REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST)
NCT ID: NCT05164198
Last Updated: 2021-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
448 participants
INTERVENTIONAL
2022-01-15
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Open-label reduced-dose TNFi
Participants in the experimental arm will receive one of the intervention below according to the TNFi agent used at baseline:
1. Adalimumab 40mg subcutaneous every 3 weeks (Q3W) from week 0 to week 48.
2. Etanercept 50mg subcutaneous every 10 days (Q10D) from week 0 to week 48.
3. Golimumab 50mg (100mg if a participant's body weight ≥ 100kg) subcutaneous every 5 weeks (Q5W) from week 0 to week 48.
4. Remsima SC 120mg subcutaneous every 3 weeks (Q3W) from week 0 to week 48.
Adalimumab and its biosimilars
1. Active substance: Adalimumab
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 100mg/mL
4. Route of administration: Subcutaneous injection
Biological: Etanercept and its biosimilars
1. Active substance: Etanercept
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 50mg/mL
4. Route of administration: Subcutaneous injection
Golimumab
1. Active substance: Adalimumab
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 100mg/mL
4. Route of administration: Subcutaneous injection
Infliximab biosimilar
1. Active substance: Infliximab
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 120mg/mL
4. Route of administration: Subcutaneous injection
Open-label full-dose TNFi
Participants in the comparator arm will receive one of the intervention below according to the TNFi agent used at baseline:
1. Adalimumab 40mg subcutaneous every 2 weeks (Q2W) from week 0 to week 48.
2. Etanercept 50mg subcutaneous every week (QW) from week 0 to week 48.
3. Golimumab 50mg (100mg if a participant's body weight ≥ 100kg) subcutaneous every 4 weeks (Q4W) from week 0 to week 48.
4. Remsima SC 120mg subcutaneous every 2 weeks (Q2W) from week 0 to week 48.
Adalimumab and its biosimilars
1. Active substance: Adalimumab
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 100mg/mL
4. Route of administration: Subcutaneous injection
Biological: Etanercept and its biosimilars
1. Active substance: Etanercept
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 50mg/mL
4. Route of administration: Subcutaneous injection
Golimumab
1. Active substance: Adalimumab
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 100mg/mL
4. Route of administration: Subcutaneous injection
Infliximab biosimilar
1. Active substance: Infliximab
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 120mg/mL
4. Route of administration: Subcutaneous injection
Interventions
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Adalimumab and its biosimilars
1. Active substance: Adalimumab
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 100mg/mL
4. Route of administration: Subcutaneous injection
Biological: Etanercept and its biosimilars
1. Active substance: Etanercept
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 50mg/mL
4. Route of administration: Subcutaneous injection
Golimumab
1. Active substance: Adalimumab
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 100mg/mL
4. Route of administration: Subcutaneous injection
Infliximab biosimilar
1. Active substance: Infliximab
2. Pharmaceutical form: Prefilled syringe
3. Concentration: 120mg/mL
4. Route of administration: Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 screening.
* Ankylosing Spondylitis Disease Activity Score (ASDAS) \< 2.1 at screening and 12 weeks prior to screening
* 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
* 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 Years
65 Years
ALL
No
Sponsors
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Linical Korea
INDUSTRY
Hanyang University Seoul Hospital
OTHER
Responsible Party
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Principal Investigators
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Tae-Hwan Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hanyang University
Central Contacts
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Other Identifiers
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HC21C0076
Identifier Type: -
Identifier Source: org_study_id