An Observational Study to Evaluate RoActemra/Actemra (Tocilizumab) Treatment in a Real-Life Setting

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01664104
First received: August 7, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This observational, multi-center study will evaluate the treatment regimen, trea tment responses and safety of RoActemra/Actemra (tocilizumab) therapy in a routi ne clinical practice in patients with moderate to severe rheumatoid arthritis. D ata will be collected for 6 months.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With Tocilizumab

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Dosage/schedule used in routine clinical practice [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in treatment regimen [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Clinical patient characteristics at the time of treatment initiation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Disease activity according to joint count evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Correlation of C-reactive protein and treatment response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Correlation of body mass index (BMI) with treatment response [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety: incidence of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Correlation of C-reactive protein with disability index/morning stiffness/VAS fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Correlation of body mass index with disability disability index/morning stiffness/VAS fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 152
Study Start Date: June 2012
Study Completion Date: December 2013
Primary Completion Date: December 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

Patients with rheumatoid arthritis treated with RoActemra/Actemra according to routine clinical practice.

Criteria

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of moderate to severe rheumatoid arthritis
  • Patients have started RoActemra/Actemra treatment according to routine clinical practice within 3 months prior to study start
  • Patients have been given oral and written information about the study and have signed the informed consent form

Exclusion Criteria:

  • Patients who have started RoActemra/Actemra treatment more than 3 months prior to site opening
  • Patients who have previously received RoActemra/Actemra in a clinical trial setting or for compassionate use
  • Patients who have been enrolled in an ongoing clinical trial and/or have received treatment with any investigational drug within 4 weeks prior to study start
  • Patients with a history of autoimmune disease or joint inflammatory disease other than rheumatoid arthritis
  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: NCT01664104

Locations
Italy
Coppito, Abruzzo, Italy, 67100
Reggio Calabria, Calabria, Italy, 89133
Benevento, Campania, Italy, 82100
Telese Terme, Campania, Italy, 82037
Bologna, Emilia-Romagna, Italy, 40138
Roma, Lazio, Italy, 00128
Bergamo, Lombardia, Italy, 24127
Castel Goffredo, Lombardia, Italy, 46042
Gavardo, Lombardia, Italy, 25085
Milano, Lombardia, Italy, 20122
Monza, Lombardia, Italy, 20052
Pavia, Lombardia, Italy, 27100
Novara, Piemonte, Italy, 28100
Barletta, Puglia, Italy, 76121
Casarano (LE), Puglia, Italy, 73042
Foggia, Puglia, Italy, 71100
Catania, Sicilia, Italy, 95124
Catania, Sicilia, Italy, 95126
Palermo, Sicilia, Italy, 90146
Firenze, Toscana, Italy, 50139
Pisa, Toscana, Italy, 56100
Cona (Ferrara), Veneto, Italy, 44124
Verona, Veneto, Italy, 37126
Verona, Veneto, Italy, 37134
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: NCT01664104     History of Changes
Other Study ID Numbers: ML28336
Study First Received: August 7, 2012
Last Updated: August 4, 2014
Health Authority: Italy: AIFA - Italian Medicines Agency

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

ClinicalTrials.gov processed this record on September 18, 2014