Long-Term Efficacy and Safety of CT-P10 in Patients With RA

Rheumatoid Arthritis Clinical Trial

Official title:

An Open-Label, Single-Arm, Maintenance Study to Demonstrate Long-Term Efficacy and Safety of CT-P10 in Patients With Rheumatoid Arthritis Who Were Treated With Rituximab (MabThera or CT-P10) in Study CT-P10 1.1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873443
• Other study ID #: CT-P10 1.3
• Secondary ID: 2012-005502-21
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2013
• Last updated: November 25, 2015
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and safety of CT-P10 co-administered with MTX and folic acid in patients with RA who have completed the scheduled visits in Study CT-P10 1.1

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient has disease improvement (moderate or good response) according to Disease Activity Score using 28 joint counts (DAS28) during the last course of treatment in Study CT-P10 1.1.

• Patient has completed all of the scheduled visits in the Study CT-P10 1.1 Main Study Period, including the Core Study Period and/or Extension Study Period.

Exclusion Criteria:

• Patient has been withdrawn from Study CT-P10 1.1 for any reason.

• Patient has, at the time of providing informed consent, any current medical issues such as serious adverse events (SAEs) or current or previous intolerance issues that mean continuation in this maintenance study could be detrimental to their health, in the opinion of the investigator.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Rituximab, MTX, folic acid
Rituximab IV 1000mg MTX 10~25mg/week Folic acid at least 5mg/week

Locations

Country	Name	City	State
Korea, Republic of	Inha University College of Medicine Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy evaluation by ACR criteria and safety evaluation by hypersensitivity monitoring	Efficacy will be assessed by evaluation of ACR criteria (ACR 20% , ACR 50% , ACR 70%, and hybrid ACR response), Safety will be assessed by evaluation of hypersensitivity monitoring via vital sign measurements (including blood pressure, heart and respiratory rates, and body temperature),etc,.	8 week interval	Yes