Investigation of Early Structural Changes in Patients with Anklosing Spondyloarthritis
- Conditions
- Axial Spondyloarthritis (AxSpA)MedDRA version: 14.1Level: PTClassification code 10051265Term: SpondyloarthropathySystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2010-020077-16-FI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Subject eligibility should be reviewed and documented by an appropriately qualified member
of the investigator’s study team before subjects are included in the study.
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study;
- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment
into the study:
1. Diagnosis of axial spondyloarthritis, as defined by the ASAS criteria (excluding
active uncontrolled inflammatory bowel disease or uveitis) of >3 months and
<5 years of duration at the time of consent.
2. Active symptoms defined by a BASDAI >4.
3. Axial symptoms of inflammatory back pain with a less than favorable response to current intake of an NSAID at maximum tolerated dose as determined by the investigator. Subjects must have failed at least 2 NSAIDs taken separately at the maximum tolerated dose with a total combined duration of >4 weeks.
4. Subject must be taking a stable dose of an NSAID for at least 14 days before baseline.
5. Female or male 18 years or older but less than 45 years at the time of consent.
6. In the opinion of the investigator, subject is a reasonable candidate for treatment with etanercept.
7. No contraindication to MRI examination (metal implants or inability to lay flat for
30-60 minutes for example).
8. Negative serum pregnancy test taken at screening, negative urine pregnancy test taken at baseline and serum pregnancy test collected at baseline.
9. Agreement by male subjects who are not surgically sterile and female subjects who are not surgically sterile or post menopausal to use a highly effective method of birth control for the duration of the study.
10. Ability to self-inject drug or have a designee who can do so.
11. Ability to store injectable test article under refrigerated conditions.
12. Demonstrates an adequate screening for tuberculosis (TB) in accordance with local country guideline.
13. Subject is able to complete health outcomes assessments and test article diary.
Main Inclusion Criteria Period 2
1. Successfully completed Period 1.
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 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Subject has had previous or current treatment with any tumor necrosis factor-alpha (TNF-a) inhibitor, B/T cell inhibitor or other biologic agent.
2. Any orthopedic or medical condition that can cause chronic back pain (different than SpA) such as spondylodiscitis, tumor or advance discopathy.
3. Subjects with active uncontrolled uveitis or inflammatory bowel disease.
4. Radiological sacroiliitis grade is 3-4 unilaterally or grade =2 bilaterally as defined by the NY criteria
5. Subject has a known or suspected allergy, hypersensitivity, or contraindication to ETN, its excipients, or other compounds related to this class of medication.
6. Has current or recent (within 2 years) active TB infection
7. Serious infection (infection associated with hospitalization and/or intravenous antibiotics) within 1 month before test article administration.
8. Active infection at screening, including systemic fungal infections.
9. Presence or history of cancer (or carcinoma in situ) other than resected cutaneous basal cell or squamous cell carcinoma;
10. Subject has an abnormal hematology or blood chemistry at screening
11. Known history or presence of hepatitis B or chronic hepatitis C or HIV infection;
12. Subjects who are investigational site or sponsor staff , members or has direct involvement with trial
13. Hypertension greater than 160/100 at screening
14. Planned elective surgery
15. Subject received any live vaccines (attenuated vaccines) within 4 weeks before baseline.
16. Myocardial infarction within 12 months before the screening visit;
17. Coronary artery by pass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within 12 months before the baseline visit;
18. Unstable angina pectoris within 6 months before the screening visit;
19. Severe pulmonary disease requiring recurrent hospitalizations or supplemental oxygen;
20. Presence or history of confirmed blood dyscrasias;
21. Diagnosis of multiple sclerosis or other central or peripheral nervous system demyelinating diseases;
22. Presence or history of cancer (or carcinoma in situ) other than resected cutaneous basal cell or squamous cell carcinoma;
23. Uncontrolled diabetes mellitus;
24. Diagnosis of rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or polymyositis;
25. Open cutaneous ulcers;
26. Liver cirrhosis or fibrosis;
27. Subject has concurrent treatment with more than 1 NSAID within 14 days at baseline.
28. Subject has a dose of NSAID that changed within 14 days before baseline.
29. DMARDS other than methotrexate, sulfasalazine and hydroxychloroquine within 4 weeks of baseline.
30. Subject has had a dose of prednisone >10 mg/day (or equivalent) or has had a dose changed within 4 weeks before baseline.
31. Severe acute or chronic medical or psychiatric condition, substance abuse or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
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