16.0040 Ankylosing Spondylitis Study

Amgen

Status and phase: Completed; Phase 3

Conditions: Ankylosing Spondylitis

Treatments: Drug: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00356356

20021640

016.0040

Details and patient eligibility

About

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

Full description

This multicenter, open-label extension study will evaluate the safety and clinical benefit of etanercept in the treatment of Ankylosing Spondylitis in subjects previously enrolled in Protocol 16.0037.

Enrollment: 257 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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257 participants in 1 patient group

All subjects

Experimental group

Description:

257 subjects

Treatment:

Drug: Etanercept