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An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis

An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00421980
Enrollment
84
Registered
2007-01-15
Start date
2002-06-30
Completion date
2004-07-31
Last updated
2007-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Brief summary

The primary objective of this study was to determine the long-term safety of etanercept in adults with AS who had completed study 0881A3-311-EU.

Detailed description

This was an open-label, multicenter extension study that was conducted to evaluate the safety and efficacy of etanercept in the treatment of adult subjects with AS who had completed study 0881A3-311-EU. The study consisted of an open-label treatment period of up to approximately 96 weeks.

Interventions

DRUGEtanercept

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
Yes

Inclusion criteria

1. Completed the entire 12 weeks of therapy in study 0881A3-311-EU, or completed at least 8 weeks of therapy and returned for the week 12 visit in study 0881A3-311-EU. 2. Negative serum β-HCG pregnancy test at baseline (all women of childbearing potential). 3. Sexually active women of childbearing potential had to use a medically acceptable form of contraception. Medically acceptable forms of contraception included oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms was suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy. 4. Sexually active men had to agree to use a medically accepted form of contraception during the study. 5. Able to reconstitute and self-inject test article or have a designee who can do so. 6. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures were performed. 7. Able to store injectable test article at 2°C to 8°C.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026