Participants
Participants
Baseline, Weeks 4, 8, 12, 14
ID
Title
Description
OG000
Induction Period: PF-06480605 50 mg
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
OG001
Induction Period: PF-06480605 150 mg
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
OG002
Induction Period: PF-06480605 450 mg
Secondary
Chronic Period: Percentage of Participants Who Achieved Clinical Remission
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Percentages have been rounded off to the nearest whole number.
Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis.
Posted
Number
90% Confidence Interval
percentage of participants
At Week 56
ID
Title
Description
OG000
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG001
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Secondary
Chronic Period: Percentage of Participants Who Achieved Sustained Clinical Remission
Clinical remission was defined as total Mayo Score ≤2, with no individual subscore >1. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Participants were assessed at Week 56 if they achieved remission at Week 14. No participants in the Placebo (Induction) to PF-06480605 50 mg (Chronic) met the remission criteria at Week 14. Hence, this arm has been excluded.
Posted
Number
90% Confidence Interval
percentage of participants
At Weeks 14 and 56
ID
Title
Description
OG000
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG001
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Secondary
Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 1 (Modified Remission 1)
Modified remission 1 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), stool frequency subscore = 0 (normal number of stools per day), and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Evaluable mITT population included all participants randomly assigned to IP and who took at least 1 dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Participants were assessed at Week 56 if they achieved remission at Week 14. No participants in Placebo (Induction) to PF-06480605 50 mg (Chronic) and Placebo (Induction) to PF-06480605 150 mg (Chronic) met remission criteria at Week 14. Hence, these arms have been excluded.
Posted
Number
90% Confidence Interval
percentage of participants
At Weeks 14 and 56
ID
Title
Description
OG000
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Secondary
Chronic Period: Percentage of Participants Who Achieved Sustained Remission as Per FDA Definition 2 (Modified Remission 2)
Modified remission 2 was defined as an endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease), ≥1 point decrease from baseline to achieve a stool frequency subscore = 0 (normal number of stools per day) or 1 = 1 or 2 more stools than normal, and rectal bleeding subscore = 0 (no blood seen) at Week 14/Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease activity. Participants with sustained clinical remission were defined as those who achieved clinical remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Participants were assessed at Week 56 if they achieved remission at Week 14.
Posted
Number
90% Confidence Interval
percentage of participants
At Weeks 14 and 56
ID
Title
Description
OG000
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Secondary
Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Improvement
Endoscopic improvement was defined as an endoscopic subscore of 0 (Normal or inactive disease) or 1 (Mild disease [erythema, decreased vascular pattern, mild friability]) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic improvement were defined as those who achieved improvement at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Participants were assessed at Week 56 if they achieved improvement at Week 14.
Posted
Number
90% Confidence Interval
percentage of participants
At Weeks 14 and 56
ID
Title
Description
OG000
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG001
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Secondary
Chronic Period: Percentage of Participants Who Achieved Sustained Endoscopic Remission
Endoscopic remission was defined as an endoscopic subscore of 0 (Normal or inactive disease) at both Week 14 and Week 56. Mayo Score was a tool designed to measure disease activity for UC. The score ranges from 0 - 12 and was a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and PGA subscore. Each of the four assessments was rated with a score from 0 to 3. Higher scores indicate more severe disease activity. Participants with sustained endoscopic remission were defined as those who achieved endoscopic remission at both Weeks 14 and 56. Percentages have been rounded off to the nearest whole number.
Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Participants were assessed at Week 56 if they achieved remission at Week 14. No participants in Placebo (Induction) to PF-06480605 50 mg (Chronic) met remission criteria at Week 14. Hence, this arm has been excluded.
Posted
Number
90% Confidence Interval
percentage of participants
At Weeks 14 and 56
ID
Title
Description
OG000
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG001
Secondary
Chronic Period: Change From Week 16 in Fecal Calprotectin
Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG001
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG002
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Secondary
Chronic Period: Change From Week 14 in hsCRP
Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG001
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG002
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Secondary
Chronic Period: Change From Week 14 in Serum sTL1A
Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chornic period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point.
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG001
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG002
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Secondary
Change From Baseline in Fecal Calprotectin Through the End of Study
Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. As pre-specified in the statistical analysis plan (SAP), data is presented using the treatment sequence in the chronic period.
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG001
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG002
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Secondary
Change From Baseline in hsCRP Through the End of Study
Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. As pre-specified in the SAP, data is presented using the treatment sequence in the chronic period.
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG001
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG002
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Secondary
Change From Baseline in Serum sTL1A Through the End of Study
Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. As pre-specified in the SAP, data is presented using the treatment sequence in the chronic period.
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG001
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG002
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Secondary
Chronic Period: Number of Participants With ADA and NAbs to PF-06480605
Samples were considered to be positive for ADA against PF-06480605 if the titer was ≥ 60, and an ADA sample was considered to be negative if the titer was < 60. Samples were considered to be positive for NAb against PF-06480605 if the titer was ≥ 5, and an NAb sample was considered to be negative if the titer was < 5.
Evaluation of NAb is generally relevant only in participants who are positive for ADA. Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoints.
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG001
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Time Frame
Induction Period: From initiation of study treatment to either first dose in the chronic period or end of safety follow-up, whichever occurs first. (Approximately 16 weeks plus 12-week safety follow-up, if applicable.) Chronic Period: From first dose of study treatment in the chronic period to end of safety follow-up. (Approximately 40 weeks plus 12-week safety follow-up.)
Description
Safety analysis population included all participants who took at least one dose of IP during the induction period.
Evaluable mITT population included all participants randomly assigned to IP and who took at least one dose of IP in the chronic period.
Induction period: Results may differ from publications that used Week 14 as the end of the AE reporting timeframe.
