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Trial record 1 of 1 for:    NCT00520572
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A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)

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ClinicalTrials.gov Identifier: NCT00520572
Recruitment Status : Completed
First Posted : August 24, 2007
Results First Posted : October 4, 2010
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: AZD9056
Drug: Etanercept
Drug: Placebo
Enrollment 385
Recruitment Details 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 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
Arm/Group Title AZD9056 50 mg AZD9056 100 mg AZD9056 200 mg AZD9056 400 mg Placebo Etanercept
Hide Arm/Group Description AZD9056 50 mg, oral tablets, once daily, double blinded AZD9056 100 mg, oral tablets, once daily, double blinded AZD9056 200 mg, oral tablets, once daily, double blinded AZD9056 400 mg, oral tablets, once daily, double blinded Placebo to AZD9056, oral tablets, once daily, double blinded Etanercept 50 mg, subcutaneous injection, once weekly, open label
Period Title: Overall Study
Started 64 [1] 64 [2] 64 [1] 64 [2] 65 [2] 64 [2]
Completed 52 [3] 50 [3] 49 [3] 50 [3] 53 [3] 62 [3]
Not Completed 12 14 15 14 12 2
Reason Not Completed
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 completed the study.
Arm/Group Title AZD9056 50 mg AZD9056 100 mg AZD9056 200 mg AZD9056 400 mg Placebo Etanercept Total
Hide Arm/Group Description AZD9056 50 mg, oral tablets, once daily, double blinded AZD9056 100 mg, oral tablets, once daily, double blinded AZD9056 200 mg, oral tablets, once daily, double blinded AZD9056 400 mg, oral tablets, once daily, double blinded Placebo to AZD9056, oral tablets, once daily, double blinded Etanercept 50 mg, subcutaneous injection, once weekly, open label Total of all reporting groups
Overall Number of Baseline Participants 63 64 63 64 65 64 383
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 64 participants 63 participants 64 participants 65 participants 64 participants 383 participants
52  (12.8) 54  (11.5) 50  (11.9) 52  (11.8) 51  (11.9) 51  (10.8) 51.7  (11.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 64 participants 63 participants 64 participants 65 participants 64 participants 383 participants
Female
56
  88.9%
54
  84.4%
51
  81.0%
59
  92.2%
54
  83.1%
55
  85.9%
329
  85.9%
Male
7
  11.1%
10
  15.6%
12
  19.0%
5
   7.8%
11
  16.9%
9
  14.1%
54
  14.1%
1.Primary Outcome
Title American College of Rheumatology 20 Response (ACR20) at 6 Months
Hide Description 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
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD9056 50 mg AZD9056 100 mg AZD9056 200 mg AZD9056 400 mg Placebo Etanercept
Hide Arm/Group Description:
AZD9056 50 mg, oral tablets, once daily, double blinded
AZD9056 100 mg, oral tablets, once daily, double blinded
AZD9056 200 mg, oral tablets, once daily, double blinded
AZD9056 400 mg, oral tablets, once daily, double blinded
Placebo to AZD9056, oral tablets, once daily, double blinded
Etanercept 50 mg, subcutaneous injection, once weekly, open label
Overall Number of Participants Analyzed 63 64 63 64 65 64
Measure Type: Number
Unit of Measure: Participants
23 26 23 21 21 42
2.Secondary Outcome
Title American College of Rheumatology 50 Response (ACR50) at 6 Months
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD9056 50 mg AZD9056 100 mg AZD9056 200 mg AZD9056 400 mg Placebo Etanercept
Hide Arm/Group Description:
AZD9056 50 mg, oral tablets, once daily, double blinded
AZD9056 100 mg, oral tablets, once daily, double blinded
AZD9056 200 mg, oral tablets, once daily, double blinded
AZD9056 400 mg, oral tablets, once daily, double blinded
Placebo to AZD9056, oral tablets, once daily, double blinded
Etanercept 50 mg, subcutaneous injection, once weekly, open label
Overall Number of Participants Analyzed 63 64 63 64 65 64
Measure Type: Number
Unit of Measure: Participants
13 8 9 13 11 30
3.Secondary Outcome
Title American College of Rheumatology 70 Response (ACR70) at 6 Months
Hide Description 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
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD9056 50 mg AZD9056 100 mg AZD9056 200 mg AZD9056 400 mg Placebo Etanercept
Hide Arm/Group Description:
AZD9056 50 mg, oral tablets, once daily, double blinded
AZD9056 100 mg, oral tablets, once daily, double blinded
AZD9056 200 mg, oral tablets, once daily, double blinded
AZD9056 400 mg, oral tablets, once daily, double blinded
Placebo to AZD9056, oral tablets, once daily, double blinded
Etanercept 50 mg, subcutaneous injection, once weekly, open label
Overall Number of Participants Analyzed 63 64 63 64 65 64
Measure Type: Number
Unit of Measure: Participants
6 7 5 5 3 15
4.Secondary Outcome
Title Disease Activity Score (Based on 28 Joint Count) (DAS28) at 6 Months.
