A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: September 17, 2008
Last updated: March 3, 2014
Last verified: March 2014

This single arm, open-label study will assess the safety and efficacy with regard to reduction of signs and symptoms of treatment with tocilizumab in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is <500 individuals.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Drug: methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-arm, Open-label Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients with an ACR50 response [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with ACR20/70 responses; change from baseline in ACR core set components; change in disease activity score (DAS28); categorical DAS28 responders; Quality of Life assessments. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Adverse events, clinical laboratory tests, physical exam including vital signs. [ Time Frame: Throughout trial ] [ Designated as safety issue: No ]

Enrollment: 453
Study Start Date: February 2009
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 [RoActemra/Actemra]
8mg/kg iv, every 4 weeks
Drug: methotrexate
10-25mg oral or parenteral weekly.


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

Inclusion Criteria:

  • patients >=18 years with moderate to severe active RA for at least 6 months;
  • swollen joint count >=6 (66 joint count) and tender joint count >=8 (68 joint count) at screening;
  • inadequate response to stable dose of MTX;
  • patients of reproductive potential must be using a reliable means of contraception.

Exclusion Criteria:

  • rheumatic autoimmune disease other than RA;
  • patients with functional class IV RA;
  • diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of current inflammatory joint disease other than RA;
  • prior treatment failure with anti-tumor necrosis factor agent;
  • pregnant or breastfeeding women.
  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: NCT00754572

  Show 70 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
ClinicalTrials.gov Identifier: NCT00754572     History of Changes
Other Study ID Numbers: ML21530
Study First Received: September 17, 2008
Last Updated: March 3, 2014
Health Authority: Peru: Amador Vargas Guerra

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Signs and Symptoms
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

ClinicalTrials.gov processed this record on April 19, 2015