Chronic period: Results may differ from publications that used Week 56 as the end of the AE reporting timeframe.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Induction Period: Placebo
Participants received PF-06480605 matching placebo, as a SC injection, Q4W up to Week 12.
0
45
4
45
16
45
EG001
Induction Period: PF-06480605 50 mg
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
0
47
3
47
11
47
EG002
Induction Period: PF-06480605 150 mg
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
0
62
1
62
20
62
EG003
Induction Period: PF-06480605 450 mg
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
0
91
4
91
34
91
EG004
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
0
12
0
12
5
12
EG005
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
0
14
0
14
9
14
EG006
Placebo (Induction) to PF-06480605 (Chronic) 450mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
0
14
0
14
9
14
EG007
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
0
46
5
46
24
46
EG008
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
0
27
1
27
15
27
EG009
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
0
30
0
30
12
30
EG010
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
0
26
2
26
14
26
EG011
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
0
26
1
26
15
26
EG012
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
0
29
4
29
14
29
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG0030 events0 affected91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0121 events1 affected29 at risk
Hypereosinophilic syndrome
Blood and lymphatic system disorders
MedDRA version: 25.1
Systematic Assessment
EG0001 events1 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0001 events1 affected45 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected62 at risk
EG003
Duodenal ulcer haemorrhage
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0001 events1 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected62 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Cytomegalovirus infection
Infections and infestations
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA version: 25.1
Systematic Assessment
EG0001 events1 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Abortion spontaneous complete
Pregnancy, puerperium and perinatal conditions
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Haemorrhoid operation
Surgical and medical procedures
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Embolism
Vascular disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Drug ineffective
General disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Neoplasm of appendix
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA version: 25.1
Systematic Assessment
EG0004 events4 affected45 at risk
EG0012 events2 affected47 at risk
EG0025 events5 affected62 at risk
EG0032 events2 affected91 at risk
EG0041 events1 affected12 at risk
EG0052 events2 affected14 at risk
EG0060 events0 affected14 at risk
EG0074 events4 affected46 at risk
EG0081 events1 affected27 at risk
EG0090 events0 affected30 at risk
EG0103 events3 affected26 at risk
EG0113 events3 affected26 at risk
EG0122 events2 affected29 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected62 at risk
EG003
Angular cheilitis
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0012 events2 affected47 at risk
EG0021 events1 affected62 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0012 events2 affected47 at risk
EG0021 events1 affected62 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0001 events1 affected45 at risk
EG0013 events3 affected47 at risk
EG0022 events2 affected62 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0001 events1 affected45 at risk
EG0011 events1 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Fatigue
General disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected62 at risk
EG003
Injection site reaction
General disorders
MedDRA version: 25.1
Systematic Assessment
EG0001 events1 affected45 at risk
EG0012 events1 affected47 at risk
EG0024 events3 affected62 at risk
EG003
Oedema
General disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Pain
General disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Pyrexia
General disorders
MedDRA version: 25.1
Systematic Assessment
EG0001 events1 affected45 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected62 at risk
EG003
COVID-19
Infections and infestations
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected62 at risk
EG003
Chorioretinitis
Infections and infestations
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version: 25.1
Systematic Assessment
EG0002 events2 affected45 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected62 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected62 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0013 events3 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA version: 25.1
Systematic Assessment
EG0002 events2 affected45 at risk
EG0011 events1 affected47 at risk
EG0021 events1 affected62 at risk
EG003
Blood pressure increased
Investigations
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
SARS-CoV-2 antibody test positive
Investigations
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0021 events1 affected62 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0022 events2 affected62 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version: 25.1
Systematic Assessment
EG0001 events1 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0013 events1 affected47 at risk
EG0021 events1 affected62 at risk
EG003
Headache
Nervous system disorders
MedDRA version: 25.1
Systematic Assessment
EG0001 events1 affected45 at risk
EG0012 events2 affected47 at risk
EG0022 events2 affected62 at risk
EG003
Adnexa uteri pain
Reproductive system and breast disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0001 events1 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Hand dermatitis
Skin and subcutaneous tissue disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA version: 25.1
Systematic Assessment
EG0001 events1 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0001 events1 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Peripheral swelling
General disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0022 events2 affected62 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Dermatitis psoriasiform
Skin and subcutaneous tissue disorders
MedDRA version: 25.1
Systematic Assessment
EG0000 events0 affected45 at risk
EG0010 events0 affected47 at risk
EG0020 events0 affected62 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
OG003
Induction Period: PF-06480605 450 mg
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
Units
Counts
Participants
OG00045
OG00147
OG00262
OG00391
Title
Denominators
Categories
Title
Measurements
OG00025
OG00116
OG00229
OG00349
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
OG002
Induction Period: PF-06480605 150 mg
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
OG003
Induction Period: PF-06480605 450 mg
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
Units
Counts
Participants
OG00045
OG00147
OG00262
OG00391
Title
Denominators
Categories
Title
Measurements
OG0004
OG0013
OG0021
OG0034
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
OG002
Induction Period: PF-06480605 150 mg
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
OG003
Induction Period: PF-06480605 450 mg
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
Units
Counts
Participants
OG00045
OG00147
OG00262
OG00391
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG002
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG003
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00012
OG00114
OG00214
OG00346
OG00427
OG00530
OG00626
OG00726
OG00829
Title
Denominators
Categories
Title
Measurements
OG0005
OG0019
OG0029
OG00330
OG00416
OG00515
OG00618
OG00718
OG00820
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG002
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG003
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00012
OG00114
OG00214
OG00346
OG00427
OG00530
OG00626
OG00726
OG00829
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0035
OG0041
OG0050
OG0062
OG0071
OG0084
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG002
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG003
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00012
OG00114
OG00214
OG00346
OG00427
OG00530
OG00626
OG00726
OG00829
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG002
Induction Period: PF-06480605 150 mg
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
OG003
Induction Period: PF-06480605 450 mg
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
OG004
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG009
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG010
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG011
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG012
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00043
OG00147
OG00260
OG00388
OG00412
OG00513
OG00614
OG00742
OG00827
OG00926
OG01025
OG01124
OG01228
Title
Denominators
Categories
Title
Measurements
OG0007.0(2.59 to 16.96)
OG00114.9(8.05 to 25.12)
OG00213.3(6.81 to 21.83)
OG00314.8(9.50 to 21.77)
OG00416.7(4.52 to 39.84)
OG00523.1(8.80 to 46.97)
OG00621.4(8.15 to 46.00)
OG00716.7(9.06 to 27.68)
OG00822.2(10.15 to 38.16)
OG00923.1(10.56 to 39.84)
OG01016.0(7.17 to 30.73)
OG01120.8(10.50 to 36.99)
OG01217.9(8.95 to 33.31)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Chan and Zhang Method
0.1398
One-sided P-value
Risk Difference (RD)
7.92
2-Sided
90
-3.62
20.04
Superiority
OG000
OG002
Chan and Zhang Method
0.2038
One-sided P-value
Risk Difference (RD)
6.36
2-Sided
90
-4.88
17.06
Superiority
OG000
OG003
Chan and Zhang Method
0.1498
One-sided P-value
Risk Difference (RD)
7.80
2-Sided
90
-3.70
17.06
Superiority
Participants received PF-06480605, 50 mg, as a SC injection, Q4W up to Week 12.
OG002
Induction Period: PF-06480605 150 mg
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
OG003
Induction Period: PF-06480605 450 mg
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
OG004
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG009
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG010
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG011
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG012
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00043
OG00147
OG00260
OG00388
OG00412
OG00513
OG00614
OG00742
OG00827
OG00926
OG01025
OG01124
OG01228
Title
Denominators
Categories
Title
Measurements
OG00011.6(5.77 to 22.88)
OG00129.8(19.94 to 42.34)
OG00235.0(25.14 to 45.24)
OG00331.8(23.65 to 40.77)
OG00450.0(27.13 to 72.87)
OG00530.8(14.16 to 54.45)
OG00635.7(16.30 to 59.44)
OG00731.0(19.38 to 43.33)
OG00833.3(20.38 to 50.00)
OG00938.5(23.32 to 56.43)
OG01028.0(15.76 to 45.61)
OG01133.3(17.80 to 52.14)
OG01235.7(20.85 to 52.70)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Chan and Zhang Method
0.0189
One-sided P-value
Risk Difference (RD)
18.16
2-Sided
90
3.25
32.23
Superiority
OG000
OG002
Chan and Zhang Method
0.0045
One-sided P-value
Risk Difference (RD)
23.37
2-Sided
90
6.24
36.28
Superiority
OG000
OG003
Chan and Zhang Method
0.0117
One-sided P-value
Risk Difference (RD)
20.19
2-Sided
90
3.22
31.31
Superiority
OG002
Induction Period: PF-06480605 150 mg
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
OG003
Induction Period: PF-06480605 450 mg
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
OG004
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG009
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG010
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG011
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG012
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00043
OG00147
OG00260
OG00388
OG00412
OG00513
OG00614
OG00742
OG00827
OG00928
OG01025
OG01124
OG01228
Title
Denominators
Categories
Title
Measurements
OG00018.6(9.61 to 30.24)
OG00140.4(28.33 to 53.46)
OG00238.3(27.81 to 48.61)
OG00340.9(32.06 to 50.00)
OG00466.7(39.84 to 84.58)
OG00538.5(17.28 to 62.14)
OG00642.9(22.38 to 64.51)
OG00738.1(25.56 to 51.95)
OG00837.0(22.12 to 54.66)
OG00939.3(23.83 to 56.49)
OG01036.0(21.43 to 54.39)
OG01137.5(22.08 to 55.27)
OG01250.0(33.31 to 66.69)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Chan and Zhang Method
0.0146
One-sided P-value
Risk Difference (RD)
21.82
2-Sided
90
4.14
37.30
Superiority
OG000
OG002
Chan and Zhang Method
0.0167
One-sided P-value
Risk Difference (RD)
19.73
2-Sided
90
2.76
34.05
Superiority
OG000
OG003
Chan and Zhang Method
0.0094
One-sided P-value
Risk Difference (RD)
22.30
2-Sided
90
3.22
34.95
Superiority
Participants received PF-06480605, 150 mg, as a SC injection, Q4W up to Week 12.
OG003
Induction Period: PF-06480605 450 mg
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
OG004
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG009
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG010
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG011
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG012
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00043
OG00147
OG00260
OG00388
OG00412
OG00513
OG00614
OG00742
OG00827
OG00928
OG01025
OG01124
OG01228
Title
Denominators
Categories
Title
Measurements
OG0007.0(2.59 to 16.96)
OG00119.1(11.18 to 30.27)
OG00210.0(4.45 to 18.01)
OG00310.2(5.72 to 16.58)
OG00416.7(4.52 to 39.84)
OG00523.1(8.80 to 46.97)
OG00628.6(13.09 to 54.00)
OG00711.9(5.91 to 22.74)
OG0087.4(1.99 to 20.38)
OG0097.1(1.92 to 20.10)
OG01016.0(7.17 to 30.73)
OG0118.3(2.24 to 22.08)
OG01221.4(9.77 to 36.62)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Chan and Zhang Method
0.0489
One-sided P-value
Risk Difference (RD)
12.17
2-Sided
90
0.05
25.25
Superiority
OG000
OG002
Chan and Zhang Method
0.3396
One-sided P-value
Risk Difference (RD)
3.02
2-Sided
90
-7.66
12.88
Superiority
OG000
OG003
Chan and Zhang Method
0.3995
One-sided P-value
Risk Difference (RD)
3.25
2-Sided
90
-7.42
11.58
Superiority
OG003
Placebo (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG009
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG010
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG011
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00045
OG00159
OG00286
OG00312
OG00414
OG00513
OG00643
OG00726
OG00828
OG00924
OG01026
OG01129
Title
Denominators
Categories
Postdose on Day 1
ParticipantsOG00041
ParticipantsOG00159
ParticipantsOG00286
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
Title
Measurements
OG000NA± NAThe mean and standard deviation (SD) was not estimable as samples were below the limit of quantification (BLQ).
