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

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ClinicalTrials.gov Identifier: NCT01873443
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : November 26, 2015
Sponsor:
Information provided by (Responsible Party):
Celltrion

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Rituximab, MTX, folic acid Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rituximab, MTX, folic acid Drug: Rituximab, MTX, folic acid
Rituximab IV 1000mg MTX 10~25mg/week Folic acid at least 5mg/week
Other Name: Rituximab=CT-P10




Primary Outcome Measures :
  1. Efficacy evaluation by ACR criteria and safety evaluation by hypersensitivity monitoring [ Time Frame: 8 week interval ]
    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,.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873443


Locations
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Korea, Republic of
Inha University College of Medicine Hospital
Incheon, Korea, Republic of
Sponsors and Collaborators
Celltrion
Investigators
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Study Director: DaeHyun Yoo, Ph.D Hanyang University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT01873443     History of Changes
Other Study ID Numbers: CT-P10 1.3
2012-005502-21 ( EudraCT Number )
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Folic Acid
Vitamin B Complex
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Hematinics
Vitamins
Micronutrients
Nutrients
Growth Substances