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An Observational Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01375478
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This open-label, retrospective, observational study will evaluate the compliance to RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid arthritis. Six months data will be collected from patients records.

Condition or disease
Rheumatoid Arthritis

Study Type : Observational
Actual Enrollment : 197 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION Study)
Study Start Date : April 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Cohort



Primary Outcome Measures :
  1. Percentage of patients who remained under continued RoActemra/Actemra treatment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Reasons for withdrawal [ Time Frame: 6 months ]
  2. Frequency of withdrawal [ Time Frame: 6 months ]
  3. Frequency of dose modification [ Time Frame: 6 months ]
  4. Reasons for dose modification [ Time Frame: 6 months ]
  5. Safety: Incidence of adverse events [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with rheumatoid arthritis
Criteria

Inclusion Criteria:

  • Adult patients, over 18 years of age
  • Moderate to severe rheumatoid arthritis
  • RoActemra/Actemra treatment must have been initiated 6 months prior to signing the informed consent form

Exclusion Criteria:

  • Patients with rheumatic autoimmune disease other than rheumatoid arthritis
  • Patients who are not willing to sign the informed consent form
  • Patients who participate in interventional trials during the period of this observational study

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): NCT01375478


Locations
Greece
Athens, Greece, 11521
Athens, Greece, 14527
Athens, Greece, 155 62
Crete, Greece, 71110
Patras, Greece, 265 04
Patra, Greece, 26335
Patra, Greece, 26443
Rhodes, Greece, 851 00
Thessaloniki, Greece, 546 42
Thessaloniki, Greece, 54636
Thessaloniki, Greece, 54643
Thessaloniki, Greece, 56429
Voula, Greece, 16673
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01375478     History of Changes
Other Study ID Numbers: ML25580
First Posted: June 17, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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