OG0011.227± 6.7722
OG0021.279± 10.209
Postdose on Week 4
ParticipantsOG00045
ParticipantsOG00158
ParticipantsOG00285
ParticipantsOG0030
Postdose on Week 8
ParticipantsOG00045
ParticipantsOG00159
ParticipantsOG00284
ParticipantsOG0030
Postdose on Week 12
ParticipantsOG00045
ParticipantsOG00155
ParticipantsOG00282
ParticipantsOG0030
Postdose on Week 14
ParticipantsOG00033
ParticipantsOG00140
ParticipantsOG00255
ParticipantsOG0030
Postdose on Week 16
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00311
Postdose on Week 20
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00312
Postdose on Week 24
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00312
Postdose on Week 28
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00311
Postdose on Week 32
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00311
Postdose on Week 36
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00311
Postdose on Week 40
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00311
Postdose on Week 44
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00310
Postdose on Week 48
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0039
EOT (Week 52)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00310
FU Visit 1 (Week 56)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0039
FU Visit 2 (Week 60)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0039
FU Visit 3 (Week 64)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0038
Units
Counts
Participants
OG00037
OG00141
OG00255
OG00382
Title
Denominators
Categories
Baseline
ParticipantsOG00037
ParticipantsOG00141
ParticipantsOG00255
ParticipantsOG00382
Title
Measurements
OG00010.62± 2.145
OG0019.99± 2.105
OG00210.78± 2.120
OG003
Change From Baseline at Week 4
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00249
ParticipantsOG00379
Change From Baseline at Week 8
ParticipantsOG00034
ParticipantsOG00140
ParticipantsOG00243
ParticipantsOG00375
Change From Baseline at Week 12
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00244
ParticipantsOG00374
Units
Counts
Participants
OG00040
OG00147
OG00262
OG00391
Title
Denominators
Categories
Baseline
ParticipantsOG00040
ParticipantsOG00147
ParticipantsOG00262
ParticipantsOG00391
Title
Measurements
OG0001.76± 2.135
OG0011.47± 1.990
OG0021.41± 1.799
OG003
Change From Baseline at Week 4
ParticipantsOG00040
ParticipantsOG00146
ParticipantsOG00261
ParticipantsOG00389
Change From Baseline at Week 8
ParticipantsOG00039
ParticipantsOG00147
ParticipantsOG00258
ParticipantsOG00386
Change From Baseline at Week 12
ParticipantsOG00038
ParticipantsOG00143
ParticipantsOG00254
ParticipantsOG00382
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
Units
Counts
Participants
OG00039
OG00142
OG00258
OG00388
Title
Denominators
Categories
Baseline
ParticipantsOG00039
ParticipantsOG00142
ParticipantsOG00258
ParticipantsOG00388
Title
Measurements
OG0006.86± 0.441
OG0016.74± 0.499
OG0026.77± 0.534
OG003
Change From Baseline at Week 4
ParticipantsOG00039
ParticipantsOG00140
ParticipantsOG00256
ParticipantsOG00386
Change From Baseline at Week 8
ParticipantsOG00039
ParticipantsOG00142
ParticipantsOG00255
ParticipantsOG00383
Change From Baseline at Week 12
ParticipantsOG00036
ParticipantsOG00140
ParticipantsOG00253
ParticipantsOG00381
Participants received PF-06480605, 450 mg, as a SC injection, Q4W up to Week 12.
