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Trial record 16 of 2725 for:    Rheumatoid Arthritis

Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02721004
Recruitment Status : Completed
First Posted : March 28, 2016
Last Update Posted : July 4, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid arthritis participants receiving tocilizumab as per the product label.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Tocilizumab

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Study Type : Observational
Actual Enrollment : 592 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Documentation of the Efficacy and Safety of RoActemra in the Treatment of Rheumatoid Arthritis
Study Start Date : March 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Group/Cohort Intervention/treatment
Rheumatoid arthritis participants
Rheumatoid arthritis participants receiving tocilizumab intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study.
Drug: Tocilizumab
Tocilizumab administered as an intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study.
Other Name: RoActemra




Primary Outcome Measures :
  1. Disease Activity Score Based on 28-joints Count (DAS28) [ Time Frame: Month 12 ]
  2. Simplified Disease Activity Index (SDAI) Score [ Time Frame: Month 12 ]
  3. Clinical Disease Activity Index (CDAI) Score [ Time Frame: Month 12 ]
  4. Percentage of Participants Achieving American College of Rheumatology (ACR) Response [ Time Frame: Month 12 ]
  5. Tender Joint Count (TJC) [ Time Frame: Month 12 ]
  6. Swollen Joint Count (SJC) [ Time Frame: Month 12 ]

Secondary Outcome Measures :
  1. Percentage of Participants with any Adverse Event (AE) [ Time Frame: Up to 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with rheumatoid arthritis will be enrolled in this trial.
Criteria

Inclusion Criteria:

- Participants with rheumatoid arthritis receiving tocilizumab as per product label

Exclusion Criteria:

- No specific exclusion criteria were specified for this non-interventional trial


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): NCT02721004


Locations
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Austria
Bludenz, Austria, 6700
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: NCT02721004     History of Changes
Other Study ID Numbers: ML22551
First Posted: March 28, 2016    Key Record Dates
Last Update Posted: July 4, 2016
Last Verified: July 2016

Keywords provided by Hoffmann-La Roche:
Rheumatoid arthritis
RoActemra
Tocilizumab

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