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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217086
• Other study ID #: CT-P13 3.1
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2010
• Last updated: March 11, 2013
• Start date: October 2010
• Est. completion date: July 2012

Study information

• Verified date: March 2013
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 617
• Est. completion date: July 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK equivalence to remicade		PK sampling at week 30	No
Secondary	efficacy endpoint	-ACR criteria comparison with Baseline at Weeks 14,30,54	up to week 54.	No
Secondary	efficacy endpoint	- Time to onset of ACR20 response	Up to week 54.	No
Secondary	efficacy endpoint	- Mean decrease in disease activity measured by DAS28 comparison with Baseline at week 30	Up to week 54.	No
Secondary	efficacy endpoint	- Proportion of patients with a good response, defined according to the EULAR response criteria	Up to week 54.	No
Secondary	efficacy endpoint	- ACR20 at weeks 14 and 54	Up to week 54.	No
Secondary	efficacy endpoint	- ACR50 and ACR70 at weeks 14, 30, and 54	Up to week 54.	No
Secondary	efficacy endpoint	- Hybrid ACR response at weeks 14, 30, and 54	Up to week 54.	No
Secondary	efficacy endpoint	- SDAI and CDAI at weeks 14, 30, and 54	Up to week 54.	No
Secondary	efficacy endpoint	- Joint damage progression at week 54	Up to week 54.	No
Secondary	efficacy endpoint	- SF-36 at weeks 14, 30, and 54	Up to week 54.	No
Secondary	efficacy endpoint	- Fatigue	Up to week 54.	No
Secondary	efficacy endpoint	- Number of patients requiring salvage retreatment at weeks 30 and 54	Up to week 54.	No