search
Back to results

To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tocilizumab
DMARDs
Sponsored by
JW Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients Who have been satisfied the in/exclusion criteria of CWP-TCZ301
  • Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study
  • Patients who able to enroll in this study within 12 weeks after last infusion of CWP-TCZ301
  • Willing to give written informed consent

Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions to Investigational product in CWP-TCZ301 study
  • ALT or AST > ULNⅹ2.5
  • Platelet count < 100ⅹ103/ μL
  • WBC < 3,000/mm3
  • Absolute neutrophil count < 1,000/mm3
  • Absolute lymphocyte count < 500/mm3
  • Total bilirubin > ULNⅹ2

Sites / Locations

  • Seoul National Univ. Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tocilizumab 8mg/kg + DMARDs

Arm Description

Outcomes

Primary Outcome Measures

Safety results
All AE/ADR during study Physical examination including vital signs and ECG Clinical laboratory results

Secondary Outcome Measures

Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy
Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy
Change of individual parameter in ACR core set
Change of individual parameter in DAS28
Change of individual parameter in Rheumatoid factor

Full Information

First Posted
October 28, 2010
Last Updated
November 18, 2013
Sponsor
JW Pharmaceutical
search

1. Study Identification

Unique Protocol Identification Number
NCT01256736
Brief Title
To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Official Title
Prospective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Pharmaceutical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate 1 year extension study of the efficacy and the safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with moderate to severe active RA and an inadequate response to current DMARD.

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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tocilizumab 8mg/kg + DMARDs
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks
Intervention Type
Drug
Intervention Name(s)
DMARDs
Intervention Description
DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)
Primary Outcome Measure Information:
Title
Safety results
Description
All AE/ADR during study Physical examination including vital signs and ECG Clinical laboratory results
Time Frame
48weeks
Secondary Outcome Measure Information:
Title
Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy
Time Frame
48weeks
Title
Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy
Time Frame
48weeks
Title
Change of individual parameter in ACR core set
Time Frame
48weeks
Title
Change of individual parameter in DAS28
Time Frame
48weeks
Title
Change of individual parameter in Rheumatoid factor
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients Who have been satisfied the in/exclusion criteria of CWP-TCZ301 Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study Patients who able to enroll in this study within 12 weeks after last infusion of CWP-TCZ301 Willing to give written informed consent Exclusion Criteria: History of severe allergic or anaphylactic reactions to Investigational product in CWP-TCZ301 study ALT or AST > ULNⅹ2.5 Platelet count < 100ⅹ103/ μL WBC < 3,000/mm3 Absolute neutrophil count < 1,000/mm3 Absolute lymphocyte count < 500/mm3 Total bilirubin > ULNⅹ2
Facility Information:
Facility Name
Seoul National Univ. Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32508063
Citation
Choi IA, Sagawa A, Lee EY, Lee EB, Song YW. Tocilizumab Increases Body Weight and Serum Adipokine Levels in Patients with Rheumatoid Arthritis Independently of Their Treatment Response: a Retrospective Cohort Study. J Korean Med Sci. 2020 Jun 8;35(22):e155. doi: 10.3346/jkms.2020.35.e155.
Results Reference
derived

Learn more about this trial

To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

We'll reach out to this number within 24 hrs