Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis

Wyeth

Status and phase: Completed; Phase 4

Conditions: Ankylosing Spondylitis

Treatments: Other: Placebo; Drug: Etanercept (Enbrel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420238

0881A3-403

Details and patient eligibility

About

Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.

Enrollment: 82 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Active and severe ankylosing spondylitis
• Ankylosing spondylitis refractory to standard anti-rheumatic treatment
• Between 18 and 70 years of age

Exclusion criteria

• Prior exposure to any TNF-inhibitor, including etanercept
• DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks of study drug initiation
• Dose of NSAIDs changed within two weeks of study drug initiation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Etanercept (Enbrel)

B

Placebo Comparator group

Treatment:

Other: Placebo