Extension Study Evaluating Etanercept in Ankylosing Spondylitis

Wyeth

Status and phase: Completed; Phase 4

Conditions: Ankylosing Spondylitis

Treatments: Drug: Enbrel (etanercept)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00410046

0881A3-405

Details and patient eligibility

About

The primary purpose of this study is to evaluate the health care resource utilization and work status of patients with ankylosing spondylitis undergoing treatment with etanercept by comparing study evaluations with the baseline evaluations in the ASCEND (0881A3-402)(NCT00247962) study.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who completed 16 weeks of treatment and have completed the baseline health care resource utilization questionnaire at screening in the ASCEND study 0881A3-402-WW from participating countries.

Exclusion criteria

• Withdrawal from the ASCEND study for safety or any other reason.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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84 participants in 1 patient group

Etanercept (ETN)

Experimental group

Description:

Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.

Treatment:

Drug: Enbrel (etanercept)