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REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST)

NCT05164198 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2021-12-20

No results posted yet for this study

Summary

Participants maintaining stable disease activity of Ankylosing Spondylitis (AS) with standard-dose tumor necrosis factor inhibitor (TNFi) treatment will randomly split into two groups: maintaining standard-dose TNFi, versus reduced-dose TNFi. The proportion of participants not underwent flare between the two groups will be analyzed.

Conditions

Interventions

BIOLOGICAL

Adalimumab and its biosimilars

1. Active substance: Adalimumab 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 100mg/mL 4. Route of administration: Subcutaneous injection

BIOLOGICAL

Biological: Etanercept and its biosimilars

1. Active substance: Etanercept 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 50mg/mL 4. Route of administration: Subcutaneous injection

BIOLOGICAL

Golimumab

1. Active substance: Adalimumab 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 100mg/mL 4. Route of administration: Subcutaneous injection

BIOLOGICAL

Infliximab biosimilar

1. Active substance: Infliximab 2. Pharmaceutical form: Prefilled syringe 3. Concentration: 120mg/mL 4. Route of administration: Subcutaneous injection

Sponsors & Collaborators

  • Linical Korea

    collaborator INDUSTRY

  • Hanyang University Seoul Hospital

    lead OTHER

Principal Investigators

  • Tae-Hwan Kim, MD, PhD · Hanyang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-15
Primary Completion
2024-10-31
Completion
2024-10-31
FDA Drug
Yes

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05164198 on ClinicalTrials.gov