NCT01217086

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

Randomized, Double-blind, Parallel-group, Phase 3 Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 617 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-11-01
• Completion: 2012-07-01
• First posted: 2010-10-08
• Last updated: 2013-03-12

Locations

1 site across 1 country: South Korea