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CompletedNCT01258712Updated Dec 13, 2012

Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients

A Phase 3 interventional study of Tocilizumab + methotrexate(MTX) and Tocilizumab placebo + methotrexate(MTX) in Rheumatoid Arthritis (RA), sponsored by Chugai Pharma Taiwan. Completed at 12 sites in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-12-13.

Sponsored by Chugai Pharma Taiwan · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study summary

This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with Rheumatoid Arthritis.

02

Conditions studied

  • Rheumatoid Arthritis (RA)
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 86 is close to the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Chugai Pharma Taiwan is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients diagnosed with history of moderate-to- severe rheumatoid arthritis for more than 6 months according to the American College of Rheumatology (ACR) 1987 revised criteria for the classification of RA.
  • Patients who failed to achieve clinical response to treatment of at least 2 DMARDs(disease modifying anti-rheumatic drug) (including MTX) for at least 12 weeks within 12 months prior to screening, of which MTX must have been at a stable dose of 10-20 mg/wk for at least 12 weeks prior to screening. All other DMARDs should be given at standard therapeutic dose.
  • Patients who satisfy swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
  • C-reactive protein (CRP) level ≥ 1 mg/dl or an erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour at screening and at baseline.

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    1

    Drug: Tocilizumab + methotrexate(MTX)

  • Placebo comparator
    2

    Drug: Tocilizumab placebo + methotrexate(MTX)

Interventions

  • DrugTocilizumab + methotrexate(MTX)

    Tocilizumab:8 mg/kg every4weeks,IV infusion methotrexate:10-20 mg/week

  • DrugTocilizumab placebo + methotrexate(MTX)

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

06

What researchers measure

Primary outcomes

  1. Proportion of patients with an American College of Rheumatology 20(ACR20) response

    Time frame: at baseline and week 24

Secondary outcomes

  1. Proportion of patients with ACR50 response

    Time frame: at baseline and week 24

  2. Proportion of patients with ACR70 response

    Time frame: at baseline and 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. Result of 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 (including Hb, Ht, RBC, WBC & differential, platelet counts).

    Time frame: from baseline to week 24

  10. Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results (including AST, ALT, Alk-p, γ-GTP, LDH, total protein, albumin, total bilirubin, BUN, uric acid, creatinine, glucose, ferritin, K, Na, Cl, Ca, P.).

    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

07

Study locations

12 sites
  • Buddhist Dalin Tzu Chi General Hospital
    Chiayi, Taiwan
  • Chang Gung Memorial Hospital -Kaohsiung
    Kaohsiung, Taiwan
  • Kaohsiung Medical University Hospital
    Kaohsiung, Taiwan
  • Kaohsiung Veterans General Hospital
    Kaohsiung, Taiwan
  • Chung Shan Medical University Hospital
    Taichung, Taiwan
  • Taichung Veterans General 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01258712
Lead sponsor
Chugai Pharma Taiwan
Responsible party
Sponsor
First posted
Dec 13, 2010
Start date
Dec 2010
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Dec 13, 2012

Study contacts

Yoshiaki Someya
study chair · Chugai Pharma Taiwan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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