A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— ESCAPE  

Official title:

A Randomised, Double Blind, Placebo Controlled, Phase IIb Dose Ranging Study (With Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713544
• Other study ID #: D1710C00009
• Status: Completed
• Phase: Phase 2
• First received: July 9, 2008
• Last updated: August 26, 2011
• Start date: July 2008
• Est. completion date: April 2009

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBulgaria: Bulgarian Drug AgencyColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyLatvia: State Agency of MedicinesNetherlands: Medicines Evaluation Board (MEB)Russia: Pharmacological Committee, Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSlovakia: State Institute for Drug ControlUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid Arthritis (RA) and if so how it compares to placebo (a substance which does not have any action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when added to treatment with methotrexate. The purpose of this study is also to find out which dose of AZD5672 is the most effective at treating RA and to find out how well the body tolerates AZD5672 when taken for up to 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: April 2009
• Est. primary completion date: April 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 of positive rheumatoid factor (blood test), current presence of positive rheumatoid factor (blood test), baseline radiographic erosion, presence of serum anti-cyclic citrullinated peptide antibodies (bloo

• Be receiving either: Oral (tablets) or subcutaneous (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, etc).

• Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes.

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• AZD5672
20 mg oral, once daily
• Etanercept
50 mg, subcutaneous injection, weekly
• Placebo
placebo, oral, once daily
• AZD5672
50 mg oral, once daily
• AZD5672
100 mg oral, once daily
• AZD5672
150 mg oral, once daily

Locations

Country	Name	City	State
Bulgaria	Research Site	Blagoevgrad
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Colombia	Research Site	Bogota
Colombia	Research Site	Bucaramanga
Colombia	Research Site	Medellin
Czech Republic	Research Site	Ceska Lipa
Czech Republic	Research Site	Ceske Budejovice
Czech Republic	Research Site	Hlucin
Czech Republic	Research Site	Pardubice
Czech Republic	Research Site	Praha 11 - Chodov
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Praha 6
Czech Republic	Research Site	Zlin
Hungary	Research Site	Bekescsaba
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Kecskemet
Hungary	Research Site	Mako
Hungary	Research Site	Sopron
Italy	Research Site	Siena	SI
Latvia	Research Site	Valmiera
Malta	Research Site	Birkirkara
Poland	Research Site	Bialystok
Poland	Research Site	Dzialdowo
Poland	Research Site	Krakow
Poland	Research Site	Lublin
Poland	Research Site	Sopot
Poland	Research Site	Szczecin
Poland	Research Site	Torun
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Romania	Research Site	Brasov
Romania	Research Site	Bucharest
Romania	Research Site	Ploiesti
Russian Federation	Research Site	Saint-petersburg
Russian Federation	Research Site	Yaroslavl
Serbia	Research Site	Belgrade
Serbia	Research Site	Niska Banja
Slovakia	Research Site	Banska Bystrica
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Piestany
South Africa	Research Site	Cape Town	Western Cape
South Africa	Research Site	Durban	Kwazulu Natal
South Africa	Research Site	Pretoria	Gauteng
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Ivano-frankivsk
Ukraine	Research Site	Kiev
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Simferopol

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Colombia,  Czech Republic,  Hungary,  Italy,  Latvia,  Malta,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology 20 Response (ACR20)	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 12 Weeks' treatment.	12 weeks	No
Secondary	American College of Rheumatology 50 Response (ACR50)	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 12 Weeks' treatment.	12 weeks	No
Secondary	American College of Rheumatology 70 Response (ACR70)	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 12 Weeks' treatment.	12 weeks	No
Secondary	Disease Activity Score (Based on 28 Joint Count) (DAS28)	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 12 Weeks' 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 12 Weeks	No
Secondary	Health Assessment Questionnaire - Disability Index (HAQ-DI)	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 12 Weeks 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 12 Weeks	No