Trial record 1 of 1 for:
NCT00550355
Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00550355 |
Recruitment Status :
Completed
First Posted : October 29, 2007
Last Update Posted : July 14, 2009
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Sponsor:
Pfizer
Information provided by:
Pfizer
Tracking Information | ||||
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First Submitted Date ICMJE | October 25, 2007 | |||
First Posted Date ICMJE | October 29, 2007 | |||
Last Update Posted Date | July 14, 2009 | |||
Study Start Date ICMJE | August 2007 | |||
Actual Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Multiple dose pharmacokinetic and pharmacodynamic profile of intravenously administered PD 0360324 determined throughout the study | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis | |||
Official Title ICMJE | A Randomized, Subject and Investigator-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Intravenously Administered Doses of PD-0360324 in Patients With Rheumatoid Arthritis Receiving Methotrexate | |||
Brief Summary | This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD 0360324 in patients with rheumatoid arthritis receiving methotrexate. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Arthritis, Rheumatoid | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
78 | |||
Original Enrollment ICMJE |
60 | |||
Actual Study Completion Date ICMJE | June 2009 | |||
Actual Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 21 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Bulgaria, Czech Republic, Mexico, Poland, Slovakia, Spain, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00550355 | |||
Other Study ID Numbers ICMJE | A6261002 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | July 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |