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

Phase 1

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Drug: Infliximab

• Registration Number: NCT01220518
• Lead Sponsor: Celltrion

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-14
• Primary Completion: 2011-11
• Study Completion: 2012-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 257

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P13	Infliximab	infliximab
Remicade	Infliximab	infliximab

Primary Outcome Measures

Name	Time	Method
PK equivalence to remicade	PK sampling at week 22

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 20% criteria	at week 14, 30 and 54
Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 40 criteria	at week 14, 30 and 54
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline	at week 14, 30 and 54
Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 14, 30 and 54 compared with Baseline	at week 14, 30 and 54
Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 30 and 54 compared with Baseline	at weeks 14, 30 and 54
Chest expansion at Weeks 14, 30 and 54 compared with Baseline	at weeks 14, 30 and 54
Quality of life questionnaire (SF-36)	at week 14, 30 and 54

Trial Locations

Locations (1)

Inha University Hostpital; 🇰🇷 Incheon, Korea, Republic of