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

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Infliximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01217086

CT-P13 3.1

Details and patient eligibility

About

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.

Enrollment: 617 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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617 participants in 2 patient groups

CT-P13

Active Comparator group

Treatment:

Drug: Infliximab

Remicade

Active Comparator group

Treatment:

Drug: Infliximab