Units
Counts
Participants
OG00045
OG00159
OG00288
Title
Denominators
Categories
ADA at Baseline
ParticipantsOG00041
ParticipantsOG00159
ParticipantsOG00288
Title
Measurements
OG0000
OG0011
OG0022
NAb at Baseline
ParticipantsOG0000
ParticipantsOG0012
ParticipantsOG0022
Title
Measurements
OG001
ADA at Week 4
ParticipantsOG00045
ParticipantsOG00158
ParticipantsOG00286
Title
Measurements
OG000
NAb at Week 4
ParticipantsOG00033
ParticipantsOG00127
ParticipantsOG00235
Title
Measurements
OG000
ADA at Week 8
ParticipantsOG00045
ParticipantsOG00158
ParticipantsOG00284
Title
Measurements
OG000
NAb at Week 8
ParticipantsOG00044
ParticipantsOG00141
ParticipantsOG00241
Title
Measurements
OG000
ADA at Week 12
ParticipantsOG00044
ParticipantsOG00156
ParticipantsOG00282
Title
Measurements
OG000
NAb at Week 12
ParticipantsOG00042
ParticipantsOG00140
ParticipantsOG00246
Title
Measurements
OG000
ADA at Week 14
ParticipantsOG00045
ParticipantsOG00154
ParticipantsOG00283
Title
Measurements
OG000
NAb at Week 14
ParticipantsOG00042
ParticipantsOG00139
ParticipantsOG00238
Title
Measurements
OG000
OG002
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG003
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00012
OG00113
OG00214
OG00342
OG00427
OG00526
OG00625
OG00724
OG00828
Title
Denominators
Categories
Title
Measurements
OG00033.3(15.42 to 60.16)
OG00138.5(17.28 to 62.14)
OG00235.7(16.30 to 59.44)
OG00331.0(19.38 to 43.33)
OG00429.6(15.68 to 45.34)
OG00534.6(20.86 to 52.62)
OG00624.0(11.01 to 41.68)
OG00725.0(11.49 to 42.28)
OG00839.3(23.83 to 56.49)
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG002
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG003
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG0001
OG0014
OG00212
OG0036
OG0048
OG0057
OG0066
OG0077
Title
Denominators
Categories
Title
Measurements
OG0000(0 to 0)
OG00125.0(2.60 to 67.95)
OG00250.0(27.13 to 72.87)
OG00350.0(20.09 to 79.91)
OG00462.5(28.92 to 85.31)
OG00528.6(7.88 to 65.87)
OG00650.0(20.09 to 79.91)
OG00785.7(50.00 to 98.51)
OG001
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG002
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG003
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG0003
OG0017
OG0025
OG0033
OG0044
OG0053
OG0065
Title
Denominators
Categories
Title
Measurements
OG00033.3(3.45 to 80.42)
OG00128.6(7.88 to 65.87)
OG00240.0(11.22 to 75.34)
OG00366.7(19.58 to 96.55)
OG00425.0(2.60 to 67.95)
OG0050(0 to 53.58)
OG00680.0(37.93 to 97.91)
OG001
Placebo (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG002
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG003
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG0001
OG0011
OG0023
OG00314
OG00410
OG00511
OG0069
OG00710
OG0088
Title
Denominators
Categories
Title
Measurements
OG0000(0.00 to 90.00)
OG0010(0.00 to 90.00)
OG00233.3(3.45 to 80.42)
OG00342.9(22.38 to 64.51)
OG00470.0(39.34 to 88.42)
OG00554.5(30.24 to 80.04)
OG00633.3(12.95 to 61.04)
OG00760.0(34.08 to 81.24)
OG00875.0(41.82 to 93.14)
Participants who received placebo and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG002
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG003
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG0002
OG0012
OG0024
OG00319
OG00410
OG00513
OG00613
OG00711
OG00810
Title
Denominators
Categories
Title
Measurements
OG00050.0(5.13 to 94.87)
OG0010(0.00 to 68.38)
OG00225.0(2.60 to 67.95)
OG00347.4(27.39 to 66.28)
OG00480.0(50.00 to 94.55)
OG00561.5(37.86 to 82.72)
OG00646.2(24.55 to 71.30)
OG00763.6(34.98 to 83.08)
OG00880.0(50.00 to 94.55)
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG002
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG003
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG0002
OG0011
OG0029
OG0032
OG0044
OG0053
OG0062
OG0073
Title
Denominators
Categories
Title
Measurements
OG0000(0.00 to 68.38)
OG0010(0.00 to 90.00)
OG00222.2(6.08 to 51.52)
OG00350.0(5.13 to 94.87)
OG00425.0(2.60 to 67.95)
OG00566.7(19.58 to 96.55)
OG00650.0(5.13 to 94.87)
OG00766.7(19.58 to 96.55)
OG003
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00012
OG00111
OG00212
OG00343
OG00423
OG00527
OG00622
OG00724
OG00829
Title
Denominators
Categories
Week 16
ParticipantsOG00012
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00343
ParticipantsOG00423
ParticipantsOG00527
ParticipantsOG00622
ParticipantsOG00724
ParticipantsOG00829
Title
Measurements
OG00010.22± 1.414
OG0019.28± 2.578
OG0029.77± 2.347
OG003
Change From Week 16 at Week 20
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00212
ParticipantsOG00339
Change From Week 16 at Week 24
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00212
ParticipantsOG00341
Change From Week 16 at Week 28
ParticipantsOG00012
ParticipantsOG00111
ParticipantsOG00211
ParticipantsOG00337
Change From Week 16 at Week 32
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG00211
ParticipantsOG00336
Change From Week 16 at Week 36
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00332
Change From Week 16 at Week 40
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00334
Change From Week 16 at Week 44
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG00332
Change From Week 16 at Week 48
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00331
Change From Week 16 at Week 52
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00211
ParticipantsOG00332
Change From Week 16 at Week 60
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG00328
Change From Week 16 at Week 64
ParticipantsOG00010
ParticipantsOG0018
ParticipantsOG0029
ParticipantsOG00327
OG003
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00012
OG00114
OG00214
OG00346
OG00426
OG00530
OG00626
OG00726
OG00829
Title
Denominators
Categories
Week 14
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00346
ParticipantsOG00426
ParticipantsOG00530
ParticipantsOG00626
ParticipantsOG00726
ParticipantsOG00829
Title
Measurements
OG0001.22± 1.667
OG0012.49± 2.149
OG0020.43± 2.484
OG003
Change From Week 14 at Week 16
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00345
Change From Week 14 at Week 20
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00342
Change From Week 14 at Week 24
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00342
Change From Week 14 at Week 28
ParticipantsOG00011
ParticipantsOG00113
ParticipantsOG00212
ParticipantsOG00339
Change From Week 14 at Week 32
ParticipantsOG00011
ParticipantsOG00114
ParticipantsOG00213
ParticipantsOG00340
Change From Week 14 at Week 36
ParticipantsOG00011
ParticipantsOG00114
ParticipantsOG00213
ParticipantsOG00336
Change From Week 14 at Week 40
ParticipantsOG00011
ParticipantsOG00113
ParticipantsOG00212
ParticipantsOG00333
Change From Week 14 at Week 44
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00334
Change From Week 14 at Week 48
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00333
Change From Week 14 at Week 52
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00333
Change From Week 14 at Week 56
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00329
Change From Week 14 at Week 60
ParticipantsOG0009
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG00330
Change From Week 14 at Week 64
