A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

NCT ID: NCT00887341

Last Updated: 2014-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-12-31

Brief Summary

This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using 2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have shown an inadequate response to DMARDs (Disease Modifying Anti Rheumatic Drugs) or anti-TNFs.Patients will be randomized to one of 2 groups, to receive tocilizumab 8mg/kg iv every 4 weeks either a)over a 1h infusion time for all administrations or b) a 1h infusion time for the first administration, followed by a 31 minute infusion time for subsequent administrations (unless drug-related infusion reactions occur).The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Conditions

Rheumatoid Arthritis

Study Design

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

Study Groups

1

Group Type: EXPERIMENTAL

tocilizumab [RoActemra/Actemra]

Intervention Type: DRUG

8mg/kg iv every 4 weeks for 6 infusions; first infusion 1h duration, subsequent infusions 31 minutes duration

2

Group Type: ACTIVE_COMPARATOR

tocilizumab [RoActemra/Actemra]

Intervention Type: DRUG

8mg/kg iv every 4 weeks for 6 infusions; each infusion 1h duration

Interventions

tocilizumab [RoActemra/Actemra]

8mg/kg iv every 4 weeks for 6 infusions; first infusion 1h duration, subsequent infusions 31 minutes duration

Intervention Type: DRUG

tocilizumab [RoActemra/Actemra]

8mg/kg iv every 4 weeks for 6 infusions; each infusion 1h duration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• adult patients, >=18 years of age;
• active moderate or severe rheumatoid arthritis;
• active disease for >6 months;
• inadequate response to a stable dose of non-biologic DMARDs or antiTNFs.

Exclusion Criteria

• rheumatic autoimmune disease other than rheumatoid arthritis;
• prior history of, 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.

• 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

Vitoria-Gasteiz, Alava, Spain

Villajoyosa, Alicante, Spain

Ávila, Avila, Spain

Menorca, Balearic Islands, Spain

Palma de Mallorca, Balearic Islands, Spain

Palma de Mallorca, Balearic Islands, Spain

Badalona, Barcelona, Spain

L'Hospitalet de Llobregat, Barcelona, Spain

Mollet del Vallès, Barcelona, Spain

Torrelavega, Cantabria, Spain

Castellon, Castellon, Spain

Alcalá de Henares, Madrid, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

San Sebastián de los Reyes, Madrid, Spain

Vigo, Pontevedra, Spain

Vigo, Pontevedra, Spain

Gijón, Principality of Asturias, Spain

Oviedo, Principality of Asturias, Spain

Alzira, Valencia, Spain

San Juan, Valencia, Spain

Valenica, Valencia, Spain

Galdakao, Vizcaya, Spain

Zaragoza, Zaragoza, Spain

Countries

Spain

Other Identifiers

2008-006443-39

Identifier Type: -

Identifier Source: secondary_id

ML22254

Identifier Type: -

Identifier Source: org_study_id