Hide Description 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).
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD9056 50 mg AZD9056 100 mg AZD9056 200 mg AZD9056 400 mg Placebo Etanercept
Hide Arm/Group Description:
AZD9056 50 mg, oral tablets, once daily, double blinded
AZD9056 100 mg, oral tablets, once daily, double blinded
AZD9056 200 mg, oral tablets, once daily, double blinded
AZD9056 400 mg, oral tablets, once daily, double blinded
Placebo to AZD9056, oral tablets, once daily, double blinded
Etanercept 50 mg, subcutaneous injection, once weekly, open label
Overall Number of Participants Analyzed 63 64 63 64 65 64
Mean (Standard Deviation)
Unit of Measure: Composite score
-1.2  (1.27) -1.4  (1.63) -1.1  (1.47) -1.4  (1.37) -1  (1.24) -2.3  (1.38)
5.Secondary Outcome
Title Health Assessment Questionnaire - Disability Index (HAQ-DI) at 6 Months.
Hide Description 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).
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AZD9056 50 mg AZD9056 100 mg AZD9056 200 mg AZD9056 400 mg Placebo Etanercept
Hide Arm/Group Description:
AZD9056 50 mg, oral tablets, once daily, double blinded
AZD9056 100 mg, oral tablets, once daily, double blinded
AZD9056 200 mg, oral tablets, once daily, double blinded
AZD9056 400 mg, oral tablets, once daily, double blinded
Placebo to AZD9056, oral tablets, once daily, double blinded
Etanercept 50 mg, subcutaneous injection, once weekly, open label
Overall Number of Participants Analyzed 63 64 63 64 65 64
Mean (Standard Deviation)
Unit of Measure: Composite score
-0.3  (0.57) -0.3  (0.51) -0.2  (0.5) -0.3  (0.55) -0.3  (0.46) -0.6  (0.66)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AZD9056 50 mg AZD9056 100 mg AZD9056 200 mg AZD9056 400 mg Placebo Etanercept
Hide Arm/Group Description AZD9056 50 mg, oral tablets, once daily, double blinded AZD9056 100 mg, oral tablets, once daily, double blinded AZD9056 200 mg, oral tablets, once daily, double blinded AZD9056 400 mg, oral tablets, once daily, double blinded Placebo to AZD9056, oral tablets, once daily, double blinded Etanercept 50 mg, subcutaneous injection, once weekly, open label
All-Cause Mortality
AZD9056 50 mg AZD9056 100 mg AZD9056 200 mg AZD9056 400 mg Placebo Etanercept
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
AZD9056 50 mg AZD9056 100 mg AZD9056 200 mg AZD9056 400 mg Placebo Etanercept
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/63 (3.17%)   0/64 (0.00%)   1/63 (1.59%)   1/64 (1.56%)   1/65 (1.54%)   2/64 (3.13%) 
Eye disorders             
