A 6-month Randomised, Double-blind, Open Arm Comparator,... | NCT00520572 | Trialant
NCT00520572
Sponsor
AstraZeneca
Status
Completed
Last Update Posted
Feb 4, 2013Estimated
Enrollment
385Actual
Phase
Phase 2
Conditions
Rheumatoid Arthritis
Interventions
AZD9056
Etanercept
Placebo
Countries
United States
Argentina
Australia
Belgium
Canada
Czechia
France
Mexico
Poland
Romania
Russia
Slovakia
Protocol Section
Identification Module
NCT ID
NCT00520572
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
D1520C00001
Secondary IDs
Not provided
Brief Title
A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)
Official Title
A Randomised, Double-Blind (With Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients With Active Disease Receiving Background Methotrexate or Sulphasalazine
Acronym
Not provided
Organization
AstraZenecaINDUSTRY
Status Module
Record Verification Date
Jan 2013
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
Aug 2007
Primary Completion Date
Not provided
Completion Date
Mar 2009Actual
First Submitted Date
Aug 22, 2007
First Submission Date that Met QC Criteria
Aug 23, 2007
First Posted Date
Aug 24, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 22, 2010
Results First Submitted that Met QC Criteria
Sep 15, 2010
Results First Posted Date
Oct 4, 2010Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 31, 2013
Last Update Posted Date
Feb 4, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AstraZenecaINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this study is to confirm that AZD9056 is effective in treating rheumatoid arthritis with regard to signs and symptoms and to determine what dose is favourable over a 6-month treatment period. Patients will receive background treatment with either Methotrexate or Sulphasalazine
Detailed Description
Not provided
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
385Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Active Comparator
Etanercept 50mg, subcutaneous, once weekly
Drug: Etanercept
2
Experimental
50mg oral, once daily
Drug: AZD9056
3
Experimental
100 mg oral, once daily
Drug: AZD9056
4
Experimental
200 mg oral, once daily
Drug: AZD9056
5
Experimental
400mg once, daily
Drug: AZD9056
6
Placebo Comparator
oral, once daily
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AZD9056
Drug
2
3
4
5
Etanercept
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
American College of Rheumatology 20 Response (ACR20) at 6 Months
The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment
6 months
Secondary Outcomes
Measure
Description
Time Frame
American College of Rheumatology 50 Response (ACR50) at 6 Months
The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment.
6 months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of RA with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). At least one of the following: documented history and current presence of positive rheumatoid factor (blood test), baseline radiographic erosion.
Be receiving either oral (tablets) or subcutaneous/intramuscular (injection) methotrexate for at least 6 months prior to randomisation.
Exclusion Criteria:
Any other inflammatory disease in addition to RA that may interfere with the study (e.g. polymyalgia rheumatica, giant cell arteritis, reactive arthritis, e t c). Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes. Persistently abnormal liver function enzymes (blood test).
Keystone EC, Wang MM, Layton M, Hollis S, McInnes IB; D1520C00001 Study Team. Clinical evaluation of the efficacy of the P2X7 purinergic receptor antagonist AZD9056 on the signs and symptoms of rheumatoid arthritis in patients with active disease despite treatment with methotrexate or sulphasalazine. Ann Rheum Dis. 2012 Oct;71(10):1630-5. doi: 10.1136/annrheumdis-2011-143578.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Male/female participants with active rheumatoid arthritis (and on background methotrexate or sulphasalazine) were randomly assigned to receive AZD9056 at 50, 100, 200 or 400 mg once daily, placebo or etanercept. It was planned to randomise approximately 360 participants, 60 to the open-label etanercept arm and 300 to the AZD9056 or placebo arms
Recruitment Details
The first participant enrolled on 01 August 2007, the last participant completed the study on 08 April 2009. Participants were recruited from 59 centres in 12 countries in Australia, Canada, Europe, Russia, South America, and the USA.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
AZD9056 50 mg
AZD9056 50 mg, oral tablets, once daily, double blinded
FG001
AZD9056 100 mg
AZD9056 100 mg, oral tablets, once daily, double blinded
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Hungary
Sweden
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug
1
Placebo
Drug
6
American College of Rheumatology 70 Response (ACR70) at 6 Months
The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment
6 months
Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.
Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of disease activity; and ESR) after 6 months' treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. (The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms).
Baseline to 6 months
Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.
Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months' treatment, calculated as score at 6 months minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. (The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability).
