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

• Sponsor: JW Pharmaceutical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01256736
• Collaborator: (none)
• Enrollment: 89
• Location: 1
• Arm: 1
• Duration (Months): 44.1
• Patients Per Site Per Month: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Tocilizumab; Drug: DMARDs	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 89 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Mar 1, 2010
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tocilizumab 8mg/kg + DMARDs	Drug: Tocilizumab; intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks; Drug: DMARDs; DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)

Outcome Measures

Primary Outcome Measures

1. Safety results [48weeks]

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

Secondary Outcome Measures

1. Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy [48weeks]

2. Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy [48weeks]

3. Change of individual parameter in ACR core set [48weeks]

4. Change of individual parameter in DAS28 [48weeks]

5. Change of individual parameter in Rheumatoid factor [48 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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• Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National Univ. Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• JW Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: JW Pharmaceutical
• ClinicalTrials.gov Identifier: NCT01256736
• Other Study ID Numbers: CWP-TCZ302
• First Posted: Dec 9, 2010
• Last Update Posted: Nov 20, 2013
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Nov 20, 2013