Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects
NCT00252668
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Subjects who completed the previous double-blind,randomized study.
- Ability to reconstitute and self-inject test etanercept (ETN) or have a designee who can do so.
- Dose of prednisone>10 mg/day (or equivalent) or dose changed within 2 weeks before
week 0 evaluation.
- Clinically relevant concurrent medical events including: uncompensated congestive
heart failure (CHF), diagnosis of multiple sclerosis or other central demyelinating
diseases, presence or history of confirmed blood dyscrasias, cancer or history of
cancer, serious infection within 1 month of test article administration or active
infection at week 0.
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| Descriptive Information | ||||||||||||||||||||||||||||
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| Brief Title ICMJE | Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects | |||||||||||||||||||||||||||
| Official Title ICMJE | An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects | |||||||||||||||||||||||||||
| Brief Summary | This study is an open label extension of a previously completed double-blind, randomized study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. All subjects will receive combination treatment with etanercept and methotrexate. | |||||||||||||||||||||||||||
| Detailed Description | Not Provided | |||||||||||||||||||||||||||
| Study Type ICMJE | Interventional | |||||||||||||||||||||||||||
| Study Phase ICMJE | Phase 4 | |||||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||||||||||||||||||||||||||
| Condition ICMJE | Rheumatoid Arthritis | |||||||||||||||||||||||||||
| Intervention ICMJE |
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| Study Arms ICMJE | Not Provided | |||||||||||||||||||||||||||
| Publications * | Not Provided | |||||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||||||||||||||||||||
| Recruitment Information | ||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Completed | |||||||||||||||||||||||||||
| Enrollment ICMJE | 300 | |||||||||||||||||||||||||||
| Original Enrollment ICMJE | Same as current | |||||||||||||||||||||||||||
| Actual Study Completion Date ICMJE | September 2005 | |||||||||||||||||||||||||||
| Primary Completion Date | Not Provided | |||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (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 | Not Provided | |||||||||||||||||||||||||||
| Removed Location Countries | ||||||||||||||||||||||||||||
| Administrative Information | ||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT00252668 | |||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | 0881A1-101631 B1801221 0881A1-400 | |||||||||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||||||||||||||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||||||||||||||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||||||||||||||
| Responsible Party | Not Provided | |||||||||||||||||||||||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | |||||||||||||||||||||||||||
| Investigators ICMJE |
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| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||||||||||||||
| Verification Date | May 2011 | |||||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||||||||||||||||||||