Back to resultsLong-Term Efficacy and Safety of CT-P10 in Patients With RA
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rituximab, MTX, folic acid
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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- Patient has been withdrawn from Study CT-P10 1.1 for any reason.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.
Sites / Locations
- Inha University College of Medicine Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rituximab, MTX, folic acid
Arm Description
Outcomes
Primary Outcome Measures
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,.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01873443
Brief Title
Long-Term Efficacy and Safety of CT-P10 in Patients With RA
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rituximab, MTX, folic acid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rituximab, MTX, folic acid
Other Intervention Name(s)
Rituximab=CT-P10
Intervention Description
Rituximab IV 1000mg MTX 10~25mg/week Folic acid at least 5mg/week
Primary Outcome Measure Information:
Title
Efficacy evaluation by ACR criteria and safety evaluation by hypersensitivity monitoring
Description
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,.
Time Frame
8 week interval
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DaeHyun Yoo, Ph.D
Organizational Affiliation
Hanyang University
Official's Role
Study Director
Facility Information:
Facility Name
Inha University College of Medicine Hospital
City
Incheon
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
28600696
Citation
Park W, Suh CH, Shim SC, Molina FFC, Jeka S, Medina-Rodriguez FG, Hrycaj P, Wiland P, Lee EY, Shesternya P, Kovalenko V, Myasoutova L, Stanislav M, Radominski S, Lim MJ, Choe JY, Lee SJ, Lee SY, Kim SH, Yoo DH. Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis. BioDrugs. 2017 Aug;31(4):369-377. doi: 10.1007/s40259-017-0233-6.
Results Reference
derived
Learn more about this trial
Long-Term Efficacy and Safety of CT-P10 in Patients With RA
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