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

Ankylosing Spondylitis Clinical Trial

Official title:

Randomized, Double-blind, Parallel-group, Phase 1 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220518
• Other study ID #: CT-P13 1.1
• Status: Completed
• Phase: Phase 1
• First received: October 4, 2010
• Last updated: March 11, 2013
• Start date: October 2010
• Est. completion date: June 2012

Study information

• Verified date: March 2013
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: June 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hostpital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK equivalence to remicade		PK sampling at week 22	No
Secondary	Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 20% criteria		at week 14, 30 and 54	No
Secondary	Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 40 criteria		at week 14, 30 and 54	No
Secondary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline		at week 14, 30 and 54	No
Secondary	Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 14, 30 and 54 compared with Baseline		at week 14, 30 and 54	No
Secondary	Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 30 and 54 compared with Baseline		at weeks 14, 30 and 54	No
Secondary	Chest expansion at Weeks 14, 30 and 54 compared with Baseline		at weeks 14, 30 and 54	No
Secondary	Quality of life questionnaire (SF-36)		at week 14, 30 and 54	No