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
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Drug: AZD9056
Drug: Etanercept
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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).


Enrollment: 385
Study Start Date: August 2007
Study Completion Date: March 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520572

  Hide Study Locations
Locations
United States, Florida
Research Site
Aventura, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
Tampa, Florida, United States
United States, Michigan
Research Site
Petoskey, Michigan, United States
United States, New York
Research Site
Syracuse, New York, United States
United States, Oregon
Research Site
Portland, Oregon, United States
United States, Washington
Research Site
Olympia, Washington, United States
Argentina
Research Site
Rosario, Santa Fe, Argentina
Research Site
Buenos Aires, Argentina
Research Site
Cordoba, Argentina
Research Site
Planta Baja San Juan, Argentina
Research Site
San Miguel de Tucuman, Argentina
Australia, Queensland
Research Site
Woolloongabba, Queensland, Australia
Australia, South Australia
Research Site
Woodsville, South Australia, Australia
Australia, Western Australia
Research Site
Victoria Park, Western Australia, Australia
Australia
Research Site
George Town, Australia
Belgium
Research Site
Hasselt, Belgium
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
Research Site
St Johns, Newfoundland and Labrador, Canada
Czech Republic
Research Site
Prague, Czech Republic
Research Site
Uherske Hradiste, Czech Republic
Research Site
Zlin, Czech Republic
France
Research Site
Bobigny, France
Research Site
Bordeaux, France
Research Site
Tours, France
Mexico
Research Site
Cd. Juarez, Mexico
Research Site
Chihuahua, Mexico
Research Site
Guadalajara, Mexico
Research Site
Mexico City, Mexico
Research Site
Tapachula, Mexico
Research Site
Tijuana, Mexico
Poland
Research Site
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
Romania
Research Site
Brasov, Romania
Research Site
Bucharest, Romania
Research Site
Cluj-napoca, Romania
Research Site
Iasi, Romania
Research Site
Ploiesti, Romania
Research Site
Sf. Gheorghe, Romania
Russian Federation
Research Site
Sankt-peterburg, Russian Federation
Slovakia
Research Site
Bansky Bystrica, Slovakia
Research Site
Bratislava, Slovakia
Research Site
Piestany, Slovakia
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Edward Keystone, MD, FRCPC Mount Sinai Hospital, New York
Study Chair: Zoltan Koroknai, MD, D.E.A.A. Omnicare Clinical Research
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00520572     History of Changes
Other Study ID Numbers: D1520C00001
Study First Received: August 22, 2007
Results First Received: July 22, 2010
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by AstraZeneca:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 02, 2014