Text Size

Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chugai Pharma Taiwan
ClinicalTrials.gov Identifier:
NCT01347983
First received: May 3, 2011
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

24 week open-labeled extension study to continue monitoring the same group of patients in the previous MRA230TW phase IIIb trial in order to evaluate the long term efficacy and safety of tocilizumab.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: Tocilizumab+Methotrexate(MTX)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chugai Pharma Taiwan:

Primary Outcome Measures:
  • Proportion of patients with an American College of Rheumatology 70 (ACR70) response [ Time Frame: at week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with ACR50 response [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients with ACR20 response [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively [ Time Frame: at baseline and week 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28) [ Time Frame: at baseline and week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving DAS28 remission (DAS28 < 2.6) [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Adverse event incidence [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: Yes ]
  • Mean change from baseline to evaluation visits in vital signs [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: Yes ]
  • Change in Electrocardiogram. From baseline to evaluation visits [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: Yes ]
  • Mean change from baseline visit to evaluation visits in quantitative hematological exam results. [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: Yes ]
  • Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results. [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: Yes ]
  • Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results. [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: Yes ]
  • Mean change from baseline visit to evaluation visits in quantitative urinalysis results. [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: Yes ]

Enrollment: 72
Study Start Date: May 2011
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tocilizumab+Methotrexate(MTX)
    Tocilizumab: 8 mg/kg every 4 weeks, IV infusion Methotrexate: 10-20 mg/week
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who had completed at least 5 out of the 7 visits scheduled for weeks 2, 4, 8, 12, 16, 20 and 24 in the tocilizumab Phase IIIb study(MRA230TW).
  • Patients assigned in the Phase IIIb study(MRA230TW), who had received scheduled dose for at least 16 weeks but still failed to achieve adequate treatment response characterized by ACR20

Exclusion Criteria:

  • Patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment.
  • Patients with rheumatoid autoimmune disease other than RA, including but not limited to SLE(system lupus erythematosus), or significant systemic involvement secondary to RA.
  • Patients who belong to the Class IV of the ACR classification criteria for functional status of RA. (ACR Amended Criteria for the Classification of Functional Capacity in Rheumatoid Arthritis; Class IV: Largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care).
  • Patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them.
  • Patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(TB),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis B, hepatitis C, or herpes zoster and etc. However, a patient with hand & foot fungal infections can participate.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347983

Locations
Taiwan
Buddhist Dalin Tzu Chi General Hospital
Chiayi, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan
Chang Gung Memorial Hospital -Kaohsiung
Kaohsiung, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Cathay General Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan, Taiwan
Sponsors and Collaborators
Chugai Pharma Taiwan
Investigators
Study Chair: Yoshiaki Someya Chugai Pharma Taiwan
  More Information

No publications provided

Responsible Party: Chugai Pharma Taiwan
ClinicalTrials.gov Identifier: NCT01347983     History of Changes
Other Study ID Numbers: MRA230TW EX
Study First Received: May 3, 2011
Last Updated: April 3, 2013
Health Authority: Taiwan : Food and Drug Administration

Keywords provided by Chugai Pharma Taiwan:
RA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013