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
Results First Received: July 22, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: AZD9056
Drug: Etanercept
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first participant enrolled on 01 August 2007, the last participant completed the study on 08 April 2009. Participants were recruited from 59 centres in 12 countries in Australia, Canada, Europe, Russia, South America, and the USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Male/female participants with active rheumatoid arthritis (and on background methotrexate or sulphasalazine) were randomly assigned to receive AZD9056 at 50, 100, 200 or 400 mg once daily, placebo or etanercept. It was planned to randomise approximately 360 participants, 60 to the open-label etanercept arm and 300 to the AZD9056 or placebo arms

Reporting Groups
  Description
AZD9056 50 mg AZD9056 50 mg, oral tablets, once daily, double blinded
AZD9056 100 mg AZD9056 100 mg, oral tablets, once daily, double blinded
AZD9056 200 mg AZD9056 200 mg, oral tablets, once daily, double blinded
AZD9056 400 mg AZD9056 400 mg, oral tablets, once daily, double blinded
Placebo Placebo to AZD9056, oral tablets, once daily, double blinded
Etanercept Etanercept 50 mg, subcutaneous injection, once weekly, open label

Participant Flow:   Overall Study
    AZD9056 50 mg     AZD9056 100 mg     AZD9056 200 mg     AZD9056 400 mg     Placebo     Etanercept  
STARTED     64 [1]   64 [2]   64 [3]   64 [2]   65 [2]   64 [2]
COMPLETED     52 [4]   50 [4]   49 [4]   50 [4]   53 [4]   62 [4]
NOT COMPLETED     12     14     15     14     12     2  
Adverse Event                 9                 3                 6                 9                 7                 2  
Withdrawal by Subject                 0                 9                 5                 2                 2                 0  
Protocol Violation                 0                 0                 1                 0                 0                 0  
Lack of Efficacy                 1                 1                 1                 2                 1                 0  
Lost to Follow-up                 0                 0                 0                 0                 1                 0  
Incorrect enrollment                 1                 0                 1                 0                 1                 0  
Oral corticotherapy for acute urticaria                 0                 1                 0                 0                 0                 0  
Long break in taking Medication                 0                 0                 0                 1                 0                 0  
Did not receive Treatment                 1                 0                 1                 0                 0                 0  
[1] Participants randomised. One of these participants did not subsequently receive treatment.
[2] Participants randomised.
[3] Participants randomised. One of these participants did not subsequently receive treatment.
[4] Participants completed the study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AZD9056 50 mg AZD9056 50 mg, oral tablets, once daily, double blinded
AZD9056 100 mg AZD9056 100 mg, oral tablets, once daily, double blinded
AZD9056 200 mg AZD9056 200 mg, oral tablets, once daily, double blinded
AZD9056 400 mg AZD9056 400 mg, oral tablets, once daily, double blinded
Placebo Placebo to AZD9056, oral tablets, once daily, double blinded
Etanercept Etanercept 50 mg, subcutaneous injection, once weekly, open label
Total Total of all reporting groups

Baseline Measures
    AZD9056 50 mg     AZD9056 100 mg     AZD9056 200 mg     AZD9056 400 mg     Placebo     Etanercept     Total  
Number of Participants  
[units: participants]
  63     64     63     64     65     64     383  
Age  
[units: Years]
Mean ± Standard Deviation
  52  ± 12.8     54  ± 11.5     50  ± 11.9     52  ± 11.8     51  ± 11.9     51  ± 10.8     51.7  ± 11.76  
Gender  
[units: Participants]
             
Female     56     54     51     59     54     55     329  
Male     7     10     12     5     11     9     54  



  Outcome Measures
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1.  Primary:   American College of Rheumatology 20 Response (ACR20) at 6 Months   [ Time Frame: 6 months ]

2.  Secondary:   American College of Rheumatology 50 Response (ACR50) at 6 Months   [ Time Frame: 6 months ]

3.  Secondary:   American College of Rheumatology 70 Response (ACR70) at 6 Months   [ Time Frame: 6 months ]

4.  Secondary:   Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.   [ Time Frame: Baseline to 6 months ]

5.  Secondary:   Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.   [ Time Frame: Baseline to 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Hybrid ACR, ACRn, individual ACR components, Erythrocyte sedimentation rate, Short-form-36, Rheumatoid Arthritis Quality of Life, Patient Assessment of Fatigue and DEXA X-ray scanning did not provide extra information so are not presented


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

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