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

Primary Purpose

Ankylosing Spondylitis

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Infliximab

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Inha University Hostpital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

CT-P13

Remicade

Arm Description

infliximab

Outcomes

Primary Outcome Measures

PK equivalence to remicade

Secondary Outcome Measures

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

Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 40 criteria

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline

Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 14, 30 and 54 compared with Baseline

Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 30 and 54 compared with Baseline

Chest expansion at Weeks 14, 30 and 54 compared with Baseline

Quality of life questionnaire (SF-36)

Full Information

NCT ID

NCT01220518

First Posted

October 4, 2010

Last Updated

March 11, 2013

Sponsor

Celltrion

1. Study Identification

Unique Protocol Identification Number

NCT01220518

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celltrion

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankylosing Spondylitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

257 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CT-P13

Arm Type

Active Comparator

Arm Description

infliximab

Arm Title

Remicade

Arm Type

Active Comparator

Arm Description

infliximab

Intervention Type

Drug

Intervention Name(s)

Infliximab

Intervention Description

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

Primary Outcome Measure Information:

Title

PK equivalence to remicade

Time Frame

PK sampling at week 22

Secondary Outcome Measure Information:

Title

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

Time Frame

at week 14, 30 and 54

Title

Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 40 criteria

Time Frame

at week 14, 30 and 54

Title

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline

Time Frame

at week 14, 30 and 54

Title

Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 14, 30 and 54 compared with Baseline

Time Frame

at week 14, 30 and 54

Title

Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 30 and 54 compared with Baseline

Time Frame

at weeks 14, 30 and 54

Title

Chest expansion at Weeks 14, 30 and 54 compared with Baseline

Time Frame

at weeks 14, 30 and 54

Title

Quality of life questionnaire (SF-36)

Time Frame

at week 14, 30 and 54

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Won Park, M.D., Ph.D.

Organizational Affiliation

Inha University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inha University Hostpital

City

Incheon

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

32905628

Citation

Eser A, Reinisch W, Schreiber S, Ahmad T, Boulos S, Mould DR. Increased Induction Infliximab Clearance Predicts Early Antidrug Antibody Detection. J Clin Pharmacol. 2021 Feb;61(2):224-233. doi: 10.1002/jcph.1732. Epub 2020 Sep 9.

Results Reference

derived

PubMed Identifier

26795209

Citation

Park W, Yoo DH, Jaworski J, Brzezicki J, Gnylorybov A, Kadinov V, Sariego IG, Abud-Mendoza C, Escalante WJ, Kang SW, Andersone D, Blanco F, Hong SS, Lee SH, Braun J. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther. 2016 Jan 20;18:25. doi: 10.1186/s13075-016-0930-4.

Results Reference

derived

Learn more about this trial

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

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