ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Evaluating the Efficacy and Safety of Etanercept

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: NCT00546533
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : October 19, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
To assess the efficacy of etanercept 25 mg administered subcutaneously twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Etanercept Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Evaluation Of The Efficacy And Safety Of Etanercept In Patients With Active Rheumatoid Arthritis (RA)
Study Start Date : January 2003
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources




Primary Outcome Measures :
  1. To assess the clinical efficacy of etanercept 25 mg administered twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A negative serum or urine pregnancy test at screening and a medically acceptable form of contraception starting at screening and continuing throughout the study is required for all females of childbearing potential (defined as an oral, injectable, or implantable contraceptive, intrauterine device, or barrier method combined with a spermicide).
  • Failed therapy with at least one DMARD (DMARD failure is defined as a discontinuation because of lack of clinical efficacy).
  • Meet the 1987 American Rheumatism Association (ARA) revised criteria for rheumatoid arthritis.

Exclusion Criteria:

  • Uncooperative patients with a history of poor compliance.
  • Known hypersensitivity to etanercept or any of its components.
  • Known significant concurrent medical disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00546533


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

ClinicalTrials.gov Identifier: NCT00546533     History of Changes
Other Study ID Numbers: 0881A-101101
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: October 19, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors