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Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Infliximab
Sponsored by
Celltrion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

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

Inclusion Criteria:

  • diagnosed with active rheumatoid arthritis
  • at least 3 months of treatment with methotrexate

Exclusion Criteria:

  • have allergies to infliximab
  • serious infection

Sites / Locations

  • Hanyang University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CT-P13

Remicade

Arm Description

Outcomes

Primary Outcome Measures

PK equivalence to remicade

Secondary Outcome Measures

efficacy endpoint
-ACR criteria comparison with Baseline at Weeks 14,30,54
efficacy endpoint
- Time to onset of ACR20 response
efficacy endpoint
- Mean decrease in disease activity measured by DAS28 comparison with Baseline at week 30
efficacy endpoint
- Proportion of patients with a good response, defined according to the EULAR response criteria
efficacy endpoint
- ACR20 at weeks 14 and 54
efficacy endpoint
- ACR50 and ACR70 at weeks 14, 30, and 54
efficacy endpoint
- Hybrid ACR response at weeks 14, 30, and 54
efficacy endpoint
- SDAI and CDAI at weeks 14, 30, and 54
efficacy endpoint
- Joint damage progression at week 54
efficacy endpoint
- SF-36 at weeks 14, 30, and 54
efficacy endpoint
- Fatigue
efficacy endpoint
- Number of patients requiring salvage retreatment at weeks 30 and 54

Full Information

First Posted
October 4, 2010
Last Updated
March 11, 2013
Sponsor
Celltrion
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1. Study Identification

Unique Protocol Identification Number
NCT01217086
Brief Title
Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)
Official Title
Randomized, Double-blind, Parallel-group, Phase 3 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
July 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 is the trial to see how our product is similar to remicade by comparing the results of blood samples when co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose and folic acid in rheumatoid arthritis patients who are not receiving adequate response to methotrexate alone up to week 30.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
617 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT-P13
Arm Type
Active Comparator
Arm Title
Remicade
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Infliximab
Other Intervention Name(s)
remicade
Intervention Description
Infliximab 3mg/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 30
Secondary Outcome Measure Information:
Title
efficacy endpoint
Description
-ACR criteria comparison with Baseline at Weeks 14,30,54
Time Frame
up to week 54.
Title
efficacy endpoint
Description
- Time to onset of ACR20 response
Time Frame
Up to week 54.
Title
efficacy endpoint
Description
- Mean decrease in disease activity measured by DAS28 comparison with Baseline at week 30
Time Frame
Up to week 54.
Title
efficacy endpoint
Description
- Proportion of patients with a good response, defined according to the EULAR response criteria
Time Frame
Up to week 54.
Title
efficacy endpoint
Description
- ACR20 at weeks 14 and 54
Time Frame
Up to week 54.
Title
efficacy endpoint
Description
- ACR50 and ACR70 at weeks 14, 30, and 54
Time Frame
Up to week 54.
Title
efficacy endpoint
Description
- Hybrid ACR response at weeks 14, 30, and 54
Time Frame
Up to week 54.
Title
efficacy endpoint
Description
- SDAI and CDAI at weeks 14, 30, and 54
Time Frame
Up to week 54.
Title
efficacy endpoint
Description
- Joint damage progression at week 54
Time Frame
Up to week 54.
Title
efficacy endpoint
Description
- SF-36 at weeks 14, 30, and 54
Time Frame
Up to week 54.
Title
efficacy endpoint
Description
- Fatigue
Time Frame
Up to week 54.
Title
efficacy endpoint
Description
- Number of patients requiring salvage retreatment at weeks 30 and 54
Time Frame
Up to week 54.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with active rheumatoid arthritis at least 3 months of treatment with methotrexate Exclusion Criteria: have allergies to infliximab serious infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Hyun Yoo
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang University Medical Center
City
Seoul
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
27038608
Citation
Yoo DH, Racewicz A, Brzezicki J, Yatsyshyn R, Arteaga ET, Baranauskaite A, Abud-Mendoza C, Navarra S, Kadinov V, Sariego IG, Hong SS, Lee SY, Park W. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther. 2016 Apr 2;18:82. doi: 10.1186/s13075-016-0981-6.
Results Reference
derived
PubMed Identifier
23687260
Citation
Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, Kovalenko V, Prodanovic N, Abello-Banfi M, Gutierrez-Urena S, Morales-Olazabal L, Tee M, Jimenez R, Zamani O, Lee SJ, Kim H, Park W, Muller-Ladner U. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013 Oct;72(10):1613-20. doi: 10.1136/annrheumdis-2012-203090. Epub 2013 May 16.
Results Reference
derived

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Program evaLuating the Autoimmune Disease iNvEstigational Drug cT-p13 in RA Patients(PLANETRA)

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