Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in AS Patients(PLANETAS)

Phase 1CompletedNCT01220518

Celltrion257 enrolled

Overview

This study is the trial to demonstrate how our product is similar to remicade by comparing the results of blood samples in active Ankylosing Spondylitis patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

257

Conditions

Ankylosing Spondylitis

Interventions

InfliximabDRUG

Infliximab 5mg/kg is going to be administered for both arm as a 2-hour infusion per dose.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosed with active ankylosing spondylitis * BASDAI score ≥ 4 and visual analogue scale(VAS) score of spinal pain ≥ 4 Exclusion Criteria: * have total ankylosing of spine * have allergies to infliximab * serious infection

Locations (1)

Inha University Hostpital

Incheon, South Korea

Outcomes

Primary Outcomes

PK equivalence to remicade

Time frame: PK sampling at week 22

Secondary Outcomes

Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 20% criteria