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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 February 2015 |
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Main ID: |
NCT00649545 |
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Date of registration:
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27/03/2008 |
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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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Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis
CanAct |
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Scientific title:
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A Multi-Center Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Active Rheumatoid Arthritis |
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Date of first enrolment:
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July 2003 |
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Target sample size:
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Recruitment status: |
Approved for marketing |
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URL:
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http://clinicaltrials.gov/show/NCT00649545 |
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Study type:
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Expanded Access |
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Study design:
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N/A
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Phase:
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N/A
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient has completed (i.e. not dropped out of) the DE013 study or fulfills criteria
2-12
- Patients 18 years of age or older
- Female is either not childbearing, defined as post-menopausal for at least 1 year or
surgically sterile (bilateral tubal ligation, bilateral oophorectomy or
hysterectomy), or if childbearing potential, practicing an acceptable method of birth
control
- Female of childbearing potential must have a negative serum pregnancy test prior to
first dose of adalimumab
- Diagnosis of active RA defined by >= 5 swollen joints and one of the following:
- Positive RF
- One or more joint erosions present of x-ray
- HAQ score > 1
Exclusion Criteria:
- Patient has failed 2 or more biologics
- Patient who had previous treatment with cyclophosphamide and chlorambucil
- Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H
monoclonal antibody resulting in presistent CD4 lymphopenia (CD4 lymphocytes +<
500/mm3)
- History of cancer within the past 10 years unless successfully treated non-metastatic
cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of
the cervix
- History of malignant lymphoma or leukemia regardless of treatment
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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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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Biological: adalimumab
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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