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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00520572
First received: August 22, 2007
Last updated: January 31, 2013
Last verified: January 2013

August 22, 2007
January 31, 2013
August 2007
Not Provided
American College of Rheumatology 20 Response (ACR20) at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Not Provided
Complete list of historical versions of study NCT00520572 on ClinicalTrials.gov Archive Site
  • American College of Rheumatology 50 Response (ACR50) at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
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Not Provided
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A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)
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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: AZD9056
  • Drug: Etanercept
  • Drug: Placebo
  • Active Comparator: 1
    Etanercept 50mg, subcutaneous, once weekly
    Intervention: Drug: Etanercept
  • Experimental: 2
    50mg oral, once daily
    Intervention: Drug: AZD9056
  • Experimental: 3
    100 mg oral, once daily
    Intervention: Drug: AZD9056
  • Experimental: 4
    200 mg oral, once daily
    Intervention: Drug: AZD9056
  • Experimental: 5
    400mg once, daily
    Intervention: Drug: AZD9056
  • Placebo Comparator: 6
    oral, once daily
    Intervention: Drug: Placebo
Keystone EC, Wang MM, Layton M, Hollis S, McInnes IB; D1520C00001 Study Team. Clinical evaluation of the efficacy of the P2X7 purinergic receptor antagonist AZD9056 on the signs and symptoms of rheumatoid arthritis in patients with active disease despite treatment with methotrexate or sulphasalazine. Ann Rheum Dis. 2012 Oct;71(10):1630-5. Erratum in: Ann Rheum Dis. 2012 Dec;71(12):2064.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
385
March 2009
Not Provided

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Canada,   Czech Republic,   France,   Mexico,   Poland,   Romania,   Russian Federation,   Slovakia
 
NCT00520572
D1520C00001
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Edward Keystone, MD, FRCPC Mount Sinai Hospital, New York
Study Chair: Zoltan Koroknai, MD, D.E.A.A. Omnicare Clinical Research
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP