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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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26 September 2023 |
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Main ID: |
NCT00641225 |
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Date of registration:
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18/03/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study Evaluating Single Doses Of SBI-087 in Subjects With Rheumatoid Arthritis
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Scientific title:
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An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Rheumatoid Arthritis |
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Date of first enrolment:
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March 31, 2008 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT00641225 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the
screening visit.
- Must meet criteria for rheumatoid arthritis with functional class I to III.
- Diagnosis of rheumatoid arthritis more than 6 months before study day 1 and rheumatoid
arthritis onset after 16 years of age
Exclusion Criteria:
- Any significant health problems other than rheumatoid arthritis.
- Treatment of greater than 10 mg of prednisone per day.
- Treatment with cyclophosphamide.
Age minimum:
18 Years
Age maximum:
70 Years
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: SBI-087
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Primary Outcome(s)
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To evaluate the safety and tolerability of ascending single doses of SBI-087 in subjects with rheumatoid arthritis.
[Time Frame: 12 months]
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Secondary Outcome(s)
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To provide the initial pharmacokinetics and pharmacodynamic profile of SBI-087 in subjects with rheumatoid arthritis.
[Time Frame: 12 months]
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Secondary ID(s)
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3227K1-1000
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B2261001
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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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