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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01258712
• Date of registration: 08/12/2010
• Prospective Registration: No
• Primary sponsor: Chugai Pharma Taiwan
• Public title: Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients
• Scientific title: Randomized, Placebo-controlled Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients
• Date of first enrolment: December 2010
• Target sample size: 86
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01258712
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Taiwan

Contacts

• Name: Yoshiaki Someya
• Affiliation: Chugai Pharma Taiwan

Key inclusion & exclusion criteria

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:

- 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.



Age minimum: 20 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis (RA)

Intervention(s)

Drug: Tocilizumab placebo + methotrexate(MTX)

Drug: Tocilizumab + methotrexate(MTX)

Primary Outcome(s)

Proportion of patients with an American College of Rheumatology 20(ACR20) response [Time Frame: at baseline and week 24]

Secondary Outcome(s)

Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results. [Time Frame: from baseline to week 24]

Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively [Time Frame: at baseline and week 24]

Proportion of patients with ACR50 response [Time Frame: at baseline and week 24]

Mean change from baseline to evaluation visits in vital signs [Time Frame: from baseline to week 24]

Result of Electrocardiogram. From baseline to evaluation visits [Time Frame: from baseline to week 24]

Mean change from baseline visit to evaluation visits in quantitative urinalysis results. [Time Frame: from baseline to week 24]

Adverse event incidence [Time Frame: from baseline to week 24]

Proportion of patients achieving DAS28 remission (DAS28 < 2.6) [Time Frame: at week 24]

Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28) [Time Frame: at baseline and week 24]

Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results (including AST, ALT, Alk-p, ?-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]

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]

Proportion of patients with ACR70 response [Time Frame: at baseline and week 24]

Secondary ID(s)

MRA230TW

Source(s) of Monetary Support

Please refer to primary and secondary sponsors