A Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih Active Rheumatoid Arthritis.

NCT ID: NCT00754559

Last Updated: 2016-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-11-30

Brief Summary

This single arm study will assess the effectiveness of tocilizumab in combination with traditional DMARDs with regard to the clinical improvement in disease activity (achievement of LDAS) after 24 weeks' treatment in patients with active rheumatoid arthritis (RA) who have had an inadequate response to current traditional DMARD and/or anti-TNF therapy. Patients will receive tocilizumab 8mg/kg iv every 4 weeks, in addition to ongoing DMARDs at the stable pre-entry dose prescribed by the physician, for a total of 6 infusions during the regular treatment period and a further 6 infusions during an optional extension phase. The anticipated time on study treatment is 6 to 12 months, and the target sample size is <500 individuals.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tocilizumab

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

8mg/kg iv every 4 weeks

Interventions

Tocilizumab

8mg/kg iv every 4 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• adult patients, >=18 years of age;
• rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987 ACR criteria;
• DAS28 of >3.2;
• At screening either ESR >=28 mm/h or CRP >=1 mg/dL;
• Having received permitted DMARDs, 1 or more; current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.

Exclusion Criteria

• major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening;
• functional class IV as identified by the ACR classification of functional status in RA;
• rheumatoid autoimmune disease other than RA;
• prior history of or current inflammatory joint disease other than RA.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Aachen, , Germany

Bad Abbach, , Germany

Bad Aibling, , Germany

Bad Bramstedt, , Germany

Bad Nauheim, , Germany

Baden-Baden, , Germany

Bayreuth, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Bremen, , Germany

Cologne, , Germany

Cologne, , Germany

Cuxhaven, , Germany

Damp, , Germany

Donaueschingen, , Germany

Dresden, , Germany

Dresden, , Germany

Dresden, , Germany

Düsseldorf, , Germany

Düsseldorf, , Germany

Erfurt, , Germany

Erlangen, , Germany

Erlangen, , Germany

Essen, , Germany

Frankfurt, , Germany

Frankfurt am Main, , Germany

Fulda, , Germany

Gommern, , Germany

Goslar, , Germany

Göttingen, , Germany

Grafschaft, , Germany

Hagen, , Germany

Halle, , Germany

Halle, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hanover, , Germany

Heidelberg, , Germany

Herne, , Germany

Hildesheim, , Germany

Hofheim, , Germany

Homburg/saar, , Germany

Hoyerswerda, , Germany

Leipzig, , Germany

Ludwigsfelde, , Germany

Ludwigshafen, , Germany

Lüneburg, , Germany

Mainz, , Germany

Mainz, , Germany

Marburg, , Germany

München, , Germany

München, , Germany

München, , Germany

München, , Germany

Münster, , Germany

Naunhof, , Germany

Neuss, , Germany

Nuremberg, , Germany

Oberammergau, , Germany

Osnabrück, , Germany

Pirna, , Germany

Plochingen, , Germany

Potsdam, , Germany

Ratingen, , Germany

Rostock, , Germany

Sendenhorst, , Germany

Stuttgart, , Germany

Stuttgart, , Germany

Treuenbrietzen, , Germany

Tübingen, , Germany

Ulm, , Germany

Wiesbaden, , Germany

Würselen, , Germany

Zeven, , Germany

Countries

Germany

Other Identifiers

2008-000105-11

Identifier Type: -

Identifier Source: secondary_id

ML21469

Identifier Type: -

Identifier Source: org_study_id