Clinical trial NCT00520572: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-08-24
Enrollment: 385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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).

Primary outcomes:
measure: American College of Rheumatology 20 Response (ACR20) at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: American College of Rheumatology 50 Response (ACR50) at 6 Months
timeFrame: 6 months
measure: American College of Rheumatology 70 Response (ACR70) at 6 Months
timeFrame: 6 months
measure: Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.
timeFrame: Baseline to 6 months
measure: Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Petoskey
country: United States
facility: Research Site
state: Michigan
city: Syracuse
country: United States
facility: Research Site
state: New York
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Olympia
country: United States
facility: Research Site
state: Washington
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: Planta Baja San Juan
country: Argentina
facility: Research Site
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
city: Woolloongabba
country: Australia
facility: Research Site
state: Queensland
city: Woodsville
country: Australia
facility: Research Site
state: South Australia
city: Victoria Park
country: Australia
facility: Research Site
state: Western Australia
city: George Town
country: Australia
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: St Johns
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Prague
country: Czech Republic
facility: Research Site
city: Uherske Hradiste
country: Czech Republic
facility: Research Site
city: Zlin
country: Czech Republic
facility: Research Site
city: Bobigny
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Cd. Juarez
country: Mexico
facility: Research Site
city: Chihuahua
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
city: Tapachula
country: Mexico
facility: Research Site
city: Tijuana
country: Mexico
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Elblag
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Sopot
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Warsaw
country: Poland
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Cluj-napoca
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Sf. Gheorghe
country: Romania
facility: Research Site
city: Sankt-peterburg
country: Russian Federation
facility: Research Site
city: Bansky Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Piestany
country: Slovakia
facility: Research Site
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Edward Keystone, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Omnicare Clinical Research
name: Zoltan Koroknai, MD, D.E.A.A.
role: STUDY_CHAIR
References:
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.