A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01326962
First received: March 7, 2011
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This open-label, single arm study will evaluate the safety and efficacy of RoAct emra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoi d arthritis who have an inadequate response to disease-modifying antirheumatic d rugs (DMARDs) or anti-TNF. Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks for a total of 6 infusions. Non

-biologic DMARD therapy may be continued throughout the study. Anticipated time on study treatment is 24 weeks.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNF

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in disease activity score (DAS28) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving remission (DAS28 <2.6) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Time to remission (DAS28 <2.6) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Response according to American College of Rheumatology (ACR) criteria [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: October 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg (max. 800 mg) iv every 4 weeks, 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, >/= 18 years of age
  • Active moderate to severe rheumatoid arthritis of >/= 6 months duration
  • >/=1 non-biologic DMARD and/or anti-TNF therapy at stable dose for >/=8 weeks at any time prior to study treatment
  • Inadequate clinical response to non-biologic DMARD or anti-TNF therapy
  • Oral corticosteroids must be at stable dose for at least 25 out of 28 days prior to first dose of study drug

Exclusion Criteria:

  • Pregnant or lactating women
  • Major surgery (including joint surgery) within 8 weeks prior to screening or major surgery planned within 6 months of enrolment
  • Rheumatic autoimmune disease other than RA
  • Functional class IV (ACR classification)
  • Prior history of or current joint disease other than RA
  • Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
  • Previous treatment with RoActemra/Actemra
  • Known active current or history of recurrent infection
  • History of or currently active primary or secondary immunodeficiency
  • Active tuberculosis requiring treatment within the previous 3 years
  • Positive for HIV
  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: NCT01326962

Locations
Saudi Arabia
Dammam, Saudi Arabia, 31444
Jeddah, Saudi Arabia, 21589
Makkah, Saudi Arabia
Riyadh, Saudi Arabia, 11525
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: NCT01326962     History of Changes
Other Study ID Numbers: ML22726
Study First Received: March 7, 2011
Last Updated: October 6, 2014
Health Authority: Saudi Arabia: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014