A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment

NCT ID: NCT01468077

Last Updated: 2015-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-09-30

Brief Summary

This multi-center, randomized, parallel-group, active-controlled, open-label study will evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocilizumab) infusion time compared to the normal infusion time. Patients will be randomized to 8 mg/kg RoActemra/Actemra infusion of 31 minutes every 4 weeks or to RoActemra/Actemra 8 mg/kg infusion of 60 minutes every 4 weeks. The anticipated time on study treatment is 24 weeks.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tocilizumab, Normal Administration

Tocilizumab 8 mg/kg infusion of 60 minutes duration every 4 weeks for 6 infusions (up to 24 weeks)

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

8 mg/kg infusion

Tocilizumab, Fast Administration

Tocilizumab 8 mg/kg infusion of 31 minutes duration every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour. If an infusion reaction occurred during any treatment, 1 hour infusions were used for all subsequent infusions

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

8 mg/kg infusion

Interventions

Tocilizumab

8 mg/kg infusion

Intervention Type: DRUG

Other Intervention Names

RoActemra; Actemra

Eligibility Criteria

Inclusion Criteria

• Adult patients, at least 18 years of age, inclusive
• Diagnosis of rheumatoid arthritis of at least 6 months duration
• Moderate to severe active rheumatoid arthritis (DAS28 >/=3.2)
• Patients received at least 1 disease-modifying anti-rheumatic drug (DMARD) and/or 1 or more TNFalfa-inhibitors over a period of at least 8 weeks

Exclusion Criteria

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization
• Rheumatic autoimmune disease other than rheumatoid arthritis
• Prior history of or current inflammatory joint disease other than rheumatoid arthritis
• Functional class IV (ACR criteria)
• History of severe allergic reaction to human, humanized or murine monoclonal antibodies
• Known active current or history of recurrent infection (including tuberculosis)
• Primary or secondary immunodeficiency (history of or currently active)
• Body weight >150 kg
• Previous treatment with any cell-depleting therapies
• Previous treatment with tocilizumab

• 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

Aalborg, , Denmark

Frederiksberg, , Denmark

Hellerup, , Denmark

Holbæk, , Denmark

Odense, , Denmark

Silkeborg, , Denmark

Svendborg, , Denmark

Reykjavik, , Iceland

Countries

Denmark; Iceland

Other Identifiers

ML27901

Identifier Type: -

Identifier Source: org_study_id