A Retrospective Observational Study on Compliance in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab) in Clinical Practice (REMISSION II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01649817
First received: July 23, 2012
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This multicenter, retrospective observational study will evaluate compliance an reasons for withdrawal in patients with moderate to severe active rheumatoid art hritis on treatment with intravenous RoActemra/Actemra (tocilizumab) in daily cl inical practice. Data will be collected from each eligible patient over a period of 6 months.


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 II Study)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients on RoActemra/Actemra at 6 months after initiating treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of withdrawal (according to reasons) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Frequency of dose modifications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in disease activity (DAS28) [ Time Frame: from baseline to Month 6 or withdrawal, whichever comes first ] [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: May 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (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

Rheumatoid arthritis patients suitable for treatment with RoActemra/Actemra according to SPC

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised 1987 ACR criteria at baseline
  • RoActemra/Actemra treatment must have been initiated 6 months prior to ICF signing
  • Patient eligible according to the summary of product characteristics (SPC) and routine clinical practice/European recommendations for the use of biologic DMARDs for the treatment of rheumatoid arthritis

Exclusion Criteria:

  • Rheumatic autoimmune disease other than RA
  • Participation in interventional clinical trials during the observational period
  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: NCT01649817

Locations
Greece
Agia Paraskevi, Greece, 15342
Agios Dimitrios, Greece, 17343
Argiroupoli, Greece, 16452
Athens, Greece, 11521
Athens, Greece, 15562
Athens, Greece, 11473
Athens, Greece
Chalandri, Greece
Chania, Greece, 73134
Eleusina, Greece, 19200
Herakleio, Greece, 71307
Ioannina, Greece, 455 00
Kifisia, Greece
Korinthos, Greece, 20100
Peristeri, Greece, 12934
Peuki, Greece, 15121
Rethymno, Greece, 74100
Serres, Greece, 62122
Thessaloniki, Greece
Thessaloniki, Greece, 54624
Thessaloniki, Greece, 54623
Thessaloniki, Greece, 54622
Thessaloniki, Greece, 54621
Volos, Greece, 38221
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: NCT01649817     History of Changes
Other Study ID Numbers: ML28258
Study First Received: July 23, 2012
Last Updated: October 6, 2014
Health Authority: Greece: Ministry of Health and Welfare

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

ClinicalTrials.gov processed this record on October 21, 2014