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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520572
• Other study ID #: D1520C00001
• Status: Completed
• Phase: Phase 2
• First received: August 22, 2007
• Last updated: January 31, 2013
• Start date: August 2007
• Est. completion date: March 2009

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• AZD9056

• Etanercept

• Placebo

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Cordoba
Argentina	Research Site	Planta Baja San Juan
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	San Miguel de Tucuman
Australia	Research Site	George Town
Australia	Research Site	Victoria Park	Western Australia
Australia	Research Site	Woodsville	South Australia
Australia	Research Site	Woolloongabba	Queensland
Belgium	Research Site	Hasselt
Canada	Research Site	St Johns	Newfoundland and Labrador
Canada	Research Site	Winnipeg	Manitoba
Czech Republic	Research Site	Prague
Czech Republic	Research Site	Uherske Hradiste
Czech Republic	Research Site	Zlin
France	Research Site	Bobigny
France	Research Site	Bordeaux
France	Research Site	Tours
Mexico	Research Site	Cd. Juarez
Mexico	Research Site	Chihuahua
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mexico City
Mexico	Research Site	Tapachula
Mexico	Research Site	Tijuana
Poland	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
Romania	Research Site	Brasov
Romania	Research Site	Bucharest
Romania	Research Site	Cluj-napoca
Romania	Research Site	Iasi
Romania	Research Site	Ploiesti
Romania	Research Site	Sf. Gheorghe
Russian Federation	Research Site	Sankt-peterburg
Slovakia	Research Site	Bansky Bystrica
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Piestany
United States	Research Site	Aventura	Florida
United States	Research Site	Olympia	Washington
United States	Research Site	Orlando	Florida
United States	Research Site	Petoskey	Michigan
United States	Research Site	Portland	Oregon
United States	Research Site	Sarasota	Florida
United States	Research Site	Syracuse	New York
United States	Research Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Czech Republic,  France,  Mexico,  Poland,  Romania,  Russian Federation,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	6 months	No
Secondary	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	6 months	No
Secondary	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).	Baseline to 6 months	No
Secondary	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).	Baseline to 6 months	No