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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00887341
First received: April 22, 2009
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Multi-centre, Randomized, Parallel Group, Pilot Trial to Compare the Incidence of Tocilizumab Related Infusion Reactions in Moderate to Severe RA Patients When Infusion is Made Over 1 Hour Against 31 Minutes

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Appearance of infusion reactions [ Time Frame: Event driven; monitored throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical remission(DAS28<2.6); ACR20/50/70/90 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Adverse events;laboratory parameters [ Time Frame: Throughout study, at each clinic visit ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: May 2009
Study Completion Date: May 2011
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks for 6 infusions; first infusion 1h duration, subsequent infusions 31 minutes duration
Active Comparator: 2 Drug: tocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks for 6 infusions; each infusion 1h duration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887341

Locations
Spain
Alcala de Henares, Spain, 28805
Alzira, Spain, 46600
Avila, Spain, 05071
Badalona, Spain, 08915
Castellon, Spain, 12004
Galdakao, Spain, 48960
Gijon, Spain, 33394
Hospitalet de Llobregat, Spain, 08906
Madrid, Spain, 28935
Madrid, Spain, 28031
Menorca, Spain, 07701
Mollet Del Valles, Spain, 08100
Oviedo, Spain, 33006
Palma de Mallorca, Spain, 07198
Palma de Mallorca, Spain, 07014
San Juan, Spain, 03550
San Sebastian de Los Reyes, Spain, 28702
Torrelavega, Spain, 39300
Valencia, Spain, 46009
Vigo, Spain, 36214
Vigo, Spain, 36204
Villajoyosa, Spain, 03570
Vitoria, Spain, 01009
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00887341     History of Changes
Other Study ID Numbers: ML22254, 2008-006443-39
Study First Received: April 22, 2009
Last Updated: July 19, 2011
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 01, 2014