Ankylosing spondylitis (AS).
Conditions
Interventions
Product Name: Etanercept
Product Code: 0881
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Etanercept
rhuTNFR:Fc
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 50-
Sponsors
Wyeth Pharmaceuticals France, Wyeth Research Division
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients who completed 16 weeks of treatment and have completed the baseline HCRU questionnaire at screening in the ASCEND study 0881A3-402-WW from participating countries will be eligible to participate. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures and performed. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which include oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception). A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Agreement by male subjects who are not surgically sterile and female subjects who are not surgically sterile or postmenopausal to use reliable methods of birth control for the duration of the study. Ability to self-inject drug or have a designee who can do so. Ability to store injectable test article at 2 degrees C to 8 degrees C. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Withdrawn from ASCEND study 0881A3-402-WW for safety or any other reason.Pregnant or breast-feeding women.History of/or current psychiatric illness that would interfere with the subject’s ability to comply with protocol requirements or give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the health care resource utilization and work status in patients with ankylosing spondylitis by comparing study evaluations with the baseline evaluations in the ASCEND 0881A3-402-WW Study.;Secondary Objective: To evaluate the health care utilization in patients receiving two strategies of treatment for ankylosing spondylitis; strategy A: Start with DMARD (sulphasalazine) followed by anti-TNF (etanercept) and strategy B: Start and continue anti-TNF therapy (etanercept). To assess the new “Haywood” quality of life instrument (UK only) in relation to other key clinical and patient outcome measures. Evaluate the relationship between EQ-5D and BASDAI and BASFI in patients receiving etanercept. To assess the direct and indirect cost of therapy in patients with ankylosing spondylitis. To assess the change in clinical efficacy with treatment with etanercept.;Primary end point(s): This is primarily a study to evaluate the health economics of treatment of AS with etanercept. The Health Economics assessments will be: Assessment of subjects quality of life, 12 month recall of Health Care Resource Utilization & work status collected at screening in the ASCEND study, 0881A3-402-WW and 12 week recall of Health Care Resource Utilization & work status. | — |
Countries
Denmark, Finland, Sweden, United Kingdom
Outcome results
None listed