A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)
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
1 other identifier
interventional
385
12 countries
51
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Aug 2007
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 22, 2007
CompletedFirst Posted
Study publicly available on registry
August 24, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
October 4, 2010
CompletedFebruary 4, 2013
January 1, 2013
August 22, 2007
July 22, 2010
January 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (4)
American College of Rheumatology 50 Response (ACR50) at 6 Months
6 months
American College of Rheumatology 70 Response (ACR70) at 6 Months
6 months
Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.
Baseline to 6 months
Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.
Baseline to 6 months
Study Arms (6)
1
ACTIVE COMPARATOREtanercept 50mg, subcutaneous, once weekly
2
EXPERIMENTAL50mg oral, once daily
3
EXPERIMENTAL100 mg oral, once daily
4
EXPERIMENTAL200 mg oral, once daily
5
EXPERIMENTAL400mg once, daily
6
PLACEBO COMPARATORoral, once daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (51)
Research Site
Aventura, Florida, United States
Research Site
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
Related Publications (1)
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.
PMID: 22966146DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Keystone, MD, FRCPC
MOUNT SINAI HOSPITAL
- STUDY CHAIR
Zoltan Koroknai, MD, D.E.A.A.
Omnicare Clinical Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2007
First Posted
August 24, 2007
Study Start
August 1, 2007
Study Completion
March 1, 2009
Last Updated
February 4, 2013
Results First Posted
October 4, 2010
Record last verified: 2013-01