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

NCT01217086 | Completed Phase 3 DMC

• 1 other identifier: CT-P13 3.1
• Study Type: interventional
• Target: 617
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• PK equivalence to remicade

  PK sampling at week 30

Secondary Outcomes (12)

• efficacy endpoint

  up to week 54.

• efficacy endpoint

  Up to week 54.

• efficacy endpoint

  Up to week 54.

• efficacy endpoint

  Up to week 54.

• efficacy endpoint

  Up to week 54.

Study Arms (2)

CT-P13

ACTIVE COMPARATOR

Drug: Infliximab

Remicade

ACTIVE COMPARATOR

Drug: Infliximab

Interventions

Infliximab DRUG

Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.

Also known as: remicade

CT-P13; Remicade

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• have allergies to infliximab
• serious infection

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

Hanyang University Medical Center

Seoul, South Korea

Location

Related Publications (3)

• 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.

  PMID: 32905628 DERIVED

• 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.

  PMID: 27038608 DERIVED

• 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.

  PMID: 23687260 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Dae Hyun Yoo

  Hanyang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 8, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: July 1, 2012
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

KR (1)