16.0040 Ankylosing Spondylitis Study

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with Ankylosing Spondylitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Collaborator: Immunex Corporation
• Treatments: Etanercept

Criteria

Inclusion Criteria: - Subjects completing 24 weeks of study drug in protocol 16.0037 qualify to enroll into this study Other patients to meet the following criteria:

• Negative pregnancy test

• Subjects agree to use appropriate contraception throughout study

• Should be able to self-inject study drug or have someone who can do so

• Capable of understanding protocol and willing to provide written informed consent

Exclusion Criteria:

• Any change in NSAID or prednisone dose within 2 weeks of baseline

• Any change in hydroxychloroquine, sulfasalazine, or MTX dose within 4 weeks of baseline

• Use of DMARDs other than those mentioned above, within 4 weeks of enrollment

• Previous receipt of ani-TNF agents, other than etanercept

• Receipt of any other investigational drug within 30 days of baseline

• Grade 3 or 4 adverse event attributed to etanercept which recurred when etanercept was resumed

• Abnormality in chemistry or hematology profiles or significant concurrent medical events.