A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965653
• Other study ID #: NP22623
• Secondary ID: 2009-011349-18
• Status: Completed
• Phase: Phase 1
• First received: August 18, 2009
• Last updated: November 1, 2016
• Start date: August 2009
• Est. completion date: July 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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• DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Canada,  New Zealand,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of TCZ after QW or Q2W sc administration		multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up	No
Primary	Pharmacodynamic responses of CRP		sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment	No
Primary	Safety and tolerability, including injection site reaction		laboratory assessments every 2nd week on treatment and after 3 weeks follow-up, injection site evaluation after 1st, 2nd and last injection.	No
Secondary	Efficacy according to ACR and DAS-EULAR parameters		assessments on day 1 of weeks 1, 4, 8 and 12	No
Secondary	PD responses of IL-6, sIL-6R and anti TCZ antibody		multiple sampling after 1st and last dose, weeks 1 and 12, at bi-weekly intervals during treatment and twice on follow-up	No