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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01375478
First received: June 16, 2011
Last updated: July 5, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Rheumatoid Arthritis

Study Type: Observational
Study Design: 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)

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:
  • Percentage of patients who remained under continued RoActemra/Actemra treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reasons for withdrawal [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Frequency of withdrawal [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Frequency of dose modification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reasons for dose modification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: April 2011

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375478

Locations
Greece
Athens, Greece, 16673
Athens, Greece, 14527
Athens, Greece, 15562
Athens, Greece, 11527
Athens, Greece, 11521
Crete, Greece, 71110
Patra, Greece, 26335
Patra, Greece, 26443
Patra, Greece, 26504
Rhodes, Greece, 851 00
Thessaloniki, Greece, 56429
Thessaloniki, Greece, 54642
Thessaloniki, Greece, 54636
Thessaloniki, Greece, 54643
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: NCT01375478     History of Changes
Other Study ID Numbers: ML25580
Study First Received: June 16, 2011
Last Updated: July 5, 2012
Health Authority: Greece: National Organization of Medicines

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 19, 2013