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Rheumatoid ArthritisPhase 3NCT01347983

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

A Phase 3 study testing Tocilizumab+Methotrexate(MTX) in people with Rheumatoid Arthritis, run by Chugai Pharma Taiwan at 12 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Tocilizumab+Methotrexate(MTX)
Type of treatment
Injection or infusion
How many people
72 participants
Where
12 sitesTaiwan
Study dates
May 2011to Apr 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Taiwan12 sites

  • Buddhist Dalin Tzu Chi General Hospital

    Chiayi City

  • Chang Gung Memorial Hospital -Kaohsiung

    Kaohsiung City

  • Kaohsiung Medical University Hospital

    Kaohsiung City

  • Kaohsiung Veterans General Hospital

    Kaohsiung City

  • Chung Shan Medical University Hospital

    Taichung

  • Taichung Veterans General Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • Cathay General Hospital

    Taipei

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan

Other trials in Taiwan

About this study

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.

Being tested
Tocilizumab+Methotrexate(MTX)
Keywords
RA
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tocilizumab+Methotrexate(MTX)Drug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: at week 24

Secondary outcomes (12)

  1. Proportion of patients with ACR50 response

    Measured: at week 24

  2. Proportion of patients with ACR20 response

    Measured: at week 24

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

    Measured: at baseline and week 24

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

    Measured: at baseline and week 24

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

    Measured: at week 24

  6. Adverse event incidence

    Measured: from baseline to week 24

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

    Measured: from baseline to week 24

  8. Change in Electrocardiogram. From baseline to evaluation visits

    Measured: from baseline to week 24

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

    Measured: from baseline to week 24

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

    Measured: from baseline to week 24

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

    Measured: from baseline to week 24

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

    Measured: from baseline to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionMar 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01347983
Sponsor's protocol ID
MRA230TW EX
Status last verified
Apr 2013
First submitted
3 May 2011
Last updated
4 Apr 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tocilizumab+Methotrexate(MTX) in people with Rheumatoid Arthritis, run by Chugai Pharma Taiwan at 12 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with an American College of Rheumatology 70 (ACR70) response (time frame: at week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01347983.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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