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG00328
OG003
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00012
OG00113
OG00214
OG00346
OG00425
OG00529
OG00625
OG00726
OG00829
Title
Denominators
Categories
Week 14
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00214
ParticipantsOG00346
ParticipantsOG00425
ParticipantsOG00529
ParticipantsOG00625
ParticipantsOG00726
ParticipantsOG00829
Title
Measurements
OG0006.84± 0.443
OG0017.21± 1.254
OG0026.67± 0.463
OG003
Change From Week 14 at Week 16
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00344
Change From Week 14 at Week 20
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00344
Change From Week 14 at Week 24
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00341
Change From Week 14 at Week 28
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00212
ParticipantsOG00339
Change From Week 14 at Week 32
ParticipantsOG00011
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00340
Change From Week 14 at Week 36
ParticipantsOG00010
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00336
Change From Week 14 at Week 40
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00335
Change From Week 14 at Week 44
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00336
Change From Week 14 at Week 48
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00334
Change From Week 14 at Week 52
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00333
Change From Week 14 at Week 56
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG00330
Change From Week 14 at Week 60
ParticipantsOG0009
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00332
Change From Week 14 at Week 64
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG00329
OG003
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00012
OG00111
OG00214
OG00340
OG00427
OG00526
OG00623
OG00721
OG00828
Title
Denominators
Categories
Baseline
ParticipantsOG00012
ParticipantsOG00111
ParticipantsOG00214
ParticipantsOG00340
ParticipantsOG00424
ParticipantsOG00526
ParticipantsOG00623
ParticipantsOG00721
ParticipantsOG00828
Title
Measurements
OG00010.43± 1.530
OG00111.06± 1.450
OG00210.44± 2.984
OG003
Change From Baseline at Week 4
ParticipantsOG00012
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00336
Change From Baseline at Week 8
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00214
ParticipantsOG00339
Change From Baseline at Week 12
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00214
ParticipantsOG00335
Change From Baseline at Week 16
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00212
ParticipantsOG00337
Change From Baseline at Week 20
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00214
ParticipantsOG00339
Change From Baseline at Week 24
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00214
ParticipantsOG00338
Change From Baseline at Week 28
ParticipantsOG00012
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00332
Change From Baseline at Week 32
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00335
Change From Baseline at Week 36
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG00212
ParticipantsOG00330
Change From Baseline at Week40
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00212
ParticipantsOG00331
Change From Baseline at Week 44
ParticipantsOG00011
ParticipantsOG0018
ParticipantsOG00212
ParticipantsOG00331
Change From Baseline at Week 48
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00212
ParticipantsOG00329
Change From Baseline at Week 52
ParticipantsOG00011
ParticipantsOG0019
ParticipantsOG00212
ParticipantsOG00330
Change From Baseline at Week 60
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG00326
Change From Baseline at Week 64
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00210
ParticipantsOG00326
OG003
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00012
OG00114
OG00214
OG00346
OG00427
OG00530
OG00626
OG00726
OG00829
Title
Denominators
Categories
Baseline
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00346
ParticipantsOG00427
ParticipantsOG00530
ParticipantsOG00626
ParticipantsOG00726
ParticipantsOG00829
Title
Measurements
OG0002.08± 2.625
OG0012.41± 1.630
OG0020.86± 1.942
OG003
Change From Baseline at Week 4
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00345
Change From Baseline at Week 8
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00214
ParticipantsOG00346
Change From Baseline at Week 12
ParticipantsOG00011
ParticipantsOG00113
ParticipantsOG00214
ParticipantsOG00342
Change From Baseline at Week 14
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00346
Change From Baseline at Week 16
ParticipantsOG00012
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00345
Change From Baseline at Week 20
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00342
Change From Baseline at Week 24
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00214
ParticipantsOG00342
Change From Baseline at Week 28
ParticipantsOG00011
ParticipantsOG00113
ParticipantsOG00212
ParticipantsOG00339
Change From Baseline at Week 32
ParticipantsOG00011
ParticipantsOG00114
ParticipantsOG00213
ParticipantsOG00340
Change From Baseline at Week 36
ParticipantsOG00011
ParticipantsOG00114
ParticipantsOG00213
ParticipantsOG00336
Change From Baseline at Week40
ParticipantsOG00011
ParticipantsOG00113
ParticipantsOG00212
ParticipantsOG00333
Change From Baseline at Week 44
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00334
Change From Baseline at Week 48
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00333
Change From Baseline at Week 52
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00333
Change From Baseline at Week 56
ParticipantsOG00010
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00329
Change From Baseline at Week 60
ParticipantsOG0009
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG00330
Change From Baseline at Week 64
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG00328
OG003
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00012
OG00114
OG00213
OG00341
OG00426
OG00527
OG00624
OG00725
OG00829
Title
Denominators
Categories
Baseline
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00213
ParticipantsOG00341
ParticipantsOG00426
ParticipantsOG00527
ParticipantsOG00624
ParticipantsOG00725
ParticipantsOG00829
Title
Measurements
OG0006.76± 0.524
OG0016.93± 0.300
OG0026.89± 0.499
OG003
Change From Baseline at Week 4
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00213
ParticipantsOG00339
Change From Baseline at Week 8
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00213
ParticipantsOG00341
Change From Baseline at Week 12
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00339
Change From Baseline at Week 14
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00341
Change From Baseline at Week 16
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00213
ParticipantsOG00339
Change From Baseline at Week 20
ParticipantsOG00012
ParticipantsOG00114
ParticipantsOG00213
ParticipantsOG00339
Change From Baseline at Week 24
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00337
Change From Baseline at Week 28
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00211
ParticipantsOG00336
