A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: folic acid; Drug: methotrexate; Drug: tocilizumab [RoActemra/Actemra]

• Registration Number: NCT00965653
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-21
• Study First Posted: 2009-08-25
• Study Completion: 2011-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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• DMARDs and anti-TNFs, other than methotrexate, withdrawn prior to baseline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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	methotrexate	-
2	tocilizumab [RoActemra/Actemra]	-
1	folic acid	-
1	tocilizumab [RoActemra/Actemra]	-
2	folic acid	-
1	methotrexate	-

Primary Outcome Measures

Name	Time	Method
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
Pharmacodynamic responses of CRP	sampling in weeks 1 and 2 and at weekly or bi-weekly intervals throughout treatment
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.

Secondary Outcome Measures

Name	Time	Method
Efficacy according to ACR and DAS-EULAR parameters	assessments on day 1 of weeks 1, 4, 8 and 12
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