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A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 20, 2011
Last updated: November 3, 2014
Last verified: November 2014

This randomized, double-blind, parallel-group study will evaluate the efficacy a nd safety of RoActemra/Actemra (tocilizumab) in combination with methotrexate ve rsus RoActemra/Actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate. All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus oral methotrexate for 16 weeks. P atients achieving low disease activity at Week 16 will be randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either methotrexate or p lacebo. Anticipated time on study treatment is 28 weeks.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: methotrexate
Drug: placebo
Drug: tocilizumab [RoActemra/Actemra]
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With MTX Versus Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 > 3,2)

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in disease activity (DAS28) score [ Time Frame: from Week 16 to Week 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients achieving DAS28 remission (DAS28 < 2.6) [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving clinical disease activity index (CDAI) remission (CDAI < 2.8) [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving simplified disease activity index (SDAI) remission (SDAI < 3.3) [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
  • Physical function: Health assessment questionnaire (HAQ) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Physical function: Short-form health survey (SF-12) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Physical function: Visual analogue scale fatigue (VAS Fatigue) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Enrollment: 261
Study Start Date: September 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: methotrexate
orally, Week 1 - 16
Drug: methotrexate
orally, Week 17-28
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 28 weeks
Active Comparator: B Drug: methotrexate
orally, Week 1 - 16
Drug: placebo
methotrexate placebo orally, Week 17-28
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 28 weeks


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Active moderate to severe rheumatoid arthritis (DAS28 >/= 3.2) at baseline
  • Currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at least 15 mg/week for at least 6 weeks prior to treatment (Day 1)
  • Body weight < 150 kg
  • Oral corticoids must have been at stable dose for at least 25 out of 28 days prior to baseline; maximum dose 10 mg/day

Exclusion Criteria:

  • Pregnant or nursing women
  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
  • Rheumatic autoimmune disease other than RA
  • Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
  • Prior history of or current inflammatory joint disease other than RA
  • Treatment with a biologic agent at any time prior to baseline
  • Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
  • Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
  • Previous treatment with RoActemra/Actemra
  • History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
  • Known active current or history of recurrent infection
  • History of or currently active primary or secondary immunodeficiency
  • Active tuberculosis requiring treatment within the previous 3 years
  • Positive for HIV infection
  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 identifier: NCT01399697

  Show 54 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01399697     History of Changes
Other Study ID Numbers: ML27828
Study First Received: July 20, 2011
Last Updated: November 3, 2014
Health Authority: Spain: Agencia Espanola del Medicamento y Productos Sanitarios (AEMPS)

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on November 23, 2014