A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs

Rheumatoid Arthritis Clinical Trial

Official title:

Open Label, Multicenter Study to Evaluate the Effect of Tocilizumab in Combination With DMARDs in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Magnetic Resonance Imaging (MRI) of the Hand of Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996606
• Other study ID #: ML22413
• Secondary ID: 2009-012185-32
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2009
• Last updated: March 1, 2016
• Start date: October 2009
• Est. completion date: April 2012

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: ITALY: Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This open-label, single arm study will evaluate the efficacy and safety of tocilizumab in combination with DMARDs in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to DMARDs. Patients will receive tocilizumab (8mg/kg iv infusion) every 4 weeks in addition to their current DMARD therapy. Anticipated time on study treatment is 48 weeks, and the target sample size is <100.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >/=18 years of age

• moderate to severe active rheumatoid arthritis of >/=6 months duration

• DAS >/=3.2

• inadequate response to a stable dose of DMARDs

• patients receiving oral corticosteroids must have been at stable dose on >/=25 days in the 28 days prior to first study treatment

Exclusion Criteria:

• rheumatic autoimmune disease other than RA

• history of or current joint disease other than RA

• previous treatment with a biologic

• intraarticular or parenteral corticosteroids within 6 weeks prior to baseline

• previous treatment with any cell-depleting therapies

• functional class IV (ACR)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• DMARDs
stable dose as prescribed
• tocilizumab [RoActemra/Actemra]
8mg/kg iv infusion every 4 weeks for 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on synovitis, bone marrow edema and erosions, assessed by MRI of the hand		weeks 4, 8, 12, 24 and 48	No
Secondary	Early effect on synovitis, bone marrow edema and erosions, assessed by MRI of the hand		day 15	No
Secondary	Clinical response: DAS 28, HAQ, VAS, ESR, CRP, VGEF, Hb		assessed every 4 weeks	No
Secondary	AEs, laboratory parameters		throughout study, laboratory parameters assessed every 4 weeks	No