Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 18, 2009
Last updated: November 3, 2014
Last verified: November 2014

This open-label randomized 2arm study will investigate the pharmacokinetics, pha rmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to met hotrexate. Patients will be randomized to receive tocilizumab 162 mg sc either w eekly or every other week, in combination with methotrexate, for 12 weeks. Asses sments will be made at regular intervals during treatment and on the 3 weeks of follow-up.Target sample size is < 50 individuals.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: folic acid
Drug: methotrexate
Drug: tocilizumab [RoActemra/Actemra]
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Multicenter, Randomized, Parallel Study to Investigate pk, pd, Efficacy and Safety of Tocilizumab (TCZ, RO4877533) Following Subcutaneous Administration of TCZ 162 mg Weekly or Every Other Week in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics of TCZ after QW or Q2W sc administration [ Time Frame: multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up ] [ Designated as safety issue: No ]
  • Pharmacodynamic responses of CRP [ Time Frame: sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment ] [ Designated as safety issue: No ]
  • Safety and tolerability, including injection site reaction [ Time Frame: laboratory assessments every 2nd week on treatment and after 3 weeks follow-up, injection site evaluation after 1st, 2nd and last injection. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy according to ACR and DAS-EULAR parameters [ Time Frame: assessments on day 1 of weeks 1, 4, 8 and 12 ] [ Designated as safety issue: No ]
  • PD responses of IL-6, sIL-6R and anti TCZ antibody [ Time Frame: multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: August 2009
Estimated Study Completion Date: July 2011
Arms Assigned Interventions
Experimental: 1 Drug: folic acid
>/= 5 mg po weekly
Drug: methotrexate
7.5 - 25 mg weekly (oral or parenteral)
Drug: tocilizumab [RoActemra/Actemra]
162 mg sc weekly (QW)for 12 weeks
Active Comparator: 2 Drug: folic acid
>/= 5 mg po weekly
Drug: methotrexate
7.5 - 25 mg weekly (oral or parenteral)
Drug: tocilizumab [RoActemra/Actemra]
162 mg sc every other week (Q2W) for 12 weeks


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adults 18 - 75 years of age
  • active rheumatoid arthritis of >/= 6 months duration
  • inadequate response to at least 12 weeks of methotrexate, the last 8 prior to baseline on stable dose
  • swollen joint count (SJC)>/=4, tender joint count (TJC)>/=6 at screening and baseline
  • DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline
  • oral corticosteroids (</= 10mg/day prednisone or equivalent) and NSAIDS on stable dose </= 4 weeks prior to baseline

Exclusion Criteria:

  • rheumatic autoimmune disease other than rheumatoid arthritis
  • prior history or current inflammatory joint disease other than rheumatoid arthritis
  • major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
  • functional class IV by ACR classification
  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: NCT00965653

Canada, Newfoundland and Labrador
St John's, Newfoundland and Labrador, Canada, A1A 5E8
Canada, Ontario
Kitchener, Ontario, Canada, N2M 5N6
Canada, Quebec
Trois-rivieres, Quebec, Canada, G8Z 1Y2
New Zealand
Christchurch, New Zealand, 8011
La Coruna, La Coruña, Spain, 15006
Santiago de Compostela, La Coruña, Spain, 15706
Sevilla, Spain, 41009
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT00965653     History of Changes
Other Study ID Numbers: NP22623, 2009-011349-18
Study First Received: August 18, 2009
Last Updated: November 3, 2014
Health Authority: Spain: Ministry of Health

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 20, 2014