Study of Tocilizumab in Combination With Methotrexate for 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:
NCT01258712
First received: December 8, 2010
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis (RA)
Drug: Tocilizumab + methotrexate(MTX)
Drug: Tocilizumab placebo + methotrexate(MTX)
Phase 3

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
Official Title: Randomized, Placebo-controlled Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients

Resource links provided by NLM:


Further study details as provided by Chugai Pharma Taiwan:

Primary Outcome Measures:
  • Proportion of patients with an American College of Rheumatology 20(ACR20) response [ Time Frame: at baseline and week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with ACR50 response [ Time Frame: at baseline and week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients with ACR70 response [ Time Frame: at baseline and 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 ]
  • Result of 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 (including Hb, Ht, RBC, WBC & differential, platelet counts). [ 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 (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 ] [ 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: 86
Study Start Date: December 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Tocilizumab + methotrexate(MTX)
Tocilizumab:8 mg/kg every4weeks,IV infusion methotrexate:10-20 mg/week
Placebo Comparator: 2 Drug: Tocilizumab placebo + methotrexate(MTX)
Tocilizumab placebo: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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258712

Locations
Taiwan
Buddhist Dalin Tzu Chi General Hospital
Chiayi, Taiwan
Chang Gung Memorial Hospital -Kaohsiung
Kaohsiung, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Cathay 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: NCT01258712     History of Changes
Other Study ID Numbers: MRA230TW
Study First Received: December 8, 2010
Last Updated: December 12, 2012
Health Authority: Taiwan : Food and Drug Administration

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 August 01, 2014