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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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12 December 2020 |
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Main ID: |
NCT00867516 |
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Date of registration:
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20/03/2009 |
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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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Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis
ALD518-003 |
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Scientific title:
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A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80,160 and 320mg ALD518 Versus Placebo Administered as Multiple IV Infusions to Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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127 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00867516 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Georgia
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India
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Poland
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Russian Federation
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Serbia
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Contacts
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Name:
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Jeffrey Smith, MD, FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Alder BioPharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Active Rheumatoid Arthritis for at least 16 weeks duration
- Have a C-reactive protein (CRP) of = 10mg/L
- Have a stable dose of methotrexate (= 10mg/week) for at least 3 months
Exclusion Criteria:
- Arthritis onset prior to 16 years old
- Received any biologic therapy in the previous 12 months
- A history of or currently have active tuberculosis
- Any clinically significant concurrent medical condition
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Arthritis, Rheumatoid
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Intervention(s)
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Biological: ALD518
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Biological: Infusion without ALD518'
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Primary Outcome(s)
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Incidence and severity of AEs and SAEs during the study
[Time Frame: During entire length of study]
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Secondary Outcome(s)
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To evaluate the difference in treatment with ALD518 relative to treatment with placebo in the proportion of patients achieving a 20% improvement in ACR response (ACR20) at Week 12
[Time Frame: 12 weeks after Dose 1]
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Secondary ID(s)
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ALD518-CLIN-003
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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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