A Multicentre, 12 Week Double Blind Placebo Controlled Randomized Study of Etanercept on a Background NSAID in the Treatment of Adult Subjects with Non Radiographic Axial Spondyloarthritis with a 92 Week Open Label Extensio
- Conditions
- chronic inflammatory disease characterized by joint inflammation10023213
- Registration Number
- NL-OMON38358
- Lead Sponsor
- Pfizer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
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 (Appendix 1).
2. Active symptoms defined by a BASDAI *4.
3. Axial symptoms of back pain with a less than favorable response to current intake of an NSAID at 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 serum pregnancy test collected at baseline (Section 4.3 Lifestyle Guidelines).
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 (Section 4.3 Lifestyle Guidelines).
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.
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 *) 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 *) 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 (Appendix 2).
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.
10. Subject has a 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 after approval from the study physician clinician.
20. Participation in other studies with a therapeutic active component within 3 months before the current study begins and/or during study participation. (Participation in non-interventional or retrospective studies might be permitted following consultation with the Pfizer Clinical team.)
21. Planned elective surgery during Period 1.
22. Subject receive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this study is the proportion of subjects who achieve<br /><br>ASAS 40 at week 12.</p><br>
- Secondary Outcome Measures
Name Time Method