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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Infliximab

• Registration Number: NCT01217086
• Lead Sponsor: Celltrion

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-04
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Primary Completion: 2011-11
• Study Completion: 2012-07
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 617

Inclusion Criteria

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

Exclusion Criteria

• have allergies to infliximab
• serious infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P13	Infliximab	-
Remicade	Infliximab	-

Primary Outcome Measures

Name	Time	Method
PK equivalence to remicade	PK sampling at week 30

Secondary Outcome Measures

Name	Time	Method
efficacy endpoint	Up to week 54.	- Number of patients requiring salvage retreatment at weeks 30 and 54

Trial Locations

Locations (1)

Hanyang University Medical Center; 🇰🇷 Seoul, Korea, Republic of