Change From Baseline at Week 32
ParticipantsOG00011
ParticipantsOG00114
ParticipantsOG00212
ParticipantsOG00336
Change From Baseline at Week 36
ParticipantsOG00010
ParticipantsOG00114
ParticipantsOG00212
ParticipantsOG00333
Change From Baseline at Week 40
ParticipantsOG00011
ParticipantsOG00113
ParticipantsOG00211
ParticipantsOG00332
Change From Baseline at Week 44
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00333
Change From Baseline at Week 48
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00332
Change From Baseline at Week 52
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00331
Change From Baseline at Week 56
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG0029
ParticipantsOG00328
Change From Baseline at Week 60
ParticipantsOG0009
ParticipantsOG00111
ParticipantsOG0029
ParticipantsOG00330
Change From Baseline at Week 64
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG00327
OG002
Placebo (Induction) to PF-06480605 (Chroinc) 450 mg
Participants who received placebo and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG003
PF-06480605 50 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 50 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG004
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG005
PF-06480605 150 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 150 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG006
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 50 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 50 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG007
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 150 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 150 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
OG008
PF-06480605 450 mg (Induction) to PF-06480605 (Chronic) 450 mg
Participants who received PF-06480605, 450 mg, and completed the 12-week induction period received PF-06480605, 450 mg, as a SC injection, Q4W from Week 16 to Week 52 in the chronic period.
Units
Counts
Participants
OG00012
OG00114
OG00214
OG00343
OG00426
OG00528
OG00625
OG00726
OG00829
Title
Denominators
Categories
ADA at Week 16
ParticipantsOG00011
ParticipantsOG00113
ParticipantsOG00214
ParticipantsOG00342
ParticipantsOG00424
ParticipantsOG00528
ParticipantsOG00625
ParticipantsOG00725
ParticipantsOG00829
Title
Measurements
OG0000
OG0010
OG0020
OG003
NAb at Week 16
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00339
ADA at Week 20
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00213
ParticipantsOG00343
NAb at Week 20
ParticipantsOG00010
ParticipantsOG0019
ParticipantsOG0025
ParticipantsOG00340
ADA at Week 24
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG00211
ParticipantsOG00340
NAb at Week 24
ParticipantsOG00011
ParticipantsOG00110
ParticipantsOG0027
ParticipantsOG00338
ADA at Week 28
ParticipantsOG00011
ParticipantsOG00114
ParticipantsOG00212
ParticipantsOG00338
NAb at Week 28
ParticipantsOG00011
ParticipantsOG00113
ParticipantsOG0026
ParticipantsOG00337
ADA at Week 32
ParticipantsOG00011
ParticipantsOG00114
ParticipantsOG00213
ParticipantsOG00337
NAb at Week 32
ParticipantsOG00011
ParticipantsOG00114
ParticipantsOG0027
ParticipantsOG00335
ADA at Week 36
ParticipantsOG00011
ParticipantsOG00114
ParticipantsOG00212
ParticipantsOG00335
NAb at Week 36
ParticipantsOG00011
ParticipantsOG00114
ParticipantsOG0027
ParticipantsOG00333
ADA at Week 40
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG00212
ParticipantsOG00335
NAb at Week 40
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG0025
ParticipantsOG00334
ADA at Week 44
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00335
NAb at Week 44
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG0026
ParticipantsOG00331
ADA at Week 48
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00334
NAb at Week 48
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG0025
ParticipantsOG00330
ADA at Week 52
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00332
NAb at Week 52
ParticipantsOG00011
ParticipantsOG00111
ParticipantsOG0025
ParticipantsOG00330
ADA at Week 56
ParticipantsOG00010
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00330
NAb at Week 56
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG00329
ADA at Week 60
ParticipantsOG0009
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG00332
NAb at Week 60
ParticipantsOG0009
ParticipantsOG00112
ParticipantsOG0027
ParticipantsOG00328
ADA at Week 64
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG00329
NAb at Week 64
ParticipantsOG00010
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG00329
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0121 events1 affected29 at risk
1 events
1 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0101 events1 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0121 events1 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0121 events1 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0072 events1 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0101 events1 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
1 events
1 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0081 events1 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0111 events1 affected26 at risk
EG0120 events0 affected29 at risk
1 events
1 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
1 events
1 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
2 events
2 affected
91 at risk
EG0040 events0 affected12 at risk
EG0051 events1 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0121 events1 affected29 at risk
4 events
4 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0073 events2 affected46 at risk
EG0080 events0 affected27 at risk
EG0091 events1 affected30 at risk
EG0101 events1 affected26 at risk
EG0111 events1 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0041 events1 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
3 events
3 affected
91 at risk
EG0040 events0 affected12 at risk
EG0051 events1 affected14 at risk
EG0060 events0 affected14 at risk
EG0078 events8 affected46 at risk
EG0084 events4 affected27 at risk
EG0092 events2 affected30 at risk
EG0106 events6 affected26 at risk
EG0113 events3 affected26 at risk
EG0122 events1 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0071 events1 affected46 at risk
EG0081 events1 affected27 at risk
EG0090 events0 affected30 at risk
EG0102 events1 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0041 events1 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
2 events
2 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0074 events1 affected46 at risk
EG0082 events2 affected27 at risk
EG0093 events3 affected30 at risk
EG0102 events2 affected26 at risk
EG0111 events1 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0051 events1 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0051 events1 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0051 events1 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0111 events1 affected26 at risk
EG0121 events1 affected29 at risk
6 events
5 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0121 events1 affected29 at risk
2 events
