None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Etanercept 50mg Every 10 day
? Enbrel®
? Etoloce®
? Eucept®
2) Adalimumab 40mg Every 3 weekly
? Humira®
? Adalloce®
3) Golimumab 50mg Every 6 weekly
Sponsors
Hanyang University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects enrolled in the study must meet all of the following inclusion criteria: • Aged between 18 and 65 • Documented diagnosis of Ankylosing spondylitis (AS) and meet the modified New York classification criteria for AS • Subjects maintaining stable disease (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] < 4) with standard-dose subcutaneous tumor necrosis factor inhibitor (TNFi) treatment during previous 6 months from the screening • Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1 at screening (Week -4) and baseline (Week 0) • In subjects treated with methotrexate or sulfasalazine, the dose should be maintained (methotrexate= 25mg/day, sulfasalazine = 3 g/day) during previous 4 weeks before screening • In subjects treated with systemic glucocorticoids, the dose should be less than 10mg/day of predinisolone or equivalent during at least 2 weeks from the screening • Subjects with stable dose of concomitant NSAID (including Cox2 inhibitors) during the 2 weeks from the randomization
Exclusion criteria
Exclusion criteria: Subjects will be excluded from participating in the study if they meet any of the following criteria: • Exposure to more than 1 TNFi • History of hypersensitivity reaction to any TNFis • Subjects with concomitant fibromyalgia, as determined by the investigator • Subjects who have received any TNFis with reduced dosage • Presence of total spinal ankylosis (‘Bamboo spine’) • Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study • Subjects with a history of malignancies and lymphoproliferative disorder including lymphoma within 5 years (Basal cell carcinoma treated within previous 3 months and showing no evidence of recurrence, actinic keratosis, and treated cervical/colon carcinoma in situ were allowed.) • Subjects with current or history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac or neurological disease, as determined by the investigator • Subjects with significant laboratory abnormalities included but not limited to: 1) AST/ALT > 3.0 X ULN 2) White blood cell (WBC) 10mg/day of prednisolone or equivalent doses) • Subjects with any other condition that, in the Investigator’s judgment, would make the subject unsuitable for inclusion in the study 18) Patients who are contraindicated in administration of clinical investigational drugs -Patients with hypersensitivity to drugs -Patients at risk of sepsis or sepsis - Infections, including chronic or localized infections, severe infections, opportunistic infections, including tuberculosis patient with - Congestive heart failure (New York Heart Association Grade III or IV status)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASDAS-CRP / | — |
Secondary
| Measure | Time frame |
|---|---|
| BASDAI ;ASAS20, ASAS40, ASAS5/6, ASAS partial remission;Bath Ankylosing Spondylitis Functional Index (BASFI); Bath Ankylosing Spondylitis Disease Metrology Index (BASMI);Masstricht Ankylosing Spondylitis Enthesitis Score (MASES);Tender Joint Count, TJC / Swollen Joint Count, SJC ;Erythrocyte sedimentation rate, ESR;high sensitivity C-reactive protein, hsCRP;ASAS-health index;EQ-5D-5L;(Incremental cost-effectiveness ratio, ICER) | — |
Countries
Korea, Republic of
Contacts
Public Contactjihui shin
Hanyang University Seoul Hospital
Outcome results
None listed