Multicenter, Prospective Clinical Trial for Optimizing TNFi dose Adjustment in AS patients with Stable Disease Activity

Not Applicable

Recruiting

• Conditions: Diseases of the musculoskeletal system and connective tissue

• Registration Number: KCT0006755
• Lead Sponsor: Hanyang University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 448

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

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) < 3000/µL and/or absolute neutrophil count (ANC) < 1500/µL
3) Platelet count <100,000/µL and/or hemoglobin level <8.5 g/dL
4) Serum creatinine = 1.5 X ULN
• Subjected with any high-potency opioids (ex. methadone, hydromorphone, morphine, oxycodone, oxymorphone, fentanyl, levorphanol, buprenorphine, meperidine)
• Subjects with current acute or chronic viral hepatitis B or C or with human immunodeficiency virus (HIV) infection
• Subjects planning to receive any live attenuated vaccinations after screening
• Subjects has history of chronic alcohol abuse or drug abuse within 6 months from screening
• Subjects concomitantly treated with systemic glucocorticoid (>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)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ASDAS-CRP /

Secondary Outcome Measures

Name	Time	Method
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)