A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis
- Conditions
- Active, severe and advanced axial ankylosing spondylitisMedDRA version: 9.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
- Registration Number
- EUCTR2006-002748-27-HU
- Lead Sponsor
- Wyeth Pharmaceuticals France
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
1. Diagnosis of Ankylosing Spondylitis (AS), as defined by the Modified New York criteria.
2. Axial, defined by a score = 30 for the overall level of AS neck, back or hip pain (on a 100 mm VAS) (question 2 of the BASDAI).
3. Refractory to standard anti-rheumatic treatment (at least 2 NSAIDs at maximum tolerated dose with duration > 3 months and according to the opinion of the investigator).
4. Active, defined by BASDAI = 40 despite optimal NSAID treatment.
5. Advanced and severe, defined by the presence of 1 of the 3 following criteria :
?? 2 intervertebral adjacent bridges and/or fusion of the lumbar spine,
?? 3 intervertebral adjacent bridges and/or fusion of the dorsal spine,
?? 2 intervertebral adjacent bridges and/or fusion of the cervical spine.
6. Between 18 and 70 years of age.
7. Negative serum pregnancy test taken at screening in all women except those surgically sterile or at least 1 year post-menopausal. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which includes oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception). A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who use contraceptives or whose sexual partners are either sterile or use contraceptives.
8. Agreement by male subjects who are not surgically sterile and female subjects who are not surgically sterile or post-menopausal to use of a reliable method of birth control for the duration of the study.
9. Ability to reconstitute and self-inject drug or have a designee who can do so.
10. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific screening procedures are performed.
11. Ability to store injectable test article at 2°C-8°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
1. Previous receipt of etanercept or other TNFa inhibitors.
2. Use of disease modifying drugs other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Patients treated with hydroxychloroquine, sulphasalazine and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
3. Receipt of multiple NSAIDs at baseline.
4. Dose of NSAID changed within 2 weeks of baseline evaluation.
5. Dose of prednisone > 10mg/day (or equivalent) or changed within 2 weeks of baseline evaluation.
6. Abnormality in chemistry or haematologic profiles: white blood cell count = 3.5 x 109/L; haemoglobin = 85 g/L or 5.3 mmol/L; haematocrit = 27%; platelet count = 125 x 109/L; serum creatinine = 175 µmol/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2 times the laboratory’s upper limit of normal.
7. Significant concurrent medical events :
• Uncompensated congestive heart failure.
• Diagnosis of multiple sclerosis or other central demyelinating diseases.
• Presence or history of confirmed blood dyscrasias.
• Cancer or history of cancer (other than resected cutaneous basal cell or squamous
cell carcinoma).
• Serious infection (infection association with hospitalization and/or intravenous
antibiotics) within 1 month of test article administration or active infection at
baseline.
• Any condition that, in the physician’s judgment, might cause this study to be
detrimental to the subject.
• History of HIV+ or TB+ test (follow the local country guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF a therapy)
8. Known contraindication or hypersensitivity to etanercept or its excipients.
9. Pregnant or breast-feeding women.
10. History of poor compliance.
11. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
12. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements or give informed consent.
13. Receipt of any investigational drug or biological agent within 3 months of screening visit.
14. Employment by the investigator or reporting directly or indirectly to the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method