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A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AZD9056
Etanercept
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

5

6

Arm Description

Etanercept 50mg, subcutaneous, once weekly

50mg oral, once daily

100 mg oral, once daily

200 mg oral, once daily

400mg once, daily

oral, once daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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
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).
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).

Full Information

First Posted
August 22, 2007
Last Updated
January 31, 2013
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00520572
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Etanercept 50mg, subcutaneous, once weekly
Arm Title
2
Arm Type
Experimental
Arm Description
50mg oral, once daily
Arm Title
3
Arm Type
Experimental
Arm Description
100 mg oral, once daily
Arm Title
4
Arm Type
Experimental
Arm Description
200 mg oral, once daily
Arm Title
5
Arm Type
Experimental
Arm Description
400mg once, daily
Arm Title
6
Arm Type
Placebo Comparator
Arm Description
oral, once daily
Intervention Type
Drug
Intervention Name(s)
AZD9056
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
American College of Rheumatology 20 Response (ACR20) at 6 Months
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
American College of Rheumatology 50 Response (ACR50) at 6 Months
Description
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.
Time Frame
6 months
Title
American College of Rheumatology 70 Response (ACR70) at 6 Months
Description
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
Time Frame
6 months
Title
Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.
Description
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).
Time Frame
Baseline to 6 months
Title
Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.
Description
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).
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Keystone, MD, FRCPC
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zoltan Koroknai, MD, D.E.A.A.
Organizational Affiliation
Omnicare Clinical Research
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Petoskey
State/Province
Michigan
Country
United States
Facility Name
Research Site
City
Syracuse
State/Province
New York
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Research Site
City
Olympia
State/Province
Washington
Country
United States
Facility Name
Research Site
City
Rosario
State/Province
Santa Fe
Country
Argentina
Facility Name
Research Site
City
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Cordoba
Country
Argentina
Facility Name
Research Site
City
Planta Baja San Juan
Country
Argentina
Facility Name
Research Site
City
San Miguel de Tucuman
Country
Argentina
Facility Name
Research Site
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Woodsville
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Victoria Park
State/Province
Western Australia
Country
Australia
Facility Name
Research Site
City
George Town
Country
Australia
Facility Name
Research Site
City
Hasselt
Country
Belgium
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
St Johns
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Research Site
City
Prague
Country
Czech Republic
Facility Name
Research Site
City
Uherske Hradiste
Country
Czech Republic
Facility Name
Research Site
City
Zlin
Country
Czech Republic
Facility Name
Research Site
City
Bobigny
Country
France
Facility Name
Research Site
City
Bordeaux
Country
France
Facility Name
Research Site
City
Tours
Country
France
Facility Name
Research Site
City
Cd. Juarez
Country
Mexico
Facility Name
Research Site
City
Chihuahua
Country
Mexico
Facility Name
Research Site
City
Guadalajara
Country
Mexico
Facility Name
Research Site
City
Mexico City
Country
Mexico
Facility Name
Research Site
City
Tapachula
Country
Mexico
Facility Name
Research Site
City
Tijuana
Country
Mexico
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Elblag
Country
Poland
Facility Name
Research Site
City
Katowice
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Lublin
Country
Poland
Facility Name
Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Sopot
Country
Poland
Facility Name
Research Site
City
Torun
Country
Poland
Facility Name
Research Site
City
Warsaw
Country
Poland
Facility Name
Research Site
City
Brasov
Country
Romania
Facility Name
Research Site
City
Bucharest
Country
Romania
Facility Name
Research Site
City
Cluj-napoca
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Ploiesti
Country
Romania
Facility Name
Research Site
City
Sf. Gheorghe
Country
Romania
Facility Name
Research Site
City
Sankt-peterburg
Country
Russian Federation
Facility Name
Research Site
City
Bansky Bystrica
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Piestany
Country
Slovakia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22966146
Citation
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.
Results Reference
derived

Learn more about this trial

A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)

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