E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ankylosing spondylitis (AS). |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |