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

NCT01217086 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 617

Last updated 2013-03-12

No results posted yet for this study

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

Interventions

DRUG

Infliximab

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

Sponsors & Collaborators

Principal Investigators

  • Dae Hyun Yoo · Hanyang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-11-30
Completion
2012-07-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217086 on ClinicalTrials.gov