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Completed

NCT Number: NCT00965653

A Study of Subcutaneously Administered Tocilizumab 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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St. John's, Newfoundland and Labrador, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline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

Treatment and study plan

Folic Acid

Drug

>/= 5 mg po weekly

methotrexate

Drug

7.5 - 25 mg weekly (oral or parenteral)

tocilizumab [RoActemra/Actemra]

Drug

162 mg sc weekly (QW)for 12 weeks

Primary outcomes

  1. 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

  2. Pharmacodynamic responses of CRP

    Time frame: sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment

  3. 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.

Secondary outcomes

  1. Efficacy according to ACR and DAS-EULAR parameters

    Time frame: assessments on day 1 of weeks 1, 4, 8 and 12

  2. 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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2009
Study completion
2011
First posted
Aug 25, 2009
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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