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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)

Interventions

  • Drug: AZD9056
  • Drug: Etanercept
  • Drug: Placebo

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Etanercept 50mg, subcutaneous, once weekly
  • Experimental: 2
    • 50mg oral, once daily
  • Experimental: 3
    • 100 mg oral, once daily
  • Experimental: 4
    • 200 mg oral, once daily
  • Experimental: 5
    • 400mg once, daily
  • Placebo Comparator: 6
    • oral, once daily

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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.
  • 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
  • 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).
  • 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).

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Edward Keystone, MD, FRCPC, Principal Investigator, MOUNT SINAI HOSPITAL
    • Zoltan Koroknai, MD, D.E.A.A., Study Chair, Omnicare Clinical Research

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.