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

January 31, 2013 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

385

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Etanercept 50mg, subcutaneous, once weekly
Drug: Etanercept
Experimental: 2
50mg oral, once daily
Drug: AZD9056
Experimental: 3
100 mg oral, once daily
Drug: AZD9056
Experimental: 4
200 mg oral, once daily
Drug: AZD9056
Experimental: 5
400mg once, daily
Drug: AZD9056
Placebo Comparator: 6
oral, once daily
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American College of Rheumatology 20 Response (ACR20) at 6 Months
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
American College of Rheumatology 50 Response (ACR50) at 6 Months
Time Frame: 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
American College of Rheumatology 70 Response (ACR70) at 6 Months
Time Frame: 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
Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.
Time Frame: Baseline to 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
Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.
Time Frame: Baseline to 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

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Edward Keystone, MD, FRCPC, Mount Sinai Hospital
  • Study Chair: Zoltan Koroknai, MD, D.E.A.A., Omnicare Clinical Research

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

August 1, 2007

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 22, 2007

First Submitted That Met QC Criteria

August 23, 2007

First Posted (Estimate)

August 24, 2007

Study Record Updates

Last Update Posted (Estimate)

February 4, 2013

Last Update Submitted That Met QC Criteria

January 31, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1520C00001

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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