Baseline to 6 months
Orlando
Florida
United States
Research Site
Sarasota
Florida
United States
Research Site
Tampa
Florida
United States
Research Site
Petoskey
Michigan
United States
Research Site
Syracuse
New York
United States
Research Site
Portland
Oregon
United States
Research Site
Olympia
Washington
United States
Research Site
Rosario
Santa Fe Province
Argentina
Research Site
Buenos Aires
Argentina
Research Site
Córdoba
Argentina
Research Site
Planta Baja San Juan
Argentina
Research Site
San Miguel de Tucumán
Argentina
Research Site
Woolloongabba
Queensland
Australia
Research Site
Woodsville
South Australia
Australia
Research Site
Victoria Park
Western Australia
Australia
Research Site
George Town
Australia
Research Site
Hasselt
Belgium
Research Site
Winnipeg
Manitoba
Canada
Research Site
St. John's
Newfoundland and Labrador
Canada
Research Site
Prague
Czechia
Research Site
Uherské Hradiště
Czechia
Research Site
Zlín
Czechia
Research Site
Bobigny
France
Research Site
Bordeaux
France
Research Site
Tours
France
Research Site
Cd. Juarez
Mexico
Research Site
Chihuahua City
Mexico
Research Site
Guadalajara
Mexico
Research Site
Mexico City
Mexico
Research Site
Tapachula
Mexico
Research Site
Tijuana
Mexico
Research Site
Bialystok
Poland
Research Site
Elblag
Poland
Research Site
Katowice
Poland
Research Site
Krakow
Poland
Research Site
Lublin
Poland
Research Site
Poznan
Poland
Research Site
Sopot
Poland
Research Site
Torun
Poland
Research Site
Warsaw
Poland
Research Site
Brasov
Brașov County
Romania
Research Site
Bucharest
Romania
Research Site
Cluj-Napoca
Romania
Research Site
Iași
Romania
Research Site
Ploieşti
Romania
Research Site
Sf. Gheorghe
Romania
Research Site
Saint Petersburg
Russia
Research Site
Bansky Bystrica
Slovakia
Research Site
Bratislava
Slovakia
Research Site
Piešťany
Slovakia
FG002
AZD9056 200 mg
AZD9056 200 mg, oral tablets, once daily, double blinded
FG003
AZD9056 400 mg
AZD9056 400 mg, oral tablets, once daily, double blinded
FG004
Placebo
Placebo to AZD9056, oral tablets, once daily, double blinded
FG005
Etanercept
Etanercept 50 mg, subcutaneous injection, once weekly, open label
FG00064 subjectsParticipants randomised. One of these participants did not subsequently receive treatment.
FG00164 subjectsParticipants randomised.
FG00264 subjectsParticipants randomised. One of these participants did not subsequently receive treatment.
FG00364 subjectsParticipants randomised.
FG00465 subjectsParticipants randomised.
FG00564 subjectsParticipants randomised.
COMPLETED
FG00052 subjectsParticipants completed the study.
FG00150 subjectsParticipants completed the study.
FG00249 subjectsParticipants completed the study.
FG00350 subjectsParticipants completed the study.
FG00453 subjectsParticipants completed the study.
FG00562 subjectsParticipants completed the study.
NOT COMPLETED
FG00012 subjects
FG00114 subjects
FG00215 subjects
FG00314 subjects
FG00412 subjects
FG0052 subjects
Type
Comment
Reasons
Adverse Event
FG0009 subjects
FG0013 subjects
FG0026 subjects
FG0039 subjects
FG0047 subjects
FG0052 subjects
Withdrawal by Subject
FG0000 subjects
FG0019 subjects
FG0025 subjects
FG0032 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Incorrect enrollment
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Oral corticotherapy for acute urticaria
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Long break in taking Medication
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Did not receive Treatment
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
AZD9056 50 mg
AZD9056 50 mg, oral tablets, once daily, double blinded
BG001
AZD9056 100 mg
AZD9056 100 mg, oral tablets, once daily, double blinded
BG002
AZD9056 200 mg
AZD9056 200 mg, oral tablets, once daily, double blinded
BG003
AZD9056 400 mg
AZD9056 400 mg, oral tablets, once daily, double blinded
BG004
Placebo
Placebo to AZD9056, oral tablets, once daily, double blinded
BG005
Etanercept
Etanercept 50 mg, subcutaneous injection, once weekly, open label
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00063
BG00164
BG00263
BG00364
BG00465
BG00564
BG006383
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
BG00052± 12.8
BG00154± 11.5
BG00250± 11.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00056
BG00154
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
American College of Rheumatology 20 Response (ACR20) at 6 Months
The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment
Posted
Number
Participants
6 months
ID
Title
Description
OG000
AZD9056 50 mg
AZD9056 50 mg, oral tablets, once daily, double blinded
OG001
AZD9056 100 mg
AZD9056 100 mg, oral tablets, once daily, double blinded
OG002
AZD9056 200 mg
AZD9056 200 mg, oral tablets, once daily, double blinded
OG003
AZD9056 400 mg
AZD9056 400 mg, oral tablets, once daily, double blinded
OG004
Placebo
Placebo to AZD9056, oral tablets, once daily, double blinded
OG005
Etanercept
Etanercept 50 mg, subcutaneous injection, once weekly, open label
Units
Counts
Participants
OG00063
OG00164
OG00263
OG003
Title
Denominators
Categories
Title
Measurements
OG00023
OG00126
OG00223
OG003
Secondary
American College of Rheumatology 50 Response (ACR50) at 6 Months
The number of participants with greater to or equal to 50% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment.
