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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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)
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
Secondary ID [1] 0 0
D1520C00001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AZD9056
Treatment: Drugs - Etanercept
Treatment: Drugs - Placebo

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


Treatment: Drugs: AZD9056


Treatment: Drugs: Etanercept


Treatment: Drugs: Placebo


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
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).
Timepoint [3] 0 0
Baseline to 6 months
Secondary outcome [4] 0 0
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).
Timepoint [4] 0 0
Baseline to 6 months

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Research Site - Woolloongabba
Recruitment hospital [2] 0 0
Research Site - Woodsville
Recruitment hospital [3] 0 0
Research Site - Victoria Park
Recruitment hospital [4] 0 0
Research Site - George Town
Recruitment postcode(s) [1] 0 0
- Woolloongabba
Recruitment postcode(s) [2] 0 0
- Woodsville
Recruitment postcode(s) [3] 0 0
- Victoria Park
Recruitment postcode(s) [4] 0 0
- George Town
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
Argentina
State/province [6] 0 0
Santa Fe
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
Cordoba
Country [9] 0 0
Argentina
State/province [9] 0 0
Planta Baja San Juan
Country [10] 0 0
Argentina
State/province [10] 0 0
San Miguel de Tucuman
Country [11] 0 0
Belgium
State/province [11] 0 0
Hasselt
Country [12] 0 0
Canada
State/province [12] 0 0
Manitoba
Country [13] 0 0
Canada
State/province [13] 0 0
Newfoundland and Labrador
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Prague
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Uherske Hradiste
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Zlin
Country [17] 0 0
France
State/province [17] 0 0
Bobigny
Country [18] 0 0
France
State/province [18] 0 0
Bordeaux
Country [19] 0 0
France
State/province [19] 0 0
Tours
Country [20] 0 0
Mexico
State/province [20] 0 0
Cd. Juarez
Country [21] 0 0
Mexico
State/province [21] 0 0
Chihuahua
Country [22] 0 0
Mexico
State/province [22] 0 0
Guadalajara
Country [23] 0 0
Mexico
State/province [23] 0 0
Mexico City
Country [24] 0 0
Mexico
State/province [24] 0 0
Tapachula
Country [25] 0 0
Mexico
State/province [25] 0 0
Tijuana
Country [26] 0 0
Poland
State/province [26] 0 0
Bialystok
Country [27] 0 0
Poland
State/province [27] 0 0
Elblag
Country [28] 0 0
Poland
State/province [28] 0 0
Katowice
Country [29] 0 0
Poland
State/province [29] 0 0
Krakow
Country [30] 0 0
Poland
State/province [30] 0 0
Lublin
Country [31] 0 0
Poland
State/province [31] 0 0
Poznan
Country [32] 0 0
Poland
State/province [32] 0 0
Sopot
Country [33] 0 0
Poland
State/province [33] 0 0
Torun
Country [34] 0 0
Poland
State/province [34] 0 0
Warsaw
Country [35] 0 0
Romania
State/province [35] 0 0
Brasov
Country [36] 0 0
Romania
State/province [36] 0 0
Bucharest
Country [37] 0 0
Romania
State/province [37] 0 0
Cluj-napoca
Country [38] 0 0
Romania
State/province [38] 0 0
Iasi
Country [39] 0 0
Romania
State/province [39] 0 0
Ploiesti
Country [40] 0 0
Romania
State/province [40] 0 0
Sf. Gheorghe
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Sankt-peterburg
Country [42] 0 0
Slovakia
State/province [42] 0 0
Bansky Bystrica
Country [43] 0 0
Slovakia
State/province [43] 0 0
Bratislava
Country [44] 0 0
Slovakia
State/province [44] 0 0
Piestany

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT00520572
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edward Keystone, MD, FRCPC
Address 0 0
MOUNT SINAI HOSPITAL
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications