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Completed

NCT Number: NCT01347983

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

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Buddhist Dalin Tzu Chi General Hospital, Chiayi City, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tocilizumab+Methotrexate(MTX)

Drug

Tocilizumab: 8 mg/kg every 4 weeks, IV infusion Methotrexate: 10-20 mg/week

Primary outcomes

  1. Proportion of patients with an American College of Rheumatology 70 (ACR70) response

    Time frame: at week 24

Secondary outcomes

  1. Proportion of patients with ACR50 response

    Time frame: at week 24

  2. Proportion of patients with ACR20 response

    Time frame: at week 24

  3. Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively

    Time frame: at baseline and week 24

  4. Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28)

    Time frame: at baseline and week 24

  5. Proportion of patients achieving DAS28 remission (DAS28 < 2.6)

    Time frame: at week 24

  6. Adverse event incidence

    Time frame: from baseline to week 24

  7. Mean change from baseline to evaluation visits in vital signs

    Time frame: from baseline to week 24

  8. Change in Electrocardiogram. From baseline to evaluation visits

    Time frame: from baseline to week 24

  9. Mean change from baseline visit to evaluation visits in quantitative hematological exam results.

    Time frame: from baseline to week 24

  10. Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results.

    Time frame: from baseline to week 24

  11. Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results.

    Time frame: from baseline to week 24

  12. Mean change from baseline visit to evaluation visits in quantitative urinalysis results.

    Time frame: from baseline to week 24

Sponsors and collaborators

Lead sponsor

Chugai Pharma Taiwan

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 5, 2011
Registry last updated
Apr 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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