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A Non-Interventional Study in Patients With Rheumatoid Arthritis Who Are Treated With RoActemra/Actemra (Tocilizumab)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01893255
Recruitment Status : Withdrawn
First Posted : July 8, 2013
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Who Are Treated With Tocilizumab
Study Start Date : September 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Cohort



Primary Outcome Measures :
  1. Proportion of patients on RoActemra/Actemra at 6 months after treatment initiation [ Time Frame: Month 6 ]

Secondary Outcome Measures :
  1. Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: approximately 6 months ]
  2. Rates of dose modifications/interruptions [ Time Frame: approximately 6 months ]
  3. Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR [ Time Frame: approximately 6 months ]
  4. Physician's Global Assessment of Disease Activity [ Time Frame: approximately 6 months ]
  5. Safety: Incidence of adverse events [ Time Frame: approximately 6 months ]
  6. Patient reported outcomes (Patient Global Assessment of disease activity, HAQ-DI, VAS-Fatigue, severity of pain and morning stiffness) [ Time Frame: approximately 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra in monotherapy
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
  • Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in accordance with the local label; this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
  • Patients who for any reason do not take methotrexate and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy
  • Patients who were previously on a TNF inhibitor as monotherapy, and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy
  • Concomitant treatment with corticosteroids (orally and intra-articularly) and/or NSAIDs is allowed

Exclusion Criteria:

  • Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
  • Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
  • Patients receiving concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
  • Patients who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893255


Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01893255    
Other Study ID Numbers: ML28443
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases