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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00520572
Registration number
NCT00520572
Ethics application status
Date submitted
22/08/2007
Date registered
24/08/2007
Date last updated
4/02/2013
Titles & IDs
Public title
A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)
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Scientific 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
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Secondary ID [1]
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D1520C00001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Active comparator: 1 - Etanercept 50mg, subcutaneous, once weekly
Experimental: 2 - 50mg oral, once daily
Experimental: 3 - 100 mg oral, once daily
Experimental: 4 - 200 mg oral, once daily
Experimental: 5 - 400mg once, daily
Placebo comparator: 6 - oral, once daily
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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American College of Rheumatology 20 Response (ACR20) at 6 Months
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Assessment method [1]
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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
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Timepoint [1]
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6 months
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Secondary outcome [1]
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American College of Rheumatology 50 Response (ACR50) at 6 Months
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Assessment method [1]
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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.
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Timepoint [1]
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6 months
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Secondary outcome [2]
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American College of Rheumatology 70 Response (ACR70) at 6 Months
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Assessment method [2]
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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
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Timepoint [2]
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6 months
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Secondary outcome [3]
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Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.
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Assessment method [3]
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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).
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Timepoint [3]
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Baseline to 6 months
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Secondary outcome [4]
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Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.
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Assessment method [4]
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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).
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Timepoint [4]
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Baseline to 6 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2009
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Sample size
Target
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Accrual to date
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Final
385
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Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
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Recruitment hospital [1]
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Research Site - Woolloongabba
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Recruitment hospital [2]
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Research Site - Woodsville
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Recruitment hospital [3]
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Research Site - Victoria Park
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Recruitment hospital [4]
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Research Site - George Town
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Recruitment postcode(s) [1]
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- Woolloongabba
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Recruitment postcode(s) [2]
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- Woodsville
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Recruitment postcode(s) [3]
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- Victoria Park
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Recruitment postcode(s) [4]
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- George Town
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Recruitment outside Australia
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United States of America
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Florida
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Michigan
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New York
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Santa Fe
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Hasselt
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Prague
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Uherske Hradiste
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Zlin
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Cluj-napoca
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Iasi
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Ploiesti
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Bratislava
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Slovakia
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Piestany
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT00520572
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Trial related presentations / publications
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. Erratum In: Ann Rheum Dis. 2012 Dec;71(12):2064.
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Public notes
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Contacts
Principal investigator
Name
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Edward Keystone, MD, FRCPC
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Address
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MOUNT SINAI HOSPITAL
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00520572
Download to PDF