Visual Acuity Reduced  1  0/63 (0.00%)  0/64 (0.00%)  1/63 (1.59%)  0/64 (0.00%)  0/37 (0.00%)  0/64 (0.00%) 
Non-Cardiac Chest Pain  1  0/63 (0.00%)  0/64 (0.00%)  0/63 (0.00%)  1/64 (1.56%)  0/65 (0.00%)  0/64 (0.00%) 
Injury, poisoning and procedural complications             
Humerus Fracture  1  0/63 (0.00%)  0/64 (0.00%)  0/63 (0.00%)  0/64 (0.00%)  0/65 (0.00%)  1/64 (1.56%) 
Tibia Fracture  1  0/63 (0.00%)  0/64 (0.00%)  0/63 (0.00%)  0/64 (0.00%)  0/65 (0.00%)  1/64 (1.56%) 
Musculoskeletal and connective tissue disorders             
Joint Effusion  1  0/63 (0.00%)  0/64 (0.00%)  0/63 (0.00%)  0/64 (0.00%)  1/65 (1.54%)  0/64 (0.00%) 
Renal and urinary disorders             
Renal Colic  1  1/63 (1.59%)  0/64 (0.00%)  0/63 (0.00%)  0/64 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
Ureteral Polyp  1  0/63 (0.00%)  0/64 (0.00%)  0/63 (0.00%)  0/64 (0.00%)  0/65 (0.00%)  1/64 (1.56%) 
Reproductive system and breast disorders             
Uterine Polyp  1  1/63 (1.59%)  0/64 (0.00%)  0/63 (0.00%)  0/64 (0.00%)  0/65 (0.00%)  0/64 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AZD9056 50 mg AZD9056 100 mg AZD9056 200 mg AZD9056 400 mg Placebo Etanercept
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/63 (26.98%)   24/64 (37.50%)   20/63 (31.75%)   29/64 (45.31%)   20/65 (30.77%)   11/64 (17.19%) 
Gastrointestinal disorders             
Nausea  1  3/63 (4.76%)  7/64 (10.94%)  2/63 (3.17%)  7/64 (10.94%)  2/65 (3.08%)  1/64 (1.56%) 
Abdominal Pain Upper  1  2/63 (3.17%)  0/64 (0.00%)  5/63 (7.94%)  7/64 (10.94%)  3/65 (4.62%)  1/64 (1.56%) 
Diarrhoea  1  1/63 (1.59%)  0/64 (0.00%)  4/63 (6.35%)  6/64 (9.38%)  3/65 (4.62%)  0/64 (0.00%) 
Infections and infestations             
Bronchitis  1  3/63 (4.76%)  4/64 (6.25%)  0/63 (0.00%)  2/64 (3.13%)  2/65 (3.08%)  1/64 (1.56%) 
Musculoskeletal and connective tissue disorders             
Rheumatoid Atheritis  1  8/63 (12.70%)  6/64 (9.38%)  4/63 (6.35%)  6/64 (9.38%)  12/65 (18.46%)  2/64 (3.13%) 
Back Pain  1  1/63 (1.59%)  3/64 (4.69%)  4/63 (6.35%)  3/64 (4.69%)  1/65 (1.54%)  2/64 (3.13%) 
Nervous system disorders             
Headache  1  3/63 (4.76%)  3/64 (4.69%)  7/63 (11.11%)  10/64 (15.63%)  4/65 (6.15%)  0/64 (0.00%) 
Vascular disorders             
Hypertension  1  2/63 (3.17%)  4/64 (6.25%)  2/63 (3.17%)  3/64 (4.69%)  0/65 (0.00%)  6/64 (9.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00520572    
Other Study ID Numbers: D1520C00001
First Submitted: August 22, 2007
First Posted: August 24, 2007
Results First Submitted: July 22, 2010
Results First Posted: October 4, 2010
Last Update Posted: February 4, 2013