Investigation of Early Structural Changes in Patients with Anklosing Spondyloarthritis
- Conditions
- Axial Spondyloarthritis (AxSpA)MedDRA version: 17.0Level: PTClassification code 10051265Term: SpondyloarthropathySystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2010-020077-16-CZ
- Lead Sponsor
- Pfizer Inc
- 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. Duration of symptoms.of >3 months and <5 years at the time of consent.
2. Active symptoms defined by a BASDAI =4 at the screening visit.
3. Axial symptoms of back pain with a less than favorable response to current intake of an NSAID at the optimal tolerated dose as determined by the investigator. Subjects must have failed at least 2 NSAIDs (including the current one) taken separately at the optimal 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 50 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 negative 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
Subjects presenting with any of the following will not be included in the study:
1. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
2. Any previous treatment with a tumor necrosis factor-alpha (TNF-a) inhibitor, B/T cell inhibitor or other biologic or immunosuppressive agent for a condition other than IBD.
3. Subject is currently being treated or had previous treatment within 6 months for IBD with any tumor necrosis factor-alpha (TNF-a) inhibitor or any other immunosupressant.
4. Any orthopedic or medical condition that can cause chronic back pain (different than SpA) such as spondylodiscitis, tumor or advance discopathy.
5. Evidence of IBD flare within 6 months of baseline.
6. Evidence of current or recent episodes of uveitis within 6 months of baseline.
7. Radiological sacroiliitis grade is 3-4 unilaterally or grade ?2 bilaterally as defined by the NY criteria. Only results from the central imaging reader will determine eligibility. Historical x-rays (obtained within 4 months of screening) may be utilized, however these subjects must exhibit radiological sacroilitis grade 0-1 unilaterally or grade 0 bilaterally.
8. Subject has a known or suspected allergy, hypersensitivity, or contraindication to ETN, its excipients, or other compounds related to this class of medication.
9. Subject has concurrent treatment with more than 1 NSAID within 14 days at baseline. Aspirin use, at daily doses up to 325 mg if indicated for cardiovascular protection is permissible and will not be counted as an additional NSAID.
10. Subject has had the dose of NSAID that changed within 14 days before baseline.
11. DMARDS other than methotrexate, sulfasalazine and hydroxychloroquine within 4 weeks of baseline.
12. Subject has had a dose of prednisone >10 mg/day (or equivalent) or has had a dose changed within 4 weeks before baseline.
13. Subject has received an intra-articular, intravenous, intramuscular, or subcutaneous (SC) corticosteroid within 4 weeks before baseline.
14. Subject is a pregnant or breastfeeding woman.
15. Has current or recent (within 2 years of screening) active TB infection.
? Local country guidelines should be followed for appropriate TB screening in the setting of anti-TNF therapy, including a minimum of a chest radiograph and objective TB testing such as purified protein derivative [PPD] or Quantiferon depending on what is acceptable per local guidelines.
16. Untreated latent TB.
? Subjects with known latent TB infection may be allowed only if local guidelines are followed for prophylactic therapy and if TB chemoprophylaxis has been adequately completed or initiated at least 4 weeks prior to screening.
17. Received TB chemoprophylaxis during screening and has had ALT and/or AST >2x upper limit of normal [ULN] during this period.
? For subjects that have been diagnosed with TB and started chemoprophylaxis during the screening period, additional blood samples for ALT and AST must be drawn between 3- 4 weeks after initiating chemoprophylaxis. The results need to be reviewed prior to randomization.
18. Serious infection (infection associated with hospitalization and/or intravenous antibiotics) within 1 month before test article administration.
19. Active infection at the time of the screening visit and/or the baseline visit. Certain minor active infections (ie, vaginitis, tinea, etc) could be allowed on a case-by-case basis only afte
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to compare the efficacy of ETN against placebo in improving symptoms of early non-radiographic axial SpA at 12 weeks when added to a background NSAID at the optimal anti-inflammatory dose.;Secondary Objective: 1. To assess the efficacy and safety of ETN + background NSAID over 104 weeks;<br>2. To compare the effect of ETN 50 mg once weekly versus placebo on inflammation seen in MRI of the spine at 12 weeks when added to a background NSAID at the optimal anti-inflammatory dose;<br>3. To compare the quality of life between those subjects treated with ETN 50 mg once weekly versus placebo over 12 weeks when added to a background NSAID at the optimal anti-inflammatory dose.;Primary end point(s): The primary endpoint of this study is the proportion of subjects who achieve ASAS 40 at week 12.;Timepoint(s) of evaluation of this end point: Week 12 (End of Double Blind Treatment Period)<br>
- Secondary Outcome Measures
Name Time Method