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A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00965653
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

August 18, 2009
August 25, 2009
November 2, 2016
August 2009
Not Provided
  • 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 ]
  • Pharmacodynamic responses of CRP [ Time Frame: sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment ]
  • 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. ]
  • Pharmacokinetics of TCZ after QW or Q2W sc administration [ Time Frame: multiple sampling after 1st and last dose, weeks 1 and 11/12, at bi-weekly intervals during treatment and twice on follow-up ]
  • Pharmacodynamic responses of CRP [ Time Frame: sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment ]
  • 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. ]
Complete list of historical versions of study NCT00965653 on ClinicalTrials.gov Archive Site
  • Efficacy according to ACR and DAS-EULAR parameters [ Time Frame: assessments on day 1 of weeks 1, 4, 8 and 12 ]
  • 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 ]
  • Efficacy according to ACR and DAS-EULAR parameters [ Time Frame: assessments on day 1 of weeks 1, 4, 8 and 12 ]
  • PD responses of IL-6, sIL-6R and anti TCZ antibody [ Time Frame: multiple sampling after 1st and last dose, weeks 1 and 11/12, at bi-weekly intervals during treatment and twice on follow-up ]
Not Provided
Not Provided
 
A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis
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
This open-label randomized 2arm study will investigate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneously administered tocilizumab in patients with rheumatoid arthritis who have shown an inadequate response to methotrexate. Patients will be randomized to receive tocilizumab 162 mg sc either weekly or every other week, in combination with methotrexate, for 12 weeks. Assessments will be made at regular intervals during treatment and on the 3 weeks of follow-up.Target sample size is < 50 individuals.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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
  • Drug: tocilizumab [RoActemra/Actemra]
    162 mg sc every other week (Q2W) for 12 weeks
  • Experimental: 1
    Interventions:
    • Drug: folic acid
    • Drug: methotrexate
    • Drug: tocilizumab [RoActemra/Actemra]
  • Active Comparator: 2
    Interventions:
    • Drug: folic acid
    • Drug: methotrexate
    • Drug: tocilizumab [RoActemra/Actemra]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
24
July 2011
Not Provided

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   New Zealand,   Spain
United Kingdom
 
NCT00965653
NP22623
2009-011349-18
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP