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An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biologic DMARD and/or Anti-TNF Therapy

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01362062
First received: May 26, 2011
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

This observational study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra in patients with moderate to severe rheumatoid arthritis who have an inadequate response to current non-biologic DMARD and/or anti-TNF therapy. Data will be collected from each patient during RoActemra/Actemra therapy and on follow-up for a total of 12 months.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Observe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti TNF Therapy.

Resource links provided by NLM:

Drug Information available for: Tocilizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of patients achieving Disease Activity Score (DAS 28) reduction of at least 1.2 units [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of patients achieving DAS 28 < 3.2 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of patients achieving remission (DAS 28 < 2.6) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of patients achieving response according to American College of Rheumatology criteria; ACR20/50/70/90 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in biomarkers: C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life: Visual analogue scale (global assessment disease activity/pain) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Rheumatoid arthritis patients with inadequate response to DMARD and/or anti-TNF therapy

Criteria

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Active rheumatoid arthritis with inadequate response to existing therapies (DMARDs and/or anti-TNFs)
  • Considered eligible for RoActemra/Actemra therapy by the treating physician as per routine clinical practice

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • Immunization with live/attenuated vaccine within 4 weeks prior to baseline
  • History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
  • Know active current or history of recurrent infection
  • History of or currently active primary or secondary immunodeficiency or known HIV positive status
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01362062

Contacts
Contact: Reference Study ID Number: ML22835 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
India
Not yet recruiting
Ahmedabad, India, 380009
Recruiting
Chandigarh, India, 160015
Recruiting
Guwahati, India, 781007
Completed
Hubli, India, 580020
Suspended
Mumbai, India, 400007
Recruiting
Mumbai, India, 400086
Recruiting
New Delhi, India, 110060
Recruiting
Noida, India, 201 301
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: NCT01362062     History of Changes
Other Study ID Numbers: ML22835
Study First Received: May 26, 2011
Last Updated: May 23, 2013
Health Authority: India: 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 May 23, 2013