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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00713544 |
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Date of registration:
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09/07/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis
ESCAPE |
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Scientific title:
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A Randomised, Double Blind, Placebo Controlled, Phase IIb Dose Ranging Study (With Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate. |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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373 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00713544 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Argentina
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Bulgaria
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Colombia
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Czech Republic
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Hungary
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Italy
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Latvia
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Malta
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Netherlands
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Peru
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Poland
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Romania
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Russian Federation
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Serbia
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Slovakia
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South Africa
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Ukraine
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Contacts
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Name:
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Mark Layton |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Name:
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Paul P Tak, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Amsterdam |
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Key inclusion & exclusion criteria
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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 of positive rheumatoid factor (blood
test), current presence of positive rheumatoid factor (blood test), baseline
radiographic erosion, presence of serum anti-cyclic citrullinated peptide antibodies
(bloo
- Be receiving either: Oral (tablets) or subcutaneous (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, etc).
- Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: AZD5672
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Drug: Placebo
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Drug: Etanercept
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Primary Outcome(s)
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American College of Rheumatology 20 Response (ACR20)
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Disease Activity Score (Based on 28 Joint Count) (DAS28)
[Time Frame: Baseline to 12 Weeks]
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Health Assessment Questionnaire - Disability Index (HAQ-DI)
[Time Frame: Baseline to 12 Weeks]
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American College of Rheumatology 70 Response (ACR70)
[Time Frame: 12 weeks]
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American College of Rheumatology 50 Response (ACR50)
[Time Frame: 12 weeks]
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Secondary ID(s)
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D1710C00009
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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