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

August 26, 2011 updated by: AstraZeneca

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

373

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Blagoevgrad, Bulgaria
        • Research Site
      • Plovdiv, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
  • Colombia
      • Bogota, Colombia
        • Research Site
      • Bucaramanga, Colombia
        • Research Site
      • Medellin, Colombia
        • Research Site
  • Czech Republic
      • 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, Czech Republic
        • Research Site
  • Hungary
      • Bekescsaba, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
      • Mako, Hungary
        • Research Site
      • Sopron, Hungary
        • Research Site
  • Italy
    • SI
      • Siena, SI, Italy
        • Research Site
  • Latvia
      • Valmiera, Latvia
        • Research Site
  • Malta
      • Birkirkara, Malta
        • Research Site
  • Poland
      • 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, Poland
        • Research Site
  • Romania
      • Brasov, Romania
        • Research Site
      • Bucharest, Romania
        • Research Site
      • Ploiesti, Romania
        • Research Site
  • Russian Federation
      • Saint-petersburg, Russian Federation
        • Research Site
      • Yaroslavl, Russian Federation
        • Research Site
  • Serbia
      • Belgrade, Serbia
        • Research Site
      • Niska Banja, Serbia
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia
        • Research Site
      • Bratislava, Slovakia
        • Research Site
      • Piestany, Slovakia
        • Research Site
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa
        • Research Site
    • Kwazulu Natal
      • Durban, Kwazulu Natal, South Africa
        • Research Site
    • Western Cape
      • Cape Town, Western Cape, South Africa
        • Research Site
  • Ukraine
      • Donetsk, Ukraine
        • Research Site
      • Ivano-frankivsk, Ukraine
        • Research Site
      • Kiev, Ukraine
        • Research Site
      • Kyiv, Ukraine
        • Research Site
      • Simferopol, Ukraine
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Drug: Etanercept
50 mg, subcutaneous injection, weekly
Other Names:
  • Enbrel
EXPERIMENTAL: 2
20mg
Drug: AZD5672
20 mg oral, once daily
Drug: AZD5672
50 mg oral, once daily
Drug: AZD5672
100 mg oral, once daily
Drug: AZD5672
150 mg oral, once daily
EXPERIMENTAL: 3
50mg
Drug: AZD5672
20 mg oral, once daily
Drug: AZD5672
50 mg oral, once daily
Drug: AZD5672
100 mg oral, once daily
Drug: AZD5672
150 mg oral, once daily
EXPERIMENTAL: 4
100mg
Drug: AZD5672
20 mg oral, once daily
Drug: AZD5672
50 mg oral, once daily
Drug: AZD5672
100 mg oral, once daily
Drug: AZD5672
150 mg oral, once daily
EXPERIMENTAL: 5
150mg
Drug: AZD5672
20 mg oral, once daily
Drug: AZD5672
50 mg oral, once daily
Drug: AZD5672
100 mg oral, once daily
Drug: AZD5672
150 mg oral, once daily
PLACEBO_COMPARATOR: 6
Drug: Placebo
placebo, oral, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American College of Rheumatology 20 Response (ACR20)
Time Frame: 12 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American College of Rheumatology 50 Response (ACR50)
Time Frame: 12 weeks
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
American College of Rheumatology 70 Response (ACR70)
Time Frame: 12 weeks
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
Disease Activity Score (Based on 28 Joint Count) (DAS28)
Time Frame: Baseline to 12 Weeks
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
Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame: Baseline to 12 Weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Paul P Tak, MD, PhD, University of Amsterdam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

July 9, 2008

First Submitted That Met QC Criteria

July 10, 2008

First Posted (ESTIMATE)

July 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 3, 2011

Last Update Submitted That Met QC Criteria

August 26, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1710C00009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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