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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01468077
First received: November 7, 2011
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This multi-center, randomized, parallel-group, active-controlled, open-label stu dy will evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocil izumab) infusion time compared to the normal infusion time. Patients will be ran domized 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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab
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: Multicenter, Randomized, Parallel Group Study to Compare the Incidence of Tocilizumab Related Infusion Reactions in Patients With Moderate to Severe Active RA, When Infusion is Given Over 31 Minutes Compared to 1 Hour

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Incidence of infusion reactions [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients stopping treatment due to adverse or serious adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients stopping treatment due to other events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with increased alanine amino transferase values [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with increased aspartate amino transferase values [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with increased lipid values [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with clinically significant improvement in Disease Activity Score 28 (DAS28) (reduction of at least 1.2 points) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with Disease Activity Score 28 (DAS28) below 3.2 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with Disease Activity Score 28 (DAS28) below 2.6 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with change in American College of Rheumatology (ACR) score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in C-reactive protein [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change in Health Assessment Questionnaire (HAQ) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: November 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tocilizumab
tocilizumab 8 mg/kg infusion of 31 minutes duration every 4 weeks for 6 infusions
Active Comparator: 2 Drug: tocilizumab
tocilizumab 8 mg/kg infusion of 60 minutes duration every 4 weeks for 6 infusions

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01468077

Locations
Denmark
Alborg, Denmark, 9000
Frederiksberg, Denmark, 2000
Hellerup, Denmark, 2900
Holbæk, Denmark, 4300
Odense, Denmark, 5000
Silkeborg, Denmark, 8600
Svendborg, Denmark, 5700
Iceland
Reykjavik, Iceland, 108
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01468077     History of Changes
Other Study ID Numbers: ML27901
Study First Received: November 7, 2011
Last Updated: September 22, 2014
Health Authority: Denmark: Danish Medicines Agency

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 September 30, 2014