Posted
Number
Participants
6 months
ID
Title
Description
OG000
AZD9056 50 mg
AZD9056 50 mg, oral tablets, once daily, double blinded
OG001
AZD9056 100 mg
AZD9056 100 mg, oral tablets, once daily, double blinded
OG002
AZD9056 200 mg
AZD9056 200 mg, oral tablets, once daily, double blinded
OG003
AZD9056 400 mg
AZD9056 400 mg, oral tablets, once daily, double blinded
OG004
Placebo
Secondary
American College of Rheumatology 70 Response (ACR70) at 6 Months
The number of participants with greater to or equal to 70% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 6 months' treatment
Posted
Number
Participants
6 months
ID
Title
Description
OG000
AZD9056 50 mg
AZD9056 50 mg, oral tablets, once daily, double blinded
OG001
AZD9056 100 mg
AZD9056 100 mg, oral tablets, once daily, double blinded
OG002
AZD9056 200 mg
AZD9056 200 mg, oral tablets, once daily, double blinded
OG003
AZD9056 400 mg
AZD9056 400 mg, oral tablets, once daily, double blinded
OG004
Placebo
Secondary
Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.
Change from baseline in the DAS28 composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of disease activity; and ESR) after 6 months' treatment. A change of zero indicates no effect of treatment and a negative change of 1.2 indicates a clinically important improvement in symptoms. (The DAS scale runs from 0 to 10, with the higher scores indicating worse RA symptoms).
Posted
Mean
Standard Deviation
Composite score
Baseline to 6 months
ID
Title
Description
OG000
AZD9056 50 mg
AZD9056 50 mg, oral tablets, once daily, double blinded
OG001
AZD9056 100 mg
AZD9056 100 mg, oral tablets, once daily, double blinded
OG002
AZD9056 200 mg
AZD9056 200 mg, oral tablets, once daily, double blinded
OG003
AZD9056 400 mg
AZD9056 400 mg, oral tablets, once daily, double blinded
Secondary
Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.
Change from baseline in HAQ-DI (a measure of patients assessment of physical function scored between zero and 3) after 6 months' treatment, calculated as score at 6 months minus score at baseline. A change of zero indicates no effect of treatment and a negative change of 0.22 or greater indicates an improvement in symptoms. (The HAQ-DI scale runs from 0 to 3, with higher scores indicating greater disability).
Posted
Mean
Standard Deviation
Composite score
Baseline to 6 months
ID
Title
Description
OG000
AZD9056 50 mg
AZD9056 50 mg, oral tablets, once daily, double blinded
OG001
AZD9056 100 mg
AZD9056 100 mg, oral tablets, once daily, double blinded
OG002
AZD9056 200 mg
AZD9056 200 mg, oral tablets, once daily, double blinded
OG003
AZD9056 400 mg
AZD9056 400 mg, oral tablets, once daily, double blinded
Time Frame
Not provided
Description
Not provided
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
AZD9056 50 mg
AZD9056 50 mg, oral tablets, once daily, double blinded
2
63
17
63
EG001
AZD9056 100 mg
AZD9056 100 mg, oral tablets, once daily, double blinded
0
64
24
64
EG002
AZD9056 200 mg
AZD9056 200 mg, oral tablets, once daily, double blinded
1
63
20
63
EG003
AZD9056 400 mg
AZD9056 400 mg, oral tablets, once daily, double blinded
1
64
29
64
EG004
Placebo
Placebo to AZD9056, oral tablets, once daily, double blinded
1
65
20
65
EG005
Etanercept
Etanercept 50 mg, subcutaneous injection, once weekly, open label
2
64
11
64
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Visual Acuity Reduced
Eye disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected64 at risk
EG0021 affected63 at risk
EG0030 affected64 at risk
EG0040 affected37 at risk
EG0050 affected64 at risk
Non-Cardiac Chest Pain
Eye disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected64 at risk
EG0020 affected63 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected64 at risk
EG0020 affected63 at risk
EG003
Tibia Fracture
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected64 at risk
EG0020 affected63 at risk
EG003
Joint Effusion
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected64 at risk
EG0020 affected63 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected63 at risk
