A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00965653
First received: August 18, 2009
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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: tocilizumab [RoActemra/Actemra]
Drug: methotrexate
Drug: folic acid
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: tocilizumab [RoActemra/Actemra]
162 mg sc weekly (QW)for 12 weeks
Drug: methotrexate
7.5 - 25 mg weekly (oral or parenteral)
Drug: folic acid
>/= 5 mg po weekly
Active Comparator: 2 Drug: tocilizumab [RoActemra/Actemra]
162 mg sc every other week (Q2W) for 12 weeks
Drug: methotrexate
7.5 - 25 mg weekly (oral or parenteral)
Drug: folic acid
>/= 5 mg po weekly

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00965653

Locations
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
Spain
La Coruna, La Coruña, Spain, 15006
Santiago de Compostela, La Coruña, Spain, 15706
Sevilla, Spain, 41009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00965653     History of Changes
Other Study ID Numbers: NP22623, 2009-011349-18
Study First Received: August 18, 2009
Last Updated: August 4, 2014
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Folic Acid
Vitamin B Complex
Methotrexate
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents

ClinicalTrials.gov processed this record on August 18, 2014