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: September 22, 2014
Last verified: September 2014
  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:


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
Study Completion Date: April 2012
Primary Completion Date: April 2012 (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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375478

Locations
Greece
Athens, Greece, 11521
Athens, Greece, 14527
Athens, Greece, 15562
Crete, Greece, 71110
Patra, Greece, 26335
Patra, Greece, 26443
Patras, Greece, 265 04
Rhodes, Greece, 851 00
Thessaloniki, Greece, 56429
Thessaloniki, Greece, 54636
Thessaloniki, Greece, 546 42
Thessaloniki, Greece, 54643
Voula, Greece, 16673
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: September 22, 2014
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 October 01, 2014