EG0010 affected64 at risk
EG0020 affected63 at risk
EG003
Ureteral Polyp
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 affected63 at risk
EG0010 affected64 at risk
EG0020 affected63 at risk
EG003
Uterine Polyp
Reproductive system and breast disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected63 at risk
EG0010 affected64 at risk
EG0020 affected63 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0003 affected63 at risk
EG0017 affected64 at risk
EG0022 affected63 at risk
EG0037 affected64 at risk
EG0042 affected65 at risk
EG0051 affected64 at risk
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected63 at risk
EG0010 affected64 at risk
EG0025 affected63 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected63 at risk
EG0010 affected64 at risk
EG0024 affected63 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0003 affected63 at risk
EG0014 affected64 at risk
EG0020 affected63 at risk
EG003
Rheumatoid Atheritis
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0008 affected63 at risk
EG0016 affected64 at risk
EG0024 affected63 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 11.0
Systematic Assessment
EG0001 affected63 at risk
EG0013 affected64 at risk
EG0024 affected63 at risk
EG003
Headache
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0003 affected63 at risk
EG0013 affected64 at risk
EG0027 affected63 at risk
EG003
Hypertension
Vascular disorders
MedDRA 11.0
Systematic Assessment
EG0002 affected63 at risk
EG0014 affected64 at risk
EG0022 affected63 at risk
EG003
Hybrid ACR, ACRn, individual ACR components, Erythrocyte sedimentation rate, Short-form-36, Rheumatoid Arthritis Quality of Life, Patient Assessment of Fatigue and DEXA X-ray scanning did not provide extra information so are not presented
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Gerard Lynch
AstraZeneca
aztrial_results_posting@astrazeneca.com
ID
Term
D001172
Arthritis, Rheumatoid
Ancestor Terms
ID
Term
D001168
Arthritis
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000608601
AZD9056
D000068800
Etanercept
Ancestor Terms
ID
Term
D007141
Immunoglobulin Fc Fragments
D007128
Immunoglobulin Fragments
D010446
Peptide Fragments
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D007127
Immunoglobulin Constant Regions
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D012712
Serum Globulins
D005916
Globulins
D018124
Receptors, Tumor Necrosis Factor
D018121
Receptors, Cytokine
D011971
Receptors, Immunologic
D011956
Receptors, Cell Surface
D008565
Membrane Proteins
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0050 subjects
0 subjects
FG0050 subjects
1 subjects
FG0050 subjects
1 subjects
FG0050 subjects
1 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
52
± 11.8
BG00451± 11.9
BG00551± 10.8
BG00651.7± 11.76
51
BG00359
BG00454
BG00555
BG006329
Male
BG0007
BG00110
BG00212
BG0035
BG00411
BG0059
BG00654
64
OG00465
OG00564
21
OG00421
OG00542
Placebo to AZD9056, oral tablets, once daily, double blinded
OG005
Etanercept
Etanercept 50 mg, subcutaneous injection, once weekly, open label
Units
Counts
Participants
OG00063
OG00164
OG00263
OG00364
OG00465
OG00564
Title
Denominators
Categories
Title
Measurements
OG00013
OG0018
OG0029
OG00313
OG00411
OG00530
Placebo to AZD9056, oral tablets, once daily, double blinded
OG005
Etanercept
Etanercept 50 mg, subcutaneous injection, once weekly, open label
Units
Counts
Participants
OG00063
OG00164
OG00263
OG00364
OG00465
OG00564
Title
Denominators
Categories
Title
Measurements
OG0006
OG0017
OG0025
OG0035
OG0043
OG00515
OG004
Placebo
Placebo to AZD9056, oral tablets, once daily, double blinded
OG005
Etanercept
Etanercept 50 mg, subcutaneous injection, once weekly, open label
Units
Counts
Participants
OG00063
OG00164
OG00263
OG00364
OG00465
OG00564
Title
Denominators
Categories
Title
Measurements
OG000-1.2± 1.27
OG001-1.4± 1.63
OG002-1.1± 1.47
OG003-1.4± 1.37
OG004-1± 1.24
OG005-2.3± 1.38
OG004
Placebo
Placebo to AZD9056, oral tablets, once daily, double blinded
OG005
Etanercept
Etanercept 50 mg, subcutaneous injection, once weekly, open label