Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00252668
First received: November 9, 2005
Last updated: May 17, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: Etanercept Drug: Methotrexate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multicentre, Extension Study of the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis Subjects |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- To evaluate the long-term safety of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.
Secondary Outcome Measures:
- To evaluate the long-term clinical efficacy and x-ray progression of the combination of etanercept and methotrexate in adults with RA who have completed the previous double-blind, randomized study.
| Estimated Enrollment: | 300 |
| Study Start Date: | June 2004 |
| Study Completion Date: | September 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252668
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Principal Investigator: | Trial Manager | For Germany, MedinfoDEU@wyeth.com |
| Principal Investigator: | Trial Manager | For Sweden, Denmark and Norway, MedInfoNord@wyeth.com |
| Principal Investigator: | Trial Manager | For Belgium, trials-BEL@wyeth.com |
| Principal Investigator: | Trial Manager | For Greece, decresg@wyeth.com |
| Principal Investigator: | Trial Manager | For Czech Republic, WPPGCLI@wyeth.com |
| Principal Investigator: | Trial Manager | For Romania, WPVIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Poland, WPWZMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Spain, Italy, Portugal, the Netherlands, and Finland, clinicaltrialinfo@wyeth.com |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00252668 History of Changes |
| Other Study ID Numbers: | 0881A1-101631, B1801221, 0881A1-400 |
| Study First Received: | November 9, 2005 |
| Last Updated: | May 17, 2011 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Rheumatoid Arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate TNFR-Fc fusion protein Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions |
Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
ClinicalTrials.gov processed this record on May 16, 2013