2 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0063 events1 affected14 at risk
EG0075 events1 affected46 at risk
EG0083 events3 affected27 at risk
EG0090 events0 affected30 at risk
EG0101 events1 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0051 events1 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0082 events2 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
9 events
5 affected
91 at risk
EG0042 events2 affected12 at risk
EG0051 events1 affected14 at risk
EG0061 events1 affected14 at risk
EG0074 events2 affected46 at risk
EG0082 events2 affected27 at risk
EG0092 events2 affected30 at risk
EG0104 events3 affected26 at risk
EG0110 events0 affected26 at risk
EG0121 events1 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0072 events2 affected46 at risk
EG0080 events0 affected27 at risk
EG0091 events1 affected30 at risk
EG0101 events1 affected26 at risk
EG0111 events1 affected26 at risk
EG0122 events2 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
2 events
2 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0073 events3 affected46 at risk
EG0083 events1 affected27 at risk
EG0093 events2 affected30 at risk
EG0100 events0 affected26 at risk
EG0111 events1 affected26 at risk
EG0122 events2 affected29 at risk
0 events
0 affected
91 at risk
EG0041 events1 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected46 at risk
EG0081 events1 affected27 at risk
EG0090 events0 affected30 at risk
EG0101 events1 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0091 events1 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
2 events
2 affected
91 at risk
EG0041 events1 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected46 at risk
EG0082 events2 affected27 at risk
EG0090 events0 affected30 at risk
EG0103 events2 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0051 events1 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0062 events1 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0041 events1 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0101 events1 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
1 events
1 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0073 events3 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0101 events1 affected26 at risk
EG0111 events1 affected26 at risk
EG0123 events3 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0053 events1 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0041 events1 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0111 events1 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected46 at risk
EG0080 events0 affected27 at risk
EG0091 events1 affected30 at risk
EG0101 events1 affected26 at risk
EG0112 events2 affected26 at risk
EG0120 events0 affected29 at risk
1 events
1 affected
91 at risk
EG0041 events1 affected12 at risk
EG0052 events2 affected14 at risk
EG0062 events2 affected14 at risk
EG0071 events1 affected46 at risk
EG0085 events5 affected27 at risk
EG0093 events3 affected30 at risk
EG0104 events4 affected26 at risk
EG0113 events3 affected26 at risk
EG0122 events2 affected29 at risk
5 events
4 affected
91 at risk
EG0041 events1 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0081 events1 affected27 at risk
EG0091 events1 affected30 at risk
EG0103 events2 affected26 at risk
EG0111 events1 affected26 at risk
EG0121 events1 affected29 at risk
1 events
1 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0071 events1 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0102 events2 affected26 at risk
EG0111 events1 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0051 events1 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
3 events
3 affected
91 at risk
EG0041 events1 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0077 events2 affected46 at risk
EG0083 events2 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
13 events
9 affected
91 at risk
EG0041 events1 affected12 at risk
EG0051 events1 affected14 at risk
EG0061 events1 affected14 at risk
EG0073 events3 affected46 at risk
EG0082 events2 affected27 at risk
EG0090 events0 affected30 at risk
EG0103 events2 affected26 at risk
EG0113 events2 affected26 at risk
EG0121 events1 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
1 events
1 affected
91 at risk
EG0040 events0 affected12 at risk
EG0051 events1 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0091 events1 affected30 at risk
EG0101 events1 affected26 at risk
EG0110 events0 affected26 at risk
EG0121 events1 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
3 events
2 affected
91 at risk
EG0041 events1 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0093 events3 affected30 at risk
EG0100 events0 affected26 at risk
EG0111 events1 affected26 at risk
EG0120 events0 affected29 at risk
1 events
1 affected
91 at risk
EG0040 events0 affected12 at risk
EG0051 events1 affected14 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected46 at risk
EG0081 events1 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0111 events1 affected26 at risk
EG0121 events1 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0051 events1 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
1 events
1 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0122 events2 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
4 events
2 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0072 events1 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0102 events2 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0041 events1 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0081 events1 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0051 events1 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0102 events2 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0101 events1 affected26 at risk
EG0113 events2 affected26 at risk
EG0123 events2 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0050 events0 affected14 at risk
EG0061 events1 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
1 events
1 affected
91 at risk
EG0041 events1 affected12 at risk
EG0050 events0 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
0 events
0 affected
91 at risk
EG0040 events0 affected12 at risk
EG0051 events1 affected14 at risk
EG0060 events0 affected14 at risk
EG0070 events0 affected46 at risk
EG0080 events0 affected27 at risk
EG0090 events0 affected30 at risk
EG0100 events0 affected26 at risk
EG0110 events0 affected26 at risk
EG0120 events0 affected29 at risk
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
Title
Measurements
OG0002251± 1122.5
OG0016568± 3043.4
OG00219660± 8637.7
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
Title
Measurements
OG0002232± 1858.5
OG0018381± 4769.8
OG00225160± 12194
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
Title
Measurements
OG0002181± 2080.3
OG0018914± 5425.9
OG00230900± 15724
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
Title
Measurements
OG0004198± 3252.9
OG00117110± 9380.6
OG00249480± 18086
ParticipantsOG00413
ParticipantsOG00513
ParticipantsOG00642
ParticipantsOG00724
ParticipantsOG00828
ParticipantsOG00924
ParticipantsOG01025
ParticipantsOG01129
Title
Measurements
OG003NA± NAThe mean and SD was not estimable as samples were BLQ.